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Anteralign Spinal System with Titan nanoLOCK™ Surface Technology System interbody cages with macro-, micro-, and nano- roughened surface textures are intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disease (DDD, defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device. Additionally, the Anteralign Spinal System with Titan nanoLOCK™ Surface Technology can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Anteralign Spinal System with Titan nanoLOCK™Surface Technology is intended to be used with autograff and/or allogenic bone graft comprised of cancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a combination thereof.

The Anteralign TL Interbody must be used with a posterior supplemental internal spinal fixation cleared for use in the lumbar spine.

Miniplate and bone screw components are provided as an option for the TL interbody for the lumbosacral levels obligue or lateral above the bifurcation (12-L5) of the vascular structures, Indications of spinal instrumentation systems should be understood by the surgeon

The Anteralian Spinal System with Titan nanoLOCK™ Surface Technology TL interbody may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach.

The Arteralian™ LS interbody cage as a stand-alone device or in conjunction with supplemental fixation. The Anteralian LS™ interbody fusion Device may be inserted via minimally invasive or open anterior or oblique approach at one or two contiguous levels from L2 to S1. These approaches include anterior and oblique. When used as a stand-alone device, the Anteralign™ LS cage must be used with 3 screws with devices that have standard lordosis (≤16 degrees). If the physician chooses to use less than 3 screws or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation) must be used. Additionally, cages with lordosis angles greater than 16° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation)

The Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology consists of TL and LS interbody cages, mini plates, and bone screws.

Anteralign™ Spinal System TL and LS interbody cages are additive manufactured titanium cages available in various heights, widths, lengths, and lordotic angles to accommodate patient anatomy. The TL cage is rectangular shaped whereas the LS cage is oval shaped. The interbodies are inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The interbodies have a central cavity that allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

The Anteralign™ Spinal System TL interbody cages are provided sterile and are intended to be used with supplemental fixation cleared for use in lumbar spine (L2-S1).

The TL interbody may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach. Mini plates and screws are provided as options for antimigration of the Anteralign TL interbody. The miniplate is additively manufactured from titanium powder with a machined-wrought titanium bolt. The miniplate may be positioned either laterally or obliquely and oriented in either cephalad or caudal direction on the TL cage. The bone screw, which is manufactured from wrought titanium, is then placed through the miniplate intrinsic screw hole. Miniplates and bone screws are offered in different sizes and are provided sterile. Miniplates are only to be used with the TL interbody.

The Anteralign™ LS interbody cage may be used as a standalone device or in conjunction with supplemental fixation. When used as a standalone device, the Anteralign LS interbody cage is intended to be used with three screws and must have standard lordosis (≤16 degrees). The Anteralign™ LS interbody cage is intended to be used in the lumbar sacral region between L2 and S1 and may be implanted via open or minimally invasive procedures for OLIF 51 or ALIF approaches.

The interbody designs incorporate honeycomb windows and an open void to allow bone growth through the implant. The interbody device is treated with Titan Surface Technology, where Titan nanoLOCK™ Surface Technology (MMN) is designed to improve fixation to the adjacent bone. The Titan nanoLOCK™ Surface Technology provides a microscopicroughened surface with nano-scale features. The Titan nanoLOCK™ Surface Technology is specifically engineered to have nano-textured features at a nanometer (10-9) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. The Titan nanoLOCK™ Surface Technology demonstrates the elements to be considered a Nanotechnology as outlined in the FDA Nanotechnology Guidance.

Stainless steel and titanium implants are not compatible. They must not be used together in a construct.

The provided text is a 510(k) summary for the Medtronic Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology. This document is a premarket notification to the FDA for a medical device and primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than an in-depth study proving the device meets specific performance acceptance criteria for capabilities like AI assistance or diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria, study details (like sample size, number of experts, adjudication methods for ground truth, MRMC studies, standalone AI performance), and training set details for AI-related performance cannot be extracted from this document, as this device is a physical intervertebral body fusion device and not an AI-powered diagnostic or assistive tool.

The document discusses mechanical testing to demonstrate the device's equivalent strength and performance to predicate devices, which is a different type of "performance data" than what would be generated for an AI/software device.

Here's what can be extracted and what cannot:

Information that CANNOT be extracted from this document:

• A table of acceptance criteria and reported device performance related to AI/software.
• Sample sizes used for a test set (in the context of AI/software performance).
• Data provenance for AI/software test sets.
• Number of experts used to establish ground truth for AI/software.
• Qualifications of those experts.
• Adjudication method for AI/software test sets.
• If an MRMC comparative effectiveness study was done for AI/software performance.
• Effect size of how much human readers improve with AI vs. without AI assistance.
• If a standalone (algorithm only without human-in-the-loop performance) study was done for AI/software.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) in the context of AI/software.
• The sample size for the training set (for AI/software).
• How the ground truth for the training set was established (for AI/software).

Information that CAN be inferred or extracted about the device's acceptance/testing (though not AI-related):

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implied): The mechanical strength of the subject device (Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology) must be equivalent to that of the identified predicate devices. This is a comparison for "substantial equivalence" as required for 510(k) clearance.
• Reported Device Performance:
  • "This evaluation has demonstrated that the subject devices have equivalent mechanical strength in comparison to the predicate devices."
  • The testing was performed according to industry standards:
    • ASTM F2052
    • ASTM F2077
    • ASTM F2119
    • ASTM F2182
    • ASTM F2213
    • ASTM F2267
    • Expulsion Testing

2. Sample size used for the test set and the data provenance:

• This document does not specify sample sizes for mechanical testing. It states that "Medtronic completed mechanical testing on the devices." The provenance of "data" is simply the mechanical tests conducted on the physical device. This is not a clinical study involving human patients or retrospective/prospective data collection in the sense of AI/software performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of mechanical testing for a physical implant. The "ground truth" for mechanical testing is established by the specifications defined in the ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This is not a human-reader or diagnostic study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• For mechanical testing, the "ground truth" is typically defined by the test parameters and acceptance limits set by the applicable ASTM standards.

