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Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.

Reprocessed Used Disposable Arthroscopic Blades and Burs are single use surgical devices used for resection of tissue within joint spaces under arthroscopic control. MDS Reprocessed Stryker and Dyonics Disposable Arthroscopic Blades Burs are composed of the same materials as currently marketed hand-manipulated Stryker and Dyonics Disposable Arthroscopic Blades/Burs sold new.

The provided text is a 510(k) summary for the reprocessing of used, disposable arthroscopic blades and burs. It focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, performance studies, or data related to AI or ground truth establishment.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, or information about MRMC, standalone, or AI studies based on the provided document. The document is about a reprocessed medical device, not an AI/ML-driven device, and does not describe any such studies.

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Arthroscopic blades and burs are indicated for resection of tissue within joint spaces under arthroscopic control.

Arthroscopic blades and burs are single use instruments consisting of several tubes and designs. The inner blade rotation is driven by a motor. AMI intends to reprocess arthroscopy blades and burs. Reprocessing includes all the steps performed to make a contaminated single use device patient ready. Only dispossible, non angled arthroscopy blades and burs manufactured by Dyonics and Stryker, that are currently sold on the market (which have met premarket requirements by the original manufacturer for single use) will be reprocessed by AMI.

This is a 510(k) summary for Adven Medical, Inc.'s reprocessed used disposable arthroscopic blades and burs (K012694). This document pertains to the regulatory clearance of a reprocessed medical device, not a new AI-powered diagnostic or treatment device. Therefore, much of the information typically requested for AI/ML device studies (such as diagnostic accuracy metrics, MRMC studies, or training/test set details) is not applicable here.

The core of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared predicate device, asserting that the reprocessed devices remain safe and effective for their intended use after reprocessing.

Here's an attempt to address the requested information based on the provided text, noting where specific AI/ML-related questions are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this submission are primarily focused on demonstrating that the reprocessed devices:

• Can withstand the necessary cleaning and sterilization process.
• Do not have their physical characteristics or quality adversely affected.
• Remain safe and effective for their intended use.
• Are substantially equivalent to the new, legally marketed predicate device.

The document does not provide a table with quantitative performance metrics typical for new device clearances. Instead, it relies on the assertion that the reprocessed product is substantially equivalent to a cleared predicate.

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

The document does not specify a "test set" in the context of performance data, as would be expected for a diagnostic or AI device. The submission focuses on the reprocessing protocol (Protocol Number 40006) for commercially available devices. The data provenance would relate to the validation of this reprocessing protocol, but specific numbers or details are not provided in this summary.

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

Not applicable. This is not a study assessing the diagnostic accuracy or performance of an AI model with ground truth established by experts.

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

Not applicable.

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 not an AI-powered tool for human readers.

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

Not applicable.

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

The "ground truth" for this type of submission is the demonstrated safety and effectiveness of the original, new single-use device (the predicate device, Smith & Nephew Dyonics K953695) and the evidence that the reprocessing protocol maintains these characteristics. This is achieved through validation of the cleaning, sterilization, and functional integrity after reprocessing, rather than a diagnostic "ground truth."

8. The sample size for the training set

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

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

Not applicable.

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