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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.

The Pyrenees Cervical Plate System, Translational Plate, is a spinal fixation system consisting of cervical screws and plates made from Commercially Pure titanium alloy. It's intended for anterior screw fixation to the cervical spine (C2-C7) as an adjunct to fusion.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing and comparison to predicate devices rather than a clinical study with a test set of human subjects or data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this submission. The "test set" here refers to the physical devices subjected to mechanical loads.

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

This information is not applicable as the "ground truth" for mechanical testing is established by the specifications of ASTM F1717 and the performance of predicate devices, not expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable as the assessment is based on objective mechanical measurements against a standard (ASTM F1717) and direct comparison to predicate device performance. No human adjudication is mentioned or implied for this type of test.

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

There is no mention of an MRMC comparative effectiveness study, AI assistance, or human readers in the provided document. This submission focuses on the mechanical and functional equivalence of a spinal fixation device, not a diagnostic or interpretative AI-based system.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Established mechanical testing standards: Specifically, ASTM F1717.
• Performance of legally marketed predicate devices: The Pyrenees system's performance was compared directly to that of predicate devices in static torsion, dynamic compression, and static tension.
• Material and design specifications: Adherence to ASTM and ISO standards for materials, and equivalence in design features and sizing to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is an orthopedic implant, not a machine learning model that undergoes training on a dataset.

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

This is not applicable for the reasons stated in point 8.

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The Active "10 Anterior Cervical Plate System is intended for the treatment of the cervical spine in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-11) with removal of the implants after the attainment of a solid fusion mass. The Active ™ Anterior Cervical Plate System is intended for use under the following indications:

· Degenerative disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

• · Spondylolisthesis
• · Trauma (i.e., fracture or dislocation)
• · Spinal stenosis
• · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)

• Tumor

• Pseudoarthrosis

• · Failed previous fusion

The Active " Anterior Cervical Plate System is a fixation system designed to allow for settling of the bone graft during fusion. Plates are provided in various lengths to accommodate fusions from 1 to 4 Ievels. Fixed and variable angle locking unicortical screws are provided in lengths of 12, 14, 16, and 18mm and diameters of 4mm and 4.5mm.

The provided text describes the 510(k) summary for the "Active Anterior Cervical Plate System" (K073500), a medical device intended for spinal fixation. This submission focuses on establishing substantial equivalence to previously marketed predicate devices, primarily through mechanical performance testing and comparison of technological characteristics.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of clinical data or patient samples. The evaluation of this device is based on mechanical performance attributes per ASTM F1717. For such testing, the "sample size" would refer to the number of devices or components tested. This information is not provided in the given text.

Similarly, the data provenance (country of origin, retrospective/prospective) is not applicable as the study described is a mechanical engineering test, not a clinical study involving human subjects or their data.

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

This information is not applicable. The "ground truth" for mechanical testing is typically established by the specifications of the ASTM F1717 standard and the results of the physical tests themselves. It does not involve human expert consensus in the way clinical studies do.

4. Adjudication Method for the Test Set

This is not applicable for mechanical performance testing. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where human interpretation or consensus is required to establish ground truth or resolve discrepancies in evaluations.

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

This information is not applicable. The submission describes a spinal fixation system, which is a physical implant, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This is not applicable. The device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily mechanical performance standards (ASTM F1717). The device's performance was compared to existing predicate devices based on these standards.

8. The Sample Size for the Training Set

This information is not applicable as the evaluation is based on mechanical performance testing, not a machine learning model that requires a "training set."

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

This is not applicable for the same reasons as #8.

Summary of the Study and Device Performance:

The study described for the Active Anterior Cervical Plate System is largely a technical and mechanical performance evaluation to demonstrate substantial equivalence to legally marketed predicate devices. The primary "study" involved:

• Comparison of Technological Characteristics: The device's features (augmenting stability, segmented plate for screw translation, use of titanium alloys, compression application) were compared and found to be substantially equivalent to features present in various predicate devices.
• Mechanical Testing per ASTM F1717: The device underwent mechanical performance testing according to the ASTM F1717 standard. The results of this testing demonstrated that its mechanical attributes were "substantially equivalent" to those of the predicate devices.

The FDA's review concluded that the device is substantially equivalent to predicate devices for its stated indications for use, primarily based on these comparative analyses and mechanical testing. No clinical studies with human participants, expert consensus for diagnosis, or AI performance evaluations are mentioned in this 510(k) summary.

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