(84 days)
Body Fat Analyzer and Scale measures body weight and impedance and estimates percentage of body fat, body water and body muscle mass using BIA (bioelectrical impedance analysis). It is intended for use by healthy adults 18 years of age or older who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy for body composition assessment in the home environment.
The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Conmo Electronic Company Limited Body Fat Analyzer and Scale provides weight, calculates the body fat, body water and body muscle mass. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
The Conmo Electronic Company Limited Body Fat Analyzer and Scale, Model 5786, measures body weight and impedance and estimates the percentage of body fat, body water, and body muscle mass using Bioelectrical Impedance Analysis (BIA). The provided 510(k) summary states that clinical testing was used to validate the effectiveness and accuracy of the device, with all test results reported as satisfactory. However, the document does not explicitly detail specific acceptance criteria or the study design (e.g., sample size, expert involvement, ground truth methodology) for this clinical testing.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly state specific numerical acceptance criteria for accuracy, precision, or other performance metrics. It only states that "Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." Without specific criteria, a direct comparison is not possible.
| Performance Metric | Acceptance Criteria (as stated in document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Effectiveness | Not explicitly defined (implied satisfactory performance) | "All test results were satisfactory" |
| Accuracy | Not explicitly defined (implied satisfactory performance) | "All test results were satisfactory" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Clinical testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified
- Qualifications of Experts: Not specified
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The document does not provide details on how discrepancies in ground truth establishment (if any) were resolved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or described in the document. This type of study typically involves human readers interpreting diagnostic images or data with and without AI assistance to measure the effect size of AI improvement. The device in question is a standalone measurement device for body composition, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: While the device functions as a standalone unit (measurements are taken by the device and calculations performed by internal software), the document does not provide a detailed breakdown of a standalone performance study with specific metrics beyond the general statement of "satisfactory" effectiveness and accuracy. The clinical testing mentioned seems to assess the overall device performance which, by its nature, is standalone as it outputs direct measurements.
7. The Type of Ground Truth Used
- Type of Ground Truth: The document does not explicitly state the specific "ground truth" method used for the clinical validation of body fat, body water, or body muscle mass. For body composition devices, common ground truth methods include:
- DEXA (Dual-energy X-ray absorptiometry): A gold standard for body composition.
- Hydrostatic weighing: Another accurate method.
- Air displacement plethysmography (Bod Pod): Also considered accurate.
- Calipers: For skinfold thickness.
Without this information, it's unclear against what highly accurate measurement the device's outputs were compared.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. The document describes a device that performs calculations based on Bioelectrical Impedance, height, weight, age, and gender using "internal software." It does not describe a machine learning or AI model that requires a distinct "training set" in the conventional sense. The "internal software" likely uses established BIA equations rather than a learned model from a large dataset.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable/Not specified. As there is no mention of a training set for a machine learning model, the method for establishing ground truth for such a set is not relevant here. The device's calculations are based on programmed variables and scientific formulas for BIA.
§ 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.