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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 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 and segmental fat percent and weight, total body water percent and weight, intracellular and extracellular water weight, total body and segmental muscle mass, physique rating, bone mass, visceral fat rating with healthy range, basal metabolic rate (BMR), and fat free mass (FFM), 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.

For subjects 17 years old and younger, only fat % is displayed.

The Tanita Model MC-180MA Multi-frequency Body Composition Analyzer is a computer-operated body composition analyzer that utilizes bioelectrical impedance analysis (BIA) to estimate body composition of fat, muscle and bone, water compartments, and basal metabolic rate (BMR).

Actual measurements made by the MC-180MA include body weight and bioelectrical impedance. BIA is used to make estimates based upon these measured values.

Here's an analysis of the provided text regarding the Tanita MC-180MA Multi-frequency Body Composition Analyzer and the requested information.

It's important to note that the provided text is a 510(k) summary for a premarket notification to the FDA. These documents primarily focus on demonstrating "substantial equivalence" to existing predicate devices, rather than detailed performance studies with acceptance criteria in the way a clinical trial for a novel drug or a high-risk medical device might. Therefore, some of the requested information (like specific acceptance criteria thresholds, detailed study outlines with sample sizes for test sets, expert qualifications, and multi-reader multi-case studies) is generally not present in this type of FDA submission. The focus here is on technological characteristics comparison rather than rigorous clinical validation against an established gold standard for accuracy metrics.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided K100183 510(k) summary, specific numerical acceptance criteria (e.g., "accuracy must be within X% of the gold standard") are not explicitly stated or detailed. The document focuses on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable because its underlying technology and intended use are similar to already cleared devices.

The document states:

• "Multiple-frequency measurement of bioelectrical impedance values used in estimation of percent fat, fat-free mass, total body water and extracellular water was verified in clinical testing." This indicates some form of testing was done, but details are not provided.
• "Comparison of these intended-use and technological characteristics demonstrate that the Model MC-180MA is substantially equivalent to predicate devices." This is the core "performance" claim in the context of a 510(k).

Therefore, a table of explicit acceptance criteria and corresponding performance cannot be constructed from the provided text. The "acceptance criterion" is effectively: "demonstrate substantial equivalence to predicate devices." The "reported device performance" is the assertion that this substantial equivalence has been met through comparison of technological characteristics and clinical verification.

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

The document mentions "verified in clinical testing," but does not specify the sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective or prospective nature of the "clinical testing").

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

This information is not provided in the 510(k) summary. For Bioelectrical Impedance Analysis (BIA) devices, "ground truth" would typically involve comparison to a more established body composition measurement method (e.g., DEXA, hydrostatic weighing), rather than expert consensus on images.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of BIA devices, clinical adjudication by human experts in the way it's done for image analysis or diagnostic tools is generally not applicable.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable for this device type (body composition analyzer using BIA) and is not mentioned in the document. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the study assesses the impact of AI assistance on their performance. This device is a standalone measurement tool.

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

Yes, implicitly. The device itself, the Tanita MC-180MA, is a standalone algorithm (BIA) that measures impedance and then applies algorithms to estimate body composition. The "clinical testing" mentioned would have been to verify the accuracy of these algorithms in producing the stated outputs. The device operates independently of human interpretation in its core function.

7. The Type of Ground Truth Used

The document implicitly refers to "clinical testing" where "multiple-frequency measurement of bioelectrical impedance values... was verified." For BIA devices, the "ground truth" for verification typically involves comparison with established, more accurate body composition assessment methods such as:

• Dual-energy X-ray absorptiometry (DEXA)
• Hydrostatic weighing (underwater weighing)
• Isotope dilution
• Magnetic Resonance Imaging (MRI)
• Computed Tomography (CT)

However, the specific "type of ground truth" method used in their verification is not explicitly stated in the provided text.

