The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement in orthopedic applications.

Device Description

The OSCAR 3 system consists of a generator, 3 handsets, an optional trolley and a range of single use and reusable probes. The generator is effectively an integration of the OSCAR OE3000DB and OSCAR Bone Resector generators. It comprises 3 channels, 2 of which are designed to provide power to the handsets from OSCAR OE3000DB and the third channel is dedicated to provide power to the handset from the OSCAR Bone Resector. The handsets and probes are identical to those of the predicate devices.

AI/ML Overview

The provided 510(k) summary for the OSCAR 3 ultrasonic surgical instrument does not describe acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices (Orthosonics OSCAR OE3000DB and OSCAR Bone Resector).

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

Not present in the document. The 510(k) summary states that "performance testing was carried out for some characteristics" but does not provide a table of acceptance criteria or the specific performance results in terms of metrics. It only generally concludes that "The data do in fact demonstrate equivalence."

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

Not present in the document. There is no mention of sample sizes for any test sets, nor the provenance of any data (country, retrospective/prospective).

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)

Not applicable/Not present. Since a specific performance study with a "test set" and "ground truth" to evaluate diagnostic or therapeutic accuracy is not described, there's no information on experts or their qualifications for establishing ground truth. The device is a surgical instrument for cutting bone and cement, not a diagnostic tool requiring expert interpretation as ground truth.

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

Not applicable/Not present. As there's no diagnostic or interpretative "test set" described, adjudication methods are not relevant or discussed.

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

Not applicable. The device is a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

Not applicable. This device is a physical surgical instrument, not a software algorithm.

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

Not applicable/Not present. Given the nature of a surgical instrument for cutting, the concept of "ground truth" in the diagnostic sense is not directly applicable. The "testing" mentioned is likely related to engineering performance (e.g., cutting efficiency, material compatibility, electrical safety), not diagnostic accuracy. The document states "performance testing was carried out for some characteristics," but does not elaborate on the specific nature of these characteristics or how "ground truth" would be established for them.

8. The sample size for the training set

Not applicable/Not present. This device is not an AI/ML algorithm that would have a "training set."

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

Not applicable/Not present. Same as above, not relevant for an ultrasonic surgical instrument.

Summary of what is present regarding "testing":

The document mentions two types of testing that will be carried out or have been carried out:

G. TESTING:
- FCC Part 18: "Testing to FCC Part 18 will be carried out prior to marketing the device in the USA." (Electrical emissions/interference)
- UL 60601-1: "Electrical testing to UL 60601-1 will be carried out by Underwriters Laboratories before marketing the device in the USA." (Medical electrical equipment safety)
- Performance Testing for Substantial Equivalence: "performance testing was carried out for some characteristics. The data from this testing are available and are presented in this 510(k). The data do in fact demonstrate equivalence." However, the details of this performance testing, including specific acceptance criteria and results, are not included in this summary. The purpose of this testing was to confirm substantial equivalence to predicate devices, implying that the OSCAR 3 performs comparably to the devices it is replacing or integrating.

Summary

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K093805

510(k) Summary

FEB 1 9 2010

OSCAR 3

Common Name: Ultrasonic Surgical Instrument Classification Name: Instrument, Surgical, Sonic And Accessory/Attachment Product Code: JDX and LZV Sponsor: Orthosonics Ltd Bremridge House Ashburton Devon TQ13 7JX വി T: +44 1364 652426 F: +44 1364 653589

Contact:

Dr. Michael J.R. Young,

A. REASON FOR SUBMISSION

This 510(k) is being filed to obtain clearance to market the OSCAR 3.

B. LEGALLY MARKETED PREDICATE DEVICES

This premarket notification will demonstrate that the OSCAR 3 is substantially equivalent to the Orthosonics OSCAR OE3000DB cleared by FDA as K051053 and the Orthosonics OSCAR Bone Resector (K083830).

C. DEVICE DESCRIPTION

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D. INTENDED USE

The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and polymethylmethacrylate (PMMA) bone cement in orthopedic applications.

E. TECHNOLOGICAL CHARACTERISTICS

The basic technological characteristics of the OSCAR 3 are the same as those of the predicate devices. Both OSCAR 3 and Orthosonics OSCAR OE3000DB systems are designed to use ultrasound to cut bone and bone cement during orthopedic surgery. The main difference is that the OSCAR 3 system also incorporates the ability to drive the handset from the OSCAR Bone Resector. In addition an optional dedicated trolley can be supplied for use with the OSCAR 3.

F. SUBSTANTIAL EQUIVALENCE SUMMARY

OSCAR 3 uses the same handsets and the same probe range in the same mode as the predicate devices. It has the same intended use as the OSCAR OE3000DB.

However, the descriptive characteristics may not be sufficiently precise to assure substantial equivalence. Therefore, performance testing was carried out for some characteristics. The data from this testing are available and are presented in this 510(k). The data do in fact demonstrate equivalence.

G. TESTING

Testing to FCC Part 18 will be carried out prior to marketing the device in the USA. Electrical testing to UL 60601-1 will be carried out by Underwriters Laboratories before marketing the device in the USA.

H. CONCLUSIONS

This premarket notification has demonstrated substantial 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.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

FEB 1 9 2010

Orthosonics Ltd. % Michael J.R. Young, Ph.D. Managing Director Bremridge House Ashburton Devon TQ13 7JX, United Kingdom

Re: K093805

Trade/Device Name: OSCAR 3 Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: Class II Product Code: JDX, LZV Dated: December 07, 2009 Received: December 11, 2009

Dear Dr. Young:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Michael J.R. Young, Ph.D.

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

ACTING
DSORD DIR.

FOR Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K 093805

Device Name: OSCAR 3

Indications For Use:

The Orthosonics OSCAR 3 is intended to be used for cutting and removal of bone and acrylic bone cement in orthopedic applications.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

FOR M. MELKERSON

(Div ion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of

510(k) Number K093805

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.