BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 by BOSTON MEDICAL TECHNOLOGIES, INC.

Indications: The ANScore™ System is intended for use in heart rate variability measurements in response to paced respiration and controlled exercises. It is not intended for any specific clinical diagnosis. Assessment is indicated for patients in the physician office or hospital environment

Device Description

The ANScore™ System is a cart-based system with a computer-based user interface and data acquisition system for testing, data collection and data transmission for remote processing. The device features a 3 lead ECG, an optional blood pressure monitor, and a breathing apparatus.

AI/ML Overview

The provided text is a 510(k) Summary for the ANScore™ System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria for performance metrics, nor does it describe a study that explicitly "proves" the device meets such criteria in terms of quantitative performance metrics, such as sensitivity, specificity, or accuracy derived from a clinical study.

The primary focus of this 510(k) Summary is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a de novo clinical study with detailed performance results against acceptance criteria.

I will interpret "acceptance criteria" here as the general requirements for safety and performance typically expected for such a device to be cleared by the FDA through the 510(k) pathway, based on the information provided.

Here's the breakdown of what can be extracted and what information is not available from the provided text, categorized by your requested points:

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

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Performance: Compliance with applicable recognized standards.	"The ANScore™ System was subjected to safety and performance tests against applicable recognized standards."
Functional Requirements: Confirmation that the device meets its specified functions.	"Final testing for the system included various performance tests to confirm compliance with functional requirements and performance specifications."
Performance Specifications: Confirmation that the device meets its specified performance levels.	"Final testing for the system included various performance tests to confirm compliance with functional requirements and performance specifications."
Measurement Technology: Operation similar to predicate devices.	"The ANScore™ System operates using the same monitoring technology employed in the predicates. The measurement technology and the transmission of ECG signals are similar and therefore the technological characteristics are essentially the same as those of the legally marketed predicate devices."
Intended Use: Same as legally marketed predicate devices.	"The ANScore™ System has the same intended use as the legally marketed predicate devices. The ANScore™ System is intended for use in heart rate variability measurements in response to paced respiration and controlled exercises. It is not intended for any specific clinical diagnosis. Assessment is indicated for patients in the physician office or hospital environment."
Ease of Use: Usable by clinicians.	"A usability study of the ANScore™ System was performed by clinicians to validate ease of use."
Device Output Accuracy/Reliability (e.g., ECG signal fidelity, heart rate variability measurement accuracy): (Specific quantitative metrics not provided)	"Psysiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states." (This suggests internal verification but no specific performance metrics are reported in this document relative to clinical ground truth or benchmarks.)

Note: The provided document is a 510(k) summary, which generally focuses on substantial equivalence rather than explicit performance metrics from a full clinical trial. Quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and their corresponding reported device performance values are not specified in this document. The "tests" mentioned are general statements about compliance and usability.

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

Sample Size for Test Set: Not specified. The document mentions "Psysiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states" but does not give a sample size of real patient data for a test set. A "usability study" was performed by clinicians, but no sample size for that is given either.
Data Provenance (Country of Origin, Retrospective/Prospective): Not specified. The testing appears to be internal verification and validation ("Psysiological input was simulated"). There is no mention of a clinical study involving data from patients, nor its origin or study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable/Not specified. The document does not describe the establishment of ground truth for a test set using experts in the way one would for diagnostic imaging or AI algorithms for clinical decision support. The testing described appears to be technical validation against simulated physiological inputs and a usability study by "clinicians." The "ground truth" for the simulated input would be the known parameters of the calibrated instrumentation.
Qualifications of Experts: The usability study was performed by "clinicians." No specific qualifications (e.g., number of years of experience, specialty) are provided.

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

Adjudication Method: Not applicable/Not specified. No external adjudication method is described for performance evaluation. The "tests" mentioned are internal performance tests and a usability study.

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

MRMC Comparative Effectiveness Study: No. The ANScore™ System is described as a device for "heart rate variability measurements" and "paced respiration and controlled exercises" and "not intended for any specific clinical diagnosis." It is not presented as an AI-powered diagnostic tool that assists human readers/clinicians, so an MRMC study comparing human performance with and without AI assistance is not relevant or described.

