The currently marketed Orthosonics OSCAR Ultrasonic Cement Removal System consists of a power module which generates the ultrasonic energy and provides overall control of the device, a handpiece, and a set of cement removal probes. The primary change to the system is the addition of a laparoscopic video system, which can aid the clinician in examining the inside of the bone that is having its glue removed. This part of the system would only be used when the ultrasound-powered probes are not being used. The laparoscope and optical coupler are currently marketed medical devices. In order to make room for the video module in the main system unit of the OE3000, the ultrasonic power modules were reduced in physical size. In addition, the currently marketed device now has an optional accessory that was added to the system via a letter-to-file, without filing a new 510(k). The change involves adding a "slap hammer" that can be attached to an "extraction" probe, to aid in removal of a PMMA cement plug that is NOT firmly bonded to the endosteal interface. The Extraction Probe to be used with the slap hammer is a modified version of the piercer probe that was cleared with the original 510(k).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Orthosonics OSCAR OE3000, a device intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

It explicitly states that the device was tested against safety and EMC standards. However, the document does not contain information regarding acceptance criteria for device performance (e.g., efficacy in removing cement, accuracy of the laparoscopic system, or strength of the slap hammer) nor does it describe a study to prove such performance criteria were met.

Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices, primarily through technological characteristics and safety testing. The statement "The technological characteristics of the OSCAR OE3000 are exactly the same as those of the predicate devices" is central to its claim of substantial equivalence.

Therefore, many of the requested sections regarding performance studies, sample sizes, ground truth, and expert adjudication cannot be extracted from this document.

Here's a summary of what can be extracted:

Acceptance Criteria and Device Performance Study for Orthosonics OSCAR OE3000

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety: Device meets general requirements for safety (EN60601-1, EN60601-1-1).	"The OSCAR OE3000 was tested to the requirements of... EN60601-1, EN60601-1-1."
Electrical Safety: Device meets electrical safety requirements (EN60601-1-2).	"The OSCAR OE3000 was tested to the requirements of... EN60601-1-2."
Electromagnetic Compatibility (EMC): Device meets EMC requirements (EN60601-1-2).	"The OSCAR OE3000 was tested to the requirements of... EN60601-1-2."
Substantial Equivalence: Device has the same indications for use and target population as legally marketed predicate devices, and the same technological characteristics.	"The modified OE3000 is a medical device, and it has the same indications for use and the same target population as the legally marketed predicate devices. The modified OE3000 has the same technological characteristics as the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. The document describes testing to safety and EMC standards, and a demonstration of substantial equivalence based on technological characteristics and intended use. It does not describe a clinical performance test set with a specific sample size of subjects or data, nor does it specify data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not Applicable. As no clinical performance test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

Not Applicable. No clinical performance test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a surgical tool, not an AI diagnostic aid.

6. Standalone (Algorithm Only) Performance Study:

No. The device is a physical surgical instrument system (ultrasonic cement removal, a laparoscopic video system, and a slap hammer accessory). It is not an algorithm that performs in a standalone capacity.

7. Type of Ground Truth Used:

For Safety and EMC: The ground truth for safety and EMC testing would be the "pass/fail" criteria defined by the respective EN standards (EN60601-1, EN60601-1-1, EN60601-1-2).
For Substantial Equivalence: The ground truth for demonstrating substantial equivalence was established by comparing the device's technological characteristics, indications for use, and target population against legally marketed predicate devices (K961725, K914084, K903458, K961101) as reviewed by the FDA.

8. Sample Size for the Training Set:

Not Applicable. This is a hardware device submission, not an AI/machine learning algorithm that requires a training set. The term "training set" is not relevant in this context.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As no training set is described (see point 8), there is no ground truth establishment method for it mentioned.

