The UltrAblator Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Areas of application include knee, shoulder, ankle, wrist and elbow arthroscopic procedures.

Device Description

The UltrAblator Electrode is a sterile, single-use monopolar electrode that is connected to an electrosurgical generator via an electrosurgical pencil. The modification to the UltrAblator Electrode described in this 510(k) is a change to the insulation material. This modification does not affect the indications for use, operational instructions, performance specifications or labeling.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the UltrAblator Electrode. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics in the way one might find for a novel diagnostic or AI-based device.

Here's a breakdown of the information requested, based on the provided text, and where gaps exist due to the nature of the document:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the form of a table. Instead, it makes a general claim:

Acceptance Criteria (Implied)	Reported Device Performance
No new issues regarding safety and effectiveness compared to predicate device	"Performance testing has been conducted to show that the new design does not raise any new issues regarding safety and effectiveness." (Page 2)
Maintenance of original performance specifications	"This modification does not affect the indications for use, operational instructions, performance specifications or labeling." (Page 2)

Since this is a modification to an existing device (a change in insulation material), the focus is on maintaining the established safety and effectiveness of the existing device. There aren't new performance claims that require specific, quantifiable acceptance criteria to be met.

2. Sample sized 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 the sample size for any test set or the data provenance. It only mentions "performance testing."

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)

This information is not applicable and is not provided. The device is an electrosurgical electrode, and its "performance testing" would likely involve engineering and biocompatibility evaluations, not ground truth established by medical experts in the context of diagnostic interpretation.

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

This information is not applicable and is not provided. Adjudication methods are typically relevant for studies involving subjective interpretation, often in diagnostic imaging or clinical trials, which is not the nature of this 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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices. The UltrAblator Electrode is a surgical tool, not a diagnostic AI.

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

This information is not applicable. The device is a physical surgical electrode, not an algorithm.

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

This information is not provided. Based on the nature of the device (electrosurgical electrode), "ground truth" would likely relate to engineering specifications (e.g., insulation integrity, electrical performance) or biocompatibility testing results rather than clinical diagnoses.

8. The sample size for the training set

This information is not applicable and is not provided. There is no mention of a training set as this is not an AI/machine learning device.

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

This information is not applicable and is not provided. There is no training set for this type of device.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The document states, "Performance testing has been conducted to show that the new design does not raise any new issues regarding safety and effectiveness." (Page 2). It also emphasizes that the modification (change to insulation material) "does not affect the indications for use, operational instructions, performance specifications or labeling" (Page 2).

This implies that the study conducted was a benchtop or laboratory performance test aimed at confirming that the new insulation material does not negatively impact the established performance and safety characteristics of the original UltrAblator Electrode. Specifically, the study would have focused on ensuring that the new insulation material maintained:

Electrical isolation properties: To ensure safe and effective energy delivery without leakage or unintended arcing.
Biocompatibility: To ensure the material is safe for contact with human tissue.
Mechanical integrity: To ensure the insulation remains intact during use.
Thermal properties: To ensure proper heat dissipation and prevent overheating.

The study's primary objective was to demonstrate substantial equivalence to the predicate device, meaning it performs similarly and presents similar safety and effectiveness profiles. The nature of the device (a surgical electrode with a material change) means the "study" would be a series of engineering and material science tests, not a clinical trial or an AI validation study.

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 made up of three overlapping diamonds, with the innermost diamond being solid black and the other two being outlined in black. The word "Linvatec" is written in a bold, sans-serif font.

Largo, FL 33773-4908 727-392-6464 11311 Concept Boulevard

March 6, 2003

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 UltrAblator Electrode 510(k) Number_ K030720

Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

B. Company Contact

Laura D. Seneff, RAC Manager, Requlatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX

C. Device Name

Trade Name: UltrAblator Electrode

Common Name: Electrode

Electrosurgical cutting and coagulation Classification Names: device and accessories, 878.4400

Proposed Class/Device: Class II Product Code: JOS & GEI

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Summary of Safety and Effectiveness UltrAblator Electrode 510(k) # K 0 30720 March 6, 2003 Page 2 of 2

Predicate/Legally Marketed Devices D.

UltrAblator Electrode Kaasaar Linvatec Corporation

E. Device Description

The UltrAblator Electrode is a sterile, single-use monopolar electrode that is connected to an electrosurgical generator via an electrosurgical pencil.

The modification to the UltrAblator Electrode described in this 510(k) is a change to the insulation material.

This modification does not affect the indications for use, operational instructions, performance specifications or labeling.

F. Intended Use

The UltrAblator Electrode is intended to be used in arthroscopic applications of resection, ablation, tissue modification, excision of soft tissue, hemostasis of blood vessels and in coaqulating soft tissues. Areas of application include knee, shoulder, ankle, wrist and elbow arthroscopic procedures.

G. Substantial Equivalence

The UltrAblator Electrode is substantially equivalent in design, technology and intended use to Linvatec's existing UltrAblator Electrode. Performance testing has been conducted to show that the new design does not raise any new issues regarding safety and effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and professional, reflecting the department's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2003

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

Re: K030720

Trade/Device Name: UltrAblator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, JOS Dated: May 9, 2003 Received: May 13, 2003

Dear Ms. Seneff:

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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Page 2 - Ms. Laura D. Seneff, RAC

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 Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

uriam C. Provost

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

Enclosure

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March 6, 2003

510(k) Number (if known): K030720

Device Name: UltrAblator Electrode

Indications for Use:

Muriam C. Provost

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

510(k) Number K030720

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use Prescription Use_ OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.