(126 days)
The Transtek Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older.
It is intended for use in the home/domestic setting only.
Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Glass Body Fat Analyzer LS203-B.
This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness.
Transtek Glass Body Fat Analyzer GLS203-B embeds a Bluetooth module that allows it to connect to nearby BT receiving terminal. Once measurement is over, the LCD of device displays measurement results, and the device will start to send out measurement data to paired BT terminal at the same time. Thus users can receive, display, and storage measurement results from LS203-B unit through mobile BT terminal.
The provided text describes a 510(k) summary for the Transtek Glass Body Fat Analyzer Model LS203-B. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity for its intended body composition measurements.
The document focuses on demonstrating substantial equivalence to a predicate device (TRANSTEK, Glass Body Analyzer, Model LS206-E, K123781) by highlighting that the only significant difference is the wireless communication technology (Bluetooth vs. RF). It asserts that this change does not raise new questions of safety and effectiveness, and therefore, no clinical performance testing was deemed necessary for the comparison of the two devices.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance
Not provided. The document states: "Explanation: The wireless function does not affect body analyzer measurement function. Therefore we have not done the Clinical test." This indicates that no specific performance metrics comparing the LS203-B to a gold standard were conducted or reported in this summary.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. No clinical performance test set or data provenance is mentioned. The only "tests" referred to are "bench tests," "risk management," and "design verification tests" for the modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No ground truth establishment experts are mentioned because no clinical performance study was conducted.
4. Adjudication method for the test set
Not applicable/Not provided. No adjudication method is mentioned because no clinical performance study was conducted.
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. This device is a body composition analyzer, not an AI-assisted diagnostic imaging device requiring human reader interpretation in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. While the device itself is a standalone measurement tool, the document doesn't present a study assessing its standalone performance against a clinical ground truth. It relies on the substantial equivalence to the predicate device, which presumably had established performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. No ground truth is mentioned in the context of a performance study for the LS203-B. Its substantial equivalence argument implies that the predicate device's performance, likely validated against some form of ground truth (e.g., DEXA or other established body composition methods for the predicate), is assumed to apply.
8. The sample size for the training set
Not applicable/Not provided. This document doesn't describe the development or training of an AI algorithm in the contemporary sense. It's an impedance-based device, and while it uses algorithms for calculation, it's not discussed in terms of a "training set" like a machine learning model.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there's no mention of a training set, there's no information on how its ground truth might have been established.
Summary of the Study (as described in the document):
The document describes a submission for a modified device (LS203-B) that is substantially equivalent to a predicate device (LS206-E). The "study" here is primarily a design control activity and substantial equivalence comparison, not a clinical performance validation of the LS203-B's accuracy in measuring body composition.
- Objective: To demonstrate that the modified device (LS203-B) is substantially equivalent to the predicate device (LS206-E) and does not raise new questions of safety and effectiveness.
- Key Finding: The only significant difference is the use of Bluetooth instead of RF for wireless data transmission.
- Conclusion: This modification does not impact the safety and effectiveness of the device, and therefore, no clinical performance tests were considered necessary for this 510(k) submission. The device is deemed substantially equivalent.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.