The Universal Drive System functions as a powered instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Otolaryngological, Oral/Maxillofacial, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.

Device Description

The Universal Drive System is a combination of the entire MicroChoice® System and component Linvatec handpieces/blades/burrs of the Apex® Universal Drive System. Both systems and their intended uses are cleared by MicroChoice 510(k) #K942660 and Apex Universal Drive System 510(k)'s #K944476 & #K964548.

The Universal Drive System consists of a AC powered drive console, a sterilizable handpiece cord, various motorized handpieces, various shavers, blades, burrs, drills, routers, and a foot switch.

The modification will take place within the MicroChoice drive console power unit software. A computer chip will be upgraded to allow additional motorized handpieces from the Apex Universal Drive system for orthopedic and arthroscopic type procedures.

Three handpieces from the Apex Universal Drive System will be modified with a detachable handpiece cord. The detachable handpiece cord will allow the "Apex style" handpieces to run on the same console as the MicroChoice original handpieces. All new handpieces will perform as described in the previous 510(k) submissions.

The accessories including shavers, blades, burrs, drills, and routers from the Apex Universal Drive System will be used in addition to the MicroChoice System accessories. The shavers will have diameters of 2.0-6.0mm and lengths of 75-200mm.

AI/ML Overview

The provided document is a 510(k) summary for the Linvatec Universal Drive System, submitted in 1997. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics described in your request.

Therefore, the document does not contain the specific information required to fill out the table and answer all the questions about acceptance criteria and a detailed study proving the device meets them. This filing process relies on bench testing and comparisons to existing devices, not typically extensive human clinical trials with endpoints like effect size or expert adjudication.

However, I can extract what is implied or directly stated regarding safety and effectiveness and the testing performed for substantial equivalence.

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

Based on the document's content, specific quantitative "acceptance criteria" are not explicitly stated in a table format, nor are detailed "reported device performance" metrics outside of general qualitative statements. The document focuses on demonstrating substantial equivalence to predicate devices. The implied acceptance criterion is that the new Universal Drive System would perform functionally similarly to the predicate devices for its intended surgical uses.

Acceptance Criteria (Implied)	Reported Device Performance (Implied from Substantial Equivalence Claim)
- Safe and Effective for intended use	- Deemed safe and effective (by FDA's 510(k) clearance)
- Functions as a powered instrument system for cutting soft tissue and bone (drills, saws, handpieces)	- Performs as described for orthopedic, arthroscopic, otolaryngological, oral/maxillofacial, hand, foot, neuro, and plastic/reconstructive surgical procedures.
- Similar design and function to predicate devices	- Similar design and function to Hall MicroChoice® Electric Powered System, Apex® Universal Drive System, TPS Total Performance System, and Adapteur Power System™.
- MicroChoice drive console software upgrade to allow additional motorized handpieces	- Computer chip upgraded; "Apex style" handpieces runnable on the same console.
- Modified Apex handpieces to have detachable cords.	- Handpieces modified with detachable cords.
- All new handpieces perform as described in previous 510(k) submissions.	- "All new handpieces will perform as described in the previous 510(k) submissions."
- Accessories (shavers, blades, burrs, drills, routers) from Apex system to be used	- Accessories from Apex system integrated; shavers 2.0-6.0mm diameter, 75-200mm length.

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

The document does not specify a "test set sample size" in terms of patient data or clinical study subjects. The testing mentioned refers to bench testing for engineering and functional verification, not clinical trials. There is no information about data provenance (country of origin, retrospective/prospective clinical data) because the submission is for device modification and substantial equivalence, not a clinical study.

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. This type of submission relies on engineering and functional testing rather than expert-established ground truth from clinical cases.

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

Not applicable. No expert adjudication method is mentioned or implied for 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

Not applicable. The device is a surgical drive system (drills, saws, handpieces), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. The device is a physical surgical instrument system, not an algorithm.

