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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.

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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.

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