Search Results

CAPSTONE™ SPINAL SYSTEM
The CAPSTONE™ Spinal System is indicated for interbody fusion with autogenous bone graft 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 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 graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

CLYDESDALE PTC™ SPINAL SYSTEM
The CLYDESDALE PTC™ 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 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 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.

CRESCENT™ SPINAL SYSTEM
The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft 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 of nonoperative treatment. These implants are to be used autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

CRESCENT™ SPINAL SYSTEM TITANIUM
The CRESCENT Spinal System Titanium is indicated for interbody fusion 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 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. These devices are intended to be used with Medronic supplemental fixation which has been cleared by the FDA for use in the lumbar spine.

DIVERGENCE-L™ ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The DIVERGENCE-L™ 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. 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-L™ 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 DIVERGENCEL™ Anterior/ Oblique Lumbar Fusion System interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cage is also required to be used with autogenous bone graft. These implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

The Intervertebral Body Fusion Device Systems are intended for vertebral body fixation of the thoracic or lumbar spine during the development of a thoracic or lumbar spinal fusion. Lumbar interbody fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.

This document [K191788](https://510k.innolitics.com/search/K191788) is a 510(k) premarket notification for Medtronic Intervertebral Body Fusion Device Systems (specifically, the CAPSTONE™ Spinal System, CLYDESDALE PTC™ Spinal System, CRESCENT™ Spinal System, CRESCENT™ Spinal System Titanium, and DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System).

The submission is primarily focused on an MRI Update for these existing devices, meaning the purpose is to provide data demonstrating their safety and compatibility within the Magnetic Resonance (MR) environment. This is a common type of submission for established medical devices when new safety information or a change in labeling regarding MR compatibility needs to be supported.

Based on the provided text, there is no AI/ML component to this specific submission. The "device" in question refers to intervertebral body fusion implants, which are passive mechanical implants, not software algorithms or AI-driven systems. Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML device is not applicable to this document.

Here's a breakdown based on the information provided, highlighting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

• ASTM F2052 (measurement of magnetically induced displacement force)
• ASTM F2213 (measurement of magnetically induced torque)
• ASTM F2119 (evaluation of MR image artifacts)
• ASTM F2182 (measurement of radio frequency induced heating)

The Medtronic Intervertebral Body Fusion Device Systems have been labeled in accordance with ASTM F2503 "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment." |
| No significant adverse interactions, displacement, torque, heating, or artifacts beyond specified limits during MRI. | (Implicitly met as the conclusion states the devices are "as safe and effective" as predicates and are labeled for MR safety.) Specific quantitative performance data from these tests (e.g., exact displacement forces, temperature increases, artifact sizes) are not provided in this summary document, but would have been included in the full submission. |

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

• Not Applicable (N/A) for an AI/ML test set.
• The performance data provided is for MR safety testing of physical implants, not an AI/ML algorithm. The "test set" would consist of the physical devices themselves and the materials they are made from, subjected to various MR field conditions in a lab environment.
• Data provenance is typically from controlled laboratory testing environments, not patient data in the context of AI/ML.

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

• Not Applicable (N/A). This is a question relevant to AI/ML model evaluation involving human expert interpretation. For physical device MR safety testing, ground truth is established by physical measurements and compliance with ASTM standards, not expert consensus on interpretations.

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

• Not Applicable (N/A). Adjudication methods are for human interpretation of data, often in AI/ML performance studies. MR safety testing involves physical measurements and engineering evaluations.

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 (N/A). There is no AI/ML component or human-in-the-loop scenario described in this submission. This is a K-number for physical intervertebral body fusion devices and their MR compatibility, not an AI/ML software.

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

• Not Applicable (N/A). This document concerns physical intervertebral body fusion implants, not a standalone AI/ML algorithm.

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

• Not Applicable (N/A) in the context of AI/ML.
• For the MR safety testing, the "ground truth" (or reference standard) is defined by the ASTM test methods and their specified thresholds/parameters. For example, a certain level of magnetically induced displacement is acceptable, and exceeding that is considered unsafe.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML algorithm in this submission, and therefore no training set.

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

• Not Applicable (N/A). There is no AI/ML algorithm or training set discussed in this document.

