(272 days)
The Transtek Glass Body 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.
The TRANSTEK Glass Body Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water and bone mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer. This method simultaneously calculates your personal weight, body fat, total body water, bone mass and muscle mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 8 or 10 users. As well as being an analyzer, this device can be used as a conventional scale.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets said criteria. However, based on the context of a 510(k) summary for a body composition analyzer, we can infer some general information and highlight what is missing.
The document states that the "TRANSTEK Glass Body Analyzer utilizes a "foot-to-foot" bioelectrical impedance analysis (BIA) technology to determine internal body composition" and that "BIA (Bioelectrical Impedance Analysis) technology is same as what is used in Scaleman Body Fat Scales (Model FS-148BW1)." This indicates that the primary "study" for acceptance is a demonstration of substantial equivalence to a predicate device already on the market (K083838, Scaleman Body Fat Scales).
Here's an attempt to answer your questions based on the provided text, while acknowledging the significant gaps in detail regarding a specific performance study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy of Body Composition Measurements: | The document itself does not provide any specific accuracy metrics (e.g., mean absolute error, R-squared values for correlation with a gold standard) for body fat, total body water, bone mass, or muscle mass measurements. It focuses on demonstrating that the technology (BIA at 50 KHz) and measurement method ("foot-to-foot") are the same as the predicate device. |
| Weight Measurement Accuracy: | Similar to body composition, no specific accuracy for weight measurement is provided. The device is stated to "measure weight." |
| Substantial Equivalence: | The core "performance" demonstrated is substantial equivalence to the predicate device, Scaleman Body Fat Scales (Model FS-148BW1), by showing that "the subject devices have all features of the predicate device... except the new features and the power source voltage... These differences do not affect the safety and effectiveness... BIA ... is same as what is used in Scaleman Body Fat Scales." |
| Intended Use: | The device performs as described in its intended use: "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." |
2. Sample Size for the Test Set and Data Provenance
The provided 510(k) summary does not contain any information about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The assessment relies on the equivalence to a predicate device, implying that the predicate device's performance is an acceptable benchmark.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set. Since a direct performance study is not detailed, the concept of expert-established ground truth for the device's accuracy isn't applicable in the provided information.
4. Adjudication Method
Not Applicable. No specific test set or ground truth establishment requiring adjudication is described in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable. The device is a direct measurement tool (body composition analyzer), not an AI-assisted diagnostic tool requiring human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. Standalone (Algorithm Only) Performance Study
The provided text does not detail a standalone performance study where the algorithm's accuracy for body composition measurements was rigorously tested against a gold standard. The focus is on demonstrating that the BIA technology used is the same as the predicate device. While BIA itself is an "algorithm" to derive body composition from impedance, the document doesn't provide data on its standalone accuracy.
7. Type of Ground Truth Used
Not explicitly stated for the applicant device. For a body composition analyzer, common gold standards (ground truth) would include DEXA (Dual-energy X-ray absorptiometry) scans, hydrostatic weighing, or isotopic dilution methods. However, the document does not mention that this specific device was tested against such gold standards. Instead, the ground truth is implicitly tied to the accepted performance of the predicate device, which would have undergone such validation during its own clearance process.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This type of information would be relevant if the applicant device involved novel algorithms or machine learning requiring specific training data. Since the device relies on a known technology (BIA) and aims for substantial equivalence, a "training set" in the machine learning sense is not discussed.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed, the method for establishing its ground truth is not applicable/provided.
§ 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.