The TriFIT 700M is a physical fitness assessment device which can be used in both The THFTF 700M IS a physical Inness assess for individuals to test and to measure their medical fitness levels. The assessment includes body weight, biceps strength, flexibility, phySical Intriess foven. "It estimate percentage body fat), and heart rate.

Device Description

The TriFIT 700M consists of the following components:

1. A standard desktop computer to include the monitor, keyboard, mouse, and printer
Platform weight scale 2.
1. Strength measuring handle
1. Flexibility tester
1. Skin-fold caliper
1. Heart rate monitor
  These components all attach to an interface box. This interface box attaches to the computer via a serial cable. Some components are optional.

AI/ML Overview

The provided document is a 510(k) summary for the TriFIT 700M device, which is a physical fitness assessment system. It establishes substantial equivalence to a predicate device (Microfit fitness evaluation system) rather than providing detailed acceptance criteria and a study report as would be typical for a novel device. Therefore, much of the requested information cannot be extracted directly from this document.

However, based on the information provided, here's what can be inferred and an explanation of why other requested details are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on establishing substantial equivalence to the Microfit device based on intended use and technological characteristics, rather than setting specific performance acceptance criteria for each measurement and reporting its own performance against those criteria. The comparison table essentially serves as the "acceptance criteria" through equivalence, indicating that the TriFIT 700M performs the same functions as the predicate device.

Acceptance Criteria (Based on Predicate Device Equivalence)	Reported Device Performance (Implied by Equivalence)
Intended Use:
Physical fitness assessment on apparently healthy population	Same as predicate device
Interactive Assessments:
Body Weight measurement	Same as predicate device
Biceps Strength measurement	Same as predicate device
Sit and Reach Flexibility Test	Same as predicate device
Skin-fold Calipers for Body Composition	Same as predicate device
Bike with Heart Rate Receiver and RPM pickup	Same as predicate device
Data Entry/Software:
Demographic Information (address, phone, email, etc.)	Same as predicate device
Health Risk Questionnaires	Same as predicate device
Fields tests-manual keyboard entry	Same as predicate device
Exercise Programming	Same as predicate device

No specific numerical performance metrics (e.g., accuracy, precision) for each measurement are provided in this document. The "study" for a 510(k) submission primarily involves demonstrating that the new device does not raise new questions of safety and effectiveness compared to a legally marketed predicate device.

Information Not Available in the Provided 510(k) Summary:

The remaining requested items are typically found in more detailed clinical or performance study reports, which are not part of this 510(k) summary focused on substantial equivalence.

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

Not provided. This document does not describe a clinical performance study with test sets, sample sizes, or data provenance. The equivalence is based on comparing device features and intended use.

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):

Not applicable/Not provided. Since there's no described performance study with a test set requiring ground truth establishment, there's no mention of experts for this purpose.

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

Not applicable/Not provided. As there's no performance study described, adjudication methods are not relevant here.

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:

Not applicable/Not provided. This device is a physical fitness assessment system, not an AI-assisted diagnostic imaging device for "human readers." Therefore, an MRMC study is not relevant.

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

Not applicable/Not provided. The TriFIT 700M is a system with components for direct physical measurements and does not describe a standalone algorithm or AI.

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

Not applicable/Not provided. Since no specific performance study against a ground truth is described, this information is not available.

8. The sample size for the training set:

Not applicable/Not provided. This document describes a physical measurement system, not a machine learning model requiring a training set.

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

Not applicable/Not provided. Similar to point 8, this is not relevant for the type of device described.

In summary, the provided 510(k) summary for the TriFIT 700M device focuses solely on demonstrating substantial equivalence to a legally marketed predicate device (Microfit fitness evaluation system). It compares their intended use and technological characteristics to show that the new device functions similarly and does not raise new issues of safety or effectiveness. It does not contain a detailed report of a clinical performance study with specific acceptance criteria, test sets, or ground truth establishment typically associated with novel or AI-powered devices.

