(133 days)
The TANITA Body Composition Analyzer is indicated for use in the measurement of weight and impedance, and the estimation of body mass index (BMI), total body fat percent, total body water percent and weight, muscle mass (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass, using BIA (Bioelectrical Impedance Analysis).
The device is indicated for use for healthy children 5-17 years old and healthy adults with active, moderately active, to inactive lifestyles.
The TANITA Body Composition Analyzer SC-331 is a composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body mass index (BMI), total body fat percent, total body water percent and weight, muscle (skeletal and smooth), physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), daily caloric intake (DCI), metabolic age, and target body fat percent with predicted weight and fat mass for use by adults and children.
This document focuses on the Tanita Body Composition Analyzer Model SC-331, a device that uses Bioelectrical Impedance Analysis (BIA) to measure and estimate various body composition parameters. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Tanita Body Composition Analyzer SC-331 are implicitly established by demonstrating substantial equivalence to its predicate devices (TANTA Body Fat Analyzer Professional and Consumer Models K014009 and K040778, and the TANITA Body Composition Analyzer: Model BC-53X).
The table directly from the 510(k) summary compares the specifications and indicated outputs of the SC-331 with its predicate devices. The "reported device performance" is the statement that the SC-331 "performs equivalently" to these predicate devices based on "the results of [its] whole body BIA."
| Feature/Parameter | Predicate Device (K014009) Performance/Specification | Predicate Device (K040778) Performance/Specification | Predicate Device (BC-53X) Performance/Specification | TANITA Body Composition Analyzer SC-331 Performance/Specification (Reported) | Acceptance Criteria (Implied by Substantial Equivalence and Comparison) |
|---|---|---|---|---|---|
| Analytical Method / Measurement | Patented "Foot-to-Foot" BIA, In house BIA and DEXA reference | Patented "Foot-to-Foot" BIA, In house BIA and DEXA reference | Patented "Foot-to-Foot" BIA, In house BIA and DEXA reference | Patented "Foot-to-Foot" BIA, In house BIA and DEXA reference | Must use "Foot-to-Foot" BIA, utilize in-house BIA and DEXA references. |
| Measurement Frequency | 50kHz | 50kHz | 50kHz | 50kHz | Must operate at 50kHz. |
| Number of Electrodes | 4 | 4 | 4 | 4 | Must use 4 electrodes. |
| Weight Capacity | New / 270 kg / 600 lb | 270 kg / 600 lb | 150 kg / 330 lb | 600 lb / 270 kg or 450 kg / 1,000 lb | Must meet or exceed predicate weight capacities. (SC-331 exceeds some.) |
| Weight Increments | New / 100 g / 0.2 lb | 100 g / 0.2 lb | 100 g / 0.2 lb | 0.2 lb / 100 g or 0.1 lb / 50 g | Must offer increments comparable to or better than predicate devices. |
| Body Fat % Increments | 0.1% | 0.1% | 0.1% | 0.1% | Must have 0.1% body fat increments. |
| Input Age | 5 - 99 (5-17: Child, 18-99: Adult) | 7 - 99 (7-17: Child, 18-99: Adult) | 7 - 99 (7-17: Child, 18-99: Adult) | 5 - 99 (5-17: Child, 18-99: Adult) | Must support similar or wider age ranges. (SC-331 offers wider child range). |
| Input Height | 3' - 7' 11.5" / 90 - 249.9cm | 3' - 7' 11.5" / 90 - 249.9cm | 3' 4.0" - 7' 3.0" / 100-220cm | 3' - 7' 11.5" / 90 - 249.9cm | Must cover similar or wider height ranges. (SC-331 has wider range). |
| Input Body Type | Standard / Athlete | Standard / Athlete | Standard / Athlete | Standard / Athlete | Must accommodate "Standard" and "Athlete" body types. |
| Indicated Measurements/Estimates | Similar to predicates (Weight, Impedance, FAT %, FAT M, FFM, Muscle M, Physique Rating, TBW, TBW %, BMR/DCI, Metabolic Age, Visceral Fat Rating, Bone Mass, BMI) | Yes (matching detailed table rows) | Yes (matching detailed table rows) | Yes (matching detailed table rows) | Must have the same or a superset of the measurements/estimates as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size used for the test set. It mentions "the results of [TANITA's] whole body BIA" as the basis for performance claims.
The data provenance is not specified. It does not mention the country of origin of the data, nor whether it was retrospective or prospective. The term "in house BIA and DEXA reference" suggests internal validation data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The statement "in house BIA and DEXA reference" for analytical method/measurement implies that DEXA (Dual-energy X-ray absorptiometry) was used as a reference standard, which is considered a gold standard for body composition. However, it does not specify how many experts, if any, were involved in generating or interpreting this ground truth data, nor their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set.
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
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done nor is it applicable to this device. This is a body composition analyzer, not an imaging analysis AI intended to assist human readers. The assessment is purely on the device's accuracy in measuring body composition parameters.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was implicitly performed. The device itself, the TANITA Body Composition Analyzer SC-331, is an algorithm-only device in the sense that it automatically processes BIA measurements to output body composition parameters. The study involves comparing its outputs ("whole body BIA") to "in house BIA and DEXA reference" measurements, meaning its performance is evaluated directly against a reference standard without human interpretation as part of the primary measurement.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used is DEXA (Dual-energy X-ray absorptiometry) reference. The document states "in house BIA and DEXA reference" as part of its analytical method. DEXA is widely considered a gold standard for body composition analysis, providing highly accurate measurements of bone mineral density, lean soft tissue mass, and fat mass.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set. While it mentions "in house BIA and DEXA reference" for the analytical method, it doesn't differentiate between data used for model development/training and data used for testing/validation.
9. How the Ground Truth for the Training Set was Established
The document implies that the ground truth for establishing the algorithms (which would be analogous to a training set for model development) was established using "in house BIA and DEXA reference." This means that the device's impedance measurements were correlated with and validated against highly accurate DEXA measurements to develop and refine the equations used to estimate various body composition parameters. This process would typically involve a dataset where subjects undergo both BIA measurements with the device and DEXA scans, with the DEXA results serving as the ground truth.
§ 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.