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Arthroscopic devices reprocessed by MEDISISS include burs and blades at the end of a long rod that rotates within a hollow stainless steel housing. The housing has an opening on one side of the distal end, allowing the cutting tip to resect tissue while protecting adjacent material with the housing on the opposite side of the bur or blade. This system attaches to a motorized hand piece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site. Devices are provided sterile.

AI/ML Overview

The provided document describes the 510(k) Notification for "MEDISISS Reprocessed Arthroscopic Shavers and Burs". This is a medical device submission, and the content suggests it is not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device testing and performance metrics (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance, effect size of human improvement with AI) are not applicable.

However, I can extract information related to the device's performance testing and substantial equivalence.

Here's the closest representation of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Technological Characteristics)	Reported Device Performance
Substantially equivalent to predicate devices in functionality and similar indications for use.	The technological characteristics of the subject devices are substantially equivalent to the predicate devices listed in this submission. The subject devices have the same functionality and very similar indications as the predicate devices.
Functional characteristics evaluated and found equivalent to predicate devices.	The functional characteristics of the subject devices have been evaluated and found to be equivalent to the predicate devices.
Patient-contacting materials either identical to predicate devices or fully evaluated for biocompatibility and functionality.	The patient contacting materials are either identical to the materials of the predicate devices, or have been fully evaluated for biocompatibility and functionality.
Overall conclusion of substantial equivalence based on indications, technological characteristics, and performance data.	Based on comparison of the indications for use, technological characteristics, and performance data to the predicate devices, MEDISISS Reprocessed Arthroscopic Shavers and Burs have been shown to be substantially equivalent to the predicate devices.

Regarding the study that proves the device meets the acceptance criteria:

The document states: "Performance Testing: The functional characteristics of the subject devices have been evaluated and found to be equivalent to the predicate devices. The patient contacting materials are either identical to the materials of the predicate devices, or have been fully evaluated for biocompatibility and functionality."

This indicates that internal performance testing and biocompatibility evaluations were conducted to demonstrate equivalence to the predicate devices. The specific details of these studies (e.g., protocols, raw data, statistical analysis) are not present in this summary but would have been part of the full 510(k) submission.

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

Sample size: Not specified in the provided summary.
Data provenance: Not specified in the provided summary. This would likely involve testing of reprocessed devices against new predicate devices, or comparison of properties.

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 as this is not an AI/ML medical device and does not involve ground truth establishment by experts in the context of diagnostic interpretation.

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

Not applicable for this type of device submission.

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 as this is not an AI/ML medical device submission.

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

Not applicable as this is not an AI/ML medical device submission.

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

For the "Performance Testing" mentioned, the "ground truth" or reference standard would be the characteristics and performance of the original, new predicate devices. Equivalence was shown through direct comparison of functional properties and material characteristics, rather than diagnostic "ground truth."

8. The sample size for the training set

Not applicable as this is not an AI/ML medical device submission.

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

Not applicable as this is not an AI/ML medical device submission.

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