The Sonnet™ Polypectomy Snare consists of a 240cm catheter attached to a handle at the proximal end and incorporates a braided stainless steel wire in a loop configuration that is attached to a stainless steel drive-wire and is extendable and retractable with respect to the catheter distal tip. The handle provides an active cord connection. The catheter has a single lumen.

AI/ML Overview

The provided document is a 510(k) summary for the Sonnet™ Polypectomy Snare. It is a premarket notification to the FDA for a medical device, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical safety and effectiveness through extensive studies.

Therefore, the document does not contain the detailed information required to fill out all the items in your request, such as a table of acceptance criteria and reported device performance through a clinical study, specific sample sizes for test and training sets, details on expert ground truth establishment, or multi-reader multi-case study results.

Here's a breakdown of what can be extracted and what is missing:

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The provided document describes the device and its intended use, and then states that "Test Data: Tests include electrical testing." It concludes by asserting "The subject device is safe and effective and is substantially equivalent to the predicate devices."

This K050294 submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to already legally marketed predicate devices, rather than performing de novo clinical studies with predefined acceptance criteria for novel safety and effectiveness. Therefore, the "acceptance criteria" for this submission would primarily revolve around demonstrating that the device performs similarly to its predicates through non-clinical testing (like electrical testing mentioned) and design comparisons. There isn't a "study" in the sense of a clinical trial designed to prove specific performance metrics against clinical acceptance criteria.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred from 510(k) process)	Reported Device Performance (as per document)
Functional/Safety Equivalence	Electrical Safety and Performance	"Tests include electrical testing." The document asserts the device is "safe and effective."
Intended Use Equivalence	Monopolar electrosurgical device for endoscopic polypectomy, similar to predicates.	"The Sonnet™ Polypectomy Snare is a monopolar electrosurgical device used with an electrical unit for endoscopic polypectomy." (Matches predicate's intended use).
Design Equivalence	Similar design features (catheter, handle, braided wire, active cord connection) to predicates.	"consists of a 240cm catheter attached to a handle... incorporates a braided stainless steel wire... The handle provides an active cord connection." (Implicitly deemed equivalent to predicates based on clearance).
Material Equivalence	Use of biocompatible and functional materials.	Device made of "braided stainless steel wire" (Implicitly deemed equivalent/safe based on clearance).
Performance Equivalence	Overall performance similar to predicate devices to ensure substantial equivalence.	"The subject device is similar with respect to intended use and/or design features to the predicate devices in terms of section 510(k) substantial equivalence. The subject device is safe and effective and is substantially equivalent to the predicate devices."

No specific quantitative acceptance criteria or detailed performance results (e.g., in terms of efficiency, precision, or specific clinical outcomes) are provided in this 510(k) summary. The "reported device performance" is a general statement of safety, effectiveness, and substantial equivalence, backed by electrical testing, but without detailed results.

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

Sample Size for Test Set: Not applicable / Not provided. The document refers to "electrical testing" but does not specify the sample size of devices tested or any patient/clinical data.
Data Provenance: Not applicable for clinical data. The "test data" mentioned is likely from internal laboratory/engineering testing of the device itself, not patient data.

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

Not applicable / Not provided. This 510(k) summary does not involve a clinical study with expert-established ground truth.

4. Adjudication method for the test set

Not applicable / Not provided.

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. This device is an electrosurgical snare, not an AI-powered diagnostic tool.

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

Not applicable. This device is an electrosurgical snare, not an algorithm.

7. The type of ground truth used

Not applicable. Given this is a physical medical device, not a diagnostic algorithm based on imaging or other data, the concept of "ground truth" in the manner typically applied to AI/diagnostic studies does not apply here. The "truth" would be the device's functional and safety performance as validated through engineering tests and comparison to predicates.

8. The sample size for the training set

Not applicable / Not provided. This document refers to a physical device, not an AI algorithm requiring a training set.

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

Not applicable / Not provided.

Summary

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COOK®

MAR 3 1 2005

Cook Ireland Ltd.

O'Halloran Road, National Technology Park, Limerick, IRELAND Phone: +353 61 334440 Fax: +353 61 334441 www.cookgroup.com

K050294

Pg 1 of 2

510(k) Summary

Submitted By:

Cook Ireland Ltd. O'Halloran Road, National Technology Park, Limerick, Ireland

Contact Information:

Emmett Devereux QA/RA Manager Cook Ireland Limited O'Halloran Road National Technology Park Limerick, Ireland Phone: +353-61-334440 Fax: +353-61-334441 Email: edevereux@cook.ie April Lavender Cook Incorporated 750 Daniels Way Bloomington, IN 47401 U.S.A Phone: 812-339-2235 Fax: 812-332-0281 Email: LAVENDER@COOK.INC.COM

Date Prepared:

February 3, 2005

510(k) #:

Device:

Trade Name: Common/Usual Name: Class: Product Code:

Sonnet TM Polypectomy Snare Snare Class II FDI

Intended Use:

The Sonnet TM Polypectorny Snare is a monopolar electrosurgical device used with an electrical unit for endoscopic polypectomy.

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COOL

K050294

Pg 2 of 2

Device Description:

Test Data:

Tests include electrical testing

Substantial Equivalence:

The subject device is similar with respect to intended use and/or design features to the predicate devices in terms of section 510(k) substantial equivalence. The subject device is safe and effective and is substantially equivalent to the predicate devices.

Manufacturer	Device	510(k)
Wilson-Cook	Wilson-Cook Snare	K85195
Horizons International Corp.	Horizons Polypectomy Snare	K01166

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Image /page/2/Picture/2 description: The image shows a logo with a stylized bird in flight. The bird is facing left, and its body is represented by three curved lines. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". The logo is black and white.

MAR 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MO 20850

Mr. Emmett Devereux QA/RA Manager Cook® Ireland Limited O'Halloran Road National Technology Park LIMERICK IRELAND

Re: K050294

Trade/Device Name: Sonnet™ Polypectomy Snare Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: February 3, 2005 Received: February 7, 2005

Dear Mr. Devereux:

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 the cheroped of 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 recaussition in acoroval of a premarket approval application (PMA). You may, therefore, market the do not require approvate or a controls provisions of the Act. The general controls provisions of the Act as not regurements 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 11 your ab room be subject to such additional controls. Existing major regulations affecting your Applorary, It ifaly 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 I rease of a determination that your device complies with other requirements of the Act or any I Drivas mades and regulations administered by other Federal agencies. You must comply with all the r cacial starses and registration and 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) (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) I his letter witi anow you to begin maneting your and equivalence of your device to a legally premarket notheation. The PDA mainly of saosannal vice 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 If you desire specific advice tor your do 1706 of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation entired, consibilities under the Act from the 807.97). Tou may obtain other general missance at its toll-free number (800) DVVSlon of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmamain.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K 05 c 3 94

Device Name: Sonnet™ Polypectomy Snare

Indications for Use:

The Sonnet ™ Polypectomy Snare is a monopolar electrosurgical device used with an electrical unit for endoscopic polypectomy.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only
Counter
(Per 21 CFR § 801.109

Over-the-

Nancy C Brazdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K050294

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).