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The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NBP). non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.

The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, basal metabolism and free fat mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.

The Multi-parameter detector is a device designed for measuring of the patient's physiological parameters. The Multi-parameter detector can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.

The Multi-parameter detector are non-invasive body composition analyzers. The devices employ BIA (Bio-electrical Impedance Analysis) method and then measure body composition using an experimentally derived algorithm.

The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoqlobin (SpO2).

The provided document is a 510(k) summary for a "Multi-parameter detector." It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, along with non-clinical and clinical testing performed. However, it does not provide the detailed acceptance criteria and "study that proves the device meets the acceptance criteria" in the format requested, particularly for an AI/algorithm-based device study.

The document primarily focuses on demonstrating substantial equivalence based on performance standards for traditional medical devices (blood pressure, SpO2, temperature, body composition) rather than the rigorous evaluation of a new AI/ML-driven diagnostic or assistive technology.

Here's a breakdown of what can be extracted and what is missing based on your prompt:

Extracted Information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides performance standards and reports whether the device met them, rather than a direct "acceptance criteria" table with specific quantitative thresholds and exact results for each parameter alongside performance metrics like sensitivity/specificity for an AI.

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

• NIBP: 119 subjects.
• TEMP: 105 subjects.
• SpO2: 10 healthy subjects (aged 22-40, Fitzpatrick 2-6), but this was for the integrated FDA cleared device (K170047), not a new test for this submission's SpO2 component.
• Data Provenance: The NIBP and TEMP clinical studies were described as "single-center, randomized, self-controlled clinical trial[s]" conducted by Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. This implies prospective data, likely from China given the company's location.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not explicitly stated in the document.
• For NIBP and TEMP, the ground truth was established by comparison with "registered mercury thermometer and desktop sphygmomanometer." This implies these are the "gold standard" reference devices, not human experts.

4. Adjudication Method for the Test Set:

• Not applicable/Not stated. The ground truth was based on direct measurements from reference devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

• No. This type of study is typical for AI/ML diagnostic tools assisting human readers (e.g., radiologists). The device in question is a multi-parameter measurement device, not an AI diagnostic tool requiring human reader studies to demonstrate assistance.

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

• Yes, in spirit. The performance metrics (accuracy, standard deviation) for NIBP, TEMP, and SpO2 are reported for the device itself compared to reference standards, indicating standalone performance. The document describes the device directly measuring these parameters.

7. The Type of Ground Truth Used:

• Reference device measurements.
  • NIBP: "desktop sphygmomanometer"
  • TEMP: "registered mercury thermometer"
  • SpO2/PR: Data from a previously cleared device (K170047, K063641) presumably validated against arterial blood gas or CO-oximetry as typical for oximetry.
  • No pathology or outcomes data mentioned

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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:

Study Details

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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For use only in healthy subjects for Measurement of:

Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ICW), Total Body Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Shape Graph, Weight Control, Fat Control, Muscle Control, Segmental ECW/TBW, Segmental ICW, TBW/LBM, Leg Lean Mass, Fitness Score, AC (Arm Circumference)

Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody S10], Reactance Values [only for InBody770, InBody S10], Phase Angle [only for InBody770, InBody S10]

Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass.
These devices are impedance plethysmograph body composition analyzers. These devices determine body composition parameters 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 because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components. Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water; extra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue

The Biospace Body Composition Analyzers (Models InBody770, InBody570, InBody S10, InBody230) were evaluated through a clinical study to demonstrate substantial equivalence to previously cleared predicate devices. The primary method of evaluation involved comparing the performance of the new devices against predicate devices across a range of body composition metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating comparable performance to predicate devices already cleared by the FDA, with "very nearly 1.00" correlation coefficients between the new devices and predicates as the key performance indicator.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Approximately 80 patients.
• Data Provenance: The document does not explicitly state the country of origin. Given Biospace Corporation Limited is based in Seoul, Korea, it is highly probable the data originated from Korea. The study appears to be prospective as it states "We conducted clinical testing on each model."

3. Number and Qualifications of Experts for Ground Truth:

The document does not mention using experts to establish ground truth for the test set in the traditional sense (e.g., radiologists interpreting images). The study focuses on comparing the output of the new devices against predicate devices, implying that the predicate devices themselves serve as a form of "reference" or "ground truth" for comparative effectiveness in this context.