Summary of Document K191788:

This 510(k) premarket notification is for intervertebral body fusion device systems (implants used in spinal surgery). The core of this particular submission is an MRI Update, which means the manufacturer is providing data to demonstrate the safety and compatibility of these existing physical implants when subjected to Magnetic Resonance (MR) imaging environments. The document details the various predicate devices and the indications for use of the Medtronic systems. The "performance data" section explicitly lists MR safety testing conducted according to recognized ASTM standards. The conclusion states that based on this data, the devices are "as safe and effective as the following predicates" and have been appropriately labeled for MR safety. The document does not involve any artificial intelligence, machine learning, or software algorithm performance evaluation.

Ask a specific question about this device

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 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft 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 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. 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. These patients should be skeletally mature and have had six months of nonoperative treatment. The CLYDESDALE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach.

CLYDESDALE® Spinal System: The CLYDESDALE® 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The purpose of this 510(k) submission is to expand the indications of the CLYDESDALE® Spinal System to allow the device to be used with the aforementioned allogenic bone graft.

CAPSTONE® Spinal System: 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The CAPSTONE® Spinal System includes various instruments, including trials used to assist in placement of the implants. The purpose of this 510(k) submission is to expand the indications of the CAPSTONE® Spinal System to allow the device to be used with the aforementioned allogenic bone graft.

This document describes a 510(k) premarket notification for the Medtronic Sofamor Danek USA CLYDESDALE® Spinal System and CAPSTONE® Spinal System. The purpose of this submission is to expand the indications for these intervertebral body fusion devices to allow the use of allogenic bone graft.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria for a novel device. The "acceptance criteria" here relate to demonstrating that the expanded indication (use with allogenic bone graft) does not introduce new safety or effectiveness concerns.

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

• Sample Size: Not explicitly stated as a separate "test set" for a new study. The submission refers to "Published retrospective clinical data." The sample size of these published studies is not provided in this document.
• Data Provenance: The data is "retrospective clinical data" from published sources. The country of origin is not specified but implicitly refers to data relevant to demonstrating the use of allogenic bone graft in lumbar interbody fusion.

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

This type of information is generally not applicable to a 510(k) submission that relies on demonstrating substantial equivalence to predicate devices and referencing published clinical literature. The "ground truth" here is derived from the established surgical outcomes and safety profiles reported in professional medical literature concerning the use of allogenic bone graft in spinal fusion. There isn't a specific "test set" with ground truth established by a panel of experts for this particular submission.

4. Adjudication Method for the Test Set

Not applicable. As noted above, there isn't a specific test set requiring adjudication in the context of this 510(k) submission.

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 submission concerns spinal fusion devices and bone graft materials, not AI-assisted reading or diagnostic imaging.

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

Not applicable. This submission does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Clinical Outcomes/Safety Data: As reported in "published retrospective clinical data" regarding the use of allogenic bone graft in interbody fusion procedures. This data serves as evidence for the safety and effectiveness of the expanded indication.
• Established Predicate Device Performance: The primary ground truth for a 510(k) is the demonstrated safety and effectiveness of the legally marketed predicate devices. The submission asserts that the subject devices are identical in design and materials to the predicates, and the expanded indication does not alter this fundamental equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that would involve a training set.

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

Not applicable, as there is no training set for this type of device submission.

Ask a specific question about this device

The PERIMETER® C Spinal System is intended to be used for 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 who have had six weeks of non-operative treatment. 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. Additionally, the PERIMETER® C Spinal System implants are to be used with autogenous bone graft and supplemental fixation and implanted via an open, anterior approach.

The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft 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® Spinal System is indicated 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 graft. 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 CAPSTONE® L 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 CAPSTONE® L 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 PERIMETER® Interbody Fusion Device is indicated for interbody fusion 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 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® C Spinal System consists of PEEK spacers with tantalum markers of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft and is to be used with supplemental fixation in all procedures.

The CAPSTONE® PEEK Spinal System consists of PEEK cages with tantalum markers 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. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The CAPSTONE® L 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. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft.

The PERIMETER® Interbody Fusion Device consists of PEEK cages with tantalum markers 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. Additionally, the superior and inferior surfaces of the implant are designed with teeth which interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental fixation instrumentation.

