The HydroCision ArthroJet System with Cautery, TurboBurr, and Curette is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of 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 drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and minimally invasive spinal surgeries and small and large joint arthroscopic procedures.

Device Description

The HydroCision ArthroJet System with Cautery, TurboBurr and Curette employs two basic system components to achieve its mechanism of action:

the reusable power console unit
the sterile, disposable pump cartridge, handpiece and tubing assembly.

The handpiece component of the sterile, disposable assembly is comprised of two principal components:

a high pressure fluid conduit with integral fluidjet nozzle.
a low pressure collection tube.

The high pressure conduit consists of a hollow stainless steel tube with a nozzle at the distal end. The collection tube incorporates an opening at its distal end such that the fluidjet is directed into the opening when in use. Because of the hydrodynamic design of the fluidjet/collection tube combination, the orifice serves to pull excised tissue fragments and other debris into the collection tube. Controls on the front panel allows the user to adjust the pressure, from zero to a factory pre-set limit of 15,000 psi.

AI/ML Overview

The provided 510(k) summary for the HydroCision ArthroJet System with Cautery, TurboBurr, and Curette (K041233) describes an electrosurgical cutting and coagulation device. However, it does not contain the specific information requested about acceptance criteria and a study proving device performance against those criteria in the context of AI/ML or diagnostic accuracy studies.

The document discusses substantial equivalence to a predicate device based on:

Design similarities: between the proposed system and the currently marketed HydroCision ArthroJet with Cautery, TurboBurr and Curette.
Performance testing: Stated as "Bench testing was conducted to determine device functionality and conformance to design input requirements."

This summary is typical for a traditional medical device (like a surgical tool) 510(k) submission, where the focus is on physical characteristics, mechanical function, and comparison to a predicate device, rather than the kind of diagnostic accuracy or AI/ML performance study metrics outlined in your request.

Therefore, I cannot provide the requested information for the acceptance criteria and study details as they pertain to AI/ML or diagnostic performance based on the input document.

The document does not mention:

Specific acceptance criteria with numerical targets.
Reported device performance against such criteria.
Sample sizes for test sets or training sets.
Data provenance.
Number or qualifications of experts.
Adjudication methods.
MRMC comparative effectiveness study or human reader improvement with AI.
Standalone algorithm performance.
Types or establishment of ground truth in the context of diagnostic accuracy.

Summary

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K041233

HydroCision 100 Burtt Rd. Suite G01 Andover, MA 01810 Tel: 978-474-9300 Fax: 978-474- 5037

510K Summary of Safety and Effectiveness May 5, 2004 Modification to the HydroCision, Inc. ArthroJet System with Cautery

Sponsor Name 1. HydroCision, Inc 100 Burtt Rd. Suite G01 Andover, MA 01810 Tel: 978-474-9300 Contact Individual: Debbie Iampietro
Device Name 2.

Proprietary Name:	ArthroJet Resector XT
Common/Usual Name:	Arthroscope and AccessoriesElectrosurgical Cutting and Coagulation Device andAccessories
Classification Name:	Arthroscope and AccessoriesElectrosurgical Cutting and Coagulation Device andAccessories

Identification of Legally Marketed Device 3.
HydroCision ArthroJet with Cautery, TurboBurr and Curette, K032529
Device Description 4.
The HydroCision ArthroJet System with Cautery, TurboBurr and Curette employs two basic system components to achieve its mechanism of action:
the reusable power console unit ●
the sterile, disposable pump cartridge, handpiece and tubing assembly .

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The handpiece component of the sterile, disposable assembly is comprised of two principal components:

a high pressure fluid conduit with integral fluidjet nozzle .
a low pressure collection tube. .

5. Intended Use

This is the same intended use as the currently marketed HydroCision ArthroJet System with Cautery, TurboBurr, and Curette.

6. Comparison of Technological Characteristics

Substantial equivalence of the HydroCision ArthroJet System with Cautery, TurboBurr and Curette is based on:

1. Design similarities between the proposed System and the currently marketed HydroCision ArthroJet with Cautery, TurboBurr and Curette
1. Performance testing. The proposed and currently marketed HydroCision ArthroJet with Cautery, TurboBurr and Curette are very similar in terms of size, materials of construction, performance characteristics, and basic design. The differences have no effects on the performance or safety of the HydroCision ArthroJet System with Cautery, TurboBurr and Curette.

7. Performance Testing

Bench testing was conducted to determine device functionality and conformance to design input requirements.

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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 or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 28 2004

HydroCision, Inc. c/o Ms. Debbie Iampietro ORC Consulting 7 Tiffany Trail Hopkinton, Massachusetts 01748

Re: K041233

Trade/Device Name: HydroCision ArthroJet System with Cautery, TurboBurr, and Curette Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: June 25, 2004 Received: June 29, 2004

Dear Ms. Iampietro:

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 - Ms. Debbie Iampietro

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. 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 from the Division of Small Marv Sacturers, 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,

Miriam C. Provost

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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Indications for Use

510(k) Number (if known): K041233

Device Name: HydroCision ArthroJet System with Cautery, TurboBurr, and Curette

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Provost

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

510(k) Number_K041233

Page 1 of

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.