4. Adjudication Method:

Given that the ground truth appears to be based on the output of predicate devices, an adjudication method in the form of expert consensus is not applicable or mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted as this device does not involve human readers interpreting diagnostic images. The study compared device outputs directly. Therefore, there is no effect size of human improvement with or without AI assistance to report.

6. Standalone Performance Study:

A standalone performance study of the algorithm (if "algorithm" refers to the core BIA calculation logic) was implicitly done in the context of comparing the new devices against predicates. The reported "very nearly 1.00" correlation coefficients represent the standalone performance of the new devices relative to the established performance of the predicate devices. The study compares the device's measurement capabilities rather than an AI algorithm without human intervention.

7. Type of Ground Truth Used:

The primary "ground truth" for comparison was the measurements obtained from predicate devices. This is a form of comparative validation against established medical devices with a known performance profile.

8. Sample Size for the Training Set:

The document does not provide information regarding a separate training set or its sample size. As a medical device based on bioelectrical impedance analysis, its underlying principles and algorithms might be well-established, potentially requiring calibration and validation rather than extensive machine learning-style "training" on a specific dataset for output generation in the same way an AI image classification model would.

9. How Ground Truth for the Training Set Was Established:

As no explicit training set is mentioned in the provided text, the method for establishing its ground truth is not discussed.

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The ARIA WiFi Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 10 years of age or older. It is intended for home use only.

ARIA is a body weight scale and a body fat analyzer that operates by using a low, safe, battery-generated electrical current through the body (using a bioelectrical impedance analysis technique) to provide body fat and body weight information. After the user registers their scale, the scale automatically recognizes the subject based on body weight and body fat readings. ARIA contains a WiFi module (802.11 module) that allows it to connect to the Internet in the user's home. The module provides a complementary interface to the Fitbit website. Body weight and body fat measurements are independent of internet communication after initial product registration.

The ARIA scale automatically measures body weight and body fat composition. The scale recognizes the user based on previous weight readings, and can accept up to eight (8) different users. The 16 most recent readings are kept in memory on the scale and readings are also transmitted to the user's optional fitbit.com personal account for trending. If users have similar weight, the proper identity can be selected by tapping the scale.

Here's a breakdown of the acceptance criteria and study information for the Fitbit ARIA WiFi Smart Scale, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ARIA WiFi Smart Scale are established not through explicit numerical thresholds but by demonstrating substantial equivalence to a predicate device (Withings Smart Body Scale K121971) and showing that its body fat measurements are not statistically different from the predicate, with variation within an acceptable range.

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Body Fat Analyzer and Scale measures body weight and impedance and estimates percentage of body fat, body water and body muscle mass using BIA (bioelectrical impedance analysis). It is intended for use by healthy adults 18 years of age or older who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy for body composition assessment in the home environment.

The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Conmo Electronic Company Limited Body Fat Analyzer and Scale provides weight, calculates the body fat, body water and body muscle mass. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.

The Conmo Electronic Company Limited Body Fat Analyzer and Scale, Model 5786, measures body weight and impedance and estimates the percentage of body fat, body water, and body muscle mass using Bioelectrical Impedance Analysis (BIA). The provided 510(k) summary states that clinical testing was used to validate the effectiveness and accuracy of the device, with all test results reported as satisfactory. However, the document does not explicitly detail specific acceptance criteria or the study design (e.g., sample size, expert involvement, ground truth methodology) for this clinical testing.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state specific numerical acceptance criteria for accuracy, precision, or other performance metrics. It only states that "Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory." Without specific criteria, a direct comparison is not possible.

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

• Sample Size for Test Set: Not specified
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Clinical testing."

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

• Number of Experts: Not specified
• Qualifications of Experts: Not specified

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document does not provide details on how discrepancies in ground truth establishment (if any) were resolved.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or described in the document. This type of study typically involves human readers interpreting diagnostic images or data with and without AI assistance to measure the effect size of AI improvement. The device in question is a standalone measurement device for body composition, not an AI-assisted diagnostic tool.

