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The DePuy OrthoTech Spiked Washer is intended for use with a 6.5mm cancellous thread or a 4.5mm cortical thread low profile head screw for fixation of soft tissue, such as tendon and ligaments, to bone in orthopaedic procedures.

The DePuy OrthoTech Spiked Washer is a circular device with eight inferior (fixative surface) spikes and a central hole for screw insertion. The DePuy OrthoTech Spiked Washer is manufactured from polyacetal polymer and is available in two outer diameters, 8mm and 13.5mm.

The provided text is a 510(k) premarket notification for a medical device called the DePuy OrthoTech Spiked Washer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable to the information contained in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify "acceptance criteria" in the sense of predefined thresholds for performance metrics from a clinical study. Instead, the "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices. The "reported device performance" is a comparison of its design, material, and intended use with the predicate devices.

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

• Sample Size: Not applicable. This submission is not based on a clinical test set with human or animal subjects that would have a "sample size." It relies on a comparison of device characteristics.
• Data Provenance: Not applicable. The data primarily consists of design specifications and regulatory information for the proposed device and its predicates.

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

• Not applicable. There was no "test set" in the traditional sense of a dataset requiring expert interpretation. The ground truth is established by the design specifications and technical characteristics of the devices themselves.

4. Adjudication method for the test set

• Not applicable. No adjudication method was used as there was no test set requiring interpretation or consensus among experts.

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 is not an AI-assisted device and no MRMC study was conducted.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" in this context is the design specifications, material composition, and stated intended use of the DePuy OrthoTech Spiked Washer and its identified predicate devices (Smith-Nephew Acufex® Tibial Anchor Screw & Spiked Washer and Synthes® Spiked Washer). Substantial equivalence is established by comparing these fundamental attributes.

8. The sample size for the training set

• Not applicable. There is no training set in the context of this 510(k) submission.

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

• Not applicable. There is no training set for which ground truth would need to be established.

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