8. The sample size for the training set:

• Not applicable. This is not an AI/software device that undergoes training.

9. How the ground truth for the training set was established:

• Not applicable.

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The UNID™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

The MEDICREA UNiD Spine Analyzer was developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery. This web-based, Software as a Medical Device (SaMD) application aims to simulate a surgical strategy, make measurements on a patient image, and draw patient-specific rods or choose from a pre-selection of standard implants and ordering the patient-specific rods. The UNiD Spine Analyzer allows the user to:

• 1. Measure radiological images using generic tools and "specialty" tools
• 2. Plan and simulate aspects of surgical procedures

The purpose of this submission is to request clearance for the UNiD Spine Analyzer v4.0. The changes introduced are as follows:

• . Addition of the Degenerative Predictive Model, which corresponds to a type of adult spinal fusion degenerative construct, trained with a retrospective longitudinal patient dataset.
• . Update to the existing Adult Predictive Model consisting of three predictive model modules trained with retrospective longitudinal patient datasets, where one was included in Adult Deformity Model 1 (TKA-12) and two included in Adult Deformity Model 2 (PTA-12 and PTA-34).
• Update to the existing Pediatric Predictive Model consisting of two predictive model modules trained with retrospective longitudinal patient datasets (PediaLL and PediaPT),
• Addition of the display of a Predicted Value derived from a static machine-learning based model . when the user views simulated quantitative radiographic parameters of a planned surgery, generated when the Degenerative, Adult or Pediatric Predictive Models are used.
• . The subject device update also includes the addition of implant templates among a preselected database of Medtronic standard implants cleared in in the following 510(k)s: K073291, K083026, K091813, K110543, K113528, K120368, K150135, K152277, K172199, K172328, and K201267.

The provided text describes the UNiD™ Spine Analyzer, a medical image management and processing system, and its submission for FDA 510(k) clearance. Here's information extracted regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative manner for the "Predictive Models" (Degenerative Predictive Model, Adult Predictive Model, Pediatric Predictive Model). Instead, it states that these additions are "similar to the display of reference and normative data, and does not raise new questions of safety and effectiveness when considered with existing methods of managing spinal compensation."

For the software as a whole, the acceptance criteria are described indirectly through the validation activities:

• Comprehension of the Health Care professional with the UNiD Spine Analyzer,
• Appropriate human factors related to the UNiD Spine Analyzer, and
• Ease of use of the UNiD Spine Analyzer. |

2. Sample size used for the test set and the data provenance:

• Predictive Models: The predictive models (Degenerative, Adult, and Pediatric) were "trained with retrospective longitudinal patient datasets." No specific sample size for these datasets or their provenance (country of origin) is provided.
• Software Validation/Verification: The document does not specify a separate "test set" sample size for the software validation activities beyond stating that "the software was tested against the established Software Design Specifications."
• Usability Study: No specific sample size (number of users) is mentioned for the usability study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The document refers to the predictive models being "trained with retrospective longitudinal patient datasets" but does not detail how the ground truth for these training sets or any potential test sets was established, nor does it mention the involvement or qualifications of experts in this process for external validation. The clinical judgment of healthcare professionals is explicitly stated as required for proper software use, but not for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted or reported for this submission. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is identical to the predicate device." The new features (predictive models) are presented as an "additional tool" similar to "display of reference and normative data" and are not claimed to improve human reader performance with a measurable effect size.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document mentions "Addition of the display of a Predicted Value derived from a static machine-learning based model" when the user views simulated quantitative radiographic parameters. This implies a standalone algorithmic prediction output. However, there are no specific performance metrics or a standalone study reported for the algorithm itself (e.g., accuracy of predictions against ground truth without human intervention).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the predictive models, the ground truth for the training data was derived from "retrospective longitudinal patient datasets." The specific nature of this ground truth (e.g., direct surgical measurements, post-operative imaging, clinical outcomes) is not explicitly stated, beyond it being used to train models for "predicted spinal compensation."

8. The sample size for the training set:

The document states that the predictive models were "trained with retrospective longitudinal patient datasets" but does not specify the sample size for these training sets.

9. How the ground truth for the training set was established:

The document states the predictive models were trained using "retrospective longitudinal patient datasets." However, it does not detail the specific methodology for how the ground truth within these datasets was established (e.g., whether it was based on expert review of images, surgical records, or patient outcomes).

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The ANATOMIC PEEK Cervical Fusion System is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK Cervical Fusion System is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open anterior approach.

The ANATOMIC PEEK PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at atone disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patent history and radiographic studies. The ANATOMIC PEEK PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The ANATOMIC PEEK PTC Cervical Fusion System is to be used with supplemental fication. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.

The CAPSTONE® Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CAPSTONE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE® Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach.

The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at 1 or 2 contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the Capstone Control™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the Capstone Control™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had 6 months of nonoperative treatment. The Capstone Control™ Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach. The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the 18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level.

The CAPSTONE CONTROL PTC™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE CONTROL PTC™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CAPSTONE CONTROL PTC™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE CONTROL PTC™ Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.

The CAPSTONE PTC™ Spinal System is indicated for interbody fusion in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.

