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

The Anscore™ 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 and a breathing apparatus, in order to conduct heart rate variability testing. Heart rate variability testing is one of various measurement tools used by physicians in their assessment of autonomic function and dysfunction.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Boston Medical Technologies, Inc. (BMT) Anscore™ Health Management System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a dedicated table format nor does it present specific performance metrics from a new study being reported in this submission for the Anscore™ Health Management System (K993875).

Instead, the submission states:

"The Anscore™ system is the same as the previously 510(k)-cleared Anscore™ Health Management System and, thus, the results of the performance testing for that cleared system apply to this device."
"Final testing for the system included various performance tests to confirm compliance with functional requirements and performance specifications."
"Physiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states."

Therefore, based on the provided text, a table can only reflect what is implicitly stated:

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Compliance with functional requirements and performance specifications	Final testing confirmed compliance. Results of prior 510(k) (K991831) are applicable. Physiological input was simulated using calibrated instrumentation.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "Physiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states."

Sample Size for Test Set: Not specified in terms of human subjects. The testing involved "simulated physiological input," implying that a physical test set of human subjects or real patient data was not used for this specific submission's performance claim. Instead, the performance relies on the previous K991831 clearance.
Data Provenance: Not explicitly stated for this particular submission's performance data, as it refers back to a previous clearance (K991831). The simulation used "calibrated instrumentation."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable, as the testing involved "simulated physiological input" and referenced prior clearance. No human expert consensus for ground truth is described in this document for the performance testing cited.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as no human expert review or adjudication process is described for establishing ground truth in the reported performance testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided text. The device is for objective physiological measurement (HRV, ECG), not for interpretation by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the described "performance tests to confirm compliance with functional requirements and performance specifications" using "simulated physiological input" indicate a standalone evaluation of the device's measurement capabilities. The Anscore™ system is an "ECG monitor and Respiration Pacer," suggesting it provides objective data, and the testing focuses on its accuracy and functionality in producing these measurements.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the performance testing, as described, was established through "calibrated instrumentation". This means the "ground truth" was the known, reference values provided by the calibrated instruments simulating physiological inputs.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The Anscore™ system, as described, appears to be a direct measurement device (ECG monitor, respiration pacer for HRV) rather than an AI/ML algorithm that requires a training set. The technical characteristics state it uses "the same monitoring technology" as predicates. Therefore, no training set for an AI component is mentioned or implied.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as no training set for an AI component is mentioned.

Summary

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AUG 1 1 2000

K993875

510(k) Summary for Boston Medical Technologies, Inc. (BMT) Anscore™ Health Management System ("Anscore™")

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

Submitter:

Cesidio Tempesta Manager of Regulatory Affairs/Quality Assurance Boston Medical Technologies, Inc. 591 North Avenue, Suite 5 Wakefield, MA Tel: 781.213.9200, Fax: 781.213.9233

This summary was prepared on July 26, 2000.

Name of Device: The name of this device is the Anscore™ Health Management System. The common name is ECG monitor and Respiration Pacer. Classification names are as follows:

Regulation Number	Classification Name
870.2340 - 74 DPS, II	Electrocardiograph

Predicate Device: The Anscore™ Health Management System is substantially equivalent to the previously 510(k)-cleared Anscore™ Health Management System (K991831).

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Intended Use: The Anscore™ has the same intended use as the legally marketed predicate devices. The Anscore™ system is intended for use in heart rate variability (HRV) measurements in response to paced respiration and controlled exercises.

Description Device: The Anscore™ 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 and a breathing apparatus, in order to conduct heart rate variability testing. Heart rate variability testing is one of various measurement tools used by physicians in their assessment of autonomic function and dysfunction. 4

Technical Characteristics: 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.

