The device consists of a handle, cable, snare loop and cable. The loop is attached to the handle assembly by means of the cable. The sheath is also connected to the handle assembly and collapses the loop upon its retraction into the sheath.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Mill-Rose Disposable Polypectomy Snare." This is a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

Based on the provided documents, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for AI/software devices.

Here's why and what can be extracted based on your questions:

Type of Device: The Mill-Rose Disposable Polypectomy Snare is a physical medical instrument used for electrosurgical removal of GI tract polyps. It is not an AI/software device, imaging device, or diagnostic tool that would typically have performance metrics like sensitivity, specificity, or reader improvement studies.
Regulatory Pathway: The 510(k) pathway focuses on demonstrating "substantial equivalence" to a predicate device already on the market. This typically involves comparing material, design, technological characteristics, and intended use to the predicate device, not necessarily conducting performance studies in the way an AI/diagnostic device would. The goal is to show it performs as safely and effectively as the predicate, not necessarily to quantify its performance against a set of statistical cutoffs like an AI model.

Therefore, the requested information categories (e.g., sample size for test sets, ground truth establishment, MRMC studies, standalone performance) are not applicable or not provided in this type of regulatory submission for this type of device.

Here's what can be answered from the provided text, largely by stating "Not Applicable" or "Not Provided" due to the nature of the device and submission:

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

Acceptance Criteria	Reported Device Performance
Not Applicable (This is a 510(k) for a physical medical device, not an AI/diagnostic tool with performance metrics like sensitivity/specificity). The acceptance criteria for this type of device focus on substantial equivalence to a predicate in terms of materials, design, technological characteristics, and intended use, rather than quantitative performance metrics against a medical condition.	Not Applicable. Performance is established through substantial equivalence to a predicate device (K912254, K792343, K951600), implying similar safety and effectiveness. No specific quantitative performance metrics are reported in the provided text.

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

Sample Size for Test Set: Not Applicable / Not Provided. This type of performance testing with a "test set" and ground truth is not described for this physical device in a 510(k) submission.
Data Provenance: Not Applicable / Not Provided.

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)

Number of Experts: Not Applicable / Not Provided.
Qualifications of Experts: Not Applicable / Not Provided.

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

Adjudication Method: 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

MRMC Study: No, Not Applicable. This is a physical device, not an AI system.
Effect Size of Human Readers with AI: Not Applicable.

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

Standalone Performance: No, Not Applicable. This is a physical device, not an algorithm.

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

Type of Ground Truth: Not Applicable / Not Provided. Performance is based on substantial equivalence to predicate devices, not on a ground truth established for diagnostic accuracy.

8. The sample size for the training set

Sample Size for Training Set: Not Applicable / Not Provided. This is a physical device, not an AI/machine learning model that requires a training set.

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

Ground Truth Establishment for Training Set: Not Applicable / Not Provided.

Summary

{0}------------------------------------------------

971275

510(k) Summary:

1.) Submitter:	Mill-Rose Laboratories, Inc.7310 Corporate Blvd.Mentor, OH 44060(216)255-7995MAY 23 1997
2). Contact Person:	Alan C. Poje
3.) Summary Preparation Date:	April 4, 1997
4.) Classification Name:	Snare, Flexible (Accessory to Endoscopic Electrosurgical Unit)
5.) Common Name:	Disposable Polypectomy Snare
6.) Proprietary Name:	Mill-Rose Disposable Polypectomy Snare
7.) Substantially Equivalent Device:	K912254 - Cox Medical Enterprises, Cox Disposable Polypectomy Snare
	K792343 - Mill-Rose Laboratories, Flexible Diathermic Snare
	K951600 - Mill-Rose Laboratories, Rotatable Polypectomy Snare

8.) Description of Subject Device:

9.) Intended Use:

The intended use of the subject device is to electrosurgically remove GI tract polyps through the channel of an endoscope

10.) Technological Characteristics:

The subject device has the same technological characteristics as the predicates. It is composed of the same type of materials and is of a similar design.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 1997

Mr. Alan C. Poje Director of Regulatory Affairs ... ......... Mill-Rose Laboratories, Inc. 7310 Corporate Boulevard Mentor, Ohio 44060-4885

Re: K971275

Mill-Rose Disposeble Polypectomy Snare . . . . . . . Dated: April 4, 1997 Received: April 7, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 FDI

Dear Mr. Poje:

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.

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 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) 594-4616. 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,

Lillian Yia, Ph.D.

Lillian Yin, Ph.D Director, Division of Reproduct Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page_ 1_ of __________________________________________________________________________________________________________________________________________________________________

K971275 510(k) Number (if known):

Mill-Rose Disposable Polypectomy Snare Device Namc:

Indications for Use:

The intended use of this device is to electro surgically remove GI tract polype _ through the channel of an endoscope.

(PI.F.A.S. DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEDDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Robert P. Salling/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,and Radiological Devices

510(k) Number K971275

Prescription Use_ (Pcr 21 CFR 801.109)

Over-The-Counter Use_

(Optional Formal 1-2-96)

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).