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

• Standalone Performance: While the device functions as a standalone unit (measurements are taken by the device and calculations performed by internal software), the document does not provide a detailed breakdown of a standalone performance study with specific metrics beyond the general statement of "satisfactory" effectiveness and accuracy. The clinical testing mentioned seems to assess the overall device performance which, by its nature, is standalone as it outputs direct measurements.

7. The Type of Ground Truth Used

• Type of Ground Truth: The document does not explicitly state the specific "ground truth" method used for the clinical validation of body fat, body water, or body muscle mass. For body composition devices, common ground truth methods include:
  • DEXA (Dual-energy X-ray absorptiometry): A gold standard for body composition.
  • Hydrostatic weighing: Another accurate method.
  • Air displacement plethysmography (Bod Pod): Also considered accurate.
  • Calipers: For skinfold thickness.
    Without this information, it's unclear against what highly accurate measurement the device's outputs were compared.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. The document describes a device that performs calculations based on Bioelectrical Impedance, height, weight, age, and gender using "internal software." It does not describe a machine learning or AI model that requires a distinct "training set" in the conventional sense. The "internal software" likely uses established BIA equations rather than a learned model from a large dataset.

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

• Ground Truth for Training Set: Not applicable/Not specified. As there is no mention of a training set for a machine learning model, the method for establishing ground truth for such a set is not relevant here. The device's calculations are based on programmed variables and scientific formulas for BIA.

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For use only in healthy subjects for Measurement of:

Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental · Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control

Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody720], Reactance Values [only for InBody720], Phase Angle fonly for InBody720]

These devices are impedance plethysmograph body composition analyzers. These devices determine body composition parameters 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 because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components. Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue

The provided document describes the Biospace Body Composition Analyzers (Models InBody 120, InBody 370, InBody 720, InBody 520) which are impedance plethysmograph body composition analyzers. The study conducted for these devices aimed to prove their substantial equivalence to their predicate devices, rather than establishing specific quantitative acceptance criteria for their performance. The acceptance criteria for these devices, as implied by the FDA 510(k) summary, is that their clinical performance is comparable to that of legally marketed predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., accuracy percentages, standard deviations) that the device must achieve. Instead, the "acceptance criteria" appear to be based on demonstrating clinical performance comparable to predicate devices. The reported device performance is therefore framed in terms of this comparability.

2. Sample Sizes used for the test set and data provenance

• InBody 120: 39 examinees
• InBody 370: 88 examinees
• InBody 520: 75 examinees
• InBody 720: 62 examinees
• Data Provenance: The studies were conducted at unknown locations but by "Biospace Corporation Limited" (KOREA). The timeframe for the studies are indicated:
  • InBody 120: August 19th - August 23rd, 2012
  • InBody 370: September 3rd - September 5th, 2012
  • InBody 520: July 2nd - July 4th, 2010
  • InBody 720: July 2nd - July 4th, 2010
• Retrospective/Prospective: The studies are described as "comparison performance tests" conducted with "groups of examinees" during specific dates. This suggests they were prospective studies where data was collected specifically for validation purposes.

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

The document does not provide information on the number or qualifications of experts used to establish ground truth.

4. Adjudication method for the test set

The document does not specify any adjudication method for the test set. Given that these are bioelectrical impedance analysis devices, the "ground truth" would likely come from other established body composition measurement methods (e.g., DEXA, hydrostatic weighing), not from expert consensus or adjudication of subjective interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The clinical studies were "comparison performance tests" between the new devices and predicate devices on groups of examinees. These are standalone device comparisons, not focused on human reader performance with or without AI assistance.

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

Yes, the studies described are, by nature, standalone performance evaluations. The devices are body composition analyzers, and their measurement outputs are compared to the predicate devices. There is no human-in-the-loop component described for the measurement process itself, other than the subject operating the device as intended. The "clinical performance" test directly evaluates the algorithm (and hardware) of the new device against the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the method used for "ground truth" during the comparison studies. However, in the context of bioelectrical impedance analysis, the "ground truth" would typically come from a more established or reference method for body composition measurement (e.g., Dual-energy X-ray absorptiometry (DEXA), hydrostatic weighing, isotopic dilution). The comparison itself is made against a "predicate device" which is already legally marketed and presumed to provide accurate measurements. Therefore, the predicate device itself serves as a proxy for "ground truth" in these comparison studies.

