The OSCAR Bone Resector consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable handpiece and a range of single use cutting blades. OSCAR Bone Resector employs longitudinal mode ultrasound in conjunction with a low frequency reciprocating motion to cut and remove bone.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that it's a 510(k) summary and therefore only provides a high-level overview of the testing conducted for substantial equivalence.

It's important to note that 510(k) summaries are not designed to be comprehensive clinical study reports. They aim to demonstrate substantial equivalence to a legally marketed predicate device, often relying on non-clinical performance testing rather than extensive human clinical trials for devices like surgical instruments. Therefore, many of the requested details (like sample size for test sets, number of experts, MRMC studies, training set details) are typically not found in a 510(k) summary if they don't directly relate to demonstrating equivalence through specific design or performance comparisons.

Acceptance Criteria and Device Performance (Based on available information)

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (Implicit/Explicit)
Safety - Electrical	Compliance with UL 60601-1	Testing will be carried out prior to marketing (commitment)
Safety - Electromagnetic Compatibility (EMC)	Compliance with FCC Part 18	Testing will be carried out prior to marketing (commitment)
Performance - Bone Cutting	Faster, more controllable, cooler cut compared to predicate devices	OSCAR Bone Resector incorporates a low frequency reciprocating action making the cut quicker, more controllable and cooler than either predicate device.
Performance - Soft Tissue Collateral Damage	Reduced likelihood of soft tissue collateral damage compared to predicate devices	Particularly reducing the likelihood of soft tissue collateral damage.
General Equivalence	Technological characteristics are the same as predicate devices; performs the same function.	OSCAR Bone Resector has the same technological characteristics as the predicate devices. Performance testing was carried out for some characteristics and demonstrated equivalence.

Note on "Reported Device Performance": For a 510(k), explicit numerical performance metrics against specific acceptance criteria are often not detailed in the summary itself, particularly for non-clinical performance. The "reported performance" here is largely based on the claims made for "substantial equivalence" and the comparative advantages stated against predicate devices.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided 510(k) summary. This document primarily focuses on asserting substantial equivalence based on technological characteristics and the types of testing performed or committed to. For a device like a surgical instrument, non-clinical performance testing (e.g., in vitro bone cutting, temperature measurements) is common, but the sample sizes for such tests are not detailed here.
- Data Provenance: Not specified. It's safe to assume any performance testing would be non-clinical (laboratory-based), as no human-subject studies are mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The testing described (FCC, UL, and comparative performance claims) does not indicate a need for expert-adjudicated "ground truth" in the way a diagnostic imaging study would. The focus is on technical compliance and direct performance comparisons.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. This type of adjudication is relevant for studies involving human interpretation (e.g., radiology reads), which is not described for this device.
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:
- No. An MRMC study is not mentioned and would be irrelevant for this type of surgical instrument. This device is not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in the sense that the device's technical characteristics and performance claims (e.g., quicker cut, cooler operation, reduced soft tissue damage) are assessed independently of a human operator's skill level. The device itself is the "algorithm" and its performance is tested. However, it's not "algorithm-only" in the AI sense, but rather a standalone physical device. The tests mentioned (FCC, UL, and comparative performance) assess the device's inherent characteristics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance testing (e.g., bone cutting), the "ground truth" would be objective measurements (e.g., cutting speed, temperature, tissue damage assessment via established laboratory methods). For regulatory compliance (FCC, UL), the ground truth is adherence to the specified technical standards. No "expert consensus" or "pathology" in a diagnostic sense is mentioned.
The sample size for the training set:
- Not applicable/Not specified. This device is a mechanical surgical instrument, not an AI or machine learning model that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this device.

Summary of Limitations due to 510(k) Context:

This 510(k) summary is a regulatory document focused on demonstrating "substantial equivalence" to predicate devices, not a detailed scientific publication of a clinical trial. As such, it highlights the types of testing done (e.g., electrical, EMC, and some unspecified "performance testing") and claims of performance improvements (quicker, cooler cut, reduced collateral damage) without providing the granular data, methodology, or specific sample sizes that would be present in a comprehensive study report or clinical trial. The "acceptance criteria" are largely implied by the need to meet regulatory standards (FCC, UL) and to perform "as well as or better than" predicate devices in key areas relevant to its intended use.

Summary

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K 083830

Section 5

MAR ஜூ 0 2009

510(k) Summary

Reason for Submission
Legally Marketed Predicate Device
Device Description
Intended Use
Technological Characteristics
Substantial Equivalence Summary
Testing
Conclusions

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K 083830

. .

510(k) Summary

OSCAR Bone Resector

Common Name: Classification Name:

Product Code: Sponsor:

Ultrasonic Surgical Instrument Instrument, Surgical, Sonic And Accessory/Attachment JDX Orthosonics Ltd Bremridge House Ashburton Devon TQ13 7JX nk 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 Bone Resector.

B. LEGALLY MARKETED PREDICATE DEVICES

This premarket notification will demonstrate that the OSCAR Bone Resector is substantially equivalent to the Orthosonics OSCAR OE3000DB cleared by FDA as K051053, Hall Versipower Surgical Instrument System (K895198) and the Biomet Orthopedics Inc Ultra-Drive 3 (K031280).

C. DEVICE DESCRIPTION

D. INTENDED USE

The Orthosonics OSCAR Bone Resector is intended to be used for cutting and removal of bone in orthopedic applications.

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E. TECHNOLOGICAL CHARACTERISTICS

The basic technological characteristics of the OSCAR Bone Resector are the same as those of the predicate devices. Both OSCAR Bone Resector and Orthosonics OSCAR OE3000DB systems are designed to use ultrasound to cut bone during orthopedic surgery. The main difference is that the OSCAR Bone Resector system also incorporates a low frequency reciprocating action, similar to the Hall Versipower Plus Oscillator saw, making the cut quicker, more controllable and cooler than either predicate device, and particulary reducing the likelihood of soft tissue collateral damage.

F. SUBSTANTIAL EQUIVALENCE SUMMARY

OSCAR Bone Resector is a medical device, that uses ultrasound to cut bone. This is the same function as embraced by the predicate device.

OSCAR Bone Resector has the same technological characteristics as the predicate devices. 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2009

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

Re: K083830

Trade/Device Name: OSCAR Bone Resector Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachment Regulatory Class: II Product Code: JDX Dated: December 18. 2008 Received: December 23, 2008

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.

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

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

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

O.A. m.D. for
Mark N. Moller

Mark N. Melkerson 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): 1 083 830

Device Name: OSCAR Bone Resector

Indications For Use:

The Orthosonics OSCAR Bone Resector is intended to be used for cutting and removal of bone in orthopedic applications.

Prescription Use V (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)

Neil R.C. Glesner

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

Page 1 of 1

083830 510(k) Number

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.

Acceptance Criteria and Device Performance (Based on available information)

Study Details

K 083830

Section 5

MAR ஜூ 0 2009

510(k) Summary

Contents

K 083830

510(k) Summary

A. REASON FOR SUBMISSION

B. LEGALLY MARKETED PREDICATE DEVICES

C. DEVICE DESCRIPTION

D. INTENDED USE

E. TECHNOLOGICAL CHARACTERISTICS

F. SUBSTANTIAL EQUIVALENCE SUMMARY

G. TESTING

H. CONCLUSIONS

Public Health Service

Indications for Use

§ 888.4580 Sonic surgical instrument and accessories/attachments.