(111 days)
The Transtek 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 Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body far 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 Transtek Body Fat Analyzer (GBF-1251-B, BF-1256-B, and GBF-1257-B).
This method simultaneously calculates personal body water, muscle mass, and bone mass, giving a more accurate reading of overall health and fitness. As well as being an analyzer, this device can be used as a conventional weight scale.
The Transtek Body Fat Analyzer embeds a Bluetooth (BT) module that allows it to connect to nearby BT receiving end. The LCD of device displays results. And once measurement is over, the device will start transmission data by BT. Thus users can receive, and display/storage, measurement data of Transtek Body Fat Analyzer unit through their end devices that embedded BT module.
Here's an analysis of the provided text regarding the Transtek Body Fat Analyzer and its acceptance criteria and study information:
Acceptance Criteria and Study Information for Transtek Body Fat Analyzer
Based on the provided 510(k) summary (K130311), here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or reported device performance metrics for body fat, total body water percentage, muscle mass, or bone mass estimation. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to general safety and electrical standards.
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | Not explicitly stated in the document |
The document primarily focuses on demonstrating that the Transtek Body Fat Analyzer (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B) is substantially equivalent to the predicate device, Transtek Glass Body Fat Analyzer, Model GBF-950-D (K112932). The key argument for substantial equivalence is that the only significant difference is the addition of a wireless data communication function, which is an add-on and does not affect the safety and effectiveness of the body composition analysis function.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size or provide details on a "test set" used for clinical validation of the body composition measurements. The assessment appears to rely on a demonstration of design control activities and performance tests focusing on adherence to electrical safety and electromagnetic compatibility standards, rather than a clinical trial with a defined test set for accuracy of body composition measurements.
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. (The submitter is from China, but there's no indication of where any testing data, if clinical, would originate).
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that no explicit clinical test set for body composition accuracy is described, there's no information regarding experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
As no explicit clinical test set is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned in the provided document. The focus is on device equivalence, not on comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a Body Fat Analyzer that directly measures and displays results. The concept of "standalone performance" in the context of an algorithm's output versus human interpretation (as often seen in imaging AI) is not applicable to this type of device based on the provided information. The device itself is the "algorithm" and produces the output for the user.
7. The Type of Ground Truth Used
The document does not specify a type of ground truth (e.g., pathology, outcomes data, expert consensus) for body composition measurements. The substantial equivalence argument implies reliance on the already accepted performance of the predicate device and adherence to relevant standards.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This implies that the device's algorithms for body composition measurement were either developed or previously validated, and this 510(k) focused on demonstrating equivalence and safety of the new wireless feature rather than re-validating the core body composition algorithms.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth was established.
Summary of Study Information Gaps:
The K130311 summary for the Transtek Body Fat Analyzer primarily focuses on demonstrating substantial equivalence to an existing predicate device, particularly concerning the addition of a wireless data transmission function. It emphasizes compliance with general electrical safety (IEC60601-1), electromagnetic compatibility (IEC60601-1-2, FCC Part 15), and risk management (ISO14971) standards.
Crucially, the document does not provide details on specific clinical studies, test sets, sample sizes, or ground truth establishment related to the accuracy of the body composition measurements (body fat, water, muscle, bone mass). This is a common characteristic of 510(k) submissions where a device is deemed substantially equivalent to a predicate, and the modifications are considered not to raise new questions of safety or effectiveness regarding the core function. The assumption is that the predicate device's performance has already been established.
§ 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.