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

For this type of device, the "ground truth" for safety and effectiveness is largely based on:

Engineering specifications and performance metrics: Verifying that motor speeds, torque, vibration, material strength, sterility, and electrical safety meet predefined standards and are comparable to predicate devices.
Functional equivalence benchmarking: Testing that the modified system and new components perform surgical actions (cutting, drilling) in a manner consistent with, and as effectively as, the predicate devices.
Compliance with recognized standards: Meeting relevant industry standards for medical devices.

No clinical "ground truth" from human patients (e.g., pathology, outcomes data) is described in this 510(k) summary.

8. The sample size for the training set

Not applicable. This refers to a physical device, not a machine learning algorithm that requires a training set.

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

Not applicable. This refers to a physical device, not a machine learning algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a square with three angled lines inside.

JUN 18 1997

11311 Concept Boulevard Largo, Florida 33773 813 399-5334 Fax 813 399-5264

Carol A. Weideman, Ph.D.

Manager, Regulatory and Clincal Allans

971059

March 21, 1997

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Company Contact B.

Carol A. Weideman, Ph.D. Manager, Regulatory and Clinical Affairs

Device Name C.

Trade Name:	Universal Drive System
Common Name:	Drive System
Classification Name:	Instrument, Surgical,Orthopedic, AC Powered Motorand accessory/Attachment878.4820

Predicate/Legally Marketed Devices D.

Hall MicroChoice® Electric Powered System Linvatec Corporation

Apex® Universal Drive System Linvatec Corporation

TPS Total Performance System Stryker Endoscopy

Adapteur Power System™ Arthrex Inc.

Image /page/0/Picture/20 description: The image contains a single digit, specifically the number 4. The number is written in a simple, sans-serif font. The digit is slightly blurred, suggesting it may be a close-up or a low-resolution image.

Image /page/0/Picture/21 description: The image shows the logo for Bristol-Myers Squibb Company. On the left is a geometric design that looks like a stylized flower or star. To the right of the design is the text "A Bristol-Myers Squibb Company" in a serif font.

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Summary of Safety and Effectiveness Universal Drive System 510(k) # March 21, 1997 Page 2 of 4

Device Description E.

The Universal Drive System consists of a AC powered drive console, a sterilizable handpiece cord, various motorized handpieces, various shavers, blades, burrs, drills, routers, and a foot switch.

F. Intended Use

Drive System functions as a Universal powered The instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Otolaryngological, Oral/Maxillofacial, Arthroscopic, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.

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Summary of Safety and Effectiveness Universal Drive System 510 (k) # March 21, 1997 Page 3 of 4

G. Substantial Equivalence

The Universal Drive System is substantially equivalent in design, function and intended use to the Hall MicroChoice Electric Powered System (Linvatec Corporation), Apex Universal Drive System (Linvatec Corporation), TPS Total Performance System (Stryker Endoscopy), and Adapteur Power System™ (Arthrex Inc.).

Testing has been done to prove safety and effectiveness of the devices.

The similarities/dissimilarities to the predicates are shown in the attached table.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 18 1997

Carol A. Weideman, Ph.D. Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773

Re: K971059 Trade Name: Universal Drive System Regulatory Class: II Product Code: HRX Dated: March 21, 1997 Received: March 24, 1997

Dear Dr. Weideman:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Carol A. Weideman, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

fo selle

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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March 21, 1997 ---------------------------------------------------------------------------------------------------------------------------------------------------------------

	510(k) Number (if known) : _	r (1) - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1rest of the program and the provinsity of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of th+10 ]

Device Name: Universal Drive System__

Indications for Use:

The Universal Drive System functions as a powered instrument The onload brills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of include: Orthopedic, Arthroscopic, application Otolaryngological, Oral/Maxillofacial, Hand, Foot, Neuro, and Plastic/Reconstructive surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Om
Division of General Restorative Devices K9 71059
510(k) Number

Prescription Use √
(Per 21 CFR 801.109)

Over-the-Counter Use_

(Optional Format 1-2-96)

LINVATEC/HALL SURGICAL HWATECHPACE COMMON PORMATION PROPEMETION PROPERTIC

This information is exempt from This information is extemptions 3 and 4 disclosure under Exemption Act isclosure under Exempliation Act.
of the Freedom of Information Act.

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.