The CLYDESDALE® Spinal System is designed to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The CLYDESDALE® Spinal System is intended to be used in interbody fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Certain sizes of the CLYDESDALE® Spinal System may be used with INFUSE® Bone Graft in single-level Oblique Lateral Interbody Fusion (OLIF) procedures from L2 to L5 in patients diagnosed with DDD, as defined above. Consult the labeling for the INFUSE® Bone Graft/Medtronic Interbody Fusion Device for information on the specific sizes of the CLYDESDALE® Spinal System approved for use with INFUSE® Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSE® Bone Graft. INFUSE® Bone Graft is not indicated for use in a direct lateral interbody fusion (DLIF) surgical approach. Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. INFUSE® Bone Graft is not indicated for use in patients with this condition. These patients should be skeletally mature and have had six months of nonoperative treatment. The CLYDESDALE® Spinal System is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach.

The CLYDESDALE PTC™ Spinal System is designed to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTC™Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants maybe implanted via a minimally invasive lateral approach.

The CORNERSTONE® PSR device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach.

The CRESCENT™ Spinal System is indicated for interbody fusion in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The CRESCENT™ Spinal System Titanium is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with Medtronic supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 (except as defined for use with INFUSETM Bone Graft above). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non- operative treatment. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody device is intended to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior oblique above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) DDD defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions. Certain sizes of the Certain sizes of the DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody device may also be used with INFUSETM Bone Graft for patients diagnosed with DDD, as defined above. The device may be implanted at a single level using an Anterior Lumbar Interbody Fusion (ALIF) approach from L2-S1. The device may also be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody device is intended for use with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine when used to treat DDD. Consult the labeling for the INFUSETM Bone Graft/Medtronic Interbody Fusion Device for additional information on the specific sizes of the DIVERGENCE-LT™ Anterior/Oblique Lumbar Fusion System Interbody device approved for use with INFUSET™ Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSET™ Bone Graft. DIVERGENCE-L Anterior/Oblique Lumbar Fusion System interbody device may also be used with INFUSET™ Bone Graft.

The DIVERGENCET™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCETM stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCET™ stand-alone cervical interbody device is also required to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of nonoperative treatment. Patients with previous non- fusion spinal surgery at involved level may be treated with the device."

The ELEVATE™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. These implants are to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine. Certain sizes of the PEEK PERIMETER® Interbody Fusion Device may also be used with INFUSE® Bone Graft for patients diagnosed with DDD, as defined above. The device may be implanted at a single level using an Anterior Lumbar Interbody Fusion (ALIF) approach from L2-S1. The device may also be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L5 to S1. The PEEK PERIMETER® Interbody Fusion Device should be used with supplemental fixation systems cleared for use in the lumbar spine. Consult the labeling for the INFUSE® Bone Graft/Medtronic Interbody Fusion Device for additional information on the specific sizes of the PEEK PERIMETER Interbody Fusion Device approved for use with INFUSE® Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSE® Bone Graft.

The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the PIVOX™ Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non- operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach. Certain sizes of the PIVOX™ Oblique Lateral Spinal System Interbody Cage may also be used with INFUSE™ Bone Graft for patients diagnosed with DDD, as defined above, who are skeletally mature and have had six months of non- operative treatment. The device may be implanted at a single level using an Oblique Lateral Interbody Fusion (OLIF) approach from L2- L5 and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Consult the labeling for the INFUSE™ Bone Graft/ Medtronic Interbody Fusion Device for information on the specific sizes of the PIVOX™ Oblique Lateral Spinal System Interbody Cage approved for use with INFUSE™ Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSE™ Bone Graft. INFUSE™ Bone Graft is not indicated for use in a direct lateral interbody fusion (DLIF) surgical approach. Additionally, the PIVOX™ Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach. INFUSE™ Bone Graft is not indicated for use in patients with this condition. The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) DDD defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions. When used together, the PIVOX™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or two contiguous levels from L2 to S1 (except as defined for use with INFUSE™ Bone Graft above). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.

The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft and/or allograft bone graft comprised on cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the SOVEREIGN™ Spinal System is indicated for use in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions as an adjunct to fusion. These patients should be skeletally mature and have had 6 months of non- operative treatment. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. The SOVEREIGN™ interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with 3 titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 18° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).

The T2 Stratosphere™ Expandable Corpectomy System is a vertebral body replacement device intended for use in the thoracic and lumbar spine (T1-L5) and cervical spine (C2-C7). The T2 Stratosphere™ Expandable Corpectomy System is intended for use in skeletally mature patients. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collapsed, damaged, or unstable vertebral body caused by tumor, trauma (i.e. fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System may not be used with optional modular end caps. When used in the cervical spine at single or two levels, the T2 Stratosphere™ Expandable Corpectomy System is intended to be used with supplemental fixation for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation cleared for use in the cervical spine. When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is used to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The T2 Stratosphere™ Expandable Corpectomy centerpiece may be used with or without optional modular end caps which accommodate individual anatomic requirements. The device is to be used with supplemental fixation cleared for use in the thoracic and lumbar spine. When used in the cervical spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. When used in the thoracic and lumbar spine, the T2 Stratosphere™ Expandable Corpectomy System is intended for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion. The T2 Stratosphere™ Expandable Corpectomy System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical and/or thoracolumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate used at the surgeon's discretion.

The ANATOMIC PEEK Cervical Fusion System consists of cages of various widths and heights which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The ANATOMIC PEEK devices must be used with supplemental fixation.

The ANATOMIC PEEK™ PTC Cervical Fusion System consists of cages of various widths and heights which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The ANATOMIC PEEK™ PTC devices must be used with supplemental fixation.

The CAPSTONE™ Spinal System consists of PEEK cages, titanium alloy cages, and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

The CAPSTONE CONTROL™ Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. See the MDT Catalog or price list for further information about warranties and limitations of liability.

