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.

Summary

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012640

Medical Instruments Technology, Inc's. Reprocessed Electrosurgical Wand Premarket Notification

Medical Instruments Technology™

FEB 2 8 2002

Quality Reprocessing and Surgical Cost Containmen

Section 12: 510k Summary

Name of Submitter

Medical Instruments Technology, Inc. 385 North 3050 East Saint George, UT 84790 Tel: (435) 674-4010 Fax: (435) 674-9819

Contact persons

Tom Haueter, RA/QA Manager Crystal Batcabe, Assistant RA/QA Manager

Summary Prepared August 10, 2001

Device Name and Classification

Common Name: Electrosurgical Cutting and Coagulation Accessories, Electrosurgical Wands Classification: Class II per 21 CFR 878.4400

Predicate Device

MIT's reprocessed electrosurgical cutting and coagulation accessories are substantially equivalent to: Mitek (K974022) or Arthrocare Wands (K962321)

Description of Device

Intended Use

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. They are supplied sterile.

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Medical Instruments Technology, Inc's. Reprocessed Electrosurgical Wand Premarket Notification

Technological Characteristics

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. The only material change, that MIT does make, it that of the sheathing. The sheathing is replaced, because the original sheathing would be damaged in the reprocessing procedures. The replacement sheathing is substantially equivalent to the original sheathing, and actually acts as a better electrical insulator as shown in the dielectric test.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three horizontal lines below the eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 8 2002

Mr. John P. Batcabe Development Manager Medical Instruments Technology, Inc. 385 North 3050 East Saint George, Utah 84790

Re: K012640

Trade/Device Name: Reprocessed Electrosurgical Wand Regulation Number: 888.1100, 878.4400 Regulation Name: Arthroscope Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: HRX, GEI Dated: December 4, 2001 Received: December 11, 2001

Dear Mr. Haueter:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. John P. Batcabe

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicated. " a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
-Mark N. Milhux

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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012640

Medical Instruments Technology, Inc's. Reprocessed Electrosurgical Wand Premarket Notification

Section 3: Indications for Use

Intended Use:

MIT 's unique reprocessing of the wands does not change their intended use. 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.

Mark N Millman

(Division Sign-Off) Division of General, Restorative and Neurological Devices KO126.40

510(k) Number_

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.