Search Results

MEASUREMENT OF:
ESTIMATED: Body FAT
BODY LEAN+
DRY LEAN
TOTAL BODY WATER
METABOLIC RATES

ACTUAL: BODY MASS INDEX (BMI)
WAIST / HIP RATIO
IMPEDANCE AT 50 kHZ

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to complete the acceptance criteria table and study questions. The document is an FDA 510(k) clearance letter for the Bodystat® 1500MDD (K994242), which indicates the device is substantially equivalent to legally marketed predicate devices.

However, it does not include:

• Specific acceptance criteria values (e.g., target accuracy, precision) for the device's performance.
• Reported device performance values that would allow comparison against acceptance criteria.
• Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) that proved the device met specific criteria.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent for the stated indications for use (measurement of estimated body fat, body lean+, dry lean, total body water, metabolic rates; and actual body mass index, waist/hip ratio, impedance at 50 kHz). To answer your questions, I would need access to the actual 510(k) submission document or a summary of its performance data.

Ask a specific question about this device