The Mitek EXOJET* system is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures.

Device Description

Mitek's EXOJET Tissue Management System consists of reusable power control unit; sterile, disposable pump cartridge and tubing assembly, and sterile, disposable handpieces. It provides the same functions as the predicate device including cutting, evacuation, and electrocauterization. The various handpieces are designed to provide the additional functions of cutting, drilling, reaming, decorticating, and smoothing of bone The handpiece includes a rotating burr, which is driven by a liquid-jet driven motor. It is also available with a variety of burrs and drills.

AI/ML Overview

The EXOJET Tissue Management System is a medical device for orthopedic surgical procedures performing functions such as cutting, evacuation, and electrocauterization. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML device.

Therefore, the requested information for acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance, cannot be extracted from this document. The document describes a traditional medical device (arthroscope and accessories) and its functions, and its FDA clearance process through substantial equivalence. There is no mention of any AI/ML components or associated performance metrics like sensitivity, specificity, or AUC, nor any studies evaluating such performance with human readers.

Below is a table summarizing the information that can be extracted or inferred from the provided text, primarily regarding the device and its regulatory clearance process, rather than AI/ML-specific performance studies.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Device Description: The device provides cutting, evacuation, and electrocauterization functions.	The EXOJET Tissue Management System provides these functions, including additional functions of cutting, drilling, reaming, decorticating, and smoothing of bone via various handpieces and a liquid-jet driven motor.	This is a functional description, not a performance metric with a pass/fail threshold.
Indications for Use: Indicated for orthopedic surgical procedures requiring cutting and removal of soft tissue, hard tissue, or bone, and control of bleeding. Specific functions include cutting, ablation, shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in various arthroscopic procedures.	The Mitek EXOJET system is indicated for these specified procedures and functions.	This is an intended use statement, not a performance metric. The 510(k) process determined substantial equivalence for these indications.
Biocompatibility: Device must be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.	Biocompatibility studies demonstrated the EXOJET Tissue Management System to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.	This is a safety criterion, and its fulfillment is stated. No specific numerical thresholds or detailed study results are provided, typical for a 510(k) summary where only a statement of compliance is given after testing.
Substantial Equivalence: Device must be substantially equivalent to a legally marketed predicate device.	The EXOJET Tissue Management System was found substantially equivalent to the Hydrocision ARTHROJET System with Cautery and TurboBurr (K020688, K002764, K993009, K982266).	This is the primary regulatory "acceptance criterion" for 510(k) clearance. The FDA's letter states the device is substantially equivalent to the predicate.

As for the specific points related to AI/ML device studies:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document does not describe an AI/ML study.
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. For biocompatibility, the "ground truth" would be results from standard biocompatibility tests. For functional equivalence, it would be direct comparison to the predicate device.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided text is for a conventional medical device seeking 510(k) clearance, not an AI/ML-powered device. Therefore, the specific criteria and study details requested, which are pertinent to AI/ML performance evaluation, are not present. The "study" referenced in the document implicitly refers to the testing and comparisons performed to establish substantial equivalence and biocompatibility, as required for a 510(k) submission, rather than a clinical performance study with statistical endpoints for an AI/ML algorithm.

Summary

{0}------------------------------------------------

MAY 3 0 2003

SECTION 2 – 510(k) SUMMARY

EXOJET Tissue Management System

Submitter's Name andAddress:	Mitek Worldwidea division of ETHICON Inc.a Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062
Contact Person	Sergio J. Gadaleta, Ph.D.Manager, Regulatory AffairsMitek Worldwidea division of ETHICON Inc.a Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062Telephone:781-251-2018Facsimile:781-278-9578e-mail:sgadalet@ethus.jnj.com
Name of Medical Device	Classification Name:Arthroscope and AccessoriesCommon/Usual Name:Arthroscope and AccessoriesProprietary Name:EXOJET Tissue Management
Substantial Equivalence	EXOJET Tissue Management System is substantially equivalent to:Hydrocision ARTHROJET System with Cautery and TurboBurrK020688, K002764, K993009, K982266 – Distributed by MitekWorldwide a division of Ethicon, Inc., a Johnson & JohnsonCompany, 249 Vanderbilt Avenue, Norwood, MA 02062 andmanufactured by Hydrocision Inc., 100 Burtt Road G01, Andover,MA 01810.
Device Classification	Arthroscopes and accessories are classified by FDA as a Class IIMedical Devices under the generic category of Arthroscope(reference 21 CFR §888.1100), product code HRX.

{1}------------------------------------------------

Mitek's EXOJET Tissue Management System consists of reusable Device Description power control unit; sterile, disposable pump cartridge and tubing assembly, and sterile, disposable handpieces. It provides the same functions as the predicate device including cutting, evacuation, and electrocauterization. The various handpieces are designed to provide the additional functions of cutting, drilling, reaming, decorticating, and smoothing of bone The handpiece includes a rotating burr, which is driven by a liquid-jet driven motor. It is also available with a variety of burrs and drills. The Mitek EXOJE T* system is indicated for orthopedic surgical Indications for Use procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures. Biocompatibility studies have demonstrated the EXOJET Tissue Safety Management System to be non-toxic, non-irritating, nonsensitizing, and non-cytotoxic.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other to form a single shape. The profiles are enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the upper half of the circle.

MAY 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sergio J. Gadaleta, Ph.D. Manager, Regulatory Affairs Mitek Worldwide a division of Ethicon. Inc. 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K031406

Trade/Device Name: EXOJET Tissue Management System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 2, 2003 Received: May 20, 2003

Dear Dr. Gadaleta:

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.

{3}------------------------------------------------

Page 2 - Sergio J. Gadaleta, Ph.D.

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 marketed predicate device results in 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), 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) you may obtain. 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.

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

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: EXOJET Tissue Management System

Indications for Use:

for Mark A. Millerson
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number _K031406

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use__

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.