Summary

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

MAR 1 - 2005 KO336 46 Polar HealthFirst

510(k) Summary

Applicant: Polar HealthFirst Corporation 9600 San Mateo Blvd N.E. Albuquerque, New Mexico 87113 Phone (505) 344-1400 Fax (505) 344-1200

Point of Contact: Mr. Jay Skolnik, P.E.

Prepared By: Skolnik Engineering 1317-B Central Avenue S.E., Suite 115 Albuquerque, New Mexico 87123-5549 Phone (505) 299-1157 Fax (505) 299-3647

Date Prepared: December 23, 2004

Trade Name: TriFIT 700M

Common Name: Physical Fitness Assessment System

Classification Name: Computer, Diagnostic, Pre-Programmed, Single-Function

Equivalent Legally Marketed Device: TriFIT 700M is similar in function to the Microfit fitness evaluation system made by Microfit, Inc. in Mountain View, CA.

Description of Device: The TriFIT 700M consists of the following components:

1. A standard desktop computer to include the monitor, keyboard, mouse, and printer
Platform weight scale 2.
1. Strength measuring handle
1. Flexibility tester
1. Skin-fold caliper
1. Heart rate monitor

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

These components all attach to an interface box. This interface box attaches to the computer via a serial cable. Some components are optional.

Intended Use: The TriFIT 700M is used to measure an individual's physical fitness level. Measurements include body weight, biceps strength, flexibility, skin-fold thickness (to estimate percentage body fat), and heart rate.

Technological Characteristics: The TriFIT 700M is substantially equivalent to the recentorogical Characteristics.
Microfit Fitness Evaluation Systems are both operated by a PC, and consist of a bike and ancillary components for measurements that are basically identical.

Comparison Table
	Microfit	TriFIT 700M
Intended Use
Physical fitness assessment device to be used on apparently healthy population	*	*
Interactive Assessments
Body Weight	*	*
Biceps Strength	*	*
Sit and Reach Flexibility Test	*	*
Skin-fold Calipers for Body Composition	*	*
Bike with Heart Rate Receiver and RPM pickup	*	*
Data Entry/Software
Demographic Information (address, phone, email, etc.)	*	*
Health Risk Questionnaires	*	*
Fields tests-manual keyboard entry	*	*
Exercise Programming	*	*

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

MAR 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Polar HealthFirst Corporation c/o Mr. Jay Skolnik, PE Skolnik Engineering 13170-B Central Ave. SE Suite 115 Albuquerque, NM 87123

K033646 Re: Trade Name: TriFIT 700M Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate and alarm) Regulatory Class: II (two) Product Code: DRT Dated: December 23, 2004 Received: December 27, 2004

Dear Mr. Skolnik:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosure) to regard) the enactment date of the Medical Device Amendments, or to conniner that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been resulted in ause approval of a premarket approval application (PMA). alle Cosment Act (Act) that do not require the general controls provisions of the Act. The r ou may, mercroro, market of the Act include requirements for annual registration, listing of general exhilitions providers of abeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is etablifiedal controls. Existing major regulations affecting your device it may or subject to bach additions, Title 21, Parts 800 to 898. In addition, FDA ean be found in the over ents concerning your device in the Federal Register

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

Page 2 - Mr. Jay Skolnik, PE

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substainter open ies with other requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must a or any Federal Statutes and regulations daministered or registration and listing (21 comply with an the Act s requirements, mo; good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic iorul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Deceible over device as described in your Section 510(k) I his letter will anow you to begin manceing your as revivalence of your device to a legally premarket notification. "The PDT Imaxing of cation 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), please If you desire specific advice for your ac not an each of each and of the regulation entitled, colliact the Office of Complance at (176) = 16 = 21 = 21 807.97). You may obtain "Misoranding by refected to premainter notifical with the Act from the Division of Small other gelleral Information on your response Assistance at its toll-free number (800) 638-204) or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Brimmer for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(K) Number (if known): K033646

Device Name: TriFIT 700M

Indications For Use:

Prescription Use: No (Parl 21 CFR 801 Subpart D)

And/Or

Over-The-Counter Use: Yes (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Bammma

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number -

Page 1 of 1

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).