The ConMed Linvatec Osprey™ Drill System is intended for cutting, drilling, and manipulation of soft tissue and bone in the following applications: orthopedic, neurosurgical, spinal, cranial, otolaryngological, oral/maxillofacial, reconstructive, and plastic.

Device Description

Not Found

AI/ML Overview

The provided text describes a 510(k) summary for the ConMed Linvatec Osprey™ Drill System. A 510(k) submission is a premarket notification demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include detailed information about acceptance criteria and specific studies proving those criteria, especially in the context of AI/ML performance metrics as requested in the prompt.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert qualifications, and ground truth are not present in this document. The document focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific quantitative acceptance criteria through detailed studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. The document does not list specific quantitative acceptance criteria or detailed performance metrics in the way that would be found in a study proving algorithm performance (e.g., sensitivity, specificity, AUC thresholds). The "performance" described implicitly is the substantial equivalence to predicate devices, meaning it performs as intended and is as safe and effective.

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

Cannot be provided. The document describes a medical device, not an AI/ML algorithm that would use test sets of data. Therefore, there's no mention of sample sizes or data provenance for a test set.

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)

Cannot be provided. As above, there's no mention of a "test set" or involvement of experts to establish ground truth in the context of an algorithm's performance.

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

Cannot be provided. Not applicable to this type of device submission.

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

Cannot be provided. This is not an AI-assisted device. The document pertains to an electric surgical drill system.

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

Cannot be provided. This is not an AI algorithm.

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

Cannot be provided. Not applicable. The "ground truth" for a surgical drill system would be its mechanical and functional performance, safety, and effectiveness in surgical procedures, as demonstrated through engineering tests and comparison to predicate devices, not through expert consensus on data interpretation.

8. The sample size for the training set

Cannot be provided. There is no "training set" as this is not an AI/ML device.

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

Cannot be provided. Not applicable.

Summary based on the provided document:

The ConMed Linvatec Osprey™ Drill System is an electric surgical system, not an AI/ML powered device. The 510(k) submission process focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against specific quantitative acceptance criteria through studies with data sets, ground truth, and expert adjudication, which are typically associated with AI/ML device evaluations. Therefore, the requested information regarding acceptance criteria and study details (sample size, experts, ground truth, MRMC studies) is not found in this 510(k) summary.

Summary

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K08044

510(k) SUMMARY ConMed Linvatec Osprey™ Drill System

APR - 2 2008

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for the 510(k) Number

A. Submitter

ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

Company Contact B.

Sue F. Dauterman Regulatory Affairs Specialist (727) 399-5321 Telephone (727) 399-5264 FAX

C. Device Name

Trade Name:	ConMed Linvatec Osprey™ Drill System
Common Name:	Electric Surgical System
Classification Name:	Electric Cranial Drill Motor, 882.4360
Proposed Class/Device:	Class II
Product Code:	HBC

D. Predicate/Legally Marketed Devices

MicroPower Handpiece System	510(k) # K072706	ConMed Linvatec
Microspeed Uni Motor System	510(k) # K053526	Aesculap, Inc.
MicroAire 1000E System	510(k) # K014060	MicroAire Surgical Instruments
Anspach eMax Drill	510(k) # K011444	The Anspach Effort, Inc.
Hall® UltraPower® Drill	510(k) # K781979	Linvatec Corporation (acquiredfrom AMSCO/Hall® Surgical)

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has a ribbon-like design flowing from its beak.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ConMed Linvatec % Ms. Sue Dauterman Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773

APR - 2 2008

Re: K080444

Trade/Device Name: ConMed Linvatec Osprey™ Drill System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: II Product Code: HBC Dated: February 13, 2008 Received: February 19, 2008

Dear Ms. Dauterman:

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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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.

Mark N Millman

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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510(k) Number (if known): K 0804444

Device Name: ConMed Linvatec Osprey™ Drill System

Indications for Use:

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

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)

NitRL. Sglm
(Division Sign-Off) for mxm

Division of General, Restorative, and Neurological Devices

510(k) Number K080444

Regulation Number and Section

§ 882.4360 Electric cranial drill motor.

(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).