8. The Sample Size for the Training Set

The document does not specify the sample size for any training set. It refers to "multiple-regression algorithms to predict body composition," implying that these algorithms were trained or developed using some dataset, but the size is not disclosed.

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

The document does not specify how the ground truth for any training set was established. Similar to point 7, it would likely involve comparisons to other body composition assessment methods, but details are not provided.

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This device is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.

This device is intended for use only in healthy subjects between the age of 7-89.

The ioi 353 is body composition analyzer is intended for use only in healthy subjects between the age of 7-89. The device employs BIA(Bio-electrical Impedance Analysis) method and 8 electrodes placed on hands and feet, and then measure body composition using an experimentally derived algorithm. The device is powered by AC adapter.

The Jawon Medical Body Composition Analyzer Model ioi 353 did not undergo clinical testing to establish its performance against specific acceptance criteria. Instead, substantial equivalence was claimed based on compliance with electrical safety and electromagnetic compatibility standards and the device's technological similarity to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

No specific test set or clinical data is provided for the ioi 353 device, as it was not clinically tested. The evaluation relies on non-clinical tests (electrical safety and EMC) and comparison to a predicate device.

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

Not applicable, as no clinical test set was used for the ioi 353.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for the ioi 353.

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

No MRMC study was conducted or referenced. The submission explicitly states the device was "not clinically tested."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study for the algorithm was conducted or referenced in this document. The device's performance is inferred by its similarity to predicate devices.

7. Type of Ground Truth Used

The ground truth for the device's safety and effectiveness relies on compliance with international standards (IEC 60601-1, EN 60601-1-2) and the established performance of its predicate device (GAIA 359 PLUS and XBIA 500), rather than direct comparison to a clinical ground truth.

8. Sample Size for the Training Set

Not applicable. This device is not described as having an AI algorithm requiring a training set in the context of this 510(k) summary. Its algorithm is "experimentally derived," implying a fixed, pre-determined calculation based on BIA, not a machine learning model.

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

Not applicable, as no AI training set is mentioned for this device. The "experimentally derived algorithm" for the Body Composition Analyzer (using BIA) would typically be based on established physiological models and correlations between impedance measurements and body composition, often developed through various research studies, but not specifically described as a machine learning training set in this submission.

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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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For Measurement in healthy subjects of: Estimated : ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean +Dry Lean Metabolic Rates, Segmental Lean Mass. Model N40 adds: Skeletal Muscle Mass; Actual: Weight, BMI, Impedance Values

SLIMMANAGER is a body composition analyzer and uses Bioelectrical Impedance Analysis technology to determine body composition parameters. Using a principle that an electric current has a low impedance when it flows in muscle or cellular fluids containing lots of water while it has a high impedance such as in fat and bone tissues slowing and stopping an applied current, BIA sends an extremely weak electric current through the body and detects the relative response after it flows our body's various substances, and then it can determines lean tissue, fat, water mass. All measurements made by SLIMMANAGER can be recorded & saved in the website real-time by the Internet transmission as well in the device, and in his own page people could check their changing progress even a minute change without an expert's advice at anywhere, at anytime. N-40 is designed by Linux system with touch monitor, while SM-300 should be interfaced with customer's PC.

The provided text is a 510(k) Summary for a medical device called "SLIMMANAGER, Body composition analyzer (Models: N40, SM-300)". It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and performance data in a format typically found in clinical trials.

Therefore, the requested information elements related to specific acceptance criteria, test set details (sample size, data provenance, expert involvement, adjudication), multi-reader multi-case studies, standalone performance, and training set details are not explicitly available within the provided text.

The document states that "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices." and later, "After analyzing both bench and clinical testing data, it is the conclusion of AIIA Communication Inc. that the SLIMMANAGER, Body composition analyzer (Models: N40, SM-300). as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices."

This indicates that a study was conducted, and its results led to the conclusion of substantial equivalence. However, the specific acceptance criteria, method, and results of that study are not detailed in this summary.

