(181 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, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity. Actual : Weight, Body Mass Index (BMI),and Impedance Values
Models InBody 270, InBody R20, and InBody R20B are impedance plethysmograph body composition analyzers. These devices determine 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 FDA 510(k) summary for the Biospace Body Composition Analyzers (Models InBody 270, InBody R20, and InBody R20B) focuses on demonstrating substantial equivalence to a predicate device (Biospace Body Composition Analyzer Model InBody 230, K062603) rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new devices being cleared.
The core of the submission relies on the assertion that "The results of bench and software testing indicates that the new devices are as safe and effective as the predicate device." and "After analyzing bench testing data, software validation, and the risk analysis, it is the conclusion of Biospace that the Models InBody 270, InBody R20, and InBody R20B, BODY COMPOSITION ANALYZERS are as safe and effective as the predicate devices, and have few technological differences, thus rendering them substantially equivalent to the predicate device."
This means the submission does not contain the level of detail requested for a typical study that proves acceptance criteria based on direct performance measurements. It's a comparison study, arguing the new device is sufficiently similar to an already cleared device. Therefore, a direct table of acceptance criteria and reported device performance for the new devices is not explicitly provided in the document.
However, we can infer the "acceptance criteria" through the lens of substantial equivalence: the new devices must perform similarly and as safely and effectively as the predicate device for all shared indications. Any new indications (Segmental Body Fat mass, % Segmental Body Fat-Energy expenditure of activity) would implicitly have an acceptance criterion of accurate measurement, but no specific performance targets are given.
Here's an attempt to address your questions based on the provided text, acknowledging the limitations inherent in a 510(k) summary focusing on substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the 510(k) summary does not provide a table of explicit numerical acceptance criteria for the new devices and their direct performance. The acceptance criterion is primarily substantial equivalence to the predicate device (Biospace Body Composition Analyzer Model InBody 230, K062603) in terms of safety and effectiveness for shared indications, and the ability to accurately measure the new indications.
The 'reported device performance' is therefore a general statement of equivalency.
| Acceptance Criterion (Inferred from Substantial Equivalence) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| For all shared indications (e.g., Estimated: Skeletal muscle mass, ECW, ICW, TBW, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass; Actual: Weight, BMI, Impedance Values): The new devices (InBody 270, R20, R20B) must be as safe and effective as the predicate device (InBody 230). | "The results of bench and software testing indicates that the new devices are as safe and effective as the predicate device." |
| For new indications (Segmental Body Fat mass, % Segmental Body Fat, Energy expenditure of activity): The devices must accurately measure these parameters for use in healthy subjects. | Implied by the statement of "as safe and effective" and the clearance for these indications. No specific performance metrics (e.g., accuracy, precision relative to a gold standard) are provided in this summary. |
| Technical Specifications: Operate within specified parameters (e.g., Bioelectrical Impedance analysis method, 20/100kHz frequency, 8 tactile electrodes placed on thumbs, palms, heels, fore-feet, measuring at Right Arm, Left Arm, Trunk, Right Leg, Left Leg, Upright patient position). | These parameters are identical to the predicate device, indicating conformity with established specifications. |
No information is provided regarding:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) The document does not specify a separate "test set" in the context of clinical performance data for the new devices, as the primary assessment is substantial equivalence through bench and software testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience) Not applicable, as detailed clinical performance data using expert-established ground truth is not presented for the new devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set Not applicable.
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, as this device is a body composition analyzer, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone body composition analyzer. The "bench and software testing" mentioned would apply to the algorithm's performance, but no details of such a standalone performance study (e.g., accuracy against a gold standard like DEXA) are provided in this summary. The substantial equivalence argument often relies on the predicate device already having demonstrated acceptable standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not specified for the new devices. For the predicate device, ground truth for body composition analysis typically involves methods like DEXA (Dual-energy X-ray absorptiometry) or hydrostatic weighing, but these details are not in this summary.
8. The sample size for the training set Not applicable, as this is not an AI/machine learning device that involves a "training set" in the typical sense. Any internal algorithm development for the predicate or the new devices would have used internal data, but details are not provided.
9. How the ground truth for the training set was established Not applicable.
In summary, this 510(k) submission successfully argued for substantial equivalence based on technical similarities and general statements of safety and effectiveness derived from bench and software testing, without providing granular clinical study data with specific acceptance criteria and performance metrics for the new devices.
§ 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.