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The subject guide wire devices are instruments in fracture fixation and stabilization of long bones during the surgical procedure of intramedullary nailing. The implant specific instruments are to be used with the Zimmer® Natural Nail® System and Zimmer® M/DN® Intramedullary Fixation System.

The subject guide wire devices are instruments intended to assist in fracture fixation and stabilization of long bones during the surgical procedure of intramedullary nailing. The guide wires are made of either L605 Cobalt-Chrome-Tungsten-Nickel Alloy (per ASTM F90) or 316L Stainless Steel (per ASTM F138). These instruments will be provided sterile by Gamma Radiation.

This is a 510(k) Pre-Market Notification for a Class II medical device, Zimmer® Guide Wire Devices, used in orthopedic surgeries. The document does not describe the acceptance criteria or a study that proves the device meets the acceptance criteria for an AI/ML powered device. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical bench testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This document does not pertain to the performance of an AI/ML powered device. It is for Zimmer® Guide Wire Devices, which are instruments used in fracture fixation. The performance data presented are for non-clinical bench tests related to packaging and sterile barrier integrity.

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. The "test set" in this context refers to the samples used for packaging integrity bench testing, not a dataset for an AI/ML model. The document does not specify the exact sample size for each packaging test, but states that the testing verified the packaging integrity and equivalence. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of non-clinical bench testing.

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. This is for a physical medical device (guide wires), not an AI/ML system that requires expert ground truth labeling. The "ground truth" for packaging integrity is determined by established ASTM standards and objective measurements of physical properties.

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

Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses in AI/ML studies. For physical device testing like packaging integrity, "adjudication" is not a relevant concept. The results of the physical tests against pre-defined ASTM standards determine acceptance.

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 document is not about an AI-powered device, and therefore no MRMC study for AI assistance would have been conducted or is mentioned.

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

Not applicable. This document does not describe an algorithm or AI system.

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

The "ground truth" for the non-clinical testing was based on established industry standards (ASTM) for packaging integrity and sterility barrier performance. The device's packaging design and material properties were evaluated against these measurable engineering and scientific standards.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which a training set would be required.

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

Not applicable. There is no AI/ML model for which a training set's ground truth would need to be established.

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