Search Results

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.

Ask a specific question about this device

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 LS206-E. 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. This scale stores the personal data of up to 4 users. As well as being an analyzer, this device can be used as a conventional weight scale. Transtek Glass Body Fat Analyzer LS206-E embeds a Wireless network connections module that allows it to connect to nearby receiving end (such as specific equipment that named Bridge) which is connected to the Internet. Once measurement is over, the LCD of device displays results. And the device will start to send out data. The Bridge receive / storage, and transmission data to Internet server. Thus users can receive, and display/storage, measurement results from LS206-E unit through their end devices (e.g. PC, cellular, tablet) that connected Internet.

The provided text describes a 510(k) premarket notification for the "TRANSTEK Glass Body Fat Analyzer Model: LS206-E". It focuses on establishing substantial equivalence to a predicate device, the TRANSTEK Glass Body Fat Analyzer, Model GBF-950-D (K112932).

Crucially, the document explicitly states: "Explanation: The new wireless function does not affect body analyzer measurement function. Therefore we have not done the Clinical test." This means no clinical study was performed to demonstrate the device meets acceptance criteria related to its core measurement functions (body fat, total body water, muscle mass, bone mass). The focus of the submission and the performance tests summary is on the safety and effectiveness of the wireless function integration and compliance with electrical and EMI standards, not on the accuracy of the body composition measurements.

Therefore, I cannot provide acceptance criteria or a study proving the device meets those criteria for the body composition analysis function based on the given information.

However, based on the information provided, here's what can be inferred and stated regarding performance and testing related to the wireless functionality and general device safety:

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

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

The document does not mention a "test set" for body composition measurements or a clinical study. The tests performed were "bench tests" related to design control, risk management, and verification for the device modifications (primarily the wireless function) and compliance with relevant standards. No specific sample size or data provenance is mentioned for these engineering/safety tests.

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. As no clinical test was performed to establish performance for body composition measurements, there were no experts establishing ground truth for such a test set. The submission focuses on engineering and regulatory compliance.

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

Not applicable. No clinical test was performed for body composition measurements.

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 standalone body composition analyzer, not an AI-assisted diagnostic tool requiring human reader interpretation. No MRMC study was performed.

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

A "standalone" performance for the body composition analysis (BIA technology) is implied to be identical to the predicate device, K112932, as the new device's core measurement function is stated to be unchanged. The submission primarily addresses the standalone performance of the wireless communication module and its non-interference with the core function. No new standalone performance evaluation for the BIA algorithm itself was conducted for this submission.

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

For the body composition measurements, this information is not provided in the summary, as no new clinical study was conducted. It is assumed the predicate device established its performance against some form of ground truth (e.g., DEXA or other established methods), but details are not present here.

For the wireless functionality and safety aspects, the "ground truth" is compliance with engineering standards (IEC, FCC, ISO) and verification that the wireless module performs its intended data transmission without negatively impacting the existing device functions. This "ground truth" is established through bench testing and adherence to published standard requirements.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a training set in the conventional sense for its core function. The device uses BIA technology, which is based on established biophysical principles and algorithms, not a trainable model from a large dataset.

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

Not applicable, as there is no training set for an AI-based algorithm described in this submission.

Ask a specific question about this device