The CAPSTONE CONTROL PTC™ Spinal System consists of commercially pure titanium (CP Ti) coated PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

The CAPSTONE PTCTM Spinal System consists of commercially pure titanium (CP Ti) coated PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, or INFUSE® Bone Graft as designated below.

The CLYDESDALE PTCTM Spinal System consists of commercially pure titanium (CP Ti) coated PEEK cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

The CORNERSTONE® PSR Cervical Fusion System consists of cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in cervical fusion procedures. The CORNERSTONE® PSR device is to be used with supplemental instrumentation and is to be implanted via an open, anterior approach. See the MDT Catalog or price list for further information about warranties and limitations of liability.

The CRESCENT® Spinal System consists of PEEK cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. See the MDT Catalog or price list for further information about warranties and limitations of liability.

The CRESCENT® Spinal System Titanium consists of implant grade titanium alloy (Ti-6Al-4V) cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The implants may be implanted via a transforaminal or lateral approach and the procedure may be open or minimally invasive.

The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System consists of plates, bone screws, and interbody cages. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System plates and bone screws are available in a broad range of size offerings intended for anterior screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior or oblique approach. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System plate and bone screws are made from titanium alloy and are provided sterile. Additionally, the DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody cages may be used as supplemental fixation when used in conjunction with posterior fixation devices to treat deformity conditions in the thoracic and lumbar spine. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or INFUSETM Bone Graft (as designated below). The cages are manufactured from medical grade polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.

The DIVERGENCET™ Anterior Cervical Fusion System is an intervertebral body fusion device with internal screw fixation. The system is comprised of an interbody cage and bone screws. These implants are for single use only. The DIVERGENCET™ anterior cervical cages are provided in 0 and 6 degrees of lordosis, 5-12mm heights, 15-20mm widths and 12- 16mm depths. This device is intended to be radiolucent, and the interior space of the product is to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The DIVERGENCET™ stand-alone cervical interbody device is manufactured from medical grade polyetheretherketone (PEEK) and contains radiopaque markers made from medical grade titanium alloy. The PEEK interbody cage also comes preassembled with a titanium alloy, built- in rotary locking mechanism. The bone screws used with this device are provided in self-drilling and self-tapping options and are manufactured from medical grade titanium alloy. The bone screws are provided in 3.5mm and 4.0mm diameters and 9-17mm lengths. The PEEK material used conforms to ASTM F2026 and the titanium alloy material used conformsto ASTM F136. To achieve best results, do not use any of the DIVERGENCETM™ Anterior Cervical Fusion System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the DIVERGENCETM Anterior Cervical Fusion System components should ever be reused under any circumstances.

The ELEVATET™ Spinal System is an expandable PEEK, Tantalum, and Titanium alloy interbody device consisting of various lengths and starting heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The ELEVATET™ Spinal System expands for adjustable lordosis and height to match patient anatomy. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The implants may be implanted via a posterior or transforaminal approach and the procedure may be open or minimally invasive. The ELEVATET™ Spinal System can be implanted unilaterally and bilaterally. The ELEVATET™ Spinal System is intended to be inserted with ELEVATET™ Spinal System reusable instruments. ELEVATETM Spinal System implants are for single use only.

The PERIMETER® Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation. The device is offered in Titanium Alloy (Titanium- 6Aluminum-4Vanadium ELI) or PEEK (Polyetheretherketone). This interbody device is offered in sterile or non-sterile forms. Refer to the package label for specific implant sterility information. The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm to 28mm in length, and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Allov (Titanium-6Aluminum- 4Vanadium ELI) devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4 Vanadium ELI) version of this device offers lateral windows for visibility of the autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. Medical grade titanium, titanium alloy, and/or medical grade cobalt- chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy with stainless steel in the same construct. PEEK implants may be used with stainless steel, titanium, or cobalt-chromium-molybdenum alloy implants. See the MDT Catalog or price list for further information about warranties and limitations of liability.

The PERIMETER® Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with either autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or INFUSE® Bone Graft as designated below. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation. The device is offered in Titanium Alloy (Titanium-6Aluminum- 4Vanadium ELI) or PEEK (Polyetheretherketone). However, only the PEEK device is approved for use with INFUSE® Bone Graft. Consult the labeling for the INFUSE® Bone Graft/Medtronic Interbody Fusion Device for approved PEEK PERIMETER® implant sizes. This interbody device is offered in sterile or non- sterile forms. Refer to the package label for specific implant sterility information. The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK and Titanium Alloy (Titanium-6Aluminum- 4Vanadium ELI) devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy (Titanium-6Aluminum-4 Vanadium ELI) version of this device offers lateral windows for visibility of the autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.

The PIVOX™ Oblique Lateral Spinal System consists of interbody cages, plates, and bone screws. The PIVOX™ Oblique Lateral Spinal System interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate, or INFUSE™ Bone Graft (as designated below) and must be used with supplemental fixation. The cages are manufactured frommedical grade polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile. The PIVOX™ Oblique Lateral Spinal System plates and bone screws are available in a broad range of sizes intended for anterior column screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior, lateral, or oblique approach. The PIVOX™ Oblique Lateral Spinal System plate and bone screws are made from titanium alloy and are provided sterile.

The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is lens-shaped with 3 holes for placement of titanium screws using an anterior or oblique approach. The SOVEREIGN™ Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the polyetheretherketone (PEEK) interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted. The SOVEREIGN™ Spinal System interbody device is manufactured from PEEK (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.

