The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:

Knee

Meniscectomy
Lateral Release
Chondroplasty
Synovectomy
ACL Debridement
Plica Removal
Meniscal Cystectomy

Ankle

Fracture Debridement
Excision of Scar Tissue
Synovectomy
Chondroplasty

Wrist

Synovectomy
Cartiledge Debridement
Fracture Debridement

Shoulder

Labral Tear Resection
Synovectomy
Excision of Scar Tissue
Acromioplasty
Bursectomy
Subacromial Decompression
Chondroplasty

Elbow

Synovectomy
Tendon Debridement
Chondroplasty

Device Description

The Ablator Electrode is packaged in a kit containing an Electrode, pencil, and a Ablator electrosurgical dispersive pad. The electrode will also be individually. The electrode is connected sold to an electrosurgical generator via the electrosurgical pencil.

AI/ML Overview

This document is a 510(k) summary for the Linvatec Ablator Electrode, submitted to the FDA for market clearance. It primarily focuses on demonstrating substantial equivalence to previously marketed devices and outlining the device's intended use.

Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data analysis, particularly regarding AI/algorithm performance. The testing mentioned in this document is simply to prove safety and effectiveness for substantial equivalence, not to quantify specific performance metrics for an AI device.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving a device meets them with the provided input. This is not an AI/algorithm-enabled medical device submission.

However, I will address each point based on the information that would typically be present in such a submission if it were for an AI/algorithm device, noting its absence here.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable.
This document describes a conventional electrosurgical electrode, not an AI-powered device. Therefore, there are no specific numerical acceptance criteria for algorithm performance (e.g., sensitivity, specificity, AUC) or reported performance metrics against such criteria. The "performance" mentioned relates to the physical device's safety and effectiveness in its intended surgical applications, typically demonstrated through engineering tests, biocompatibility, and comparison to predicates.

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

Not applicable.
No "test set" in the context of AI/algorithm evaluation is mentioned. The document references "Testing has been done to prove safety and effectiveness of the devices" but provides no details on the nature of this testing, sample sizes, or data provenance.

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

Not applicable.
No "experts" for establishing ground truth of an imaging or diagnostic dataset are mentioned. Ground truth derivation is not relevant for this type of conventional surgical device.

4. Adjudication Method for the Test Set

Not applicable.
No adjudication method is mentioned as there is no test set or ground truth determination in the context of an AI/algorithm.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable.
No MRMC study was conducted. This device is not an AI-assisted diagnostic or interpretative tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable.
There is no standalone algorithm performance to measure, as this is a physical medical device.

7. The Type of Ground Truth Used

Not applicable.
No ground truth is used for this device as it is not an AI/algorithm-enabled device.

8. The Sample Size for the Training Set

Not applicable.
No training set is mentioned as there is no AI/algorithm in this device.

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

Not applicable.
No ground truth for a training set is established, as there is no AI/algorithm in this device.

Summary of the Document's Contents Regarding "Performance":

The document focuses on:

Device Description: The Ablator Electrode is packaged in a kit, connected to an electrosurgical generator via a pencil, and sold individually.
Intended Use: General surgical use for resection, ablation, excision of soft tissue, hemostasis, and coagulation in various arthroscopic procedures (knee, ankle, wrist, shoulder, elbow).
Substantial Equivalence: The key regulatory pathway chosen. The device is claimed to be substantially equivalent in design, function, and intended use to existing predicate devices: ESA Electrodes (Linvatec), ArthroCare® Electrosurgery System 2000 (ArthroCare), and VAPR™ (Mitek Products).
Safety and Effectiveness: The document states, "Testing has been done to prove safety and effectiveness of the devices." However, it does not provide details of these tests, specific performance metrics, or acceptance criteria. This "testing" is typically non-clinical (e.g., electrical safety, biocompatibility, mechanical strength), and comparison to predicate devices, rather than clinical trials with defined performance endpoints.

Summary

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Image /page/0/Picture/1 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 stylized diamond with three lines inside. The word "Linvatec" is in a bold, sans-serif font.

11311 Concept Boulevard Largo, Florida 33773 727 399-5334 Fax 727 399-5264

Carol A. Weideman, Ph.D.

Director Compliance and Regulatory Affairs October 16, 1998

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 Ablator Electrode, 510(k) Number K 983653

A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

B. Company Contact

Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs

c. Device Name

Trade Name:	:	Ablator Electrode
Common Name	:	Electrode
Classification Names	:	Electrosurgical cutting andcoagulation device andaccessories, 878.4400
Proposed Class/Device :Product Code	:	Class II, 79 JOS, Electrode,Electrosurgical

D. Predicate/Legally Marketed Devices

ESA Electrodes Linvatec Corporation

ArthroCare® Electrosurgery System 2000 ArthroCare Corporation

VAPR™ Mitek Products

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Summary of Safety and Effectiveness Ablator Electrode 510(k) # October 16,1998 Page 2 of 3

E. Device Description

F. Intended Use

The Ablator Electrode is designed for general surgical use, including orthopaedic and arthroscopic applications resection, ablation, excision of soft tissue, of hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery includes the following:

Knee

1. Meniscectomy
1. Lateral Release
1. Chondroplasty
1. Synovectomy
1. ACL Debridement
1. Plica Removal
1. Meniscal Cystectomy

Ankle

1. Fracture Debridement
1. Excision of Scar Tissue
1. Synovectomy
1. Chondroplasty

Wrist

1. Synovectomy
1. Cartiledge Debridement
1. Fracture Debridement

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Intended Use (cont.)

Shoulder

1. Labral Tear Resection
1. Synovectomy
1. Excision of Scar Tissue
1. Acromioplasty
1. Bursectomy
1. Subacromial Decompression
1. Chondroplasty

Elbow

1. Synovectomy
1. Tendon Debridement
1. Chondroplasty

G. Substantial Equivalence

The Ablator Electrode is substantially equivalent in design, function and intended use to the ESA Electrodes (Linvatec Corporation), ArthroCare® Electrosurgery System 2000 (ArthroCare Corporation), and VAPR™ (Mitek Products)

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1999

Ms. Laura D. Seneff Manager, Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K983652 Trade Name: Ablator Electrode Regulatory Class: II Product Code: HRX and GEI Dated: February 16, 1999 Received: February 17, 1999

Dear Ms. Seneff:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 – Ms. Laura D. Seneff

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,

Sincerely, John,

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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Image /page/5/Picture/1 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 black diamond with three white chevrons inside. The word "Linvatec" is written in a bold, sans-serif font.

11311 Concept Boulevard Largo, Florida 33773-4908 813 392-6464

October 16, 1998

Page 1 of 2

510(k) Number (if known): K983652

Device Name: Ablator Electrode

Indications for Use:

Knee

1. Meniscectomy
1. Lateral Release
1. Chondroplasty
1. Synovectomy
1. ACL Debridement
1. Plica Removal
1. Meniscal Cystectomy

Ankle

1. Fracture Debridement
1. Excision of scar tissue
1. Synovectomy
1. Chondroplasty

Wrist

1. Synovectomy
1. Cartilage Debridement
1. Fracture Debridement

Shoulder

1. Labral Tear Resection
1. Synovectomy
1. Excision of Scar Tissue
1. Acromioplasty
1. Bursectomy
1. Subacromial Decompression
1. Chondroplasty

bn Sign-Off) of General Restorative Devices

Prescription Use
(Per 21 CFR 801.109)

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Intended Use (cont.)

Page 2 of 2

Elbow

1. Synovectomy
1. Tendon Debridement
1. Chondroplasty

(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)

(Optio

(Optional Format 1-296)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983652

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.