8. The sample size for the training set

The document does not provide any information about a "training set" or its sample size. These devices use bioelectrical impedance analysis (BIA), which relies on established physiological models and algorithms, likely developed and validated over time. The submission focuses on demonstrating equivalence to predicates, implying the core algorithms are already established, rather than presenting a de novo AI development requiring a specific training set validation.

9. How the ground truth for the training set was established

As no training set is mentioned, there is no information provided on how its ground truth might have been established.

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The BIA/Vitality Analyzer™ is indicated for "generally healthy" subjects of 18 to 87 years old. The BlA/Vitality Analyzer™ is intended to estimate a person's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water.

Not Found

While the provided text describes the FDA 510(k) clearance for the Vitality Analyzer™/BIA Analyzer™, it does not contain the specific acceptance criteria or details of a study (test data, sample sizes, expert qualifications, etc.) that proves the device meets those criteria.

The document is a regulatory clearance letter, confirming the device's substantial equivalence to a predicate device. It defines the intended use and regulatory classification but does not include the technical performance evaluation that would typically involve acceptance criteria and a study.

Therefore, I cannot provide the requested information in the format requested. The document primarily focuses on regulatory approval rather than detailed performance evaluation.

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The Precision One Lifecare and Detecto Body Fat scales measure weight and use bioelectrical impedance analysis (BIA) technology to estimate and keep a record of body fat percent, total body water percent, bone mass percent, and muscle mass percent. The scales also provide a daily calorie intake recommendation and a fitness assessment. The scales are intended for use in the home/domestic setting only.

Estimated body fat percent is intended for use on individuals 7-17 years old (Healthy Children) and 18-80 years old (Healthy Adults).

Estimated body water percent, estimated muscle mass percent, estimated bone mass percent, and calorie intake are intended for use on individuals 18-80 years old.

Children under 7 years old and adults over 80 years old can use the scales for normal weighing mode only.

The scales are not intended for diagnosis.

The Body Fat scales use BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat percent, muscle percent, body water percent, and bone percent. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer.

The devices are single frequency electrical bio-impedance analyzer. All models measure current, voltage and phase angle, calculate impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition of: body fat percent, body water percent, muscle mass percent, bone mass percent, daily calories intake recommendation, and provides a fitness assessment. All models have a bi-polar set of contact electrodes which are attached to stainless steel pads on the platform of the analyzer.

The scales can store the personal data of up to 12 users. As well as being an analyzer, these devices can be used as a conventional scale. The models have one operating mode: Algorithm Mode.

Algorithm Mode; Displays estimates of body fat percent and body water percent. The devices compute these values using accepted reviewed published algorithms tailored to the candidate types: general population of the accepted age ranges of adult or children.

The devices consist of a main unit having a glass or stainless steel platform for the user to step on. On the platform, 2 stainless steel electrodes are mounted which are connected to the electronics circuitry with the analyzing MCU. When the user steps on the electrodes (1 for each foot) a small current of about 90μA will pass through the user body through the 2 feet to complete the close circuitry in order for the analyzer to measure and capture the electrical data change in terms of Bio electrical impedance, resistance, reactance, taking into account other parameters as to personal data of Age, Height, Gender, and Weight.

Here's an analysis of the acceptance criteria and the study that demonstrates the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not list specific, quantifiable acceptance criteria for the performance of the body fat scales (e.g., a specific delta or correlation coefficient for body fat percentage). Instead, the acceptance is based on a determination of substantial equivalence to a predicate device.

The reported device performance is that the "two scales provide substantially equivalent results."

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

• Sample Size for Test Set: 70 participants (50 adults and 20 children).
• Data Provenance: Not explicitly stated regarding country of origin. The study was conducted by the "sponsor," suggesting it was an internal study or sponsored by the manufacturer. It was a prospective study, as participants "standing on both the predicate scale and a Body Fat scale to obtain measureable parameters."