The provided document is a 510(k) premarket notification for Medtronic Sofamor Danek MRI Update for PEEK Interbody Fusion Devices. The primary purpose of this submission is to obtain MRI safety labeling for these devices and provide instructions on how to perform MRI scans on them. It asserts that the devices are "MR Conditional" according to ASTM F2503.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document repeatedly mentions "worst case implants" were used for testing. However, it does not specify the exact number of implants constitutive of this "worst case" test set for any of the ASTM standards.
• Data Provenance: The document does not specify the country of origin of the data. The testing was non-clinical and conducted in accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." It's reasonable to infer the testing was conducted in a laboratory setting, likely in the USA where Medtronic Sofamor Danek is based. The data would be prospective for the purpose of this 510(k) submission, as it was specifically generated to demonstrate MRI safety for these devices.

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

• This information is not provided in the document. The testing described focuses on non-clinical, objective measurements defined by ASTM standards. These standards themselves establish the "ground truth" for MR safety parameters through their methodologies. There is no mention of human experts establishing a ground truth for the test set data in the context of MRI safety.

4. Adjudication Method for the Test Set:

• None specified. The testing involves physical measurements adhering to established ASTM standards, not subjective evaluation requiring adjudication by multiple experts.

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

• No, an MRMC comparative effectiveness study was not done. This submission is for MRI safety labeling of interbody fusion devices, which are passive implants. An MRMC study would be relevant for diagnostic imaging interpretation or active devices with AI assistance, neither of which applies here.

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

• Not applicable. This device is a passive implant (interbody fusion device), not an algorithm or an AI-powered diagnostic tool. The performance evaluated is the physical interaction of the implant with MRI fields, not an algorithm's output.

7. The Type of Ground Truth Used:

• The ground truth relies on objective physical measurements and adherence to established industry standards (ASTM F2052, F2213, F2119, F2182, F2503) for assessing MRI safety of passive metallic medical implants. These standards provide the methodology and criteria for evaluating displacement force, torque, image artifacts, and RF-induced heating.

8. The Sample Size for the Training Set:

• Not applicable. This is a non-clinical evaluation of a physical device's interaction with an MRI environment, not a machine learning model. Therefore, there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft 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® Spinal System is indicated 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 graft. 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 purpose of this 510(k) submission is to add additional CAPSTONE® Spinal System implants with 3°. 6° and 9° options for angles of lordosis. The subject devices are being included to this system in order to provide the surgeon with additional options to accommodate varving patient anatomies. Additionally, subject trial instruments corresponding to the angles of lordosis of the subject implants are included in this submission.

The CAPSTONE® Spinal System consists of PEEK cages, titanium allov cages and titanium cage 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 graft. The CAPSTONE® Spinal System includes various instruments, including trials, used to assist in placement of the implants.

The provided text is a 510(k) Summary for the CAPSTONE® Spinal System, a medical device. It describes the device, its indications for use, and its substantial equivalence to previously marketed predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Based on the provided 510(k) summary, the device is a spinal implant, and the submission is to add additional angles of lordosis options. For this type of device, the "acceptance criteria" and "study" are not based on diagnostic performance metrics (like sensitivity, specificity, AUC) or clinical trials directly comparing the device to a standard of care in human patients for effectiveness. Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices through non-clinical testing and risk analysis.

Here's a breakdown of the requested information:

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

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or diagnostic imaging study. The "test set" here refers to the device modifications themselves.
• Data Provenance: The data provenance for demonstrating substantial equivalence comes from the manufacturer's internal risk analysis and engineering rationale. This is typically based on design specifications, material properties, and potentially bench testing data (which isn't detailed here but is implied by "additional supporting documentation"). This is not retrospective or prospective clinical data.

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

• This is not applicable for this type of device submission. The "ground truth" for a spinal implant is its mechanical integrity, biocompatibility, and ability to perform its intended function, which are assessed through engineering and material science principles, not expert consensus on image interpretation or clinical outcomes in a test set.

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

• Not applicable. Adjudication methods like "2+1" typically refer to reconciling disagreements between multiple human readers in a diagnostic study. This submission relies on engineering and regulatory assessment, not human reader 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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a spinal implant, not an AI diagnostic tool.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" for this device's acceptance is based on engineering and material science principles, demonstrating that the device modifications (additional lordosis angles) maintain the same levels of safety and performance as the previously cleared predicate devices. This involves demonstrating that the mechanical strength, materials, and design features are equivalent or superior such that no new risks are introduced.

8. The sample size for the training set

• Not applicable. "Training set" refers to data used to train an AI algorithm. The CAPSTONE® Spinal System is a 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 algorithm.

