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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 C-Tek® MaxAnTM Anterior Cervical Plate System is intended for anterior interbody fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the development of cervical fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.

The C-Tek® MaxAn™ Anterior Cervical Plate System consists of titanium alloy plates and screws. Screws are provided in both fixed and variable versions in sizes 4.0 mm and 4.5 mm with lengths from 8-26 mm. Screws will be provided in both sterile and nonsterile configurations. Cervical plates are provided in both sterile and non-sterile configurations for 1 - 6 levels and in appropriate lengths from 8-150 mm.

The provided text describes a 510(k) premarket notification for a medical device called the C-Tek® MaxAn™ Anterior Cervical Plate System. This is a spinal intervertebral body fixation orthosis.

Based on the document, this is not an AI/ML medical device. It is a traditional medical device (a physical implantable system of plates and screws). Therefore, many of the requested fields related to AI/ML device studies (such as sample size for training/test sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable and cannot be extracted from this type of submission.

Here's a breakdown of the information that is available and a note on what is not applicable:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable for this type of medical device (physical implant). The "test set" would refer to the physical prototypes tested in non-clinical lab settings. The document does not specify the number of samples or prototypes tested. Data provenance is not relevant in the context of clinical data for an AI/ML device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of an AI/ML device, refers to verified labels for data. For a physical medical device, "ground truth" would relate to engineering specifications and performance standards.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to methods for consensus building among human experts labeling data, which is not relevant for this device.
4. 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 not an AI/ML device and human readers are not involved in its "performance" in this context.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" for performance is likely based on engineering specifications, material properties (ASTM F-136 for Ti-6Al-4V), and biomechanical testing standards for spinal implants, demonstrating equivalency to predicate devices. The document explicitly states "Non-clinical laboratory testing was performed to determine substantial equivalence."
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Additional Information from the Submission:

• Device Description: The C-Tek® MaxAn™ Anterior Cervical Plate System consists of titanium alloy plates and screws. Screws are provided in both fixed and variable versions in sizes 4.0 mm and 4.5 mm with lengths from 8-26 mm, in both sterile and non-sterile configurations. Cervical plates are provided in both sterile and non-sterile configurations for 1-6 levels and in lengths from 8-150 mm.
• Materials: Titanium alloy (Ti-6Al-4V, ASTM F-136).
• Predicate Device(s):
  • EBI Anterior Cervical Plate System (Cyprus Anterior Cervical Plating System), K060379
  • EAGLE+ Anterior Cervical Plate system, K070994, K040197
  • Swift Plus Anterior Cervical Plate System, K072546, K040655
• Performance Claim: "The technological characteristics of the C-Tek® MaxAn™ Anterior Cervical Plate System are the same as, or similar to, the predicate devices."
• Study Conclusion: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices are functional within the intended use."

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