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The ALTA Anterior Cervical Interbody Spacer is indicated for intervertebral body fusion of the spine in skeletally mature patients. The ALTA Anterior Cervical Interbody Spacer is intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The System is intended to be used with supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The ALTA Anterior Cervical Interbody Spacer was developed as implants for the stabilization of the cervical column. The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy. This device is offered in PEEK OPTIMA LT120HA. The PEEK OPTIMA LT120HA implants have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery. The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation.

Here's an analysis of the provided text regarding the ALTA Anterior Cervical Interbody Spacer, focusing on acceptance criteria and supporting studies:

This submission is a 510(k) premarket notification for a medical device (ALTA Anterior Cervical Interbody Spacer), not an artificial intelligence (AI) or machine learning (ML) enabled device. Therefore, the questions related to AI/ML specific criteria (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size) are not applicable.

The acceptance criteria described for this device are based on its mechanical performance and material characteristics, and the study proving it meets these criteria is a non-clinical bench testing study, comparing its performance to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated regarding the number of devices or tests performed. For non-clinical bench testing, typically a statistically significant number of samples are tested to ensure robustness and reproducibility of results for each test (e.g., static compression, dynamic cyclic loading, etc.). The document indicates "analyses were conducted" without specifying the number of units per analysis.
• Data Provenance: Not applicable in the context of human data. This refers to non-clinical bench testing conducted in a laboratory setting.

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

Not applicable. Ground truth as typically defined for AI/ML (e.g., expert consensus on medical images) is not relevant for this type of mechanical device testing. The "ground truth" for these tests are the established ASTM standards and the verified performance of the predicate devices.

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

Not applicable. Adjudication methods are typically used for resolving disagreements among human experts in AI/ML performance evaluation studies. This is a non-clinical bench testing study.

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

No, an MRMC comparative effectiveness study was not done. This device is an interbody spacer, not an AI/ML diagnostic tool.

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

Not applicable. This is not an 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 adherence to recognized industry standards (ASTM F2077, ASTM F2267, ASTM F560 for materials) and demonstrated mechanical equivalence to legally marketed predicate devices. The performance of the predicate devices, which have already undergone FDA clearance, serves as the benchmark for "truth."

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The ALTA Cervical Interbody Spacer is indicated for intervertebral body fusion procedures with degenerative disc disease (DDD) of the cervical spine at disc levels (C2-T1). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with supplemental internal fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cages.

The ALTA Cervical Interbody Spacer was developed as implants for the stabilization of the cervical column. The devices have trapezoidal footprints and multiple sizes to accommodate patient anatomy. This device is offered in two material choices: PEEK and titanium. The PEEK implants have unidirectional teeth on both of their inferior and superior surfaces to prevent migration/expulsion, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants during and after surgery. The titanium implants have roughened superior and inferior surfaces to prevent migration of the spacer post implantation.

This document is a 510(k) premarket notification for the ALTA Cervical Interbody Spacer. This type of FDA submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo safety and efficacy through clinical trials. Therefore, the information typically requested about acceptance criteria and detailed study designs for AI/medical imaging devices is not present here.

Specifically for your questions:

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

   • This document does not contain quantitative acceptance criteria and reported performance metrics in the way one would see for an AI/imaging device. The device's "performance" is demonstrated through non-clinical mechanical testing, showing equivalence to predicate devices, rather than clinical outcomes or diagnostic accuracy.

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

   • No clinical "test set" data in the context of an AI/imaging device is provided. The non-clinical tests (static/dynamic compression, torsion, subsidence, expulsion) involve mechanical samples of the device itself.
   • The document explicitly states: "No clinical studies were performed."

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

   • Not applicable. There is no clinical test set requiring expert-established ground truth.

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

   • Not applicable. No clinical test set.

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

   • Not applicable. This is a medical implant, not an AI/imaging diagnostic device.

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

   • Not applicable. This is a medical implant, not an AI/imaging diagnostic device.

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

   • For the non-clinical tests, the "ground truth" is based on established ASTM standards for mechanical properties (e.g., F2077 for compression and torsion, F2267 for subsidence). The device's performance is compared against these standards or against the performance of predicate devices as per those standards.

8. The sample size for the training set

   • Not applicable. There is no AI model or "training set."

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

   • Not applicable. There is no AI model or "training set."

Summary of Device Performance (from the provided text, related to non-clinical testing):

Conclusion: The provided document describes a 510(k) submission for a cervical interbody spacer. The device received clearance based on demonstrating "substantial equivalence" to existing predicate devices, primarily through non-clinical mechanical testing and comparison of design, materials, and intended use. No clinical studies were performed, and thus, no data regarding acceptance criteria, test set, training set, expert consensus, or AI performance metrics are included.

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