In summary, this 510(k) submission for the CAPSTONE® Spinal System is a demonstration of substantial equivalence to predicate devices for minor design modifications. The "acceptance criteria" and "study" are primarily based on non-clinical engineering assessments and risk analyses, rather than clinical trials or diagnostic performance studies involving human subjects or AI.

Ask a specific question about this device

The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft 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 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 graft. 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 purpose of this 510(k) submission is to include additional sizes of PEEK cages, an inserter and to make minor clarifications to the CAPSTONE® Spinal System IFU.

The CAPSTONE® Spinal System consists of Polyetheretherketone (PEEK) cages, titanium alloy and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to provide support and correction of the lumbar spine during lumbar interbody fusion surgeries. The hollow geometry of the CAPSTONE® implants allows them to hold autogenous bone graft material.

Here's an analysis of the provided text regarding the CAPSTONE® Spinal System 510(k) summary, specifically addressing the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not mention a clinical test set or human data. All testing described is non-clinical bench testing. Therefore, there is no information on sample size for a test set, nor data provenance (country of origin, retrospective/prospective) for clinical data.

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

Not applicable. No clinical test set or ground truth established by experts is mentioned, as all testing was non-clinical bench testing.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is mentioned.

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

No. The document explicitly states: "No clinical testing was performed." Therefore, no MRMC study was conducted, and no effect size on human readers' improvement with AI vs. without AI assistance can be reported.

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

Not applicable. The device described is a spinal implant system, not a software algorithm or AI device.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established by standardized mechanical testing methodologies (ASTM F2077-03 and ASTM F2267-04) where the predicate device served as the benchmark for performance and safety equivalence.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or algorithm-based system that requires a "training set" in the computational sense. The "training data" for the device's design and manufacturing would implicitly be the specifications and performance data of the predicate devices.

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

Not applicable in the context of an AI training set. For the design and development of the new PEEK cage sizes and inserter, the "ground truth" for the predicate devices' performance and safety was established through their prior FDA clearance (e.g., K073291, K103731, K120368, K110543, K094025), which would have involved their own comprehensive testing and review processes. The current submission relies on the established safety and effectiveness of these predicates.

Ask a specific question about this device

The CAPSTONE® Spinal System is indicated for interbody fusion 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 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 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 graft. 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 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 graft.

This document is a 510(k) summary for the CAPSTONE® Spinal System, which is a premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting new clinical study data with acceptance criteria and performance metrics in the way a PMA (Pre-Market Approval) or a clinical trial report would.

Therefore, the input document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies typically found in clinical evaluation reports for novel devices or software.

The document states:

• "Documentation, including mechanical test result, was provided which demonstrated that the subject CAPSTONE® Spinal System devices are substantially equivalent to the predicate CAPSTONE® Spinal System devices (K073291 SE 04/24/08, K082342 SE 09/15/08) as well as the VERTE-STACK® Spinal System devices (K062073 SE .08/14/06)."

This clearly indicates a predicate comparison approach, not a de novo clinical study with specific acceptance criteria as requested. The "acceptance criteria" here is substantial equivalence to the predicate devices based on mechanical testing and material properties, not clinical performance metrics against a defined standard.

In summary, the provided document does not contain the information needed to fill out the requested table and answer the detailed questions about clinical study design and performance metrics.

Ask a specific question about this device

The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative 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 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 graft. 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 CAPSTONE® Spinal System consists of PEEK cages and titanium alloy 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 graft,

This document is a 510(k) summary for a medical device (CAPSTONE® Spinal System) and as such, it primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing detailed acceptance criteria and a comprehensive study report with quantitative performance metrics typical for novel AI/diagnostic device clearances.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided within this type of regulatory submission. The "study" here refers to the documentation of substantial equivalence through mechanical testing and comparison of features and intended use.

Here's an attempt to answer as much as possible based on the provided text, while acknowledging the limitations of this document type:

Acceptance Criteria and Device Performance

Note: The provided 510(k) summary does not specify explicit "acceptance criteria" in terms of performance metrics (e.g., accuracy thresholds, sensitivity, specificity) as one would expect for a diagnostic or AI device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it matches or is comparable to the predicate device.