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

This information is not provided in the document. The study compares the performance of the subject device to a predicate device, not to an independent "ground truth" established by experts in the context of diagnostic accuracy. The "ground truth" in this performance study is the measurements obtained from the predicate device itself.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in scenarios where multiple experts are evaluating cases and their agreement or disagreement needs to be resolved to establish a definitive ground truth. In this study, the comparison is directly between two devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a direct comparison between a new device and a predicate device, not an evaluation of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone (algorithm only) performance assessment was done in the sense that the device's algorithms were compared to those of the predicate device. The text states:

• "The performance of Body Fat Scales was compared to the performance of the predicate device through testing conducted by the sponsor."
• "This testing consisted of 70 participants... standing on both the predicate scale and a Body Fat scale to obtain measureable parameters which are also used for algorithm calculations. This testing showed the two scales provide substantially equivalent results."

This indicates an evaluation of the device's algorithmic output (body composition estimations) in comparison to the predicate, without human intervention in the interpretation of the output for the purpose of the substantial equivalence claim.

7. Type of Ground Truth Used

The "ground truth" for the performance comparison was the measurements obtained from the predicate device (Tanita Model: SC331). The study aimed to show that the subject device produced results "substantially equivalent" to the predicate, making the predicate's output the de facto reference for this comparison. It was not pathology, outcomes data, or expert consensus in an absolute sense, but rather a comparative reference.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The device uses "accepted reviewed published algorithms," which suggests these algorithms were developed based on prior research and data, but the specific training data for these algorithms as applied to this device is not provided. The 70 participants were part of a comparative performance test to demonstrate equivalence.

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

Since a dedicated training set for the subject device is not described, the method for establishing its ground truth is also not provided. The algorithms are stated to be "accepted reviewed published algorithms tailored to the candidate types: general population of the accepted age ranges of adult or children." This implies the underlying algorithms were developed and validated using standard, often clinically derived, methods for BIA calculation in the scientific literature. However, the specifics of this particular device's training data and its ground truth establishment are absent.

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The Transtek Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older.

It is intended for use in the home/domestic setting only.

Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Glass Body Fat Analyzer LS203-B.

This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness.

Transtek Glass Body Fat Analyzer GLS203-B embeds a Bluetooth module that allows it to connect to nearby BT receiving terminal. Once measurement is over, the LCD of device displays measurement results, and the device will start to send out measurement data to paired BT terminal at the same time. Thus users can receive, display, and storage measurement results from LS203-B unit through mobile BT terminal.

The provided text describes a 510(k) summary for the Transtek Glass Body Fat Analyzer Model LS203-B. However, it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in terms of performance metrics like accuracy, sensitivity, or specificity for its intended body composition measurements.

The document focuses on demonstrating substantial equivalence to a predicate device (TRANSTEK, Glass Body Analyzer, Model LS206-E, K123781) by highlighting that the only significant difference is the wireless communication technology (Bluetooth vs. RF). It asserts that this change does not raise new questions of safety and effectiveness, and therefore, no clinical performance testing was deemed necessary for the comparison of the two devices.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

Not provided. The document states: "Explanation: The wireless function does not affect body analyzer measurement function. Therefore we have not done the Clinical test." This indicates that no specific performance metrics comparing the LS203-B to a gold standard were conducted or reported in this summary.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. No clinical performance test set or data provenance is mentioned. The only "tests" referred to are "bench tests," "risk management," and "design verification tests" for the modification.

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

Not applicable/Not provided. No ground truth establishment experts are mentioned because no clinical performance study was conducted.

4. Adjudication method for the test set

Not applicable/Not provided. No adjudication method is mentioned because no clinical performance study was conducted.

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. This device is a body composition analyzer, not an AI-assisted diagnostic imaging device requiring human reader interpretation in an MRMC study.

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

Not applicable/Not provided. While the device itself is a standalone measurement tool, the document doesn't present a study assessing its standalone performance against a clinical ground truth. It relies on the substantial equivalence to the predicate device, which presumably had established performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. No ground truth is mentioned in the context of a performance study for the LS203-B. Its substantial equivalence argument implies that the predicate device's performance, likely validated against some form of ground truth (e.g., DEXA or other established body composition methods for the predicate), is assumed to apply.

8. The sample size for the training set

Not applicable/Not provided. This document doesn't describe the development or training of an AI algorithm in the contemporary sense. It's an impedance-based device, and while it uses algorithms for calculation, it's not discussed in terms of a "training set" like a machine learning model.

9. How the ground truth for the training set was established

Not applicable/Not provided. As there's no mention of a training set, there's no information on how its ground truth might have been established.