Summary

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510(k) Summary

K02/5002
page 1 of 3

Orthosonics OSCAR OE3000

Common/Classification Name: Bone Cement Removal System, Product Code LZV

Orthosonics, Ltd. Bremridge House Ashburton Devon TQ137JX પિ

Contact: Michael J. R. Young, Ph.D., Prepared: May 7, 2002

A. LEGALLY MARKETED PREDICATE DEVICES

Since this premarket submission is for a device modification, obviously the currently marketed version of the Orthosonics OSCAR System for Cemented Arthroplasty Revision will serve as one predicate device (K961725).

The laparoscope and optical coupler are currently marketed devices from Precision Optics of Gardner, MA. These devices were cleared as K914084 on January 22, 1992 and K903458 on October 19, 1990.

In addition, the Cement Removal/Extraction System manufactured by Stryker Instruments (K961101) includes an accessory that in terms of hardware and function is very similar to the impact hammer accessory that is also described in the present submission.

DEVICE DESCRIPTION B.

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The primary change to the system is the addition of a laparoscopic video system, which can aid the clinician in examining the inside of the bone that is having its glue removed. This part of the system would only be used when the ultrasound-powered probes are not being used. The laparoscope and optical coupler are currently marketed medical devices. In order to make room for the video module in the main system unit of the OE3000, the ultrasonic power modules were reduced in physical size.

In addition, the currently marketed device now has an optional accessory that was added to the system via a letter-to-file, without filing a new 510(k). The change involves adding a "slap hammer" that can be attached to an "extraction" probe, to aid in removal of a PMMA cement plug that is NOT firmly bonded to the endosteal interface. The Extraction Probe to be used with the slap hammer is a modified version of the piercer probe that was cleared with the original 510(k). Even though an accessory to a Class II device would normally be itself a Class II device that requires a 510(k), in this case the accessory, the slap hammer, is separately classified as a Class I device (Orthopedic Manual Surgical Instrument, 21 CFR 888.4540), and so did not require a 510(k).

INTENDED USE C.

The Orthosonics OSCAR OE3000 is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The modified OE3000 is a medical device, and it has the same indications for use and the same target population as the legally marketed predicate devices. The modified OE3000 has the same technological characteristics as the predicate devices. Those characteristics are described herein in sufficient detail to assure that the modified OE3000 is substantially equivalent to the predicate device.

TECHNOLOGICAL CHARACTERISTICS ແມ່

The technological characteristics of the OSCAR OE3000 are exactly the same as those of the predicate devices.

@1502 page 2 of 3

00034

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TESTING F.

The OSCAR OE3000 was tested to the requirements of the following standards:

General Requirements for Safety EN60601-1 EN60601-1-1 Electrical Safety EN60601-1-2 EMC

G. CONCLUSIONS

pre-market Substantial This has demonstrated Equivalence' as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

K OQ 1502

ge 3 of 3

00035

1 The meaning of the terms "substantial equivalence" and "substantially equivalent" as used in this 510(k) is limited to the way they are defined in, and used by FDA in accordance with, Sections 513(f)(1) and 513(l)(1) of the Federal Food, Drug, and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 2002 ועות

Orthosonics, Ltd. c/o T. Whit Athey, Ph.D. Senior Consultant Health Policy Resources Group, LLC 2305 Gold Mine Road, Suite 200 Brookeville, Maryland 20833

Re: K021502

Trade Name: OSCAR OE3000 Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: II Product Code: LZV Dated: May 8, 2002 Received: May 9, 2002

Dear Dr. Athey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - T. Whit Athey, 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 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.

Q. Mark n. Millerson

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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page 1 of 1

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): __ K02 1502

Device Name:

Indications For Use:

The OE3000 is intended to assist in the removal of polymethylmethacrylate (PMMA) bone cement during arthroplasty revision.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

KOJISU 510(k) Number ________________________________________________________________________________________________________________________________________________________________

00037

Regulation Number and Section

§ 888.4580 Sonic surgical instrument and accessories/attachments.

(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.