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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

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-300 device. 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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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."

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.

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Ten-Year Fracture Risk Option: The Ten-Year Fracture Risk Option for the Norland DXA Bone Densitometeters uses the femoral neck T-Score, along with certain clinical risk factors, to estimate the patient's ten-year risk of a hip fracture and/or a major osteoporotic fracture, based on the FRAX algorithm developed by the World Health Organization (WHO). This information is useful to health care professional as they manage diseases or conditions relating to bone health. This option does not diagnose disease or recommend treatment.

SIRI Table Option: The SIRI Table Option for the Norland DXA Bone Densitometers uses the SIRI UWE % Fat value, and plots it on the industry standard body fat charts. The chart used depends on the patient's gender and age, and it indicates whether the patient is Underfat, Healthy, Overfat, or Obese. These charts are the result of work done by the National Institute of Health (National Heart, Lung, and Blood Institute), who assigned underfat to obese classifications to the BMI value; and by Tanita Corporation, who related BMI to % body fat based on DXA bone densitometry. This option also calculates the patient's Body Mass Index (BMI) based solely on the height and weight data inputted by the operator, as a convenience. This information is useful to health care professional as they manage diseases or conditions relating to or affected by the patient's relative amount of fat tissue. This option does not diagnose disease or recommend treatment.

The Ten-Year Fracture Risk Option and the SIRI Table Option for the Norland DXA Bone Densitometers are software options that use presently provided scan results and related industry standards to provide additional information to the medical professional as they diagnose and treat bone related and body fat related diseases and conditions.

Here's a breakdown of the acceptance criteria and study information for the "Ten-Year Fracture Risk and SIRI Table Options for Norland DXA Bone Densitometers," based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and data provenance:

   • Ten-Year Fracture Risk: 150 patients. Data provenance is "Previously acquired data." Specific country of origin is not mentioned, but "Norland customers" are referenced for the broader testing. The data is retrospective as it refers to "previously acquired data."
   • SIRI Table Option: 150 patients. Data provenance is "Previously acquired data." Specific country of origin is not mentioned. The data is retrospective.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

   • No expert "ground truth" establishment is described for the test set. For the Ten-Year Fracture Risk option, the comparison was made against the "charts on the FRAX website" and the "FRAX publication." For the SIRI Table Option, the verification was against the "proper chart" and the "SIRI UWE % Fat value." The comparison for the Ten-Year Fracture Risk chart values was done "by a person different from the one who entered the data," suggesting an internal verification process rather than external expert consensus.

3. Adjudication method for the test set:

   • Adjudication methods like 2+1 or 3+1 are not mentioned. The testing described focuses on direct comparison and verification against established standards (FRAX website/publication, industry-standard body fat charts). For the Ten-Year Fracture Risk chart values, there was a double-check by a different person.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was not required for either of these options to establish safety or effectiveness, because they do not cause changes to the scanning or analysis processes. Instead, they just use the values presently generated to produce their results."

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance described is standalone. The software options "use presently provided scan results and related industry standards to provide additional information" and "do not affect the technology... No physical changes are required and the scanning and analysis functions are not impacted." The "proper operation of both options with real patient data was tested" which describes the standalone algorithm's output.

6. The type of ground truth used:

   • Ten-Year Fracture Risk: The ground truth used was the World Health Organization (WHO) Fracture Risk Assessment algorithm (FRAX) accessible via its website charts and publication.
   • SIRI Table Option: The ground truth used was industry-standard Body Fat Charts developed by Tanita from the work by D. Galligher, and classifications from the National Institute of Health (National Heart, Lung, and Blood Institute) relating BMI to % body fat.

7. The sample size for the training set:

   • The document does not mention a separate "training set" for the device. The device is a software option that applies existing algorithms (FRAX, Tanita/Galligher body fat charts) to pre-existing DXA scan results. Hence, the algorithms themselves would have been developed and "trained" on their respective datasets by WHO/FRAX and Tanita/Galligher/NIH over time, not by Norland for this specific device submission.

8. How the ground truth for the training set was established:

   • As there's no training set for this specific device, the ground truth for the underlying FRAX algorithm and body fat charts was established externally by the World Health Organization (WHO), Tanita Corporation, and the National Institute of Health (National Heart, Lung, and Blood Institute) respectively, based on their research and epidemiological studies. The document does not describe their ground truth establishment methods.

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A body composition analyzer that measures body weight and impedance and estimates total and segmental body fat percent, body mass index (BMI), fat mass, fat-free mass, regional muscle mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.

The TANITA BC-418, Segmental Body Composition Analyzer is a computer-operated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat percent and regional muscle mass.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a dedicated section. Instead, it relies on a comparison to a predicate device to establish substantial equivalence.

Explanation of "Acceptance Criteria" in this context: For a 510(k), the primary "acceptance criterion" is often that the new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use, and the same technological characteristics, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the predicate device. The document implies that the performance of the predicate (Model TBF-410) serves as the benchmark for acceptable performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify a sample size for the test set. It mentions "Side by side comparisons" and "results of using the previously approved BIA methodology," but no numerical data for the number of subjects or measurements.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. The study appears to be an internal comparison ("in-house BIA and DEXA reference methods") conducted by Tanita.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document mentions "in-house BIA and DEXA reference methods" for establishing ground truth, but it does not specify the number of experts or their qualifications who were involved in operating the DEXA or BIA reference methods, or in interpreting the results to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. The comparison seems to be direct performance against the predicate and reference methods rather than an expert consensus process on specific cases.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a comparison of the new device to a predicate device and reference methods, not an assessment of human reader performance with or without AI assistance. The device itself is a measurement tool, not an AI for interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the study described is essentially a standalone performance assessment of the device (algorithm only). The device is a diagnostic measurement tool. The evaluation focuses on its analytical performance (body composition measurements) compared to reference methods and a predicate, without considering a human-in-the-loop aspect for interpretation or decision-making.

7. The Type of Ground Truth Used

The ground truth was established using:

• "In-house BIA and DEXA reference methods."
  • DEXA (Dual-energy X-ray absorptiometry) is widely considered a gold standard for body composition measurement.
  • "In-house BIA" (of the predicate device) is used as a reference point for substantial equivalence, implying its output is accepted as valid.

8. The Sample Size for the Training Set

The document does not provide any information about a separate "training set" or its sample size. This type of device relies on established BIA principles and internal calibration, rather than a machine learning model that requires a distinct training set in the typical sense. The "training" here would likely refer to the development and calibration data used to create the BIA algorithms for body composition estimation embedded in the device, which is not detailed.

9. How the Ground Truth for the Training Set was Established

As no separate training set is explicitly mentioned or detailed, there is no information on how its ground truth was established. For BIA devices, the algorithms are typically derived from extensive research correlating impedance measurements with direct body composition methods (like DEXA or hydrostatic weighing) in general populations. The "in-house BIA and DEXA reference methods" mentioned likely refer to the validation of the device's algorithms, not a distinct training process for a machine learning model.

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