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510(k) Data Aggregation
(392 days)
The Multifunction Keito devices are intended to be used by general public without prescription, operated with coins, to measure personal health parameters such as weight, estimation of body fat index, blood pressure, and pulse rate. Multifunction Keito can be installed in pharmacies or in other public sites. It is not a diagnostic device, and only offers data that users can consult with their personal physicians. The results are either printed on a ticket or saved on a card.
The Multifunction Keito K6, K7 & K8 are intended for public use to measure height, weight, systolic and diastolic blood pressures, to calculate pulse rate and body mass, and to estimate the percentage of body fat by using a non-invasive bio impedance analyzer. The devices have 2 coin entries allowing the selection of two operation modes: partial or total cycle of measurements. Partial cycle measures weight, height, and estimation of body fat. Total cycle measures weight, height, blood pressure, pulse rate, and estimation of body fat.
Here's a breakdown of the acceptance criteria and the studies that illustrate how the Keito K6, K7, and K8 multifunction devices meet these criteria, based on the provided text:
Acceptance Criteria and Device Performance
The provided document details the accuracy specifications of the Keito devices and presents comparative studies against predicate devices and observed/manual measurements to demonstrate substantial equivalence. The "acceptance criteria" here are implied by the comparison to established predicate devices and the accuracy claims.
Table 1: Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from predicate/accuracy claim) | Keito K7 Reported Performance (Mean Difference vs. Observers) | Keito K5 Reported Performance (Mean Difference vs. Observers) | Keito K8 Reported Performance (Error Medium vs. Tanita) |
|---|---|---|---|---|
| Blood Pressure | ||||
| Systolic Accuracy | 1 mmHg (claimed) | -0.6 mmHg (K7-Observers) | 1.0 mmHg (K5-Observers) | N/A |
| Diastolic Accuracy | 1 mmHg (claimed) | 0.4 mmHg (K7-Observers) | -0.7 mmHg (K5-Observers) | N/A |
| Pulse Accuracy | Not explicitly stated | 0.9 bpm (K7-Observer) | -1.4 bpm (K5-Observer) | N/A |
| Weight | 100 g (claimed) | N/A | N/A | N/A |
| Height | 1 cm (claimed) | N/A | N/A | N/A |
| Body Fat | 0.1% (claimed) | N/A | N/A | -0.4% (K8-Tanita TBF-300) |
Note: The "Acceptance Criteria" column is derived from the stated accuracy of the devices and their predicates. The "Reported Device Performance" comes directly from the study results presented in the tables for K7 Blood Pressure and K8 Body Fat. The overall conclusion for blood pressure is that K7 performance is "very similar" to K5, implying K7 meets K5's established performance. For Body Fat, the results are considered "safe and accurate as TANITA TBF-300."
Study Details
2. Sample Sizes and Data Provenance
- Blood Pressure Measurement (Multifunction K7 Test Results):
- Test Set Sample Size: 267 observations for Systolic, Diastolic, and Pulse measurements. 89 patients for Age, Wrist/Arm circumference, and Sex data.
- Data Provenance: Not explicitly stated, but the submission is from a Spanish company (
Aguiflail Ibérica, S.L., Barcelona, Spain), suggesting the study was likely conducted in Spain. The data is presented as a "clinical test," implying prospective collection for the purpose of this submission.
- Body Fat Measurement (Keito K8 vs. TANITA TBF-300):
- Test Set Sample Size: 177 observations.
- Data Provenance: Not explicitly stated, but similar to the blood pressure study, it's likely from Spain and prospectively collected for this comparative study.
3. Number of Experts and Qualifications (for Ground Truth)
- Blood Pressure Measurement: The study compares the Keito K7 (and K5) devices against "Observers."
- Number of Experts: "Observer1" and "Observer2" are mentioned for inter-observer variability, and the device is compared against these "Observers." This implies at least two human observers.
- Qualifications: The qualifications of these observers are not specified in the provided document. It is not mentioned if they are medical professionals like cardiologists or nurses, nor is their experience level given.
- Body Fat Measurement: The Keito K8 is compared against the
TANITA TBF-300device. The ground truth for body fat is not established by human experts but by an established predicate device.
4. Adjudication Method for the Test Set
- Blood Pressure Measurement: For "Observer1 - Observer2" comparison, a simple comparison of their readings is used to assess inter-rater agreement. For "Keito K7 - Observers" (and K5), the device readings are compared directly against the readings of the human observers. No specific adjudication method (like 2+1 or 3+1 consensus) is described to resolve discrepancies between human observers or between the device and human observers. The "Mean Difference" and "SD of Differences" statistical metrics are used for comparison.
- Body Fat Measurement: The Keito K8 device measurements are compared directly to the TANITA TBF-300 predicate device measurements. No human adjudication is involved as the predicate device serves as the reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study evaluating human reader improvement with AI assistance was explicitly performed or detailed. The studies here are focused on demonstrating the standalone performance of the device (Keito K7/K8) in comparison to either human observers (for BP) or a predicate device (for Body Fat), not on how AI (or the device's algorithms) assists human readers. The Keito devices are intended for public self-use and are not diagnostic tools requiring human interpretation of their output.
