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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.

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.

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:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence rather than performance against specific criteria.
2. 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.
3. 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.
4. Adjudication method for the test set: Not applicable/Not provided. No test set or adjudication process 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, this is not applicable. This device is a monitor, not an AI-assisted diagnostic tool. Such a study would be irrelevant.
6. 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.
7. 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.
8. 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.
9. 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.

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