The T2 Stratosphere™ Expandable Corpectomy System is an adjustable vertebral body replacement device and features a self- adjusting end cap which provides continuous angulation between 0-8° in any direction to accommodate the patient's anatomical requirements. T2 Stratosphere™ Expandable Corpectomy System devices for use in the thoracolumbar and cervical spine are restricted to the 13mm diameter centerpieces. The T2 Stratosphere™ Expandable Corpectomy System is made of titanium alloy and is provided sterile and non-sterile. This device is inserted between two vertebral bodies in the thoracolumbar or cervical spine and is expanded to aid in the surgical correction and stabilization of the spine. The centerpieces are available in multiple heights. The system also features modular end caps which are available in various angles and diameters and are only for use in the thoracolumbar spine. The device is not intended to be used as a stand-alone implant.

This document describes Medtronic Sofamor Danek's intervertebral body fusion spinal systems and a Special 510(k) submission to update the indications for use. The core of this request is to support the use of demineralized allograft bone with bone marrow aspirate in these devices.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for a "test set" in the context of device performance testing. It states: "The subject application provides published clinical outcomes to support the use of demineralized allograft bone with bone marrow aspirate." This implies a review of existing literature rather than a new, dedicated clinical study conducted by Medtronic for this 510(k) submission.

• Sample Size (Test Set): Not explicitly stated as a separate "test set" was not created for this submission. The support comes from "published clinical outcomes."
• Data Provenance: The data provenance is described as "published clinical outcomes." No specific country of origin or whether the data was retrospective or prospective is mentioned in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. As noted above, there was no separate "test set" created by Medtronic for this submission. The clinical evidence relies on published literature regarding the use of demineralized allograft bone with bone marrow aspirate. The expertise for establishing the ground truth would therefore reside within the authors and peer-review process of those published studies.

4. Adjudication Method for the Test Set

Not applicable, as there was no new, specific test set created by Medtronic for this 510(k) where expert adjudication would be required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No performance testing was required or performed, as this modification for this Special 510(k) relates only to the indications for use." The change is based on a review of published clinical outcomes for the bone graft material, not a comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a medical implant (intervertebral body fusion system) and not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant to this submission.

7. Type of Ground Truth Used

The ground truth for concluding the safety and effectiveness of the expanded indication (use of demineralized allograft bone with bone marrow aspirate) is based on published clinical outcomes. This implies that peer-reviewed literature and clinical evidence from human patients using this type of bone graft material formed the basis for the regulatory decision.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The submission focuses on an expanded indication for an existing, cleared medical device based on clinical evidence for a specific bone graft material.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/ML device that requires a training set.

Ask a specific question about this device

The II-Type Intervertebral Spacer is intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment prior to treatment with an intervertebral cage. The II-Type Intervertebral Spacer is to be implanted via a direct posterior approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

II-Type Intervertebral Spacer consists of PEEK cages of various widths and heights, which include Ta markers, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft.

The provided text is for a medical device called an "II-Type Intervertebral Spacer," which is a physical implant used in spinal fusion surgery. This type of device does not typically involve AI, thus the questions regarding AI performance, human-in-the-loop, and training sets are not applicable.

Here's an analysis of the provided information concerning acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance:

The document describes non-clinical performance testing for the "II-Type Intervertebral Spacer" to demonstrate its substantial equivalence to predicate devices. The acceptance criteria are implicitly defined by the chosen ASTM standards, and the reported performance indicates that the device met these standards.

2. Sample size used for the test set and the data provenance:

• Sample size: The document states that testing was performed "using samples each of a worst case construct." It does not specify the exact number of samples for each test (e.g., 5 samples for axial compression, 3 for torsion, etc.), but it refers to "samples" in plural.
• Data provenance: The data is based on non-clinical (in vitro/mechanical) testing performed by Paonan Biotech Co., Ltd. The country of origin for the testing itself isn't explicitly stated, but the company is located in Taiwan, R.O.C. This is a prospective test specifically conducted for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the device is a physical intervertebral spacer being evaluated through mechanical and materials testing against engineering standards, not through clinical trials or expert assessment of diagnostic images that would require "ground truth" established by human experts.

4. Adjudication method for the test set:

This question is not applicable for the same reasons as #3. Mechanical testing results are objective measurements against specified standard limits, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. The device is a physical implant for spinal fusion and does not involve AI or diagnostic imaging interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This question is not applicable. There is no algorithm associated with this device.

7. The type of ground truth used:

The "ground truth" for this device's acceptance is based on:

• Engineering standards: Specifically, compliance with ASTM F2077-11 and ASTM F2267-04. These standards define the parameters and acceptable limits for mechanical performance.
• Material properties: The inherent biocompatibility and mechanical properties (e.g., modulus) of PEEK.
• Comparative data: Performance relative to "legally marketed lumbar interbody fusion" predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set:

This question is not applicable as there is no AI algorithm involved that would require a training set.

9. How the ground truth for the training set was established:

This question is not applicable as there is no AI algorithm involved.

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The X-spine Calix Lumbar Spinal Implant System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autogenous bone graft and implanted via an anterior, posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.

This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).

The X-spine Calix Lumbar Spinal Implant System is a generally box or oval shaped device manufactured from Invibio PEEK-Optima LT1 per ASTM F2026 with an array of holes located throughout its geometry as well as teeth on the superior and inferior surfaces. The device is supplied in several widths and heights to accommodate variations in patient anatomy. The devices contain radiographic markers made from tantalum per ASTM F560.

The hollow center of the implant allows the device to be packed with bone graft.

The provided text describes a 510(k) summary for the Calix™ Lumbar Spinal Implant System. This document focuses on the administrative and technical details of a medical device submission, specifically detailing its equivalence to previously marketed products and the performance testing conducted.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes a series of standardized tests performed to demonstrate the device's biomechanical equivalence to predicate devices. The "reported device performance" is implied by the successful completion of these tests, signifying that the device performs "at least as safely and effectively as the cited predicate devices."

