· Condition: the clinician decides to continuously monitor cardiac arrhythmia and / or ST segment.
· Part of body or type of tissue interacted with: ECG signal obtained from electrodes attached to the skin of adult, pediatric, and neonatal patients
· Frequency of use: As prescribed by clinician.
· Physiological purpose: To gain information for treatment or to rule out causes of symptoms.
Prescription versus over-the-counter: STAR is a . prescription device

Device Description

STAR is a software device that is intended to be used as the ST and Arrhythmia analysis engine in host computing devices. It can be ported to host computing devices that meet STAR specifications. The STAR device provides ST Analysis, Cardiotach Analysis, and Arrhythmia Analysis capability to compatible computing host devices. The STAR (ST and Arrhythmia) algorithm is a software engine that analyzes patient ECG's and produces parameters, events and alarms. It is designed so that it is machine (host) independent and can, therefore be used in more than one device. STAR currently operates in the Windows NT, UNIX and a proprietary HP real-time operating system. STAR has a fully specified ECG signal interface, control interface, and output signal interface as well as operating environment specifications.

AI/ML Overview

The provided text, K964122, describes the STAR software device, an algorithm for ST and Arrhythmia analysis. The document focuses on its intended use, features, and validation, but does not contain a detailed study report that proves the device meets specific acceptance criteria in a quantitative manner.

Therefore, I cannot populate all sections of your request comprehensively with information directly from the provided text. The document acts more like a general summary of the device and its validation approach rather than a detailed study report with numerical results against defined acceptance criteria.

However, I can extract information related to validation and the general approach to ensure safety and effectiveness.

Here's what I can infer and what is explicitly stated:

Acceptance Criteria and Device Performance

The document does not provide a table of explicit, quantitative acceptance criteria (e.g., specific sensitivity, specificity, or accuracy thresholds) or a corresponding table of reported device performance against such criteria.

The general statement in section 7.0 suggests that the "defined and controlled development processes followed and the documented test results obtained from extensive testing coupled with user documentation of STAR and host devices produces a very high confidence level that the device is safe and effective when used as intended."

Study Information

Given the lack of specific study details, many of the requested fields cannot be directly answered from the provided text.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: "Publicly available data bases used to validate STAR performance included the MIT, AHA, Creighton University, and European Society of Cardiology (ESC) ST-T databases." No specific country of origin or whether the data was retrospective or prospective is mentioned for these databases within this document. These are generally retrospective databases.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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 MRMC comparative effectiveness study is mentioned. The device is a "software device" intended for analysis, not directly for human reader assistance with reported metrics of improvement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The validation described (using public databases and various testing phases) focuses on the "STAR algorithm performance" directly, independent of a human-in-the-loop. Section 4.0 (4) explicitly states, "STAR algorithm performance is fully validated independent of the final host device."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the public databases mentioned (MIT, AHA, Creighton, ESC ST-T), the ground truth is typically derived from expert consensus annotations of ECG events (e.g., arrhythmias, ST segment changes). The document does not explicitly state the method for ground truth establishment for these databases but refers to their "performance" validation.
The sample size for the training set:
- Not specified. The document mentions tests during "early development" and "Final Qualification," but doesn't differentiate between training and testing set sizes.
How the ground truth for the training set was established:
- Not specified. This information is typically proprietary to the development process and not usually disclosed in general summary documents like this one. For publicly available databases, the ground truth is pre-established by their creators/experts.

Summary of what is available from the text:

Device Name: STAR (ST and Arrhythmia) algorithm software device.
Purpose: ST Analysis, Cardiotach Analysis, and Arrhythmia Analysis engine.
Validation Approach: Multi-phased, including logical component testing, integration testing, and overall performance testing in both off-line and host environments.
Testing Types: White Box, Gray Box, and Black Box tests.
Databases Used for Validation: MIT, AHA, Creighton University, and European Society of Cardiology (ESC) ST-T databases.
Standalone Performance: Validated (implicitly, as it validates the algorithm performance independent of the host device).
Ground Truth (for test data): Implied to be derived from expert annotations within the publicly available databases (MIT, AHA, Creighton, ESC ST-T).

