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The Implex Screw and Washer System is indicated for use in the attachment of ligaments, tendons and other soft tissue to bone.

The Implex Screw and Washer System consists of the Implex Continuum Bone Screw configured with a Hedrocel®/CP titanium Washer. The Implex Continuum Bone Screw has a 5 mm diameter and is offered in lengths from 15 to 65 mm, in 5 mm increments. The Washer is offered in two versions. Washer-A and Washer-A has a flat tissue-contacting Washer-B. surface and Washer-B has a flat tissue-contacting surface with recessed grooves. Both versions are round, and offered in three outer diameters, 14 mm, 17 mm, and 20 mm.

The provided text is a 510(k) summary for the Implex Screw and Washer System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data related to material and structural properties, rather than clinical studies involving human readers or AI.

Therefore, many of the requested elements for describing an acceptance criteria study, particularly those related to AI and human reader performance, are not applicable to this document.

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria for various performance metrics in a readily quantifiable format. Instead, it refers to a Material Approval File (MAF) and mechanical testing.

Acceptance Criteria (Inferred from Performance Data Section):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The term "test set" in the context of device performance usually refers to the specimens used for mechanical or material testing. The document states "Mechanical testing demonstrating the strength of the CP Titanium/Hedrocel® interface is included in this 510(k) Premarket Notification," but does not detail the sample size or provenance of these tests.

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)

This is not applicable as the study described is a mechanical/material performance study, not a study requiring expert interpretation of results to establish ground truth in the way clinical or AI studies do.

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

Not applicable. This concept is relevant for clinical studies or those involving human interpretation, not 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 physical implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI algorithm.

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

For the mechanical testing, the "ground truth" would be the direct physical measurement of material properties and interface strength against established engineering standards or internal specifications for safety and performance in its intended use. It is based on direct physical measurement and engineering principles.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm requiring a training set.

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