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The intended use of the cutting and coagulation accessory is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders.

Device Description

The cutting and coagulation system consists of a system controller that is connected to a power source. Two cables extend from the system controller, one to a foot-pedal to allow the operator to control the device; the other cable leads to the wand portion, which functions in the surgical site. The wand is the accessory for which MIT has developed the reprocessing technology.

AI/ML Overview

This submission (K012640) describes the reprocessing of electrosurgical wands. The document provided does not contain the detailed acceptance criteria or a study demonstrating that the reprocessed device meets such criteria in a format applicable to AI/ML device studies. This 510(k) is for a reprocessed electrosurgical wand, not an AI/ML device. Therefore, the questions regarding AI/ML device performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this submission.

However, based on the provided text, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices and adherence to general controls. The primary "study" or justification for acceptance is the assertion that the reprocessed device maintains the same technological characteristics and intended use as the original, legally marketed predicate devices.

Here's an attempt to structure the information based on the prompt, acknowledging that much of it is not relevant to a traditional AI/ML device evaluation:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Material Equivalence: The reprocessed device materials must be substantially equivalent to the original.	The only material change is the sheathing, which is replaced. The replacement sheathing is stated to be substantially equivalent and "actually acts as a better electrical insulator as shown in the dielectric test."
Technological Equivalence: The reprocessed device must have the same technological characteristics as the predicate devices.	"MIT's reprocessed electrosurgical devices have the same technological characteristics as the predicate devices. MIT does not change any of the design characteristics or materials during reprocessing."
Intended Use Equivalence: The reprocessed device must maintain the same intended use.	"MIT's unique reprocessing of the wands does not change their intended use. The intended use... is to ablate tissue and/or cauterize. The devices are indicated for use in joints such as, ankles, knees, hips, wrist, elbow, and shoulders."
Safety and Effectiveness: Implied by substantial equivalence to a legally marketed predicate device, and compliance with general controls.	Not explicitly detailed as a separate study with quantitative metrics in this summary, but the FDA's clearance implies this criterion was met. The dielectric test for the sheathing implicitly supports safety.

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

Not Applicable (N/A). This K012640 submission is for a reprocessed medical device (an electrosurgical wand), not an AI/ML diagnostic or prognostic device requiring a test set of data for performance evaluation in the usual sense. The testing mentioned (e.g., dielectric test for sheathing) would have been performed on the reprocessed physical devices.

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)

N/A. Ground truth in the context of expert consensus for AI/ML performance is not applicable to a submission for a reprocessed physical device. Device functionality and material equivalence are evaluated through engineering tests and comparison to specifications.

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

N/A. Not applicable, as there isn't a "test set" requiring expert adjudication 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

N/A. This is not an AI/ML device, so MRMC studies are not relevant.

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

N/A. This is not an AI/ML device.

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

N/A in the context of AI/ML ground truth. For this device, the "ground truth" for demonstrating equivalence would be based on:
- Predicate Device Specifications: The known design, material, and performance specifications of the original Mitek (K974022) or Arthrocare Wands (K962321).
- Engineering Tests: Such as the dielectric test mentioned for the sheathing, demonstrating specific physical properties.
- Functional Testing: Ensuring the reprocessed device performs its intended functions (ablation, cauterization) as expected.

8. The sample size for the training set

N/A. Not an AI/ML device.

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

N/A. Not an AI/ML device.

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