Note: The document states "biomechanical testing results indicate that the Calix Lumbar Spinal Implant System is substantially equivalent to predicate device performance and is as effective, and performs at least as safely and effectively as the cited predicate devices." This is the general statement of performance, rather than specific quantitative results against discrete acceptance values.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide a "test set" in the context you would typically find for an AI/software device (e.g., a set of medical images for diagnostic accuracy assessment). Instead, the "performance data" refers to biomechanical testing of the device itself.

• Sample Size for Test Set: Not specified in terms of number of devices or specific load cycles, but refers to "full device constructs" undergoing standardized tests. For biomechanical testing, sample size would typically refer to the number of physical devices tested under various conditions.
• Data Provenance: The tests are standard ASTM (American Society for Testing and Materials) and FDA guidance-driven tests, which implies an engineering/laboratory setting rather than clinical data from a specific country or retrospective/prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable to the provided document. The "ground truth" here is established by the specifications and pass/fail criteria of the ASTM and FDA-recommended biomechanical tests themselves, not by human expert assessment of device performance in a clinical or diagnostic setting.

4. Adjudication Method for the Test Set

This question is not applicable to the provided document as it does not involve expert review or consensus for establishing ground truth. The 'adjudication' in biomechanical testing is typically determined by whether the physical device meets the mechanical performance requirements defined by the test standard.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes biomechanical testing of a spinal implant, not a diagnostic or AI-powered medical imaging device that would involve human readers. Therefore, an MRMC study is not relevant to this content.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This question is relevant for AI/software devices. The provided document concerns a physical spinal implant and its mechanical performance testing.

7. The Type of Ground Truth Used

The "ground truth" for the performance data in this context is the established physical and mechanical properties of the predicate devices and the requirements set forth in the ASTM standards (F2077, F2267) and FDA guidance for intervertebral body fusion devices. The device's performance is compared against these engineering standards and the known performance characteristics of already cleared devices to establish "substantial equivalence."

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical implant, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for a physical implant.

In summary: The provided 510(k) summary for the Calix Lumbar Spinal Implant System focuses on demonstrating substantial equivalence to predicate devices through biomechanical performance testing. It does not contain information related to AI/software device performance, clinical studies with human readers, or image-based diagnostic accuracy. The "acceptance criteria" are implied by the successful completion of standardized engineering tests, and the "ground truth" is based on these objective engineering standards and predicate device performance.

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When used as an intervertebral body fusion device, the InterForm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The InterForm PLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm PLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior approach and used with supplemental fixation and autogenous bone graft.

The InterForm TLIF Interbody Fusion Implants consists of cage footprints widths of 9, 11, 13mm , lengths of 22, 24, 26, 28, 30, 32mm, ranging in height from 7mm to 14mm with lordosis of 5°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm TLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm OTLIF Interbody Fusion Implants consists of cage footprint widths of 9, 11, 13mm , lengths of 20, 22, 24, 26, 30, 32, 34mm, ranging in height from 7mm to 14mm with lordosis of 0°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm OTLIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, posterior or transforaminal approach and used with supplemental fixation and autogenous bone graft.

The InterForm LLIF Interbody Fusion Implants consists of cage footprint widths of 18, 20, 22, 24mm, lengths of 40, 45, 50, 55, 60mm, ranging in height from 8mm to 18mm with lordosis of 0° or 7°, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm LLIF Interbody Fusion devices are intended to be implant via a lateral approach and used with supplemental fixation and autogenous bone graft.

The InterForm ALIF Interbody Fusion Implants consists of cage footprints of 30x24mm, and 39x30mm (DxW), ranging in height from 10mm to 20mm with lordosis of 0°, 7° or 12° which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The InterForm ALIF Interbody Fusion devices are intended to be implant via an open or minimally invasive, anterior approach and used with supplemental fixation and autogenous bone graft.

All implants are packaged non-sterile to be sterilized at the hospital.

Materials:

PEEK Optima LT1 conforming to ASTM F2026. Unalloyed tantalum conforming to ASTM F560.

Function:

Maintain adequate disc space until fusion occurs.

The InterForm Interbody Cage System is intended for spinal fusion procedures.
Here's a breakdown of the acceptance criteria and the study done:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The documentation explicitly states that the device is considered "substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances." The acceptance criteria, while not explicitly numerical, are therefore met by demonstrating performance comparable to the already legally marketed predicate devices. The study concludes that the results indicate the InterForm Interbody Cage System is equivalent.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The studies listed are non-clinical tests (mechanical testing), not studies involving human or animal subjects that would generate a "test set" of data in the typical sense of evaluating AI or clinical outcomes. The provenance of the samples (e.g., specific batches of PEEK and tantalum used in testing) is not detailed, nor is it relevant given the mechanical nature of the tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies are non-clinical mechanical tests, not clinical evaluations requiring expert interpretation or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical mechanical tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This device is a physical medical implant, not an AI or imaging device that would typically involve human reader studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a physical medical implant and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established mechanical properties and performance standards outlined in the ASTM F2077 and ASTM F2267 standards, and the performance characteristics of the predicate devices. For mechanical tests, the ground truth is objectively measured physical properties and behaviors of the material and device under specific conditions.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical implant and would not have a "training set" in the context of machine learning or AI. For mechanical testing, the "samples" would be the manufactured devices or materials subjected to the tests. The exact number of units tested for each non-clinical test (static compression, dynamic compression, subsidence, expulsion) is not specified, but it would typically be a statistically significant number of physical samples to ensure reliability and reproducibility of the results according to the ASTM standards.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as #8. The "ground truth" for material and device properties in mechanical testing is established through standardized testing procedures and validated measurement techniques, as defined by organizations like ASTM.

