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This blood pressure monitor is designed to measure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 22 cm - 42 cm.

The BPBIO480KV is a digital monitor intended for use in measuring blood pressure and pulse rate in user population with upper arm circumference ranging from 22cm (8.6-inch to 16.5-inch). The systolic blood pressure and diastolic blood pressure are measured by non-invasive blood pressure ("NIBP") measuring method and also by utilizing the Auto auscultation method and Oscillometric method. The BPBIO480KV may provide useful clinical information about the current health status of not only the users who are diagnosed with hypertension but also those who are not diagnosed with hypertension. Warnings and cautions described in the user's manual should be observed at all times. Automated Auscultation is a method that combines the accuracy of auscultation, and the convenience of the Oscillometric method. To measure the blood pressure, wrap the cuff around the upper arm and inflate it to a pressure above the systolic pressure. Then slowly release the air to detect the Korotkoff sound signal and the pressure sensor signal, which you can listen with the stethoscope attached to the cuff, to measure the systolic and diastolic blood pressure. The Automated Auscultation applied to BPBIO480KV combines the accuracy of the auscultation method with the convenience of easy measurement. The signals are electronically processed to compensate for the possible errors in the auscultation method caused by movement, external noise, etc., enabling a more accurate blood pressure measurement. Included components are the main unit, a large and a medium size cuff, a users manual, an AC adapter, a power cord, and an internal rechargeable lithium rechargeable battery. Measurement methods: Auscultation and Oscillometric.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BPBIO480KV device:

Acceptance Criteria and Device Performance

Note: The text explicitly states these accuracy metrics as both "Accuracy" in the comparison table and also references conformity to ISO 81060-2:2018, which sets similar accuracy requirements. The "Validation Results" section states: "The system passed the deviation limits initially set by the protocol," which implies these criteria were met.

Study Details

1. Sample Size for Test Set and Data Provenance:

   • Sample Size: 85 total subjects (also stated as "among 93 participants" for both cuff sizes). This discrepancy might refer to 85 subjects contributing to the core data and 93 participants being enrolled to test both cuff sizes. Given the context of ISO 81060-2, a typical minimum sample size for validation is around 85 for a general population.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the mention of "European Society of Hypertension recommendations" and "ISO 14155:2020 principles for Good Clinical Practice" suggests a prospective clinical investigation.

2. Number of Experts and Qualifications for Ground Truth:

   • Number of Experts: Not explicitly stated.
   • Qualifications of Experts: Not explicitly stated. However, ISO 81060-2:2018 implicitly requires trained observers (auscultators) for reference measurements. The text mentions "medical staffs hear directly" when describing the auscultation method, implying human expert involvement in establishing ground truth.

3. Adjudication Method for Test Set:

   • Adjudication Method: Not explicitly stated. The description mentions "A 'V' tube was used to connect both the automated meter and the standard mercury sphygmomanometer to the cuff." This standard methodology for blood pressure validation typically involves simultaneous measurements by the device under test and human observers using a reference method (mercury sphygmomanometer and stethoscope), with statistical analysis of the differences. It doesn't explicitly describe an adjudication process for discrepancies between human observers, but ISO 81060-2:2018 often details such procedures (e.g., blinded observers, averaging, or a third arbitrator).

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

   • No, a MRMC comparative effectiveness study was not reported. The study focused on the standalone accuracy of the device against a reference standard, not its impact on human reader performance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop):

   • Yes, a standalone performance study was conducted. The "Clinical Testing" section describes measuring the BPBIO480KV's performance against a reference standard (mercury sphygmomanometer) using a "V" tube setup, which is a direct validation of the device's accuracy.

6. Type of Ground Truth Used:

   • Expert Consensus / Reference Standard Measurement: The ground truth was established by simultaneous measurements using a "standard mercury sphygmomanometer" and presumably auscultation by human observers, which is considered the gold standard for non-invasive blood pressure measurement in such validation studies.

7. Sample Size for Training Set:

   • Not explicitly stated. The document focuses on the validation study (clinical testing), not the development or training process of the device's algorithms.

8. How Ground Truth for Training Set Was Established:

   • Not explicitly stated. As with the training set size, the document does not elaborate on the development phase or how any internal algorithms were trained. The focus is solely on the validation demonstrating the device's accuracy against recognized standards.

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The subject device is a manual blood pressure (BP) monitor, and requires the user to listen for Korotkoff sounds to determine systolic and diastolic pressure. Further, patients whose Korotkoff sounds are not clear or absent, such as children younger than 3 years of age, will not be suitable for the subject device. Pulse rate is also measured.