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

Standalone Performance: The core function of the device is to measure heart rate variability. While its system performance was tested (e.g., against simulated physiological input), the concept of "standalone performance" for an AI algorithm is not directly applicable in the way it would be for a diagnostic AI. The device itself performs the measurements; its performance is what is being verified, not an AI component that offers an interpretation or diagnosis without human input. No specific data or metrics on this type of standalone performance (e.g., accuracy of algorithmic interpretation) are provided beyond the general statements of "compliance with functional requirements and performance specifications" and "measurement technology... similar" to predicates.

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

Type of Ground Truth: For the technical performance tests, the ground truth was likely based on the calibrated instrumentation used to simulate physiological input. For the usability study, the "truth" would be the subjective feedback and observations from the clinicians. There is no mention of ground truth established via expert consensus, pathology, or outcomes data, as the device is not for diagnosis, but for physiological measurement.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. The document describes a device that performs measurements, not an AI algorithm that requires a "training set" in the context of machine learning.

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

Ground Truth for Training Set: Not applicable/Not specified. As the device is not described as involving a machine learning algorithm requiring a training set, this information is not relevant or provided.

Summary

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13,39 JUN 11

510(k) Summary 10.0

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

1. The submitter of this premarket notification is: Donald Brooks Director of Operations Boston Medical Technologies, Inc. 591 North Avenue, Suite 5 Wakefield, MA Tel: 781.213.9200, Fax: 781.213.9233
  This summary was prepared on June 10, 1999.
The name of this device is the ANScore™ System. The common name is 2. ECG monitor and Respiration Pacer. Classification names are as follows:

Regulation Number	CALLERS AN HORE CHARLES COLLEGE AND A FRIEND A BRICAL CONTRACTORS CONTRACTOR COLLEGIAL CONTRACTOR COLLEGIAL CONTRACTOR COLLEGIAL CONTRACTOR COLLECTION CONTRACTOR COLLECTION C
LA COLORIO COLLECTION LA COLLECTION LA BOLLER AND	Classification Name
870.2340 74 DPS.IT	1Electrocardiograph

1. The ANScore™ System is substantially equivalent to the following predicate devices: The qmed monitor one nDx (K972991), and the D.E. Hokanson, Inc. ANS2000 (K973426),
1. The ANScore™ System is a cart-based system with a computer-based user interface and data acquisition system for testing, data collection and data transmission for remote processing. The device features a 3 lead ECG, an optional blood pressure monitor, and a breathing apparatus.
The ANScore™ System has the same intended use as the legally marketed S. predicate Devices. The ANScore™ System is intended for use in heart rate variability measurements in response to paced respiration and controlled exercises. It is not intended for any specific clinical diagnosis. Assessment is indicated for patients in the physician office or hospital environment.

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ఈ. The ANScore™ System operates using the same monitoring technology employed in the predicates. The measurement technology and the transmission of ECG signals are similar and therefore the technological characteristics are essentially the same as those of the legally marketed predicate devices.
1. The ANScore™ System was subjected to safety and performance tests against applicable recognized standards. Final testing for the system included various performance tests to confirm compliance with functional requirements and performance specifications. Psysiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states. A usability study of the ANScore™ System was performed by clinicians to validate ease of use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1999

Mr. Donald James Sherratt Boston Medical Technologies, Inc. Intertek Testing Services 70 Codman Hill Road Boxborough, MA 01719

K991831 Re: ANScore™ Health Management System Requlatory Class: II (two) Product Code: 74 DPS Dated: May 26, 1999 Received: May 28, 1999

Dear Mr. Sherratt:

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 legally marketed predicate 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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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Page 2 - Mr. Donald James Sherratt

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/dsma/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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Indications for Use Statement

510(k) Number	K991831
Device Name	The ANScore™ System
Indications for Use	Indications: The ANScore™ System is intendedfor use in heart rate variability measurementsin response to paced respiration and controlledexercises. It is not intended for any specificclinical diagnosis. Assessment is indicated forpatients in the physician office or hospitalenvironment

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. H. Ciavol.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

Prescription Use (Per 21 CFR 801.109)

510(k) Number Over-The-Counter Use

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).