See The American Association of Clinical Endocrinologists Medical Guidelines for the Management of Diabetes Mellitus: The AACE System of Intensive Diabetes Self-management -2000 Update, Endocrine Practice 2000; 6(1):43-84; American Heart Association, 1999. AHA Scientific Statement: Diabetes and cardiovascular disease. Circulation 100:1134-1146; Assessment: Clinical autonomic testing report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology, 1996;46:873-880; Consensus Statement: Report and recommendations of the San Antonio Conference on Diabetic Neuropathy, Diabetes 1988:37:1000-1004; Proceedings of a consensus development conference on standardized measures in diabetic neuropathy. Autonomic nervous system testing. Neurology 1992; 42(9):1831-1837; Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Heart rate variability: standards of measurement, physiological interpretation, and clinical use. Circulation 1996; 93(5)1043-1065; R. Freeman. Noninvasive evaluation of heart rate variability: the time domain. In Low, PA (ed.) Clinical Autonomic Disorders, 2nd ed. Lippincott-Raven Publishers, 1997:297-307; Anonymous. The effect of intensive diabetes therapy on measures of autonomic nervous system function in the Diabetes Control and Complications Trial (DCCT). Diabetologia 1998; 41(4):416-423; A.I. Vinik and S. Suwanwalaikorn. Autonomic Neuropathy. In deFronzo. R.M. (ed.) Current Therapy of Diabetes Mellitus. Yearbook Inc. 1997;165-176; D.J. Ewing. Cardiac Autonomic Neuropathy. In Jarret (ed.) Diabetes and Heart Disease. Elsevier, 1984;99-132; D. Ziegler et al. Effects of treatment with antioxidant alpha-lipoic acid on cardiac autonomic neuropathy in NIDDM patients: a 4-month randomized controlled multi-center trial (DEKAN Study). Diabetes Care 1997:369-373: H. Genovely and M.A. Pfeifer, 1988. RR-variation: the autonomic test of choice in diabetes, Diabetes/Metabolism Review 4(3):225-271.

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Performance Data: The Anscore™ system is the same as the previously 510(k)-cleared Anscore™ Health Management System and, thus, the results of the performance testing for that cleared system apply to this device. Final testing for the system included various performance tests to confirm compliance with functional requirements and performance specifications. Physiological input was simulated using calibrated instrumentation representative of a range of test subjects and physiological states.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is oriented towards the upper right of the image. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

AUG 1 1 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Cesidio Tempesta Boston Medical Technologies, Inc. 591 North Avenue, Suite 5 Wakefield, MA 01880-1641

K993875 Re: R999873 Regulatory Class: II (two) Product Code: DPS Dated: July 14, 2000 Received: July 14, 2000

Dear Mr. Tempesta:

We have reviewed your Section 510(k) notification of intent to market we nave reviewed your boosized we have determined the device is the device referenced above and as addications for use stated in the SubStantially Cquivaters (eted predicate devices marketed in encrosure) to regally may 28, 1976, the enactment date of the Interstate Commerce prior of to devices that have been reclassified Medical Device Americanship, is ons of the Federal Food, Drug, and In accordance with the provisions of the device, subject to the general controls provisions of the Act. The general controls che general controls provisions of the success for annual registration, provisions of the not in manufacturing practice, labeling, and Frochibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special II your device is crabbirou (it may be subject to such controls) of class fri (firsting major regulations affecting your device additional concerner. Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set with the Quality System Regulation (QS) for Medical Devices: _ General regulation (21 CFR Part 820) and that, through periodic QS oencrai regaracion od Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Trailer of Ottion, FDA may publish further announcements rogaroom your device in the Federal Register. Please note: _ this concerning your avremarket notification submission does not affect any response of your got have under sections 531 through 542 of the Act obrigation you might Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Cesidio Tempesta

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,

for Mark N Milkinson

James E. Riddle, III

E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

The ANScore™ Health Management System Device Name The Anscore™ system is intended for use in heart rate variability Indications for Use (HRV) measurements in response to paced respiration and controlled exercises.

K993875

510(k) Number:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

2 Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

for Mark N. Melkerson
Division of Cardiovascular & Respiratory Devices
510(k) Number K993875

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).