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The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.

The Cavetto®-SA Cervical Cage System is an intervertebral fusion device made from medical grade titanium per ASTM F136. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies.

The provided text is a 510(k) summary for the Cavetto®-SA Cervical Cage System, which is an intervertebral fusion device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets acceptance criteria for a new AI/ML-driven medical device.

Therefore, many of the requested categories for acceptance criteria and study details (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set) are not applicable to this submission as it describes a traditional medical device (implantable cage and screws) that typically undergoes mechanical testing rather than AI/ML performance evaluation.

Based on the provided text, here's what can be extracted and what information is not available due to the nature of the device:

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

The document mentions "Performance Data" but specifies that it was a "comparison of the previously cleared device material and the subject device material was completed in lieu of mechanical testing." This suggests that the acceptance criteria would be related to material properties and substantial equivalence to the predicate device's materials, rather than a clinical performance metric. Specific quantitative acceptance criteria and reported performance metrics in a table format are not provided in this document. The conclusion states "The overall technology and material characteristics lead to the conclusion that the Cavetto®-SA Cervical Cage System is substantially equivalent to the predicate device." This "substantial equivalence" is the primary performance claim rather than a separate set of performance criteria.

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. The document describes a traditional implantable medical device, not a diagnostic or AI/ML device that would use test sets of patient data in this manner. The performance data mentioned refers to material comparison, not clinical trial data with patient samples.

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

• Not Applicable. This is not relevant for the type of device described. Ground truth for an AI/ML diagnosis is established by expert consensus or other definitive methods, which is not what is being evaluated here.

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

• Not Applicable. See point 3.

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. An MRMC study is relevant for AI-assisted diagnostic devices. This is a physical implantable device.

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

• Not Applicable. This device does not involve an algorithm.

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

• Not Applicable. The "performance data" mentioned focuses on material comparison to a predicate device, not establishing clinical ground truth for diagnosis/prognosis.

8. The sample size for the training set:

• Not Applicable. This device does not utilize a training set in the context of machine learning.

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

• Not Applicable. See point 8.

In summary, the provided document is a 510(k) summary for a physical medical implant (intervertebral fusion device). It asserts substantial equivalence to a predicate device based on technological characteristics and material comparisons, rather than providing the detailed performance study information typically associated with AI/ML-driven diagnostic or prognostic devices as requested in your prompt.

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The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.

The Cavetto®-SA Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F560, and tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies.

The provided document is a 510(k) premarket notification for the Cavetto®-SA Cervical Cage System, an intervertebral body fusion device. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold format for each test. Instead, it states that the "results of this non-clinical testing show that the strength of the Cavetto®-SA Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

This implies that the acceptance criterion for each test was to meet or exceed the performance of the legally marketed predicate devices. The specific performance values for the predicate devices are not provided in this summary.

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

• Sample Size: The document does not specify the number of samples or units tested for each non-clinical performance test (e.g., how many cages were subjected to static axial compression).
• Data Provenance: The data is from non-clinical testing (mechanical testing), not human or animal studies. Therefore, concepts like country of origin for human data or retrospective/prospective don't apply in the same way. The testing was conducted to established ASTM standards.

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

• Not applicable. This submission relies on non-clinical, mechanical performance data, not expert-derived ground truth based on interpreting medical images or clinical outcomes. The "ground truth" here is the physical measurement of the device's mechanical properties according to established engineering standards (ASTM).

4. Adjudication Method for the Test Set:

• Not applicable. As the data is purely mechanical testing against engineering standards, there's no "adjudication" in the sense of reconciling differing expert opinions. The tests are performed and measured objectively.

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

• No. This document describes a 510(k) submission based on non-clinical bench testing for a physical implantable device (a cervical cage). MRMC studies evaluate the performance of diagnostic algorithms or imaging techniques, often involving human readers. This type of study is not relevant to the evaluation of the Cavetto®-SA Cervical Cage System as presented here.

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

• Not applicable. This device is a physical medical implant, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. The Type of Ground Truth Used:

• For the non-clinical performance tests, the "ground truth" is established by adherence to published ASTM standards and the expected mechanical properties for devices of this type for their intended use. The comparison is made to predicate devices which have already demonstrated safety and effectiveness through their regulatory clearance based on similar mechanical and material properties.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of this 510(k) submission. This is a physical medical device, not a machine learning model that requires training data.

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

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

In summary, the provided document focuses on demonstrating the substantial equivalence of a physical medical implant (intervertebral cage) through non-clinical mechanical testing, rather than evaluating the performance of a diagnostic algorithm or AI system. Therefore, many of the requested categories (expert ground truth, MRMC studies, training sets) are not applicable to this type of regulatory submission. The core of the "proof" is that the device's mechanical properties, tested against recognized ASTM standards, are sufficient for its intended use and comparable to already cleared predicate devices.

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