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

1. A table of acceptance criteria and the reported device performance

• Not explicitly provided. The document states that "bench and clinical testing indicates that the new device is as safe and effective as the predicate devices," implying an comparison was made, but the specific metrics, thresholds, or performance values are not listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not explicitly provided. The document mentions "clinical testing data" but does not specify the sample size, data provenance, or whether it was retrospective or 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 applicable/Not explicitly provided. For a body composition analyzer using Bioelectrical Impedance Analysis (BIA), ground truth would typically be established against a gold standard method (e.g., DEXA or underwater weighing), not by expert consensus interpreting images. The document does not describe how ground truth was established, nor does it mention any expert involvement for this purpose.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not explicitly provided. As expert consensus is not the stated method for ground truth, an adjudication method isn't relevant in the typical sense.

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 standalone body composition analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.

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

• Yes, implicitly. The device itself is what is being evaluated for its "safe and effective" performance in comparison to predicate devices, indicating a standalone evaluation of its measurement capabilities.

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

• Not explicitly stated, but implied to be a comparison to predicate devices. The document states "as safe and effective as the predicate devices." In BIA studies, "ground truth" for body composition parameters is typically established using established gold-standard methods (e.g., DEXA, underwater weighing, or multi-compartment models). The 510(k) summary doesn't specify which "ground truth" was used in their clinical testing. It primarily focuses on equivalence to other BIA devices.

8. The sample size for the training set

• Not applicable/Not explicitly provided. While the device uses Bioelectrical Impedance Analysis (BIA), which can involve algorithms, the summary doesn't describe a machine-learning-based "training set" in the context of AI. BIA devices typically use established physiological models and equations.

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

• Not applicable/Not explicitly provided. See point 8.

Summary of available information regarding the study:

• Device: SLIMMANAGER, Body composition analyzer (Models N40, SM-300)
• Purpose of Study (as described): To demonstrate that the new device is as safe and effective as the predicate devices (Biospace InBody 230 K062603; AIIA communication Inc. SLIMMANAGER (SM-X, SM-E) K051589).
• Methodology: Bench and clinical testing was performed.
• Conclusion: The device is substantially equivalent to the predicate devices.
• Measured Parameters (Indications for Use): Estimated: ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean +Dry Lean Metabolic Rates, Segmental Lean Mass. Model N40 adds: Skeletal Muscle Mass. Actual: Weight, BMI, Impedance Values.

To fully answer your questions, one would need to refer to the detailed clinical study report that was submitted as part of the 510(k) application, which is not included in this summary.

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The EasyBody 202 and EasyBody 203 are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.

The EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM, recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.

The EasyBody 202, EasyBody 203 and EasyBody 205 measure the impedance and weight of the user, and are intended for use only in healthy subjects between the age of 5-89.

The EasyBody 202, EasyBody 203 and EasyBody 205 are non-invasive body composition analyzers intended for use only in healthy subjects between the age of 5-89. The devices employ BIA(Bio-electrical Impedance Analysis) method, 4 electrodes for EasyBody 202 and EasyBody 203, 8 electrodes for EasyBody 205, and then measure body composition using an experimentally derived algorithm. The devices are powered by four AA batteries (DC 6V) or AC adapter.

Here's a summary of the acceptance criteria and the study details for the Jawon Medical Body Composition Analyzer Models EasyBody 202, EasyBody 203, and EasyBody 205, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "no significant difference" and substantial equivalence to the predicate device, ZEUS 9.9 (K053556). The specific performance metrics for acceptance are not explicitly listed as numerical targets (e.g., "accuracy > 90%"). Instead, the performance is judged against the established performance of the predicate.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical comparison tests," but does not provide details on the number of subjects or cases used in these tests.
• Data Provenance: Not explicitly stated, but the submitter and contact person are from the Republic of Korea, suggesting the clinical tests were likely conducted there. It is described as "clinical comparison tests," implying prospective data collection for the purpose of the study.

