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The ACTAEON™ Probe arthroscopic cartilage stiffness tester is indicated for an arthroscopic in vivo point measurement of articular cartilage stiffness in humans. The ACTAEON™ Probe can be used arthroscopically or in open joint procedures.

The ACTAEON™ Probe is a hand-held device which when activated by the user measures the reaction force (resistance) of articular cartilage against a known rate and force of indentation applied by the disposable indenting tip of the device.

This document does not contain the detailed information necessary to complete all sections of your request. The provided text is a 510(k) summary for the ACTAEON™ Probe, which focuses on regulatory approval based on substantial equivalence to a predicate device, rather than a detailed study report describing acceptance criteria and device performance.

Here's what can be extracted and what is missing:

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

Unfortunately, the provided text does not include a table of acceptance criteria or specific reported device performance metrics. The summary states that "The ACTAEON™ Probe is designed to meet and comply with all sections of IEC 60601," which refers to electrical safety standards, not performance criteria for measuring cartilage stiffness.

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 available in the provided text. A 510(k) summary primarily focuses on demonstrating substantial equivalence, and often such detailed clinical study information is not included in this document type unless a specific performance study was required.

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 information is not available in the provided text.

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

This information is not available in the provided text.

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

The ACTAEON™ Probe is described as an "arthroscopic cartilage stiffness tester," which is a physical measurement device, not an AI or imaging diagnostic tool that would typically involve "human readers" or "AI assistance" in the sense of image interpretation. Therefore, an MRMC study as you've described it is not applicable to this device.

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

This concept is not applicable to this device. The device is a physical probe that measures stiffness; it's not an algorithm operating in a standalone capacity. The human user operates the device.

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

This information is not available in the provided text. For a device measuring stiffness, ground truth would typically come from comparative mechanical measurements or correlation with pathological findings, but the document does not elaborate on this.

8. The sample size for the training set

This information is not available in the provided text. Since this is not an AI/machine learning device, the concept of a "training set" for an algorithm, as commonly understood in modern AI development, is not applicable here. If "training set" refers to calibration or development data for the physical probe, that information is not provided.

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

This information is not available in the provided text and is not applicable in the context of AI/ML training as defined by your request.

Summary of what is available from the document:

• Device: ACTAEON™ Probe, an arthroscopic cartilage stiffness tester.
• Intended Use: For arthroscopic in vivo point measurement of articular cartilage stiffness in humans, usable arthroscopically or in open joint procedures.
• Predicate Device: Artscan 200 Arthroscopic Cartilage Stiffness Tester from Artscan Oy. Helsinki. Finland.
• Regulatory Basis: Substantial equivalence to the predicate device.
• Stated Compliance: Designed to meet and comply with all sections of IEC 60601 (electrical safety).

The provided text serves as a regulatory summary for device clearance, not a detailed technical report of a performance study.

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