(406 days)
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.
The provided text describes the Jawon Body Composition Analyzers (Model X-CONTACT 350, X-CONTACT 350M, X-CONTACT 350S) and their substantial equivalence to predicate devices, but it does not contain specific acceptance criteria with numerical thresholds or a detailed study proving the device directly meets such criteria. Instead, it refers to a "performance test-clinical" to demonstrate that "there is no significant difference in measurements" compared to a predicate device.
Here's an attempt to answer your questions based only on the provided text, highlighting where information is missing:
Acceptance Criteria and Device Performance
There is no explicit table of acceptance criteria with numerical thresholds provided in the document. The general acceptance criterion implied is that the device "demonstrated that there is no significant difference in measurements" compared to the predicate device. The document also states that the devices meet "in-house test criteria" and "the requirements of IEC 60601-1, IEC 60601-1-2" (electrical safety and electromagnetic compatibility standards).
Implied Acceptance Criteria & Reported Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No significant difference in measurements compared to predicate. | "No significant difference in measurements" (Jawon X-Contact 350 vs. predicate) |
| Compliance with IEC 60601-1 | "meets the requirements of IEC 60601-1" |
| Compliance with IEC 60601-1-2 | "meets the requirements of IEC 60601-1-2" |
| Meet in-house test criteria | "meets...in-house test criteria" |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "results of performance tests using X-Contact 350."
- Data Provenance: Not specified, but the applicant is Jawon Medical Co., Ltd. from Republic of Korea, suggesting the testing might have been conducted there. The document doesn't explicitly state whether the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The study described focuses on comparison to a predicate device, not necessarily establishing a "ground truth" through expert consensus in the traditional sense, but rather through comparison to medically validated measurements or the predicate device's output.
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Adjudication method for the test set:
- Not specified. This type of adjudication (e.g., 2+1, 3+1) is typically associated with expert review of medical images or diagnoses, not direct body composition measurements.
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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:
- No. This is a body composition analyzer, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
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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 "performance test-clinical" likely evaluates the accuracy of the device's measurements and calculations independently, though in comparison to a predicate device. The phrasing "results of performance tests using X-Contact 350 demonstrated that there is no significant difference in measurements" suggests evaluation of the device's direct output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the ground truth or "reference" for the performance study was the measurements from the predicate devices (ioi 353 and EasyBody 202) or other established clinical measurement methods used in that context. It states, "there is no significant difference in measurements" (referring to comparisons against some established standard or the predicate). It does not specify pathology or outcomes data.
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The sample size for the training set:
- Not specified. Body composition analyzers often use empirical models or prediction equations, which would be "trained" or developed using a dataset. However, the details of this development are not provided.
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How the ground truth for the training set was established:
- Not specified. Assuming a training set for model development, the ground truth would typically be established through highly accurate reference methods for body composition (e.g., DEXA, hydrostatic weighing, dilution methods). However, the document does not provide these details.
§ 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.