The Axya Model 100 Sonic Scalpel™ Ultrasonic Surgical System is indicated for use in endoscopic and open surgical procedures for the cutting and coagulation of soft tissue structures.

Device Description

The Sonic Scalpel™ Ultrasonic Surgical System consists of an Ultrasonic Generator / Co. Unit, a reusable handpiece that contains the ultrasonic transducer, and a family of disposable cutting / coagulation shears. The Sonic Scalpel™ shears are available with a range of shaft lengths, diameters and blade lengths as single-patient-use, sterile instruments. The shears are coupled to the reusable handpiece by means of a collar. The titanium instrument blade tip consists of one fixed blade and one movable blade. The tip may be rotated to facilitate the surgical approach. The shears are designed for cutting, coagulation and blunt dissection.

AI/ML Overview

The provided text describes the Axya Model 100 Sonic Scalpel™ Ultrasonic Surgical System and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a detailed study that proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

Instead, the submission focuses on:

Design and functional comparison: Demonstrating that the blade amplitude and temperature range are comparable to a predicate device.
In vitro and in vivo studies (summarized): Mentioning that in vitro studies evaluated blade excursion and temperature, and an in vivo study in laboratory animals evaluated efficacy, producing "similar results to the performance of typical electrosurgical systems."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I fill in most of the requested details about a study focusing on meeting specific performance metrics with a test set, expert consensus, or comparative effectiveness.

Here’s what can be extracted from the provided text based on the categories you requested:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Blade excursion (amplitude) comparable to predicate device (Ultracision)	Data presented demonstrate that the blade amplitude of the Axya Model 100 Sonic Scalpel Ultrasonic Surgical System is comparable to those parameters for the predicate Ultracision device.
Blade temperature comparable to predicate device (Ultracision)	Data presented demonstrate that the blade temperature range of the Axya Model 100 Sonic Scalpel Ultrasonic Surgical System is comparable to those parameters for the predicate Ultracision device.
Efficacy in vivo comparable to typical electrosurgical systems	In vivo study in laboratory animals indicates the system produces results similar to the performance of typical electrosurgical systems.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for any of the studies (in vitro or in vivo).
Data Provenance: The in vivo study was conducted in "laboratory animals." No country of origin is specified. The studies are by nature "retrospective" from the perspective of the FDA review, as they were completed prior to submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The studies mentioned (in vitro and in vivo) likely involved technical measurements and observations by researchers, but "experts" establishing a ground truth in the context of diagnostic performance (e.g., radiologists for imaging) is not applicable here.

4. Adjudication method for the test set

Not applicable/not specified for the types of engineering and animal studies mentioned.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical instrument, not an AI or diagnostic imaging device that would typically involve human readers.

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

Not applicable as this is a surgical instrument, not an algorithm or AI. The "standalone" performance would refer to the device's physical function, which was evaluated in the in vitro and in vivo studies.

7. The type of ground truth used

For the in vitro studies, the "ground truth" would be direct physical measurements (e.g., actual amplitude, actual temperature).
For the in vivo animal study, the "ground truth" would be the observed tissue responses (cutting, coagulation efficacy) as evaluated against the performance of "typical electrosurgical systems." No specific pathology or outcomes data is detailed.

8. The sample size for the training set

This concept (training set) typically applies to machine learning or AI models. It is not applicable to the development or testing of this physical surgical device.

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

Not applicable for the reasons mentioned in point 8.

Summary of Device Acceptance:

The device's acceptance was based on demonstrating substantial equivalence to existing legally marketed predicate devices (Ultracision Ultrasonic Scalpel and Olympus SonoSurg™ System). The studies presented were primarily to show that the Axya Model 100 Sonic Scalpel Ultrasonic Surgical System's fundamental operational characteristics (blade amplitude, temperature) and efficacy in animal models were comparable to these predicates, thus supporting its safety and effectiveness for the stated indications. The FDA's 510(k) clearance process focuses on this substantial equivalence rather than requiring extensive de novo clinical trials with specific acceptance criteria thresholds on performance metrics typically seen for diagnostic devices or novel treatments.

Summary

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KOZI929

SUMMARY OF SAFETY AND EFFECTIVENESS

General Company Information

Name:	Axya Medical, Inc.
Address:	100 Cummings CenterSuite 444CBeverly, MA 01915
Telephone:	(978) 232 - 9997
Fax:	(978) 232 - 9998

General Device Information

Product Name:	Model 100 Sonic Scalpel™ Ultrasonic Surgical System
Classification:	"Ultrasonic Surgical System", Product code: LFLClass II

Predicate Devices

Ultracision, Inc. (currently marketed by Ethicon, Inc.) Ultrasonic Scalpel [501(k) Number K895252]

Olympus Optical Co. SonoSurg™ System [510(k) Number K972114].

Description

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Indications

The Axva Model 100 Sonic Scalpel™ Ultrasonic Surgical System is indicated for use in endoscopic and open surgical procedures for the cutting and coagulation of soft tissue structures.

Substantial Equivalence

This submission supports the position that the Axya Model 100 Ultrasonic Surgical System is substantially equivalent to a number of previously cleared devices, including the Ultracision. Inc. (currently marketed by Ethicon, Inc.) Ultrasonic Scalpel [501(k) Number K895252] and the Olympus Optical Co. SonoSurg™ System [510(k) Number K9721141. These systems are designed, manufactured and tested to meet the requirements of IEC 601-1, IEC 601-1-2. CISPR11 and UL2601-1.

The 510(k) Notice contains summaries of in vitro studies that were conducted to evaluate the shears blade excursion (amplitude) at various power settings and the blade temperature over a range of operating conditions.

The data presented demonstrate that the blade amplitude and temperature range of the Axya Model 100 Sonic Scalpel Ultrasonic Surgical System is comparable to those parameters for the predicate Ultracision device.

The Notice contains a summary report of an in vivo study that evaluated the efficacy of the Ultrasonic Surgical System in laboratory animals. The results of this testing indicate that the system produces results similar to the performance of typical electrosurgical systems.

The single-patient-use shears component of the Ultrasonic Surgical System is provided sterile.

Axya Medical. Inc. believes that the information provided establishes that similar legally marketed systems have been used for the same clinical applications as the Axya Model 100 Ultrasonic Surgical System. The materials from which the Axya device is fabricated have an established history of use in medical applications.

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & H" arranged in a semi-circle on the left side of the image. To the right of the text is a symbol consisting of four curved lines that resemble a stylized human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2002

Axya Medical, Inc. Howard L. Schrayer 100 Cummings Center, Suite 444 C Beverly, Massachusetts 01915

Re: K021929

Trade/Device Name: Axya, Model 100 Sonic Scalpel™ Ultrasonic Surgical System Regulatory Class: Unclassified Product Code: LFL Dated: June 11, 2002 Received: June 12, 2002

Dear Mr. Schrayer:

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 – Mr. Howard L. Schrayer

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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" (21 CFR Part 807.97), 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,

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Axya, Model 100 Sonic Scalpel™ Ultrasonic Surgical System

Indications For Use:

The Axya Model 100 Sonic Scalpel™ Ultrasonic Surgical System is indicated for use in endoscopic and open surgical procedures for the cutting and coagulation of soft tissue structures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styt Purke

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

510(k) Number_Ko21929

Prescription Use
(Per 21 CFR 801.109)
[checkmark]

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

N/A