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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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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 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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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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