(168 days)
Calculation and Historical Tracking of:
- . Actual Resistance
- Actual Reactance .
- Actual Impedance
- Actual Phase Angle (PA) .
- Estimated Body Fat Mass (FM) ●
- Estimated Fat Free Mass (FFM)
- Estimated Total Body Water (TBW) .
- Estimated Intra-Cellular Water (ICW) ●
- Estimated Extra-Cellular Water (ECW) ●
- Estimated Basal Metabolic Rate (BMR) .
- Estimated Daily Energy Expenditure (DEE) .
- Actual Body Mass Index (BMI) .
The device is not intended for use for diagnosis.
The actual resistance, reactance, impedance and phase angle have no clinical utility and are for calculation of body composition only.
The data are stored in PC in the Backup system of the E.S-BC software.
As regard to the estimated TWB , ICW and ECW , the device is intended for use on healthy subjects' over 12 years old and under 80 years old and non-Hispanic whites, non-Hispanic blacks and Mexican Americans in the US population .
As regard to the estimated FM and FFM, the device is intended for use on healthy subjects over 19 years old and under 63 years old and Caucasian and Hispanic Americans in the US population. The device is for over-the-counter use
The E.S- BC is a single frequency electrical bioimpedance analyzer. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), total body water (TWB) and fluid distribution: intracellular water, and extracellular water.
It has a tetra-polar set of leads, which are attached to self- adhesive skin electrodes. The E.S- BC has two operating modes: Direct and Algorithm.
Direct Mode measures and displays values for impedance (Z), phase (Ph), resistance (R) and reactance (Xc).
Algorithm Mode displays estimates of fat-free mass (FFM) ,fat mass (FM), total body Water (TBW), intracellular water (ICW), and extracellular water (ECW), plus their percentages. The device computes these values using accepted peer reviewed published algorithms tailored to the patient type: general population, obese patients, or children.
The provided text describes a 510(k) premarket notification for the E.S-BC Electro Sensor / Body Composition device. It details the device's summary and substantial equivalence to predicate devices but does not contain specific acceptance criteria, a detailed study protocol, or quantitative performance data beyond general statements of testing.
Therefore, I cannot fill in a table of acceptance criteria vs. device performance, or provide the detailed study information regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies as requested. The document only mentions "Performance testing: 1. Testing and Calibration, 2. Software verification (SRS/STD/STR), 3. Clinical investigation (Miami University)" as evidence of performance.
Based on the information available, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not specify quantitative acceptance criteria for the performance of the E.S-BC device's Body Composition estimations (FM, FFM, TBW, ICW, ECW) nor does it provide detailed performance results from the clinical investigation. It only generally states that testing and calibration and a clinical investigation were performed to show that specific differences (USB power, direct data transmission, different peer-reviewed algorithms) "do not affect the performances and the effectiveness of the E.S/BC system."
2. Sample Size Used for the Test Set and Data Provenance
The document states a "Clinical investigation (Miami University)" was conducted, but it does not specify the sample size for this test set or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described in the provided document. The device's primary function is direct measurement and algorithmic calculation, not human-in-the-loop diagnostic assistance for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
The document implies a standalone performance, as the device directly measures and computes body composition metrics. It has an "Algorithm Mode" that "displays estimates" using "accepted peer reviewed published algorithms." However, detailed results of such a standalone study (like accuracy metrics against a reference standard) are not provided beyond the general statement of a clinical investigation.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the clinical investigation. For body composition devices, common ground truth methods include DEXA scans, hydrostatic weighing, or isotope dilution, but the document does not specify which, if any, were used.
8. The Sample Size for the Training Set
The document mentions the use of "accepted peer reviewed published algorithms tailored to the patient type" for the Algorithm Mode. This implies that the algorithms were developed and likely "trained" (or validated) using pre-existing datasets. However, the document does not specify any training set sample sizes directly used by the applicant for algorithm development or refinement for the E.S-BC device itself.
9. How the Ground Truth for the Training Set Was Established
Since the document refers to "accepted peer reviewed published algorithms," the ground truth for any underlying training data would have been established by the original researchers who developed and published these algorithms. The document does not provide details on how that ground truth was established, as it is leveraging existing algorithms rather than developing new ones from scratch.
§ 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.