6. Standalone (Algorithm Only) Performance
- Yes, standalone performance was assessed. The studies presented (7.1.1 and 7.1.2 for Blood Pressure, 7.2 for Body Fat) represent the standalone performance of the Keito K7, K5, and K8 devices, respectively. The data shows the device's measurements compared to a reference (human observers for BP, predicate device for Body Fat) without human intervention in the device's measurement process itself. The devices operate "without prescription" and provide results directly to the user.
7. Type of Ground Truth Used
- Blood Pressure Measurement: The ground truth for blood pressure and pulse rate is established by human observers (referred to as "Observer1" and "Observer2") directly measuring the same parameters. This effectively serves as a "clinical reference standard" in this context.
- Body Fat Measurement: The ground truth for body fat percentage is established by a predicate device, the
TANITA TBF-300. This is a comparative study where the predicate device acts as the reference standard.
8. Sample Size for the Training Set
- The document does not provide details on the sample size used for the training set for the algorithms within the Keito devices. The studies described are validation/testing studies for device performance. It states that the K6, K7, and K8 are an "evolution" of the K5 unit, implying that the underlying technology and software have a history of development, but the specifics of training data are not disclosed.
9. How the Ground Truth for the Training Set was Established
- As the document does not specify a training set or its sample size, it also does not detail how the ground truth for any training set was established. We can infer that the original Keito K5, and presumably its predecessors or early development, would have been built and refined using data, likely compared against established measurement techniques or other reference devices, similar to the validation studies presented here. However, this is an inference and not explicitly stated in the provided text.
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(83 days)
The BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old.
The proposed Athletic IQ, Inc. (AIQ) BC100 Body Composition Analysis System is a noninvasive bioimpedance analyzer for use in healthy subjects for measurement of actual height, actual weight and estimated body fat percentage. The applicable age range is 10 to 80 years old. The device determines estimated body fat percentage 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, whereas fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA permits differentiation of fat vs. lean tissue. When combined with the subject's height and weight parameters, age, and gender, an estimated body fat percentage may be calculated using an experimentally derived algorithm.
The provided text states that "Clinical testing was conducted to establish the algorithm used by the BC100 system for estimation of percent body fat using bioelectrical impedance data." However, it does not provide details on the acceptance criteria, the specific study design, or the results of this clinical testing. Therefore, I cannot construct the requested tables or provide detailed answers to many of your questions based only on the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not specified in the provided text, beyond the general statement that "Clinical testing was conducted to establish the algorithm."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (country of origin, retrospective/prospective).
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 specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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/Not specified. This device is a diagnostic tool, not an AI-assisted interpretation tool for human readers. It directly provides an estimated body fat percentage.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device "determines estimated body fat percentage based on bioelectrical impedance analysis (BIA)" and calculates it "using an experimentally derived algorithm." This indicates a standalone algorithm performance without human intervention in the result generation. However, the performance metrics for this standalone algorithm are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. For body fat analysis, a common ground truth method would be DEXA (Dual-energy X-ray absorptiometry) or hydrostatic weighing, but the text does not mention the method used.
8. The sample size for the training set
- Not specified. The text mentions "an experimentally derived algorithm," implying a training set was used, but no details are given.
9. How the ground truth for the training set was established
- Not specified.
Summary of what is known from the provided text:
- Device Name: BC100 Body Composition Analysis System
- Intended Use: Noninvasive bioimpedance analyzer for measurement of actual height, actual weight, and estimated body fat percentage in healthy subjects aged 10-80 years old.
- Technology: Bioelectrical Impedance Analysis (BIA) combined with subject's height, weight, age, and gender, using an experimentally derived algorithm.
- Performance Claim: "Clinical testing was conducted to establish the algorithm used by the BC100 system for estimation of percent body fat using bioelectrical impedance data."
- Regulatory Conclusion: Found "safe and effective for its intended use" based on this clinical testing and comparison to predicate devices.
Missing Information:
Crucially, the provided 510(k) summary and FDA letter do not contain the detailed clinical study results, acceptance criteria, or sample sizes that would allow for a comprehensive answer to your request. These details are typically found in the full 510(k) submission, not necessarily in the summary or clearance letter.
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(58 days)
The device is a noninvasive bioimpedance meter used to estimate body fat percentage in the home setting. The device is for normal, healthy people only, and the applicable age range is 10 to 80 years old.
The device is to be used in a home environment having normal temperature and humidity conditions.
HEALTH & LIFE HL 188 & HL 189 BODY FAT METER is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.
