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For the purposes of performing a non-invasive BIA measurement on normal healthy human adults and children to determine their Body Composition status.

The measurements include Body Mass Index (BMI), waist/hip ratio, tissue impedance at 5kHz and at 50kHz. These measurements are used to calculate the estimated levels of body fat, body lean and dry lean, total body water, and metabolic rates,

Bodystat BODY MANAGER and WELLNESS SOFTWARE PROGRAMS are automatically included with this device.

The Body Manager Program is designed for when a client returns to be tested in order to track their changes in body composition over a period of time.

The Wellness Program is designed for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.

The Bodystat 1500MDD Body Composition Monitoring Unit is a light weight, handheld, batteryoperated device that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body. The impedance of tissue is proportional to the amount of fluid in the tissue; water is low in fat tissues, thus fat tissue has a high impedance, and high in lean tissues, thus lean tissue has a low impedance. The subject's age, sex, height, waist measurement, and hip measurement are also used to calculate various values.

In practice, a small constant current is passed between electrodes spanning the body and the voltage drop between electrodes provides a measure of impedance. Prediction equations, previously generated by correlating impedance measures against an independent estimate of TBW (total body water), may be used subsequently to convert a measured impedance to a corresponding estimate of TBW. Lean body mass is then calculated from this estimate using an assumed hydration fraction for lean tissue; Bodystat uses a proprietary regression equation for this calculation. Fat mass is calculated as the difference between body weight and lean body mass. A body composition analysis report is comprised of Body Fat, Lean Body Mass, Dry Lean Mass, Total Body Water, and Optimal Ranges. Metabolic rates, Waist/Hip Ratio, and BMI are also reported. In addition, raw values are shown for Impedance at 5 kHz and at 50 kHz. The Bodystat 1500MDD contains separate equations for children aged 6 - 17 years and for adults aged 18 - 70 years.

The provided text does NOT include details about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Bodystat 1500MDD Body Composition Monitoring Unit, indicating its substantial equivalence to previously cleared devices. It describes the device, its intended use, and a comparison to predicate devices, but lacks information on performance criteria or a study with specific results.

Therefore, I cannot populate the table or answer the specific questions about the study from the given input.

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For the purposes of performing a non-invasive bio-impedance analysis (BIA) measurements on normal healthy human adults to determine their Body Composition status.

This device measures bio-electrical impedance when a 50 kHz signal is applied at specific locations on the subject. From this and the subject's age, gender, weight, height, waist and hip circumferences (optional), the device calculates the following estimated values: fat%, fat weight, lean%, lean weight, total body water%, total body water, dry lean weight, basal metabolic rate, basal metabolic rate/body weight ratio, average requirement (EAR), and actual body mass index and waist/hip ratio.

OPTIONAL ACCESSORIES: Bodystat (1) BODY MANAGER and (2) WELLNESS SOFTWARE PROGRAMS.

The Body Manager Program is ideal when a client returns to be tested in order to track their changes in body composition over a period of time.

The Wellness Program is ideal for first time assessments on subjects. The program's graphical presentations provide information on each of the specific measurements in an educational format.

The Bodystat 1500 Body Composition Monitoring Unit is an impedance plethysmograph that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body. The impedance of tissue is proportional to the amount of fluid in the tissue; water is low in fat tissues, thus fat tissue has a high impedance, and high in lean tissues, thus lean tissue has a high impedance.

In practice, a small constant current is passed between electrodes spanning the body and the voltage drop between electrodes provides a measure of impedance. Prediction equations, previously generated by correlating impedance measures against an independent estimate of TBW (total body water), may be used subsequently to convert a measured impedance to a corresponding estimate of TB W. Lean body mass is then calculated from this estimate using an assumed hydration fraction for lean tissue; Bodystat uses a proprietary regression equation for this calculation. Fat mass is calculated as the difference between body weight and lean body mass.

The provided text is a 510(k) summary for the Bodystat 1500 Body Composition Monitoring Unit. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain information on acceptance criteria, specific study details (like sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies), or actual device performance metrics against acceptance criteria.

The document primarily focuses on establishing substantial equivalence to a previously cleared device (K951097) through hardware and software modification, sharing the same intended use and operating principle. The FDA letter confirms the 510(k) clearance based on this review.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details from the provided text. The document states that "Based on the data and information presented here, the modified BODYSTAT® 1500 Body Composition Monitoring Unit is substantially equivalent to the previously cleared Bodystat 1500 device," implying that the data was used to demonstrate this equivalence, but it does not describe the specific study parameters or results.

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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.

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ESTIMATED MEASUREMENT OF: FAT, LEAN, WATER, INTRA-CELLULAR WATER, EXTRA-CELLULAR WATER, TOTAL ESTIMATED WATER AND IMPEDANCE VALUES AT 50 KHZ

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Bodystat® LTD. DuelScan 2005 Dual-Frequency Monitoring Unit). This document primarily focuses on regulatory approval and the device's substantial equivalence to previously marketed devices.

It does not contain the detailed information required to answer your questions regarding acceptance criteria, study design, performance results, or ground truth establishment. The letter refers to indications for use but does not provide the specifics of a study proving those indications or device performance against acceptance criteria.

Therefore, I cannot extract the information required to populate the table and answer the study-related questions based on this document.

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MEASUREMENT OF ESTIMATED EXTRA-CELLULAR WATER; ESTIMATED INTRA-CELLULAR WATER. ESTIMATED TOTAL BODY WATER; AND

Not Found

I apologize, but the provided text does not contain the information needed to describe acceptance criteria, device performance, or details about a study. The document is an FDA 510(k) clearance letter for a device called "BodyStat® MultiScan 5000" and an "Indications For Use" statement.

It primarily states that the device is substantially equivalent to a pre-amendment device and outlines regulatory general controls and responsibilities. There is no information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth was established for training data.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

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