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The Pyrenees and K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from Commercially Pure titanium alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization of cervical segments of the spine.

This document is a 510(k) Summary for a medical device called the "Pyrenees Cervical Plate System, Semi-constrained Screw." It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "mechanically tested," implying physical testing, but does not provide details on the number of devices or components tested.
• Data Provenance: The study is described as "mechanical testing" and "comparison to predicate systems and other currently marketed systems." This is laboratory-based testing, not human patient data. Therefore, questions of country of origin or retrospective/prospective are not applicable in this context.

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

This type of study (mechanical testing for substantial equivalence of a spinal implant) does not typically involve human "experts" establishing a clinical ground truth in the way a diagnostic AI might. The "ground truth," in this case, is defined by the objective performance standards of ASTM F1717 and the characteristics of the predicate devices. The "experts" involved would be engineering and regulatory professionals performing and analyzing the mechanical tests and comparing specifications, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring human adjudication for data interpretation. The "adjudication" is based on meeting the defined mechanical test standards and comparing physical and functional characteristics to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This document describes a 510(k) submission for a physical medical device (spinal implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI assistance is not relevant.

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

Not applicable, as this is not an algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth used for this submission is:

• Mechanical Performance Standards: Specifically, ASTM F1717 for mechanical testing.
• Predicate Device Specifications: The documented design features, materials, and intended uses of previously cleared, legally marketed spinal plate systems.
• Regulatory Definitions: The FDA's criteria for substantial equivalence under 510(k).

8. The Sample Size for the Training Set

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

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

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

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The Pyrenees Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2 - C7) for the following indications: degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from Commercially Pure titanium and titanium alloy per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.

The provided text describes a 510(k) premarket notification for a medical device called the "Pyrenees Cervical Plate System". This document focuses on demonstrating substantial equivalence to legally marketed predicate devices through material and functional comparisons, not on efficacy studies involving AI or complex statistical analysis of diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, device performance, ground truth, and expert evaluation is not present in this type of submission.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

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

This type of information (specific performance metrics for AI, such as sensitivity, specificity, or AUC) is not applicable to this medical device submission. The submission is for a spinal fixation system, not a diagnostic AI tool.

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 is a submission for a physical medical device (cervical plate system), not an AI diagnostic tool that uses datasets. The "testing" mentioned refers to mechanical and material compliance testing, not clinical studies with patient data in the context of an AI algorithm.

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 "ground truth" in the AI diagnostic sense for a cervical plate system. The ground truth for this device would be established through engineering specifications, material science, and possibly in-vitro mechanical testing.

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

Not applicable. This relates to expert review of AI diagnostic outcomes, which is not relevant for this device.

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 device is not an AI diagnostic tool and does not involve human readers interpreting images with or without AI assistance.

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

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

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

For this type of device, the "ground truth" is primarily engineering and material specifications, and performance against established standards (e.g., ASTM F1717 for mechanical properties). Clinical outcomes would be observed post-market but are not part of this 510(k) summary for substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the AI sense for this device.

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

Not applicable. There is no AI training set.

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