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The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral), pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis. trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudoarthrosis, and failed fusion.

The Selective-Axis Posterior Noncervical Plating System ("Selective-Axis Plating System") is comprised of the following components: Selective-Axis anchor screw assemblies, connecting beam assemblies, and jam nuts. All of the components of the Selective-Axis Plating System are manufactured from Ti6Al4V-ELI titanium alloy per ASTM F136.

The provided text describes a medical device, the "Selective-Axis Posterior Noncervical Plating System," and its clearance process. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document explicitly states: "Mechanical testing of the Selective-Axis Plating System was performed in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s, dated May 3, 2004."

This sentence indicates that mechanical testing was performed according to a guidance document, but it does not provide the results of that testing, nor does it specify any acceptance criteria used to evaluate those results. It focuses on the substantial equivalence of the device to predicate devices based on technological characteristics.

Therefore, I cannot fulfill your request for the detailed table and study information because the provided text does not contain that level of detail regarding performance data.

To answer your request, if this information were available in the text, it would be presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance
(This table cannot be filled from the provided text as the information is missing.)

2. Sample size used for the test set and the data provenance:

(This information is not provided in the text. Mechanical testing uses physical samples of the device components, not "test sets" of data in the way a diagnostic AI would.)

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

(Not applicable. This device is a mechanical implant, not a diagnostic tool requiring expert interpretation for ground truth.)

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

(Not applicable for mechanical testing.)

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 a mechanical implant and does not involve AI or human readers for its primary function.)

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

(Not applicable for mechanical testing of an orthopedic implant.)

7. The type of ground truth used:

(For mechanical testing, the "ground truth" would be established mechanical engineering standards and measurements. For example, the ground truth for yield strength is the actual force at which the material deforms permanently, measured directly during testing.)

8. The sample size for the training set:

(Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.)

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

(Not applicable. This is a mechanical device.)

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