What is explicitly missing from the text to fulfill the request:

Quantitative acceptance criteria.
Quantitative reported device performance against specific criteria (e.g., sensitivity, specificity, accuracy).
Specific sample sizes for test and training sets.
Detailed expert qualifications or adjudication methods for ground truth panels.
Results from MRMC comparative effectiveness studies.

Summary

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

K964122

CHAPTER 34:SUMMARY OF SAFETY AND EFFECTIVENESS

1.0 USE

1.1 What it is

STAR is a software device that is intended to be used as the ST and Arrhythmia analysis engine in host computing devices. It can be ported to host computing devices that meet STAR specifications.

1.2 What it does

The STAR device provides ST Analysis, Cardiotach Analysis, and Arrhythmia Analysis capability to compatible computing host devices.

1.3 Where Can it be Used

STAR can only be used in prescription host devices that meet the STAR interface and environment specifications.

1.4 Who Uses it on Whom

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

1.5 Who Prescribes it

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

1.6 Where is it Used

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

It is not intended for home use.

2.0 Indications for Use

The indications for use of the STAR ST and Arrhythmia algorithm software device are:

· Condition: the clinician decides to continuously monitor cardiac arrhythmia and / or ST segment.
· Part of body or type of tissue interacted with: ECG signal obtained from electrodes attached to the skin of adult, pediatric, and neonatal patients
· Frequency of use: As prescribed by clinician.
· Physiological purpose: To gain information for treatment or to rule out causes of symptoms.
Prescription versus over-the-counter: STAR is a . prescription device

3.0 How it Works

The STAR (ST and Arrhythmia) algorithm is a software engine that analyzes patient ECG's and produces parameters, events and alarms. It is designed so that it is machine (host) independent and can, therefore be used in more than one device. STAR currently operates in the Windows NT, UNIX and a proprietary HP real-time operating system. STAR has a fully specified ECG signal interface, control interface, and output signal interface as well as operating environment specifications as shown in the following STAR Block Diagram.

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

STAR BLOCK DIAGRAM FIGURE I:

Image /page/1/Figure/2 description: The image shows a diagram of a host device with a STAR component. The STAR component includes Cardiotach, Arrhythmia, and ST Algorithms. The host device has an input interface, a control interface, and an output interface. The diagram also indicates that the operating environment meets the STAR specification.

In addition to the STAR algorithm, the complete ST and Arrhythmia monitoring application encompasses several aspects: user interaction and control, data management, and alarm presentation and annuciation. That functionality is provided by the host product in which the STAR algorithm is embedded.

4.0 Summary of Major Features

(1) Arrhythmia analysis and ST segment analysis are "combined" into one software device.
(2) The common source code of the STAR algorithm can be configured to achieve the appropriate level of functionality and to conform to the operating environment of the device.
(3) STAR software is written to be independent of the host device with complete specifications of the following:
- · ECG signal input interface,
- · control input interface,
- · output interface,
- · and operating resource requirement.
(4) STAR algorithm performance is fully validated independent of the final host device.
(5) QRS detection and arrhythmia analysis on multiple leads of ECG.

5.0 How it Compares to other Devices

STAR is similar to the predicates when operating in the single lead configuration and has improved performance when operating in the multi-lead configuration when compared to single lead devices.

6.0 How was it Verified and Validated

STAR Verification and Validation was a multiphased activity. During early development, tests were created to test logical components, the integration of the logical components and the overall arrhythmia and ST algorithm performance in the STAR off-line development environment. As it became possible to port the STAR algorithm into host environments, additional unit and integration testing was performed within host environments.

The algorithm was first shown to satisfy performance expectations such as accuracy, portability, configurability and efficiency. Then a Final Qualification, Verification, and Validation of STAR was performed by the Algorithm R&D Development Team by repeating White Box, Gray Box, and Black Box tests on STAR. Publicly available data bases used to validate STAR performance included the MIT, AHA, Creighton University, and European Society of Cardiology (ESC) ST-T databases.

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

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

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

The defined and controlled development processes followed and the documented test results obtained from extensive testing coupled with user documentation of STAR and host devices produces a very high confidence level that the device is safe and effective when used as intended.

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

Summary of Safety and Effectiveness 34-4

. •

ili

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.