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The PLIF Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

PLIF Cage is a hollow, generally rectangular box made The of polyetheretherketone (PEEK) and having titanium x-ray markers. It is provided in a variety of shapes and sizes, and is intended to be filled with a bone graft material. The smallest footprint of the device is 8mm medial-lateral x 20mm anterior-posterior. The largest footprint is 12mm medial-lateral x 30mm anteriorposterior. Available heights range from 7mm to 16mm. The device is available either in a non-lordosed configuration, or with a built-in six degree lordotic angle.

The PLIF cage may be inserted via an open or minimally invasive approach. It may be placed singly or in pairs.

Bone graft volume of the device is variable depending on the device size; larger sizes have more volume for graft. The smallest graft volume, in the 20x8x7mm non-fordotic device is approximately 354.1mm² (0.4cc), while the largest in the 30x12x16 lordotic device is approximately 3,530mm3 (3.5cc).

The surface area of the device contacting the endplates ranges from 118mm² to 220mm2 for the smallest and largest footprint devices, respectively.

The PLIF cage may be made either from Zeniva PEEK (Solvav Advanced Polymers, Alpharetta, GA USA) or PEEK Optima (Invibio, Inc., West Conshohocken, PA USA). The particular grade of PEEK used is tracked via product lot numbering and is displayed on the package label.

The provided text does not describe acceptance criteria for a diagnostic device or a study validating its performance in the context of medical imaging or AI. Instead, it details the 510(k) summary for a medical device called "PLIF Cage," which is an intervertebral fusion device, and the FDA's decision regarding its substantial equivalence to predicate devices.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document focuses on the mechanical testing and material equivalence of a physical implant (PLIF Cage) rather than the performance metrics of a diagnostic tool or an AI algorithm.

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The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

The CLYDESDALE® Spinal System is intended to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The CLYDESDALE® Spinal System consists of PEEK™ OPTIMA™ LT-1 cages of various widths and heights, which include tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

Here is an analysis of the provided text regarding the CLYDESDALE® Spinal System:

The provided document is a 510(k) summary for the CLYDESDALE® Spinal System, specifically for a Special 510(k) submission seeking clearance for "additional size options" to an already cleared device. This type of submission typically relies heavily on equivalence to a predicate device and engineering rationales, rather than new, extensive clinical trials. Therefore, much of the information requested in your prompt (e.g., sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance) is not applicable or not provided in this type of regulatory submission for a physical medical device like a spinal implant. These kinds of details are more common for AI/ML-based diagnostic or imaging devices.

Based on the provided text, here's what can be extracted and inferred:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

• Resist loads during interbody fusion.
• Maintain stability and support vertebral bodies.
• Demonstrate acceptable subsidence characteristics. | Substantially Equivalent to Predicate Devices:
• Engineering Theoretical Analysis based on predicate testing in accordance with ASTM F2077-03 ("Test Methods for Intervertebral Body Fusion Devices") and ASTM F2267-04 ("Standard Test Method for Measuring Load Induced Subsidence for the Intervertebral Body Fusion Device under Static Axial Compression").
• Data provided demonstrated substantial equivalence to predicate devices (CLYDESDALE® Spinal System K100175, PERIMETER™ Spinal System K090353, CAPSTONE® Spinal System K073291). |
  | Material Biocompatibility:
• PEEK™ OPTIMA™ LT-1 material is safe and compatible for implantation. | Same Material as Predicate:
• The fundamental technology and material (PEEK™ OPTIMA™ LT-1) are the same as the current CLYDESDALE® Spinal System (K100175). Biocompatibility would have been established for the original clearance. |
  | Design Integrity:
• New sizes do not compromise the device's fundamental design or function. | Minor Dimensional Changes:
• The design is fundamentally the same as the current CLYDESDALE® Spinal System, with only minor dimensional changes for additional size options. |
  | Indications for Use:
• Suitable for DDD patients at L2-S1 with specified conditions (spondylolisthesis, non-operative treatment, skeletally mature). | Same Indications for Use as Predicate:
• The indications for use are identical to the predicate device, further supporting equivalence. |

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a non-clinical testing program involving "Engineering Theoretical Analysis" based on predicate device testing. This involved testing performed in accordance with established ASTM (American Society for Testing and Materials) standards:

• ASTM F2077-03: "Test Methods for Intervertebral Body Fusion Devices"
• ASTM F2267-04: "Standard Test Method for Measuring Load Induced Subsidence for the Intervertebral Body Fusion Device under Static Axial Compression"

The "data to support these rationales were provided to demonstrate that the subject devices are substantially equivalent to the predicate devices." This means that the new sizes were shown to perform mechanically comparably to already cleared devices under standardized test conditions, and the material and fundamental design remained unchanged.

Additional Information Breakdown:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable in the context of this 510(k) for a physical implant. The documentation refers to engineering testing based on ASTM standards, not a patient-based test set. The "samples" would be a certain number of manufactured devices tested according to the ASTM protocols. The specific number of devices tested is not detailed in this summary.
• Data Provenance: Not applicable for patient data. The engineering tests would have been performed in a lab setting, likely in the US (given the company's US address and FDA submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. "Ground truth" in this context would refer to the established mechanical properties and performance standards defined by the ASTM committees that developed the test methods, as well as the mechanical testing engineers who conducted the tests and interpreted the results. There were no human experts establishing ground truth for a diagnostic outcome in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There was no clinical test set requiring human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI/ML-based diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI/ML-based diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is based on engineering standards and established mechanical properties as defined by ASTM test methodologies. The "truth" is whether the device can withstand specified loads, exhibits acceptable subsidence, and matches the performance established for its predicate devices through these objective engineering tests.

