Condition: the clinician decides to centrally monitor up to 8 adult, pediatric, and/or neonatal patients:
and for the embedded STAR:
Condition: the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and/or neonatal patients and/or ST segment of adult patients.
Part of body or type of tissue interacted with: None, all patient connections are made by other remote devices.
Frequency of use: As prescribed by clinician.
Physiological purpose: To gain information for treatment, to monitor adequacy of treatment, or to rule out causes of symptoms.
Prescription versus over-the-counter: Central-Vue Software is a prescription device.

Device Description

CentralVue Software is a centralized patient monitoring application that executes on an NT Workstation and operates on data received from other networked medical devices. CentralVue Software displays physiologic waves and parameters, provides retrospective review of physiologic waves and parameters and provides the secondary annunciation of alarms for up to eight patients at a centralized location. CentralVue Software embeds STAR ST Segment and Arrhythmia analysis for up to eight patients. CentralVue Software can format data for compliant strip chart recorders such as the CentralVue Recorder.

AI/ML Overview

This submission does not contain enough information to complete the requested table and answer the questions thoroughly. The provided text, K9CC4832 from May 15, 1997, describes the "CentralVue Software" and its functionalities, indications for use, and a general statement about its verification and validation. However, it lacks specific details about acceptance criteria, actual device performance metrics, study methodologies, sample sizes, ground truth establishment, or expert involvement relating to a performance study.

Here's how I can (or cannot) answer each point based on the provided text:

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

Cannot create. The document mentions "STAR ST Segment and Arrhythmia monitoring software embedded in CentralVue Software was tested to assure that it performed as disclosed in an earlier submission." This implies that acceptance criteria and performance data for the STAR component exist in another document, but they are not disclosed in this text. There are no specific performance metrics (e.g., sensitivity, specificity, accuracy, detection rates for arrhythmias or ST segment changes) outlined for CentralVue Software itself or the embedded STAR component within this document.

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

Cannot answer. The document generally states "When the black box, gray box, white box, and STAR regression tests were completed a separate test group validated that CentralVue Software meets its performance claims and is safe and effective in its intended use." This indicates testing occurred, but no details about the sample size of patients, data sets, or their provenance (country, retrospective/prospective) are 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)

Cannot answer. There is no mention of experts or how ground truth was established for any performance testing.

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

Cannot answer. The document does not describe any adjudication methods used for testing or validation.

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

Cannot answer. The document describes a "centralized patient monitoring application" with "embedded STAR ST Segment and Arrhythmia analysis." It does not describe a study involving human readers or comparing their performance with and without AI assistance. This device's function is to display data and provide analysis, not to assist humans in interpreting images in a way that would require an MRMC study.

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

Partially addressed, but not with specific performance data. The STAR ST Segment and Arrhythmia monitoring is described as "software that run in the monitoring mode." This implies a standalone algorithmic function. However, details of its standalone performance (e.g., sensitivity, specificity for arrhythmia detection) are not provided in this document, only that it "was tested to assure that it performed as disclosed in an earlier submission."

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

Cannot answer. The document does not specify the type of ground truth used for any testing.

8. The sample size for the training set

Cannot answer. The document does not mention a "training set" or "training" in the context of machine learning. The STAR ST Segment and Arrhythmia monitoring software is mentioned, but its development process (e.g., whether it uses machine learning with training data) is not elaborated upon in this text.

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

Cannot answer. As no training set is mentioned, the method for establishing its ground truth is also not mentioned.

Summary

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K9CC4832

MAY 15 1997

1.0 Use

1.1 What it is

CentralVue Software is a centralized patient monitoring application that executes on an NT Workstation and operates on data received from other networked medical devices.

1.2 What it does

CentralVue Software displays physiologic waves and parameters, provides retrospective review of physiologic waves and parameters and provides the secondary annunciation of alarms for up to eight patients at a centralized location. CentralVue Software embeds STAR ST Segment and Arrhythmia analysis for up to eight patients. CentralVue Software can format data for compliant strip chart recorders such as the CentralVue Recorder.

1.3 Who Uses it on Whom

CentralVue Software is intended to be used by trained clinicians to monitor cardiac function in neonatal, pediatric, or adult patients.

1.4 Who Prescribes it

In the USA. Federal law restricts CentralVue Software to sale by or on the order of a physician.

1.5 Where is it Used

CentralVue Software is intended to be used in a professional health care facility.

CentralVue Software is not intended for home use.

2.0 Indications for Use

The indications for use of the Hewlett-Packard CentralVue Software are:

· Condition: the clinician decides to centrally monitor up to 8 adult, pediatric, and/or neonatal patients:
and for the embedded STAR:
· Condition: the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and/or
neonatal patients and/or ST segment of adult patients.

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· Part of body or type of tissue interacted with: None, all patient connections are made by other remote devices.
· Frequency of use: As prescribed by clinician.
· Physiological purpose: To gain information for treatment, to monitor adequacy of treatment, or to rule out causes of symptoms.
· Prescription versus over-the-counter: Central-Vue Software is a prescription device.

3.0 How it Works

System Requirements 3.1

Central Vue Software can only be used on NT Workstations that are specified in the labeling or that are subsequently qualified by Hewlett-Packard.

3.2 How CentralVue Software Functions

CentralVue Software is a software device that consists of monitoring applications, STAR ST Segment and Arrhythmia monitoring software that run in the monitoring mode. In addition, system management software runs when in the non-monitoring mode.

Monitoring mode applications provide patient monitoring functionality. STAR ST Segment and Arrhythmia monitoring is a subset of the patient monitoring software that runs in monitoring mode.

Non-monitoring mode software provides the startup, shut-down, installation, and other system management functions.

4.0 Summary of Major Features

Key features of CentralVue Software are shown in the patient monitoring Main Screen and All Controls menu:

Main Screen - up to 8 patients, up to 2 waves per patient, maximum of 16 waves per screen.

Patient Management - easy patient admit, discharge, bed transfer, change of monitoring equip

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ment from bedside to telemetry, and customization of the Main Screen patient sector.

Alarm Management and Setup - separate adjustment of arrhythmia and ST segment monitoring alarms for each patient.

Patient Data Review - access to stored patient data for alarms, trends, events, full disclosure waveform, and ST segment review.

Configuration and Support - direct access to sound volume control, device status and error information, and service support information; clinical password access to monitor default configurations; support password access to a wide range of service support functions.

5.0 How it Compares to other Devices

CentralVue Software is similar to the predicates in that it has the same use, features, and specifications.

6.0 How was it Verified and Validated

The development team tested the device during development by performing unit and integration testing. STAR ST Segment and Arrhythmia monitoring software embedded in CentralVue Software was tested to assure that it performed as disclosed in an earlier submission. When the black box, gray box, white box, and STAR regression tests were completed a separate test group validated that CentralVue Software meets its performance claims and is safe and effective in its intended use.

7.0 How we Know it is Safe and Effective When Used as Labeled

The defined and controlled development processes followed, and the documented test results obtained from extensive testing produces a very high confidence level that the device is safe and effective when used as intended.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.