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 relies on comparison to a predicate device, rather than a separate expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the manner typically associated with AI products where human readers improve with or without AI assistance. This device is a standalone body composition analyzer, not a diagnostic aid for human readers. The clinical tests were for comparing the device's performance to another device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The "clinical comparison tests" evaluate the device's outputs (PBF, MBF, LBM, BMR, etc.) against the predicate device's outputs directly. The device operates independently to measure and estimate these parameters.

7. Type of Ground Truth Used

The "ground truth" for the test set was essentially the measurements and estimations provided by the predicate device (ZEUS 9.9). The study aimed to show that the new devices produced comparable results to an already legally marketed, substantially equivalent device. There is no mention of an independent, gold-standard reference ground truth (e.g., DEXA scan, hydrostatic weighing, pathology).

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI algorithm learning from data. The devices "measure body composition using an experimentally derived algorithm," which likely refers to a pre-defined algorithm based on physiological models and potentially some internal calibration data, rather than a machine learning model trained on a large dataset. Therefore, a sample size for a training set in the AI sense is not applicable/not provided.

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

As noted above, the concept of a "training set" and its "ground truth" (in the AI/machine learning sense) is not applicable to the description of this device's algorithm development. The algorithm is described as "experimentally derived," which typically implies a scientific or engineering approach to formula derivation and calibration, rather than a data-driven machine learning training process with ground truth labels.

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These devices are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.

These devices are intended for use only in healthy subjects between the age of 7-89.

The X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are body composition analyzers intended for use only in healthy subjects between the age of 7-89. The devices employ BIA(Bio-electrical Impedance Analysis) method and 8 electrodes placed on hands and feet (or ankles), and then measure body composition using an experimentally derived algorithm. For only XBIA 500, optional ankle electrode is not supplied. The devices are powered by AC100~230V 50/60Hz.

The provided document is a 510(k) summary for Jawon Medical Co., Ltd.'s Body Composition Analyzers. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the current device meets specific acceptance criteria through a novel study. As such, the document does not contain the detailed information typically found in a clinical study report that directly addresses acceptance criteria and device performance in the way requested.

Here's a breakdown of the information that can be extracted or inferred, and what is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document as a set of acceptance criteria for the new devices (X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500, and XBIA 900).

Instead, the document states:

• "The results of clinical comparison tests with predicate device ZEUS 9.9 demonstrate that there is no significant difference between the modified devise and the predicate device."
• "Conclusion: II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500 and XBIA 900 are as safe, as effective, and perform as well as the predicate devices VENUS 5.5 and ZEUS 9.9."

This implies that the acceptance criterion was "no significant difference" in performance compared to the predicate devices (VENUS 5.5 and ZEUS 9.9). The reported device performance is that this criterion was met. However, specific metrics (e.g., accuracy for PBF, LBM etc., and the numerical performance values) for either the new or predicate devices are not provided.

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

• Sample Size for Test Set: Not specified. The document mentions "clinical comparison tests" but does not give the number of subjects or measurements.
• Data Provenance: The study was a "clinical comparison test" conducted in South Korea by Jawon Medical Co., Ltd. The document does not specify if it was retrospective or prospective, but clinical comparison tests are typically prospective.

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

• Number of Experts: Not applicable/Not specified. The document describes a "clinical comparison test" against a predicate device, not a study where experts establish ground truth for a diagnostic finding. The ground truth for body composition analyzer performance is typically established by comparing against a reference method (e.g., DEXA, hydrostatic weighing) or by demonstrating equivalence to an already validated device, rather than expert consensus on images.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. Similar to the previous point, an adjudication method is not relevant for this type of equivalence testing where the primary goal is comparison to a predicate device.

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

• MRMC Study: No. This document describes a "clinical comparison test" of a body composition analyzer, which is a device that provides quantitative measurements, not a device used for visual interpretation by multiple readers like an imaging device. Therefore, an MRMC study is not applicable.

