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For the purposes of performing non-invasive bio-electrical impedance analysis (BIA) measurements on healthy human adults and children to determine their Body Composition status. Such measurements include Body Mass Index (BMI), waist/hip ratio, and tissue Impedance at 5, 50, 100 and 200 kHz. These measurements are used to calculate the estimated levels of extra-cellular water, intracellular water, total body water, body fat, body lean and dry lean, and metabolic rates. QuadScan 4000 for Windows Software Program is automatically included with the device.

The OuadScan 4000 Body Composition & Fluid Monitoring Unit is a light weight, handheld, battery operated device that uses bio-electrical impedance analysis (BIA) to measure the impedance of the flow of an electrical current through the body; impedance is measured at four frequencies: 5, 50, 100, and 200 kHz. 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 lean tissue is high in water, thus lean tissue has a low impedance. The subject's age, sex, height, weight, 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) and ECW (extra-cellular water), may be used subsequently to convert measured impedances to corresponding estimates of TBW and ECW. By deduction, ICW is estimated. By applying the unique Bodystat® equation, Body Fat, Lean Mass and Dry Lean Mass can be assessed. The QuadScan 4000 contains separate body composition equations for children 6 years to 17 years, and adults 18 - 70 years.

The provided text is a 510(k) summary for the Bodystat QuadScan 4000 Body Composition & Fluid Monitoring Unit. This document states that the device is substantially equivalent to a previously cleared predicate device (OuadScan Ouad Frequency Monitoring Unit & OuadScan Wellness and Hydration Software Program cleared under K002835). As such, it primarily focuses on comparing the new device to the predicate rather than presenting a de novo study with specific acceptance criteria and performance data for the new device.

Therefore, the text does not contain detailed information regarding:

• Specific acceptance criteria (e.g., performance thresholds for accuracy, precision of body composition measurements).
• A dedicated study proving the device meets acceptance criteria, beyond the demonstration of substantial equivalence to a predicate device.
• Sample sizes for test or training sets.
• Data provenance, expert qualifications, adjudication methods, or MRMC studies.
• Standalone algorithm performance or the type of ground truth used in a new study.

The document emphasizes that the new device is a "hardware and software modification" of the predicate, implying that its performance is expected to be similar to the established performance of the predicate.

Given this, I can only extract limited information related to the device's intended use and the nature of its operation.

Here's a summary of what the document provides, and what it explicitly does not provide:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list quantitative acceptance criteria (e.g., specific accuracy ranges for body fat percentage, water content) or present a table of reported device performance metrics against such criteria for the new device. The basis for clearance is substantial equivalence to a predicate device (K002835).

2. Sample size used for the test set and the data provenance:

Not provided. The document relies on substantial equivalence to a predicate device, not new clinical study data with test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided. There is no mention of a new test set requiring expert ground truth establishment for this 510(k) submission.

4. Adjudication method for the test set:

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:

Not applicable and not provided. The device is a Body Composition Analyzer, not an imaging device requiring human reader interpretation or AI assistance in that context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is essentially a standalone algorithm with a hardware interface (Bio-electrical Impedance Analysis). However, no new performance study metrics for this device are provided, as substantial equivalence is the basis. The performance is implied to be similar to the predicate.

7. The type of ground truth used:

Not explicitly stated for a new study. The predicate device's prediction equations were "previously generated by correlating impedance measures against an independent estimate of TBW (total body water) and ECW (extra-cellular water)." This suggests independent quantitative measures (e.g., DEXA, isotope dilution, or other reference methods for body composition) were used as ground truth for developing the equations for the predicate device.

8. The sample size for the training set:

Not provided for this submission. The "prediction equations" for the predicate device were developed using an unspecified training set size.

9. How the ground truth for the training set was established:

For the predicate device's equations, ground truth was established by "correlating impedance measures against an independent estimate of TBW (total body water) and ECW (extra-cellular water)." This indicates the use of reference methods for measuring these body composition parameters.

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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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