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The NuVasive ALIF Buttress Plate System is an anterior non-load bearing plate system that may be used in the thoracic, lumbar and sacral spine (T1-S1). The NuVasive ALIF Buttress Plate System, in conjuction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing applications.

The NuVasive ALIF Buttress Plate System is an anterior non-load bearing plate system manufactured from Ti-6A1-4V per ASTM F1472 or Ti-6Al-4V ELI per ASTM F136, Nickel-Cobalt-Chromium-Molybdenum Alloy (Carpenter MP35NTM Alloy) per ASTM F562, and Nitinol SE510 per ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

This document is a 510(k) premarket notification from the FDA for a spinal implant device, the NuVasive® ALIF Buttress Plate System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in the context of acceptance criteria and a study to prove device performance:

Crucial Caveat: This 510(k) summary does not describe a study to prove the device meets acceptance criteria in the sense of clinical performance or diagnostic accuracy for an AI/ML device. This document is for a physical medical device (a buttress plate system for spinal fusion), not an AI/ML diagnostic or predictive tool.

Therefore, the questions regarding ground truth, expert consensus, MRMC studies, standalone performance, training sets, and data provenance are not applicable to this type of device submission. The "acceptance criteria" here refer to mechanical and material performance standards for the implant, not diagnostic accuracy metrics.

Here's the information extracted from the document relevant to a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, "acceptance criteria" relate to mechanical and material safety and performance standards. The document only explicitly mentions one performance test.

Explanation: The documentation states "Nonclinical testing was performed to demonstrate the subject ALIF Buttress Plate System is substantially equivalent to other predicate devices. The following testing was performed: Static and Dynamic Cantilever Bending Testing per ASTM F1717-13." This test would have acceptance criteria within the ASTM F1717-13 standard, but those specific criteria (e.g., minimum load to failure, fatigue life) are not detailed in this summary. Instead, the summary concludes that the device is "substantially equivalent" based on this testing, among other factors.

Regarding the remaining points, they are largely not applicable to this type of device submission (physical implant) and the information is not present in the provided text.

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: This refers to clinical data for AI/ML or diagnostic devices. For a physical implant, mechanical testing is performed on manufactured units, not patient data sets. The sample size for the mechanical testing is not specified in the summary.

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" in this context would refer to material science and engineering standards, not expert medical opinion on a diagnostic outcome.

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

• Not Applicable: Adjudication methods are used to resolve discrepancies in expert labeling or diagnoses, which is not relevant for mechanical testing of a physical implant.

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: MRMC studies are for evaluating AI-assisted diagnostics. This is a physical implant.

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

• Not Applicable: This pertains to AI/ML algorithms, not a physical implant.

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

• Not Applicable: For this device, the "ground truth" for its performance is adherence to established engineering standards (like ASTM F1717-13) and material specifications, demonstrated through physical testing.

8. The sample size for the training set

• Not Applicable: There is no "training set" for a physical implant. This term applies to machine learning models.

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

• Not Applicable: As above, no training set exists for this type of device.

In summary: The provided document is a 510(k) summary for a spinal buttress plate system. Its "acceptance criteria" are based on non-clinical mechanical testing and material compatibility, demonstrating substantial equivalence to predicate devices. The questions posed are primarily designed for AI/ML or diagnostic device evaluations and are not relevant to this specific premarket notification for a physical medical implant.

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