The Perioperative Data Management System (PDMS) may be used as a data management system for electronically collecting, recording, and displaying anesthesia information.

The Perioperative Data Management System is indicated for electronically collecting, displaying, and recording perioperative information. Federal law restricts this device to sale by or on the order of a physician.

Device Description

The PDMS may be used for receiving, recording and displaying monitoring information from anesthesia systems, other medical devices in the operating room (OR), and through the hospital network and manual entry.

AI/ML Overview

The provided text describes a 510(k) submission for a Perioperative Data Management System (PDMS) and its determination of substantial equivalence to a predicate device, the O.R. Data Manager (ORDM). It does not contain specific acceptance criteria, performance data, or details of a study that directly proves the device meets such criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy).

The document focuses on the regulatory process of establishing substantial equivalence for medical devices, which is a different type of evaluation than a clinical or performance study establishing specific quantitative acceptance criteria.

Therefore, I cannot populate the table or answer most of your questions based only on the provided text.

Here's a breakdown of what can and cannot be answered:

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

Acceptance Criteria	Reported Device Performance
Not specified in the document	The PDMS was found to be "substantially equivalent" to the OR Data Manager (ORDM) based on having the "same intended use and principal of operation." Qualification included "hazard analysis, system level qualification testing, environmental testing, and electromagnetic compatibility testing."

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

Cannot be determined from the text. The document describes a regulatory submission for substantial equivalence, not a performance study with a test set of data.

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)

Cannot be determined from the text. No ground truth establishment is described for a performance test set.

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

Cannot be determined from the text. No adjudication method is described.

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 evidence of an MRMC study. This device is a data management system, not an AI-assisted diagnostic tool that would typically undergo an MRMC study with human readers.

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

Cannot be determined from the text. While the device "receives, records, and displays" data, its core function is data management, not an algorithm performing a standalone diagnostic or predictive task in the way your question implies. The document describes "system level qualification testing," but not in the context of a standalone algorithm performance study.

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

Cannot be determined from the text. No ground truth is mentioned. The evaluation for substantial equivalence relied on comparing the PDMS's intended use and principle of operation to a legally marketed predicate device (ORDM).

8. The sample size for the training set

Not applicable / Cannot be determined from the text. The device is a data management system, not described as using machine learning or needing a "training set" in the context of AI.

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

Not applicable / Cannot be determined from the text. (See point 8).

Summary of what the document does indicate regarding device evaluation:
The evaluation of the PDMS for 510(k) clearance primarily focused on demonstrating its substantial equivalence to a pre-existing device (O.R. Data Manager K900937). This was supported by:

Sharing the same intended use.
Sharing the same principle of operation.
Undergoing a hazard analysis.
Completing system level qualification testing.
Performing environmental testing.
Completing electromagnetic compatibility testing.

These are standard regulatory steps for a Class II device and do not typically involve the type of quantitative performance studies with specific accuracy/sensitivity/specificity metrics, ground truth, and expert evaluation that your questions imply for AI/diagnostic devices.

Summary

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Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

Proprietary Name:	Perioperative Data Managment System	FEB - 6 1998
Classification Name:	Gas-Machine, Anesthesia 73BSZ
Device Class:	Class II
Manufacturer:	North American Dräger3135 Quarry RoadTelford, Pennsylvania 18969
Establishment Registration Number:	2517967

Devices to which substantial equivalence is claimed: O.R. Data Manager K900937

Device Description:

Intended Use:

The Perioperative Data Managment System (PDMS) may be used as a data management system for electronically collecting, recording, and displaying anesthesia information

Substantial Equivalence:

The PDMS is substantially equivalent to the OR Data Manager (ORDM).

The PDMS and the ORDM have the same intended use and principal of operation and are substantially equivalent.

Qualification of the PDMS included a hazard analysis, system level qualification testing, environmental testing, and electromagnetic compatibility testing.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine, with a staff and two snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/1/Picture/4 description: The image shows the text 'FEB - 6 1998'. The text is in a simple, bold font. The date is likely a reference to a specific date, February 6, 1998.

Mr. James J. Brennan Director, Requlatory Affairs North American Drager 3135 Quarry Road Telford, PA 18969

Re : K973949 Perioperative Data Management System (PDMS) Regulatory Class: II (two) Product Code: 73 BSZ Dated: December 13, 1997 Received: December 17, 1997

Dear Mr. Brennan:

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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: -- -----------General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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.

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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 (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1

510(k) Number (if known):

Device Name: Perioperative Data Management System (PDMS)

Indications For Use:

197394

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Mr. Puzl-

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K97394 510(k) Number _

Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).