The DRTS™ Drape is to be used in an operating room environment to cover the DRTS™ device when it is mounted on an x-ray machine for procedures wherein it is deemed desirable to protect the DRTS™ device from contamination with patient fluids or tissues.

Device Description

AI/ML Overview

I am unable to provide a comprehensive answer to your request because the provided text describes a 510(k) Pre-Market Notification for a medical device called the "MINRAD DRTS™ Drape." This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on a standalone study with detailed performance metrics and acceptance criteria in the way you've outlined for an AI/algorithm-based device.

Here's why and what I can extract:

No Acceptance Criteria or Performance Data: The 510(k) summary explicitly states: "Any dimensional or design differences between the DRTS™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness." This indicates that a detailed performance study with quantifiable acceptance criteria and reported device performance, as you'd expect for an AI algorithm, was not conducted or required for this type of submission. The focus is on demonstrating that the new device is essentially the same as a legally marketed predicate.
Device Type: The DRTS™ Drape is a sterile plastic bag (equipment drape) designed to prevent contamination of another device (DRTS™ Dual Radiation Targeting System). It's a physical, disposable accessory, not a software algorithm or an AI-powered diagnostic tool. Therefore, the concepts of "test set," "ground truth," "MRMC study," "standalone performance," "training set," and "adjudication method" as applied to AI/algorithms do not apply to this product.

What I can provide based on the given information:

Since the request asks for specific sections, I will structure the answer by addressing each point, even if the information is not present or applicable.

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

Acceptance Criteria	Reported Device Performance
Not specified	No performance data reported, as the submission relies on substantial equivalence to predicate devices.

Explanation: The 510(k) submission for the DRTS™ Drape focuses on demonstrating substantial equivalence to existing predicate devices (Microtek Medical, Inc. Large C-Arm Drape Product Number 4982 and Contour Fabricators Number CFI-600, equipment drape). The document explicitly states that "any dimensional or design differences between the DRTS™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness." This implies that extensive performance testing with specific acceptance criteria, as one would see for a novel diagnostic or therapeutic device, was not deemed necessary for this classification. The primary "performance" is that it functions as an equipment cover without introducing new risks.

2. Sample size 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 reported.
Data Provenance: Not applicable.

Explanation: As this is a sterile equipment drape, not a data-driven diagnostic or AI device, there was no "test set" in the context of data analysis. The submission focuses on physical characteristics and intended use.

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.
Qualifications of Experts: Not applicable.

Explanation: Ground truth establishment is relevant for tasks involving interpretation (e.g., image analysis, diagnoses). An equipment drape does not require "ground truth" to be established by experts.

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

Adjudication Method: Not applicable.

Explanation: Adjudication is used to resolve disagreements in expert interpretations for establishing ground truth. This is not relevant for an equipment drape.

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.
Effect Size: Not applicable.

Explanation: MRMC studies are for evaluating interpretative performance, often of AI-assisted systems versus unassisted human readers. This concept does not apply to a sterile equipment drape.

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

Standalone Performance Study: No.

Explanation: The device is a physical drape, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept.

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

Type of Ground Truth: Not applicable.

Explanation: Ground truth refers to the true state or outcome being predicted or interpreted. For an equipment drape, the "truth" is its ability to cover and provide a sterile barrier, which is evaluated through physical properties and sterilization validation, not expert consensus on an interpretation task.

8. The sample size for the training set

Sample Size for Training Set: Not applicable / Not reported.

Explanation: This device is not an AI/machine learning model, so there is no "training set."

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

Ground Truth Establishment for Training Set: Not applicable.

Explanation: As there is no training set, there is no ground truth establishment for one.

Summary

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K973162

MINRAD DRTS™ Drape 510(k) Summary

NOV 20 1997

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Contact Person: Howard M. Holstein Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Phone: (202) 637-5794 Facsimile: (202) 637-5910

Date Prepared: August 21, 1997

Name of Device and Name/Address of Sponsor

DRTS™ Drape MINRAD, Inc. 6576 East Quaker Street Orchard Park, NY 14127

Device Name

Trade Name:	Dual Radiation Targeting System DRTS™ Drape
Common Names:	Equipment Cover, Equipment Drape
Classification Name:	Light Beam Patient Position Indicator Accessory

Predicate Devices

(1) Microtek Medical, Inc. -- Large C-Arm Drape Product Number 4982 (2) Contour Fabricators Number CFI-600, equipment drape

Intended Use

The DRTS™ Drape is intended to help prevent contamination of the DRTS™ device when used in the operating room or other surgical environment.

Technological Characteristics and Substantial Equivalence

The DRTS™ Drape is a sterile plastic bag to cover the DRTS™ Dual Radiation Targeting System. The drape contains an optically flat clear window that will allow undistorted transmission of the laser beam from the DRTS™ to the patient. Any dimensional or design differences between the DRTS™ Drape and the predicate devices are minor and raise no new issues of safety or effectiveness.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 20 1997

Chris Healy Hogan & Hartson c/o Minrad, Inc. 6576 East Quaker St. Orchard Park, NY 14127 Re:

K973162 Dual Radiation Targeting System DRTS Drape Dated: August 21, 1997 Received: August 22, 1997 Regulatory class: II 21 CFR 892.5780/Procode: 90 IWE 21 CFR 878.4370/Procode: 79 KKX

Dear Mr. Healy:

: $2

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 inclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 of affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 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 (2). CFR. Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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.

h.T.Liau Yu

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

Enclosure

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MINRAD 510(K) Notification DRTS™ Drape INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K973162

Device Name:

DRTS™ Drape

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lind L. de yong
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K973162

র্ম Prescription Use _ (Per 21 C.F.R. § 801.109) Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.5780 Light beam patient position indicator.

(a)
Identification. A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.