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510(k) Data Aggregation
(233 days)
OMV
(1) BodyMetrix BX2000 is indicated for the measurement of localized fat layer thickness and localized muscle thickness. When used with the BodyView Software it can be used to estimate total body fat percentage (%BF). The BX2000 is only intended to be used on generally healthy adults and children (6 or older) and is not for diagnosis of disease or condition.
(2) The BodyView Software is indicated for the calculation of the estimated total body fat percentage (%BF), localized fat layer thickness, and localized muscle thickness. The BodyView Software is indicated for calculating Waist-to-Hip Ratio (WHR), and Body Mass Index (BMI). The Body View Software is indicated for estimating Basal Metabolic Rate (BMR). The Body View software can track changes in the measurements, and generate body composition reports.
BodyMetrix BX2000™ is a portable, hand-held device that uses A-mode ultrasound to measure tissue thickness. The device is powered and communicates with a portable or desktop computer through a USB interface. A piezoelectric transducer is used to generate and transmit ultrasound. sound waves into tissue. The reflected sound waves are detected by a second and separate piezoelectric transducer and digitized before the data is transferred through a USB cable to the computer.
The BodyMetrix BX2000™ measures localized fat and muscle thickness and, with BodyView Software, estimates total body fat percentage (%BF), Waist-to-Hip Ratio (WHR), Body Mass Index (BMI), and Basal Metabolic Rate (BMR) for generally healthy adults and children (6 or older).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document details the device's preclinical acoustic output limits, but it does not explicitly state specific acceptance criteria (e.g., accuracy thresholds, precision targets) for its ability to measure tissue thickness or estimate body fat percentage. It only states that "Clinical testing was conducted and submitted as part of the 510(k) application to confirm that BodyMetrix BX2000™ is as safe and effective device for measuring tissue thickness and estimating percentage body fat."
The reported device performance, in terms of clinical accuracy or comparison to a gold standard, is not provided in a quantifiable manner within this summary.
| Metric (Implied) | Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document) |
|---|---|---|
| Tissue Thickness Measurement | Likely accuracy against a gold standard | The document states clinical testing was done to confirm safety and effectiveness, but results are not quantified. |
| Estimated Total Body Fat (%BF) | Likely accuracy against a gold standard | The document states clinical testing was done to confirm safety and effectiveness, but results are not quantified. |
| Acoustic Output (ISPPA.3) | ≤ 60 mW/cm² | 60 mW/cm² (Maximum) |
| Acoustic Output (ISPTA.3) | ≤ 0.02 mW/cm² | 0.02 mW/cm² (Maximum) |
| Mechanical Index (MI) | ≤ 0.02 | 0.02 (Maximum) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that "Clinical testing was conducted and submitted as part of the 510(k) application," but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size regarding human reader improvement with or without AI assistance. The device is described as an ultrasonic device for body composition, not explicitly an AI-assisted diagnostic tool that would typically involve such a study with human readers interpreting output.
6. Standalone Performance Study:
The document indicates that clinical testing was conducted to confirm the device's safety and effectiveness for measuring tissue thickness and estimating body fat. This implies a standalone performance evaluation of the algorithm's output, as the device is intended to provide these measurements directly. However, detailed results of this standalone performance are not provided.
7. Type of Ground Truth Used:
The document states that the BodyMetrix BX2000™ "uses the same measurement points and formulas that are used for skinfold calipers." This implies that the ground truth for comparison in the clinical testing likely involved measurements obtained through traditional skinfold calipers or another established body composition assessment method. However, it does not explicitly state the specific "gold standard" or type of ground truth used (e.g., DEXA, hydrodensitometry, pathology, outcomes data).
8. Sample Size for the Training Set:
The document does not provide information on the sample size used for any training set. Given that the device "uses the same measurement points and formulas that are used for skinfold calipers," it's possible that the "algorithm" is based on established formulas rather than a machine learning model requiring a distinct training set. If machine learning was involved, this information is not disclosed.
9. How the Ground Truth for the Training Set Was Established:
As no training set is explicitly mentioned, the document does not describe how ground truth for a training set was established.
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