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The Camber Spine Technologies TLS 5.0 Interbody Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Camber Spine Technologies TLS 5.0 Interbody Cage is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
Camber Spine Technologies TLS 5.0 Interbody Cage implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Camber Spine Technologies, TLS 5.0 Interbody Cage is a device for interbody fusion of the anterior column of the spine. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces.
Camber Spine Technologies, TLS 5.0 Interbody Cage is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths, heights and shapes. Camber Spine designed the Camber Spine Technologies, TLS 5.0 Interbody Cage to be placed through a transforaminal or posterior approach and to address vertebrae in the lumbosacral region of the spine.

The provided text describes the Camber Spine Technologies TLS 5.0 Interbody Cage, a medical device, and its regulatory submission. It does not describe an AI or algorithm-based device. Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable or cannot be extracted.

However, the document does contain information regarding acceptance criteria and the studies performed to demonstrate equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Not Applicable. This document describes the non-clinical testing of a physical medical device (interbody cage) for mechanical and material properties, not an AI or algorithm. The "test set" for this context would refer to the physical units of the device subjected to the aforementioned tests. The document does not specify the number of units tested for each non-clinical test.
• Data Provenance: Not applicable in the context of AI/algorithm data provenance (country of origin, retrospective/prospective clinical data). The data provenience refers to the results of engineering and material science tests.

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

• Not Applicable. This is a physical device, and the ground truth for its performance is established through standardized ASTM tests and ISO sterilization validation, which have objective physical outcomes (e.g., force at failure, wear rates, sterilization efficacy). This does not involve expert interpretation or consensus as would be required for labeling medical images for AI.

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, the "test set" for this device's evaluation involved objective, standardized engineering tests, not subjective interpretations requiring adjudication.

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

• No. The document explicitly states: "No clinical tests were performed." Therefore, no MRMC study was conducted. Details about human reader improvement with AI assistance are not relevant here.

6. Standalone (Algorithm Only) Performance Study

• No. This is a physical interbody cage, not an algorithm or AI device. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

• For the non-clinical tests (mechanical properties, wear, expulsion) and sterilization validation: Objective physical measurements and engineering standards (ASTM and ISO).
• For the overall substantial equivalence: The "ground truth" used for regulatory submission is the performance and indications for use of legally marketed predicate devices. The device's performance against the acceptance criteria (derived from standards and predicate device performance) serves as the basis for demonstrating substantial equivalence.

8. Sample Size for the Training Set

• Not Applicable. This is a physical device, not an AI/ML algorithm. There is no "training set" in this context. The "design process" for such a device would involve engineering design, material selection, and manufacturing process development, not machine learning training.

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

• Not Applicable. As per point 8, there is no training set mentioned or implied for this device.

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The SYNSTER CERVICAL CAGE is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The SYNSTER (ALIF, PLIF, PTLIF and TLIF) CAGE is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

• 1. Cervical Interbody Fusion Device (SYNSTER® CERVICAL CAGE), which may be implanted as a single device via an anterior approach.
• 2. Lumbar Interbody Fusion Device [SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE], which may be implanted
  • As a single device via an Anterior or Anterolateral or Lateral (ALIF) approach; ।
  • Bi-laterally via a posterior (PLIF) approach; ।
  • As a single device via a posterior transforaminal (PTLIF) approach; -
  • As a single device via a transforaminal (TLIF) approach. -

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE is implanted by using the (SCCI, SACI, SPCI, SPTCI and STCI) instruments manufactured from stainless steel materials that conform to ASTM F899.

This submission describes the SYNSTER® CERVICAL CAGE and SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE, intervertebral body fusion devices. The devices are made of PEEK Optima LT1 with titanium markers and are intended for intervertebral body fusion in skeletally mature patients with degenerative disc disease. The testing described for these devices primarily focuses on mechanical performance rather than AI/software performance. Therefore, many of the typical AI/ML-related questions are not applicable to this submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of number of devices tested, but the testing refers to "non-clinical tests" conducted in accordance with specific ASTM standards. These standards typically involve a defined number of samples for each test type. The document does not specify the exact number of units tested.
• Data Provenance: Not applicable in the context of clinical data. The data originates from benchtop mechanical testing performed according to ASTM standards. There is no information regarding country of origin or retrospective/prospective nature as it's not clinical data.

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

Not applicable. The ground truth for this type of device (mechanical performance) is established by adherence to recognized national/international standards (ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F 04.25.02.02) and engineering principles, not by expert consensus on clinical interpretation. The "experts" would be materials scientists and mechanical engineers performing and interpreting the tests according to the standards.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of human interpretations. Mechanical test results are objective measurements compared against specified criteria from standards.

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 is for a physical medical device (intervertebral cage), not an AI/ML software device.

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

Not applicable. This submission is for a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating the device's acceptable performance is defined by the mechanical properties and criteria stipulated in the referenced ASTM standards. These standards provide objective measures and acceptance thresholds for static and dynamic compression, shear, torsion, subsidence, and expulsion.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no training set in the conventional sense.

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

Not applicable. There is no training set for this physical medical device.

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