Study Details for Substantial Equivalence

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

   • Sample Size: Not specified in terms a number of "cases" or "patients" for a clinical study, as this is primarily a mechanical and design comparison for substantial equivalence. For mechanical testing, the "sample size" would refer to the number of devices tested, which is not provided in this summary.
   • Data Provenance: Not applicable in the context of clinical data for a device demonstrating substantial equivalence based on mechanical testing and comparison to existing predicate devices. The "data" primarily refers to design specifications, material properties, and mechanical test results, not patient data in the typical sense.

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

   • Not applicable. This device is an implant, and the "ground truth" for its performance is established through engineering and biomechanical testing, rather than expert evaluation of diagnostic output.

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

   • Not applicable. There is no "test set" of images or patient data requiring expert adjudication in this 510(k) summary.

4. 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 spinal implant, not an AI or diagnostic imaging device.

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

   • Not applicable. This is a spinal implant, not an algorithm.

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

   • The "ground truth" for this type of device is established through:
     • Mechanical Testing Standards: Compliance with industry standards for spinal implants (e.g., fatigue, compression, expulsion testing).
     • Biocompatibility Standards: Ensuring materials are safe for implantation.
     • Design Specifications: Verification that the device meets its intended design parameters.
     • Predicate Device Performance: The primary "ground truth" is that the new device performs equivalently to previously cleared predicate devices, which have a history of safe and effective use.

7. The sample size for the training set:

   • Not applicable. This is an implant, not a machine learning model requiring a "training set."

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

   • Not applicable.

Ask a specific question about this device

The CAPSTONE® Spinal System 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 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 an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal 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.

The CAPSTONE® PEEK Spinal System consists of a variety of hollow vertebral body spacers featuring a convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is made of various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 16mm in height and from 22mm to 36mm in length.

This document describes a 510(k) submission for the CAPSTONE® Spinal System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial with specific acceptance criteria and performance studies in the way an AI algorithm might be evaluated. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is Not Applicable in the context of a 510(k) for a spinal implant. The evaluation is primarily based on demonstrating substantial equivalence to existing, legally marketed predicate devices through design comparison, material analysis, and in vitro mechanical testing. It does not involve a "test set" of patient data or clinical images like an AI device would.

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

This is Not Applicable. Ground truth, expert review, and clinical outcomes for a "test set" are not part of a 510(k) substantial equivalence determination for this type of device. The "ground truth" here is established by the existing regulatory clearance and safety/effectiveness history of the predicate devices.

4. Adjudication Method for the Test Set

This is Not Applicable. There is no "test set" in the context of an adjudication method for this type of 510(k) submission.

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 is Not Applicable. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical implant and does not involve AI assistance for human readers.

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

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

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for the device's acceptable safety and effectiveness is implicitly derived from the long-standing clinical use and regulatory clearance of the identified predicate devices. The submission demonstrates that the CAPSTONE® Spinal System shares fundamental technological characteristics (design, materials, indications for use) and performs similarly to these legally marketed predicates.

8. The Sample Size for the Training Set

This is Not Applicable. There is no "training set" for an AI algorithm in this context.

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

This is Not Applicable. There is no "training set" for an AI algorithm in this context.

Summary of the Study that Proves the Device Meets Acceptance Criteria for this 510(k) Submission:

The provided text indicates that the CAPSTONE® Spinal System demonstrated substantial equivalence through:

• Documentation and Mechanical Test Results: The submission included data from mechanical tests to show that the device's physical and functional properties (e.g., strength, stability, expulsion resistance, as implied by the "angular teeth") are comparable to the predicate devices. While specific test details or quantitative results are not in this summary, they would have been part of the full 510(k) submission.
• Published Literature: Relevant scientific and clinical literature was likely used to support the safety and effectiveness of the design principles and materials used, especially concerning intervertebral body fusion devices.
• Comparison to Predicate Devices: The core of the evidence relies on a detailed comparison to five specific, previously cleared interbody cages:
  • LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek)
  • BAK® Cage (P950002, Zimmer Spine)
  • RAY® Threaded Fusion Cage (P950019, Stryker)
  • Lumbar I/F Cage (P960025, DePuy)
  • PARAMOUNT INTERVERTEBRAL BODY FUSION Device (K072120, Innovative Spinal Technologies)

The study essentially demonstrated that the CAPSTONE® Spinal System is "as safe and effective as, and performs as well as" these predicate devices by showing equivalent design, materials (e.g., PEEK), indications for use, and mechanical performance.

Ask a specific question about this device