Here's a breakdown of the acceptance criteria and study information for the HEALTH & LIFE HL 188 & HL 189 BODY FAT METER, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it indicates the device's performance was validated through a comparison study and conformity to standards.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Safety & EMC | Conformity to applicable standards. | The device conforms to applicable standards including IEC 60601-1 and IEC 60601-1-2 requirements. |
| Clinical Repeatability | Statistically and clinically acceptable repeatability across groups. | "The comparison study demonstrated that the clinical repeatability of HEALTH & LIFE HL 188 & HL 189 BODY FAT METER is statistically and clinically acceptable in all age/weight/height groups." |
| Equivalence to Predicates | No new questions of safety or effectiveness compared to predicates. | "Bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the HEALTH & HL 188 & HL 189 BODY FAT METER is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states, "Subjects were grouped as male/female, ages." It does not provide a specific number for the sample size.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be clinical. It does not specify if it was retrospective or prospective, but clinical comparison studies are generally prospective.
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 text. The ground truth was established by comparing to DEXA technology, but details on human experts involved are absent.
4. Adjudication Method for the Test Set
This information is not provided in the text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned. The study described is a comparison with DEXA technology to validate the device's performance, not a human reader study with or without AI assistance.
- Effect Size: Not applicable, as an MRMC study was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the described "comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology" is essentially a standalone performance evaluation of the HL 188 & HL 189 Body Fat Meter against a reference standard. The text focuses on the device's direct measurement capabilities.
7. The Type of Ground Truth Used
The ground truth was established using DEXA (Dual energy X-ray absorptiometry) technology. DEXA is considered a highly accurate and reliable method for body composition analysis, often used as a reference standard.
8. The Sample Size for the Training Set
This information is not provided in the text. The device is a "Body Fat Meter" which implies it's a measuring device rather than an AI/ML algorithm that requires a separate training set. The comparison study described is for validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a separate training set for an AI/ML algorithm is not described for this type of device. The device directly measures bioimpedance to estimate body fat percentage. The validation study used DEXA as the ground truth for performance comparison.
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(90 days)
The device is a noninvasive bioimpeadance analyzer used to estimate body fat percentage in home use. The device is for normal, healthy person only, and the applicable age range is 10 to 80 years old.
The device is to be used in the ENVIRONMENT of room temperature & normal environment condition.
LONG WELL LW-6Dxx Series Body Fat Analyzer is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.
Acceptance Criteria and Study Details for LONG WELL LW-6Dxx Series Body Fat Analyzer
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for the device's performance. Instead, it indicates that the device was compared to a DEXA (Dual energy X-ray absorptiometry) technology, and the outcome and acceptance criteria are qualitative, focusing on statistical and clinical acceptability.
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| "clinical repeatability of LONG WELL LW-6Dxx Series Body Fat Analyzer is statistically and clinically acceptable in all age/weight/height groups." | "A comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology was performed to validate the performance of the LONG WELL LW-6Dxx Series Body Fat Analyzer... The comparison study demonstrated that the clinical repeatability of LONG WELL LW-6Dxx Series Body Fat Analyzer is statistically and clinically acceptable in all age/weight/height groups." |
| Conformance to applicable standards: IEC 60601-1 and IEC 60601-1-2 requirements (operating specification, Safety & EMC). | "In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 requirements." |
| Substantial equivalence to predicate device (Omron HBF-306 Body Fat Analyzer K011652). | "The LONG WELL LW-6Dxx Series Body Fat Analyzer have the same intended use and similar technological characteristics as Omron HBF-306 Body Fat Analyzer( K011652 )marketed by Omron Healthcare INC. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the LONG WELL LW-6Dxx Series Body Fat Analyzer is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "Subjects were grouped as male/ female, ages," but does not provide a specific number for the sample size used in the comparison study.
- Data Provenance: The document does not explicitly state the country of origin. Given the submitter's address is Taiwan, R.O.C., it is plausible the study was conducted there, but this is not confirmed. The data appears to be prospective as a "comparison study" was performed to validate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth. The comparison study used DEXA technology as the comparator, implying DEXA results were considered the "ground truth" or reference standard.
4. Adjudication Method for the Test Set
Since human experts were not mentioned as establishing ground truth, there was no adjudication method described for the test set. The validation was based on comparison with DEXA.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No (MRMC) comparative effectiveness study was mentioned. The study described is a comparison study against DEXA technology, not a study evaluating human readers with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "comparison study with device that use DEXA (Dual energy X-ray absorptiometry) technology" was performed to validate the performance of the LONG WELL LW-6Dxx Series Body Fat Analyzer directly. This evaluates the algorithm's performance without a human in the loop, as it compares the device's output to the reference standard.
7. Type of Ground Truth Used
The ground truth used was DEXA (Dual energy X-ray absorptiometry) measurements. DEXA is a well-established and highly accurate method for body composition analysis, often considered a "gold standard" or reference standard in research.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This suggests the comparison study was primarily for validation, and details about the development and training of the device's algorithm are not included in this summary.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how ground truth for a training set was established.
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