(102 days)
The Shenzhen Healthcare Electronic Technology Body analysis scale, Model BG 17 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
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 Shenzhen Healthcare Body Analysis scale calculates the body fat percentage. 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 provided document is a 510(k) summary for the Shenzhen Healthcare Body Analysis Scale, Model BG 17. It mentions that clinical testing was used to validate the effectiveness and accuracy of the device and that "All test results were satisfactory." However, it does not provide specific details about the acceptance criteria or the study design, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot fully complete the requested table and information.
Here's what I can infer and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "All test results were satisfactory" |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (country of origin or retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided.
4. Adjudication method for the test set
- This information is not provided.
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
- This device is a "Body Analysis Scale" that uses Bioelectrical Impedance Analysis (BIA) to calculate body composition. It does not involve human readers interpreting images or data, so an MRMC comparative effectiveness study with human readers and AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device inherently operates as a standalone algorithm (internal software) to calculate body composition from sensor data (electrical impedance, height, weight, age, gender) entered by the user. The statement "Clinical testing was used to validate the effectiveness and accuracy of the device" implies a standalone performance evaluation against a reference method (though the reference method is not specified).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The document states "Clinical testing was used to validate the effectiveness and accuracy of the device." For body composition devices, the ground truth typically involves reference methods like DEXA (Dual-energy X-ray absorptiometry), hydrostatic weighing, or other highly accurate but less accessible methods. However, the specific type of ground truth used is not mentioned in this summary.
8. The sample size for the training set
- This information is not provided. The device performs calculations based on Bioelectrical Impedance Method and internal software using programmed variables; it's not explicitly described as an AI/machine learning model that would have a distinct "training set" in the modern sense. It's more likely a fixed algorithm.
9. How the ground truth for the training set was established
- Not applicable as a distinct training set (in the machine learning sense) is not described. If there were calibration data used to develop the internal algorithm, the method for establishing their ground truth is not detailed.
§ 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.