(467 days)
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.
The TriFIT 700M consists of the following components:
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- A standard desktop computer to include the monitor, keyboard, mouse, and printer
- Platform weight scale 2.
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- Strength measuring handle
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- Flexibility tester
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- Skin-fold caliper
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- 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.
- Heart rate monitor
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.
§ 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).