(209 days)
For Measurement Of: Estimated: Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Actual : Weight, Body Mass Index (BMI),and Impedance Values
InBody AP1 is an impedance plethysmograph body composition analyzer. The device determines body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components.
The provided document is a 510(k) summary for the InBody AP1 Body Composition Analyzer. It aims to demonstrate substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with defined numerical thresholds.
The document does not contain the following information:
- A table of acceptance criteria with reported device performance (in terms of specific metrics like accuracy, sensitivity, specificity, etc., with numerical targets).
- Details of a study proving the device meets acceptance criteria, as the focus is on substantial equivalence.
- Sample size for a test set, data provenance, number of experts for ground truth, adjudication methods, or details of MRMC or standalone studies.
- Training set sample size or how its ground truth was established.
Instead, the document focuses on comparing the InBody AP1 to a predicate device (BodyStat QuadScan 4000) based on their intended use, indications for use, analysis methods, and operating parameters.
Here's a summary of the available information, structured to address your request where possible, and noting where information is absent:
Acceptance Criteria and Study Details for InBody AP1 Body Composition Analyzer
The provided 510(k) summary establishes substantial equivalence to a predicate device rather than explicitly defining and demonstrating adherence to specific numerical acceptance criteria. The "acceptance criteria" can be inferred as meeting the functional and performance characteristics deemed equivalent to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria (e.g., "accuracy > 95%") are not defined in this document, the table below focuses on the comparison made to establish substantial equivalence. The "Acceptance Criteria" implicitly refer to the predicate device's established performance and characteristics, and the "Reported Device Performance" pertains to the InBody AP1 matching those characteristics.
| Feature / Criterion (as implied by predicate comparison) | Predicate Device (BodyStat QuadScan 4000) Performance/Characteristic | InBody AP1 Reported Device Performance/Characteristic |
|---|---|---|
| Intended Use | Body composition analyzer | Body composition analyzer |
| Indications for Use (Estimated) | Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates | Extra-Cellular Water, Intra-Cellular Water, Total Body Water, Body Fat, Body Lean + Dry Lean, Metabolic Rates |
| Indications for Use (Actual) | Waist/Hip Ratio, Body Mass Index (BMI), and Impedance Values | Weight, Body Mass Index (BMI), and Impedance Values |
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance |
| Operating Frequencies | 5, 50, 100, 200kHz | 5, 50, 250kHz |
| Electrode Type | adhesive | tactile |
| Number/Placement of Electrodes | 4 electrodes placed on hands and feet | 8 electrodes placed on thumbs, palms, heels, and fore-feet |
| Impedance Measuring Site | Whole Body (Right Arm to Right Leg) | Right Arm, Left Arm, Trunk, Right Leg, Left Leg |
| Patient Position | Supine | Upright |
Conclusion from the document: "After analyzing both bench and clinical testing data, it is the conclusion of Biospace that the InBody AP1 BODY COMPOSITION ANALYZER as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance:
- The document mentions "clinical testing data" but does not specify the sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a ground truth for a test set in the context of expert review.
4. Adjudication method for the test set:
- Not specified. No information is provided regarding adjudication methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:
- Not specified. The document does not mention an MRMC study or any comparison of human readers with or without AI assistance. The device itself is a body composition analyzer, not a diagnostic imaging AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is inherently a "standalone" algorithm in a sense, as it directly measures and calculates body composition parameters. It's not an assistive AI for human interpretation in the way an imaging algorithm would be. The document implies the device performs its function directly by analyzing bioelectrical impedance. No specific "standalone performance study" in the context of comparing with human performance is described.
7. The type of ground truth used:
- The document implies that the "ground truth" or reference for evaluating the InBody AP1's performance would be the established accuracy and clinical utility of its predicate devices, or other accepted methods for body composition analysis against which bioelectrical impedance analysis is typically validated. However, the specific methodology for establishing ground truth data in the "clinical testing data" mentioned is not detailed. It does not explicitly state pathology, outcomes data, or expert consensus as the ground truth.
8. The sample size for the training set:
- Not specified. The document does not provide any details about a training set. The device uses bioelectrical impedance analysis (BIA), which typically relies on established physiological models and algorithms, rather than being "trained" on a specific dataset in the way a modern machine learning algorithm would be.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. As there's no mention of a traditional "training set" in the context of machine learning, there is no information on how its ground truth might have been established.
§ 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.