(224 days)
The Beaverite Body Fat Scales -- Models 8921, 8925, 8931, 8935 and 9576 -- measure body weight and impedance, and estimate percentages of body fat and total body water. They are intended for use by healthy adults.
The Beaverite Body Fat Scales -- Models 8919, 8923, 8929, 9580, 9583, and 9588 -- measure body weight and impedance, and estimate percentages of body fat, total body water, and total muscle mass. They are intended for use by healthy adults.
The 11 models of Beaverite body fat scales submitted in this 510(k) are plethysmograph body composition analyzers. The devices estimate percentages of body fat, body water and muscle mass (as noted in the Indications statement) based on bioelectrical impedance analysis (BIA).
Body composition analyzer/scale that utilizes a 'foot-to-foot' bioelectrical impedance (BIA) technology to determine internal body composition.
The submitted document is a 510(k) summary for the Beaverite Body Fat Scales, which is a traditional 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data for acceptance criteria. The document explicitly states that the "following table illustrates the substantial equivalence in technology and intended use to the predicate device."
Therefore, the document does not describe acceptance criteria in the typical sense of performance metrics with associated thresholds for a standalone device study, nor does it detail a study performed by Beaverite to prove the device meets such criteria. Instead, it presents a comparison to a predicate device to establish substantial equivalence.
However, based on the provided text, we can infer some information relevant to the original request by reinterpreting "acceptance criteria" as the features and performance characteristics that are deemed substantially equivalent to the predicate device, and "study" as the comparison made to the predicate.
Here's the information extracted and interpreted in the context of a 510(k) submission for substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
Since specific quantitative "acceptance criteria" and their corresponding "reported device performance" are not explicitly defined in terms of clinical study outcomes within this summary, the table below reflects the comparison points made to establish substantial equivalence with the predicate device. The "Acceptance Criteria" column refers to the characteristics of the predicate device that the Beaverite device aims to match or be substantially equivalent to, and "Reported Device Performance" refers to the characteristics of the Beaverite device as presented for comparison.
| Acceptance Criteria (Predicate Device Characteristics) | Reported Device Performance (Beaverite Body Fat Scales Characteristics) |
|---|---|
| Classification #: 21 CFR 870.2770 | Classification #: 21 CFR 870.2770 |
| Product Code: MNW | Product Code: MNW |
| Indications for Use: Measures body weight and impedance, and estimates percentage of body fat and body water, visceral fat rating, bone mass, muscle mass, physique rating, daily caloric intake (DCI) and metabolic age using BIA. Intended for use by healthy children 7-17 years old and healthy adults with active, moderately active, to inactive lifestyles for body composition assessment in the home environment. | Indications for Use: Models 8921, 8925, 8931, 8935 and 9576 measure body weight and impedance, and estimate percentages of body fat and total body water. Models 8919, 8923, 8929, 9580, 9583, and 9588 measure body weight and impedance, and estimate percentages of body fat, total body water, and total muscle mass. All are intended for use by healthy adults. (Note: Beaverite's indications are slightly narrower, focusing on adults and fewer estimated parameters than the predicate, which can support substantial equivalence). |
| Device Description: Body composition analyzer/scale that utilizes a 'foot-to-foot' bioelectrical impedance (BIA) technology to determine internal body composition. | Device Description: Body composition analyzer/scale that utilizes a 'foot-to-foot' bioelectrical impedance (BIA) technology to determine internal body composition. |
| Analysis Method: BIA | Analysis Method: BIA |
| Operating Parameters: 54 KHz | Operating Parameters: 20 KHz (Models 8923, 8929); 54 KHz (Models 8919, 8921, 8925, 8931, 8935, 9576, 9580, 9583, 9588). (Note: Presence of 20 KHz models might require specific justification but falls within the general BIA technology). |
| Power source: AA batteries | Power source: Replaceable 9V or 3V batteries, depending on the model. |
| Operating keys: 13 | Operating keys: Range of 2 to 5, depending on the model. |
| Number of electrodes: 4 | Number of electrodes: 4 (except for Model 8929 = 2). (Note: The 2-electrode model might require specific justification for equivalence to a 4-electrode predicate, but is presented as equivalent). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided 510(k) summary does not contain information about a test set sample size, data provenance, or whether data was retrospective or prospective. This type of detail is typically associated with clinical studies for performance evaluation, which are not detailed in this particular summary for a traditional 510(k) based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Similar to point 2, the document does not provide any information regarding experts, ground truth establishment, or qualifications for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not provide any information regarding adjudication methods for a 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:
The device is a body fat scale using bioelectrical impedance analysis (BIA), not an imaging device that human readers would interpret. Therefore, an MRMC study is not applicable and no information regarding human reader improvement with or without AI assistance is present.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
The 510(k) summary does not describe a standalone performance study of the algorithm or device. The basis for clearance is substantial equivalence to a predicate, not independent performance validation in a clinical study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not describe the use of any specific "ground truth" in the context of a performance study for the Beaverite device. For BIA devices, ground truth for body composition is often established using methods like DEXA or hydrostatic weighing, but no such study is detailed here.
8. The sample size for the training set:
The document does not provide any information regarding a training set sample size. This is consistent with a traditional 510(k) based on substantial equivalence, which typically does not involve the development and training of new algorithms that require such data sets.
9. How the ground truth for the training set was established:
The document does not provide any information regarding the establishment of ground truth for a training set. As noted above, training sets are not typically part of a substantial equivalence claim for a device like this.
§ 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.