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When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the Dynesys system is indicated for use in patients:

• . Who are receiving fusions with autogenous graft only;
• . Who are having the device fixed or attached to the lumbar or sacral spine;
• . Who are having the device removed after the development of a solid fusion mass.

When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO Implant, rodcord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.

The Zimmer DTO Pin press has been designed to be part of the Zimmer DTO Instruments. The Zimmer DTO Implant is provided partially assembled, in that the cord is placed in the connecting part and fixed with a needle during the manufacturing process; the mechanical integrity of the cord/rod connection is achieved immediately prior to implantation by fully inserting a pin to compress the cord with an intra-operative instrument, this step is performed with the Zimmer DTO Pin press.

This document is a 510(k) summary for the Zimmer DTO Pin Press, a medical instrument, and not a study describing a device that uses AI or machine learning. Therefore, most of the requested information (acceptance criteria for AI, sample sizes for AI training/test sets, expert ground truthing, MRMC studies, standalone AI performance) is not applicable.

This document describes the process of getting a medical instrument approved by the FDA, primarily by demonstrating its substantial equivalence to a previously approved predicate device.

Here's the relevant information that can be extracted from the provided text, related to the performance testing of the instrument (the Zimmer DTO Pin Press):

1. Table of Acceptance Criteria and Reported Device Performance:

Rationale: The document states, "It has been determined that the proposed Zimmer DTO Pin Press is substantially equivalent the predicate Zimmer DTO Hand Press. Based on the results following tests: - Durability and fatigue. - Interconnection strength . - Pull-out strength ." This implies that the device successfully met the performance expectations for these tests, demonstrating equivalent performance to the predicate. The specific quantitative acceptance criteria or detailed test results are not provided in this summary.

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

The document does not specify the sample sizes used for the durability, interconnection strength, and pull-out strength tests. It also does not mention data provenance in terms of country of origin or retrospective/prospective studies, as these are typically not relevant for mechanical device testing of this nature.

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

Not applicable. Ground truth, in the context of AI and diagnostic imaging, refers to a definitive diagnosis or finding. For a mechanical instrument, "ground truth" would involve established engineering standards and test methodologies, not expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or algorithmic output review, not for mechanical device testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is an instrument, not a diagnostic or AI-driven system that would be evaluated for human reader improvement.

6. Standalone Performance Study:

Yes, in a sense. The performance testing (Durability and fatigue, Interconnection strength, Pull-out strength) evaluated the Zimmer DTO Pin Press instrument on its own to ensure it functions as intended and is substantially equivalent to its predicate. However, "standalone" in the context of AI usually refers to the algorithm's performance without human intervention, which is not relevant here.

7. Type of Ground Truth Used:

For the performance testing mentioned (durability, strength tests), the "ground truth" would be established engineering standards, material science properties, and established mechanical testing protocols. There isn't a "ground truth" in the diagnostic or clinical outcome sense for an instrument's performance validation.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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