8. The sample size for the training set

• Not applicable. This is not an AI/ML-based system. Any "training" would refer to the iterative design and testing processes that led to the predicate device and the subsequent verification of the new sizes.

9. How the ground truth for the training set was established

• Not applicable. See #8.

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The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and are intended for bilateral placement in the lumbar spine. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.

The subject TELAMON® PEEK Spinal System consists of vertebral body spacers which can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implant allows them to be packed with autogenous bone graft material. The TELAMON® PEEK Spinal System also includes instrumentation that enables the surgeon to implant the devices via an open or a minimally invasive posterior approach. The device sizes are available in various height and lordotic angle options. The implant devices are manufactured from medical grade polyetheretherketone (PEEK - OPTIMA® LT1) per ASTM F2026 and also contain tantalum markers per ASTM F-560 so that the position of the implant can be determined on X-ray or other imaging.

Here's an analysis of the provided 510(k) summary for the TELAMON® PEEK Spinal System, focusing on acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device (TELAMON® PEEK Spinal System). It does not contain information about an AI/ML powered device or a clinical study in the typical sense of evaluating diagnostic accuracy or clinical outcomes through human-in-the-loop or standalone AI performance.

Instead, this 510(k) is for an interbody fusion device, which is a physical implant. The "performance data" and "acceptance criteria" discussed relate to the mechanical properties and safety of the implant, demonstrating its equivalence to existing predicate devices.

Therefore, many of the requested fields pertinent to AI/ML device evaluations (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

I will provide the information that is available in the document regarding its performance criteria and the study that proves it meets them.

Acceptance Criteria and Device Performance for TELAMON® PEEK Spinal System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for individual tests. The studies were "pre-clinical studies conducted using worst case TELAMON® devices." This implies a limited number of devices were tested to represent the product line.
• Data Provenance: The studies are pre-clinical (laboratory-based mechanical testing), not human or patient data. Therefore, country of origin or retrospective/prospective distinctions are not applicable in the typical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. The "ground truth" here is the pass/fail criteria of standardized ASTM mechanical tests, not a clinical diagnosis or interpretation requiring expert consensus. The "experts" would be the engineers and technicians conducting the tests and performing the analysis according to the ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. This refers to clinical study data adjudication. The mechanical tests follow specific ASTM protocols. Adherence to these protocols is self-contained within the test methodology.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is a physical implant, not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used:

• For mechanical performance: The ground truth implicitly refers to the specified performance requirements and acceptance limits defined by the ASTM standards (F2077-03 and F2267-04) for interbody fusion devices, as well as comparison to the performance of legally marketed predicate devices. The "ground truth" is that the device must meet or exceed the performance of the predicate devices under these standardized tests.

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of an AI/ML model for this physical medical device.

9. How the ground truth for the training set was established:

• Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant to this device submission.

Summary of the Study Proving Acceptance Criteria:

The "study" that proves the TELAMON® PEEK Spinal System meets its acceptance criteria consists of pre-clinical mechanical and material testing. Specifically, the submission states:

• "The following pre-clinical studies were conducted using worst case TELAMON® devices: static and dynamic compression; and static and dynamic compression shear per ASTM F2077-03; and subsidence per ASTM F2267-04."

The results of these tests, when compared to legally marketed predicate devices, demonstrated that the TELAMON® PEEK Spinal System was "substantially equivalent." This substantial equivalence, based on similar design, materials, intended use, and comparable mechanical test results, formed the basis for its 510(k) clearance by the FDA. The acceptance criterion was primarily meeting comparable performance to already-cleared predicate devices under standardized engineering tests, thereby demonstrating similar safety and effectiveness.

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When used as a cervical intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least of non-operative treatment. The Lanx Cervical Intervertebral Body Fusion is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Anterior Cervical Plate System.

When used as a lumbar intervertebral body fusion device, the Lanx Intervertebral Body/VBR Fusion System ("Lanx Fusion System") is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of nonoperative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved The Lanx Fusion System is to be implanted via an anterior or posterior approach and is to be level(s). combined with supplemental fixation. Approved supplemental fixation systems include the Lanx Spinal Fixation System.

When used as vertebral body replacement, the Lanx Intervertebral Body/VBR Fusion ("Lanx Fusion System") is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumalfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from TI to LS) The Lanx Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e., T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Lanx Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Lanx Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system

All devices in the Lanx Fusion System are made of PEEK (OPTIMA®) per ASTM F2026 and Titanium alloy (Ti-6Al-4V) per ASTM F136. The Fusion System has a hollowed out area to accommodate autogenous bone graft, and transverse grooves to improve fixation and stability. It is available in a variety of different sizes to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The Lanx Fusion System is provided non-sterile.

The Lanx Fusion System, a medical device for spinal fusion and vertebral body replacement, obtained 510(k) clearance (K083815) based on mechanical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document refers to mechanical performance testing per ASTM F2077 and ASTM F2267. These are standard test methods for evaluating medical devices. The document does not specify the exact sample size (number of devices tested) for these mechanical tests, nor does it provide information about data provenance (e.g., country of origin, retrospective/prospective) for clinical or patient data, as this device's clearance was based on demonstrating substantial equivalence through engineering and mechanical testing, not new clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device's clearance was based on mechanical testing and comparison to predicate devices, not on expert-adjudicated ground truth derived from clinical cases or images.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on mechanical equivalence to predicate devices, not on comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance was:

• Engineering Standards: Compliance with established ASTM standards (F2077, F2267 for mechanical properties; F2026, F136 for materials).
• Predicate Device Performance: The mechanical characteristics of the new device were compared and found "comparable" to existing cleared predicate devices.

8. The Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The development process would involve iterative design and testing, but not in the sense of a data "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

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