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

• Standalone Performance: Yes, implicitly. Body composition analyzers are standalone devices that provide measurements directly. The comparison test likely evaluated the device's measurements directly against the predicate device's measurements. There is no "human-in-the-loop" component in the operation of the algorithm itself for these devices.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the new device's performance was its equivalence to the predicate device (ZEUS 9.9). The predicate device itself would have been validated against a more direct "ground truth" (e.g., DEXA, hydrostatic weighing, or other accepted reference methods) in its own regulatory submission, but this document does not detail that.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not specified. Body composition analyzers (especially BIA-based ones) use experimentally derived algorithms. While these algorithms are "trained" or developed using data, the document does not specify the sample size used for developing the underlying algorithm for the new devices or the predicate devices.

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

• How Ground Truth for Training Set was Established: Not specified. The document states the devices "measure body composition using an experimentally derived algorithm." This implies that the algorithm was developed using a dataset where actual body composition (likely measured by gold-standard methods like DEXA or hydrostatic weighing) was known. However, the details of this process, including the specific ground truth methods or how they were established, are not provided in this 510(k) summary.

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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), Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass. Actual : Weight, Body Mass Index (BMI),and Impedance Values

Model Inbody 230 is an impedance plethysmograph body composition analyzer. This device determines 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.

The provided text describes the Biospace Body Composition Analyzer, Model InBody 230, and its substantial equivalence to predicate devices, but it does not contain a detailed study report with specific acceptance criteria and performance data in a format that lends itself to a direct table of acceptance criteria vs. device performance, nor does it explicitly detail the methodology of a study to prove it meets acceptance criteria.

However, based on the information provided, particularly the "Substantial Equivalence Chart" and the "Conclusion" section, we can infer the acceptance criteria are implicitly met by demonstrating substantial equivalence to the existing predicate devices. The document states that "After analyzing both bench and clinical testing data, it is the conclusion of Biospace that the Model [InBody 230] is as safe and effective as the predicate devices... and has been validated via human clinical trial."

Given the limitations of the provided text, I will construct a response that extracts the relevant information and indicates where detailed information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds for body fat percentage). Instead, substantial equivalence is claimed based on comparable intended use, technology, and performance to predicate devices. The "reported device performance" is implied to be "as safe and effective as the predicate devices" and "validated via human clinical trial."

Note: The primary "acceptance criterion" demonstrated here is "substantial equivalence" to the listed predicate devices, rather than meeting specific quantitative performance targets like sensitivity, specificity, or accuracy percentages. The document does not provide a study breakdown with numerical results against pre-defined thresholds.

2. Sample Size and Data Provenance for Test Set

The document mentions "human clinical trial" and "clinical testing data" but does not specify the sample size used for the test set. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) for any clinical data used.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The study methodology is not detailed in the provided text.

4. Adjudication Method for Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size for human readers improving with or without AI assistance. This device is a measurement tool, not an AI-assisted diagnostic imaging interpretation system.

6. Standalone Performance Study

The document states that the device was "validated via human clinical trial" and that "bench and clinical testing data" support its safety and effectiveness. This implies a standalone performance evaluation of the device's measurements. However, specific details of this standalone performance, such as metrics (e.g., accuracy, precision) or comparative data against a gold standard, are not provided. The claim is primarily about substantial equivalence to predicate devices, which also perform standalone measurements.

7. Type of Ground Truth Used

The document does not explicitly state the type of "ground truth" used in the human clinical trial. For body composition analyzers, gold standards usually involve methods like DEXA (Dual-energy X-ray Absorptiometry), hydrostatic weighing, or isotopic dilution, but this is not specified here. The absence of specific ground truth details suggests that the equivalence might primarily rely on comparison of outputs and operational characteristics with existing BIA devices deemed safe and effective.

