(167 days)
For use only in healthy subjects for Measurement of: Estimated : Skeletal muscle mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water, (TBW), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass. Actual : Weight, Body Mass Index (BMI),and Impedance Values
Model Inbody 230 is an impedance plethysmograph body composition analyzer. This 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 text describes the Biospace Body Composition Analyzer, Model InBody 230, and its substantial equivalence to predicate devices, but it does not contain a detailed study report with specific acceptance criteria and performance data in a format that lends itself to a direct table of acceptance criteria vs. device performance, nor does it explicitly detail the methodology of a study to prove it meets acceptance criteria.
However, based on the information provided, particularly the "Substantial Equivalence Chart" and the "Conclusion" section, we can infer the acceptance criteria are implicitly met by demonstrating substantial equivalence to the existing predicate devices. The document states that "After analyzing both bench and clinical testing data, it is the conclusion of Biospace that the Model [InBody 230] is as safe and effective as the predicate devices... and has been validated via human clinical trial."
Given the limitations of the provided text, I will construct a response that extracts the relevant information and indicates where detailed information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds for body fat percentage). Instead, substantial equivalence is claimed based on comparable intended use, technology, and performance to predicate devices. The "reported device performance" is implied to be "as safe and effective as the predicate devices" and "validated via human clinical trial."
| Criterion Type | Predicate Device (InBody 3.0, K042528) | Predicate Device (InBody 520, K052646) | New Device (InBody 230, K062603) |
|---|---|---|---|
| Intended Use | Body composition analyzer, measurement of: Estimated ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass. Actual: Weight, BMI, Impedance Values | Body composition analyzer, measurement of: Estimated ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass. Actual: Weight, BMI, Impedance Values | Body composition analyzer, measurement of: Estimated Skeletal Muscle Mass, ECW, ICW, TBW, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass. Actual: Weight, BMI, Impedance Values |
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance |
| Operating Frequencies | 5, 50, 250, 500kHz | 5, 50, 500kHz | 20, 100kHz |
| Electrode Type | Tactile (8 electrodes) | Tactile (8 electrodes) | Tactile (8 electrodes) |
| Measuring Sites | Right Arm, Left Arm, Trunk, Right Leg, Left Leg | Right Arm, Left Arm, Trunk, Right Leg, Left Leg | Right Arm, Left Arm, Trunk, Right Leg, Left Leg |
| Patient Position | Upright | Upright | Upright |
| Performance | Implied to be safe and effective for its intended use | Implied to be safe and effective for its intended use | "As safe and effective as the predicate devices, validated via human clinical trial." (Specific performance metrics are not provided in the summary) |
Note: The primary "acceptance criterion" demonstrated here is "substantial equivalence" to the listed predicate devices, rather than meeting specific quantitative performance targets like sensitivity, specificity, or accuracy percentages. The document does not provide a study breakdown with numerical results against pre-defined thresholds.
2. Sample Size and Data Provenance for Test Set
The document mentions "human clinical trial" and "clinical testing data" but does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) for any clinical data used.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used to establish ground truth or their qualifications. The study methodology is not detailed in the provided text.
4. Adjudication Method for Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size for human readers improving with or without AI assistance. This device is a measurement tool, not an AI-assisted diagnostic imaging interpretation system.
6. Standalone Performance Study
The document states that the device was "validated via human clinical trial" and that "bench and clinical testing data" support its safety and effectiveness. This implies a standalone performance evaluation of the device's measurements. However, specific details of this standalone performance, such as metrics (e.g., accuracy, precision) or comparative data against a gold standard, are not provided. The claim is primarily about substantial equivalence to predicate devices, which also perform standalone measurements.
7. Type of Ground Truth Used
The document does not explicitly state the type of "ground truth" used in the human clinical trial. For body composition analyzers, gold standards usually involve methods like DEXA (Dual-energy X-ray Absorptiometry), hydrostatic weighing, or isotopic dilution, but this is not specified here. The absence of specific ground truth details suggests that the equivalence might primarily rely on comparison of outputs and operational characteristics with existing BIA devices deemed safe and effective.
8. Sample Size for Training Set
The document does not provide information on a separate "training set" or its sample size. This type of device (Bioelectrical Impedance Analysis) typically relies on established biophysical models rather than a machine learning training paradigm that would have a distinct training set in the AI sense.
9. How Ground Truth for Training Set Was Established
Since a distinct "training set" in the machine learning sense is not indicated, the document does not describe how ground truth for any such set was established. The device's operation is based on bioelectrical impedance principles, which leverage physiological constants and empirical equations derived from research, rather than a data-driven training process in the way an AI model would be trained.
§ 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.