Summary of the Study (as described in the document):

The document describes a submission for a modified device (LS203-B) that is substantially equivalent to a predicate device (LS206-E). The "study" here is primarily a design control activity and substantial equivalence comparison, not a clinical performance validation of the LS203-B's accuracy in measuring body composition.

• Objective: To demonstrate that the modified device (LS203-B) is substantially equivalent to the predicate device (LS206-E) and does not raise new questions of safety and effectiveness.
• Key Finding: The only significant difference is the use of Bluetooth instead of RF for wireless data transmission.
• Conclusion: This modification does not impact the safety and effectiveness of the device, and therefore, no clinical performance tests were considered necessary for this 510(k) submission. The device is deemed substantially equivalent.

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The Transtek Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older.

It is intended for use in the home/domestic setting only.

Transtek Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body far mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Transtek Body Fat Analyzer (GBF-1251-B, BF-1256-B, and GBF-1257-B).

This method simultaneously calculates personal body water, muscle mass, and bone mass, giving a more accurate reading of overall health and fitness. As well as being an analyzer, this device can be used as a conventional weight scale.

The Transtek Body Fat Analyzer embeds a Bluetooth (BT) module that allows it to connect to nearby BT receiving end. The LCD of device displays results. And once measurement is over, the device will start transmission data by BT. Thus users can receive, and display/storage, measurement data of Transtek Body Fat Analyzer unit through their end devices that embedded BT module.

Here's an analysis of the provided text regarding the Transtek Body Fat Analyzer and its acceptance criteria and study information:

Acceptance Criteria and Study Information for Transtek Body Fat Analyzer

Based on the provided 510(k) summary (K130311), here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or reported device performance metrics for body fat, total body water percentage, muscle mass, or bone mass estimation. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to general safety and electrical standards.

The document primarily focuses on demonstrating that the Transtek Body Fat Analyzer (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B) is substantially equivalent to the predicate device, Transtek Glass Body Fat Analyzer, Model GBF-950-D (K112932). The key argument for substantial equivalence is that the only significant difference is the addition of a wireless data communication function, which is an add-on and does not affect the safety and effectiveness of the body composition analysis function.

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

The document does not specify a sample size or provide details on a "test set" used for clinical validation of the body composition measurements. The assessment appears to rely on a demonstration of design control activities and performance tests focusing on adherence to electrical safety and electromagnetic compatibility standards, rather than a clinical trial with a defined test set for accuracy of body composition measurements.

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. (The submitter is from China, but there's no indication of where any testing data, if clinical, would originate).
• Retrospective/Prospective: Not specified.

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

Given that no explicit clinical test set for body composition accuracy is described, there's no information regarding experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

As no explicit clinical test set is described, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study is mentioned in the provided document. The focus is on device equivalence, not on comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a Body Fat Analyzer that directly measures and displays results. The concept of "standalone performance" in the context of an algorithm's output versus human interpretation (as often seen in imaging AI) is not applicable to this type of device based on the provided information. The device itself is the "algorithm" and produces the output for the user.

7. The Type of Ground Truth Used

The document does not specify a type of ground truth (e.g., pathology, outcomes data, expert consensus) for body composition measurements. The substantial equivalence argument implies reliance on the already accepted performance of the predicate device and adherence to relevant standards.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This implies that the device's algorithms for body composition measurement were either developed or previously validated, and this 510(k) focused on demonstrating equivalence and safety of the new wireless feature rather than re-validating the core body composition algorithms.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

Summary of Study Information Gaps:

The K130311 summary for the Transtek Body Fat Analyzer primarily focuses on demonstrating substantial equivalence to an existing predicate device, particularly concerning the addition of a wireless data transmission function. It emphasizes compliance with general electrical safety (IEC60601-1), electromagnetic compatibility (IEC60601-1-2, FCC Part 15), and risk management (ISO14971) standards.

Crucially, the document does not provide details on specific clinical studies, test sets, sample sizes, or ground truth establishment related to the accuracy of the body composition measurements (body fat, water, muscle, bone mass). This is a common characteristic of 510(k) submissions where a device is deemed substantially equivalent to a predicate, and the modifications are considered not to raise new questions of safety or effectiveness regarding the core function. The assumption is that the predicate device's performance has already been established.

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