8. Sample Size for Training Set

The document does not provide information on a separate "training set" or its sample size. This type of device (Bioelectrical Impedance Analysis) typically relies on established biophysical models rather than a machine learning training paradigm that would have a distinct training set in the AI sense.

9. How Ground Truth for Training Set Was Established

Since a distinct "training set" in the machine learning sense is not indicated, the document does not describe how ground truth for any such set was established. The device's operation is based on bioelectrical impedance principles, which leverage physiological constants and empirical equations derived from research, rather than a data-driven training process in the way an AI model would be trained.

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The ZEUS 9.9 and VENUS 5,5 body composition analyzers are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular Water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA(Bio-electrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hip Ratio) of the user.

These devices are intended for use only in healthy subjects between the age of 7-89.

The only difference between the ZEUS 9.9 and VENUS 5.5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screen

Model ZEUS 9.9/VENUS 5.5 of Jawon Medical is compact, automatic General: Impedance plethysmographer intended for estimating of body composition of user such as PBF(Percentage of Body Fat), MBF(Mass of Sody Fat), LBM(Lean Body Mass), TBW(Total Body Water), BMI(Body Mass Index), BMR(Basic Metabolic Rate), Segmental LBM, ICW(Intra-Cellular water), ECW(Extra-Cellular Water), and ratio of ECW/TBW using the BIA/Bioelectrical Impedance Analysis) method. The device measures or calculates the impedance, BMI(Body Mass Index), weight, and WHR(Waist to Hin Ratio) of the user. These devices are intended for use only in healthy subjects between age of 7-89. The only difference between the ZEUS 9.9 and VENUS 5.5 is head part of main unit; that is, the head part of the ZEUS 9.9 has a key pad and touch screen while the head part of the VENUS 5.5 has only a touch screen.

Operation: The subject device employs a measurement algorithms which is called BIA method, to measure user's body composition.

ZEUS 9.9/VENUS 5.5 device's tetra-polar type electrode connect to human body and then send an minute electric current like 360 A human body and then ZEUS 9.9/VENUS 5.5 device can measure impedance of the human body.

ZEUS 9.9/VENUS 5.5 can measure body composition of user with personal data which already saved height, weight, gender, ages and new calculated body impedance.

Power: Model ZEUS 9.9/VENUS 5.5 is AC line powered(AC 110~120V, 50/60Hz)

The provided text is a 510(k) summary for the JAWON MEDICAL BODY COMPOSITION ANALYZER Models VENUS 9.9 and ZEUS 5.5. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and explicitly defining a study to meet those criteria.

Therefore, the document does not provide explicit acceptance criteria with numerical targets. Instead, it states that the device is "equivalent in performance" and shows "no significant difference" to the predicate devices.

Here's an attempt to extract and infer the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit numerical acceptance criteria are not provided. The performance is assessed against predicate devices.

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

• Sample Size for Test Set: Not specified. The document only mentions "healthy subjects."
• Data Provenance: The study was likely conducted in Korea, given the company's address. The document does not explicitly state if it was retrospective or prospective, but clinical testing typically implies prospective data collection for performance comparison.

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

There is no mention of experts being used to establish a ground truth for the test set. The study compares the device's measurements directly to those of established predicate devices.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as a truth standard itself for the test set, as the comparison is against predicate devices.

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

No, an MRMC study was not done. This device is a standalone analyzer, and the study compares its output directly with other devices. It does not involve human readers interpreting results with or without AI assistance.

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

Yes, this was a standalone performance study. The device, which uses a BIA algorithm, was compared directly against other BIA devices.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance of the predicate devices (BODYSTAT Quad Scan 4000 and TANITA BC-418). The study aims to demonstrate that the Jawon device's measurements align with these established devices.

8. The Sample Size for the Training Set

The document does not provide information about a training set since it focuses on a comparison study for regulatory submission rather than algorithm development details. The BIA method is a well-established technique used by the device.

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

Not applicable, as no information on a training set is provided.

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