The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is intended for use in patient monitoring applications to display multi-parameter data in graphic format. The Sony. PCM-100P1MD can be used in hospital settings such as the intensive care unit, central station, and nurse station. Applications include the display of data from electrocardiographs, blood pressure and pulse measurement systems, and computed tomography and other imaging systems.

Device Description

The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is a general purpose computer monitor which has been modified for use in medical settings for patient monitoring applications. It will display images received from a computer system and is designed for use with PC-compatible computers.

AI/ML Overview

The provided 510(k) summary for the Sony PGM-100P1MD Trinitron® Color Graphic Monitor does not describe acceptance criteria or a study proving the device meets specific performance metrics.

This document is a premarket notification for a medical device (a color graphic monitor) intended for patient monitoring applications. The primary focus of a 510(k) submission is to demonstrate substantial equivalence to a predicate device already legally marketed in the US, rather than proving performance against specific acceptance criteria through a dedicated study.

Here's why the requested information isn't present and what the document does provide:

Substantial Equivalence: The document explicitly states the FDA's finding of "substantial equivalence" to predicate devices (Sony Trinitron Color Video Monitor PVM-1343MD, Electrohome M1544/1744 High Resolution Monochrome Monitors, and Siemens Sirecust 1481T Digital Telemetry System). This means the manufacturer argued that the new device has the same intended use and similar technological characteristics as existing, legally marketed devices, and does not raise new questions of safety or effectiveness.
Device Description and Intended Use: These sections clarify what the device is and how it's meant to be used (displaying multi-paramater data in graphic format for patient monitoring).
Technological Characteristics: This section highlights that the primary difference from predicate devices is "higher resolution." While improved resolution is a performance characteristic, the document doesn't quantify it with acceptance criteria or present data from a study specifically designed to prove this higher resolution meets a defined standard.

Therefore, for the specific questions asked, based solely on the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence rather than performance against specific criteria.
Sample size used for the test set and the data provenance: Not applicable/Not provided. No test set or data provenance is mentioned in the context of performance testing. The comparison is based on technological characteristics and intended use relative to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No ground truth establishment is described.
Adjudication method for the test set: Not applicable/Not provided. No test set or adjudication process is described.
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, this is not applicable. This device is a monitor, not an AI-assisted diagnostic tool. Such a study would be irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is a hardware monitor, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided. No performance testing against a ground truth is described.
The sample size for the training set: Not applicable/Not provided. This is a hardware device; there is no mention of a "training set" in the context of machine learning or algorithms.
How the ground truth for the training set was established: Not applicable/Not provided.

In summary, the provided 510(k) summary is a regulatory filing demonstrating substantial equivalence, not a detailed scientific study on device performance against specific acceptance criteria.

Summary

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

K97099

ー

510(k) Summary

for

Sony PGM-100P1MD Trinitron® Color Graphic Monitor

MAY 2 0 1997

Applicant: 1.
ﻤﺴﺘﺸﻔﺎ

Sony Medical Systems Division Sony Electronics Inc. 3 Paragon Drive Montvale, NJ 07645

Contact Person:	Anthony John Kefalos
Telephone:	201-358-4330

March 18, 1997 Date Prepared:

2. Device Name

Proprietary Name:

Sony PGM-100P1MD Trinitron® Color Graphic Monitor

Color Graphic Monitor Common/Usual Name:

Accessory to Medical Imaging, Monitoring and Classification Name: Diagnostic Devices

Classification Status: Class II

3. Predicate Devices

: Sony Trinitron Color Video Monitor PVM-1343MD . Sony Medical Systems Division K885042
Electrohome M1544/1744 High Resolution Monochrome Monitors . Electrohome Limited
Siemens Sirecust 1481T Digital Telemetry System (includes the Sony . Trinitron® Character Display CPD-1304 as the monitor component) Siemens Medical Electronics, Inc. K900319

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

Device Description 4.

Intended Use 5.

ﺔ ﺍﻟﻤﺘﺮﺟﻤﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﻧﻴ
The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is intended for use in patient monitoring applications to display multi-parameter data in graphic format.

Technological Characteristics Q.

The Sony PGM-100P1MD Trinitron® Color Graphic Monitor is intended as an addition to the Sony video monitor product line and has the same general purposes and function as the predicate devices identified above. All of the devices accept standard video signals produced by a wide range of equipment. The primary difference between the Sony PGM-100P1MD and the predicate devices is the higher resolution that it provides for use in graphical display.

3/18/97

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

Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1997

Cynthia A. Sinclair Sony Medical Systems C/O Medical Device Consult, Inc. 49 Plain Street . ...... . ........ North Attleboro, MA 02760

Re: K970999

Sony PGM-100P1MD Trinitron® Color Graphic Monitor Dated: March 18, 1997 Received: March-19; 1997 …… Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Ms. Sinclair:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desermined 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, Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, ind Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and produbtions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premater 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 equivalion assemes 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 does not affect any obligation you might have under sections 51 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed presidention for your device and this, 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 pitco diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please noted, "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 Xia, Ph.D.

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

{3}------------------------------------------------

510(k) Number (if known): _ K970999

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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

Concurrenee of CDRH, Office of Device Evaluation (ODE)

David C. Jesson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic 147494 510(k) Number

Prescription Use X
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

3/18/97

Sony PGM-100P1MD Monitor 510(k)

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.