This device can be used to measure blood pressure and pulse rate non-persistently using the Korotkoff sound method of measuring blood pressure in vitro. The user can measure the blood pressure using this device and cuff, stethoscope. Basically, it has the same function as a conventional mercury sphygmomanometer. However, instead of using harmful mercury to the human body, it displays the pressure on the LCD screen, so that the blood pressure can be measured harmlessly to the human body. In addition, using the 'Mark' function can conveniently display the systolic and diastolic pressures. And using its backlight, the user can measure blood pressure in the dark place. If air pressure exceeds 320mmHg, it will automatically exhaust quickly. If an emergency occurs during the measurement, pressing On/Off button will turn off the equipment and allow rapid exhaust. The device is for use by medical professional. The testing person supplies their own stethoscope, which is required for making the measurements.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: 102 subjects
• Data Provenance: Not explicitly stated, but the study was performed by InBody, implying internal testing. The documentation does not specify the country of origin of the data.
• Retrospective/Prospective: Not explicitly stated, but given it's a bench testing procedure to verify accuracy, it would typically be a prospective study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The document states "using the stethoscope," implying trained individuals capable of listening for Korotkoff sounds. However, no specific qualifications (e.g., radiologist, years of experience) are provided for these individuals.

4. Adjudication Method

• Adjudication Method: Not applicable/not specified. The ground truth was established by comparing the device's readings to the manual method of measuring blood pressure using a mercury manometer and a stethoscope. This is a direct comparison rather than an adjudication of multiple expert opinions.

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

• MRMC Study Done? No. The document describes a bench test comparing the device to a manual method, not an MRMC study assessing human reader performance with and without AI assistance.

6. Standalone Performance Study

• Standalone Study Done? Yes. The study focused on the accuracy of the BPBIO210/220/210T/220T device itself in comparison to the manual method using a mercury manometer and a stethoscope. This evaluates the algorithm's performance (or in this case, the device's accuracy as a measurement tool for manually read Korotkoff sounds) independent of human interpretation biases beyond the initial listening.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by direct comparison to a manual method of measuring blood pressure using a mercury manometer and a stethoscope, which is considered the gold standard for this type of device.

8. Sample Size for the Training Set

• Sample Size: Not applicable. The device is a manual blood pressure monitor that uses the Korotkoff sound method. It is not an AI/algorithm-driven device in the sense of requiring a "training set" for machine learning. The "bench testing" described is for validation and verification, not for training a model.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable, as there is no "training set" for a machine learning model. The device's operation relies on a physical process and the user's ability to interpret Korotkoff sounds.

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The Inbody blood pressure monitor is designed to measure blood pressure (diastolic and systolic) and pulse rate in adult patients with arm circumference range between 17cm - 42cm.

The models of BP170, BP160 and BP160B are designated as both Prescription use and Over-the-counter use.

The model of BPBIO250 is designated as Prescription use only.

All models have this common feature: Automatic blood pressure measurement using the oscillometric technique. This is the same method as our predicate. We have employed essentially the same technology as we used in our previous model (the predicate) but have packaged the unit differently in order to make it more portable. Instead of having a built in blood pressure cuff, we have moved that component outside of the unit so that now it plugs in to the measurement unit in the same way a large number of similar devices are designed. Instead of AC line operation only, the units can run on primary or on rechargeable batteries. The predicate device used an 8 bit microcontroller with 128Kbytes of in-system programmable flash memory. The BP170 series and the BPBIO250 use 32 bit microcontrollers with 128Kbytes of programmable flash. Most of the measurement software has been re-used from our predicate device and is virtually the same between the two new sets of models.

The BP170 is a fully automatic portable battery operated blood pressure monitor using the oscillometric technique which comes with batteries, a standard cuff, a storage pouch, and a user's manual.

BPBIO250 This product is a professional automatic blood pressure monitor used by medical professionals. 5 measurement modes can be selected according to various medical environments. Rechargeable batteries can be used without replacing batteries. The User can measure blood pressure even in dark environments. - This blood pressure monitor has cuffs of various sizes. So, User can measure the blood pressure and measure pulse rate to children and adult patients whose arm circumferences are between 17 cm and 42 cm.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • BP170 Series: 106 subjects
   • BPBIO250: 104 subjects with 312 observations
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only states that "Separate clinical investigations were performed". Given it's a 510(k) submission for a new medical device, clinical studies are typically prospective.

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

   • The document states that the comparison was to "manual blood pressure measurement". This implies human observers. However, it does not specify the number of experts, their qualifications, or how many were involved in establishing the ground truth (e.g., if multiple readings were taken and averaged). The implicit standard for manual blood pressure measurement would be trained medical professionals using a mercury manometer and stethoscope.

3. Adjudication Method for the Test Set:

   • The document implies a direct comparison between the device's measurement and a manual blood pressure measurement (using a mercury manometer and stethoscope). It does not describe any specific adjudication method among multiple manual readers (e.g., 2+1, 3+1).

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. This study focused on the accuracy of the device against a gold standard (manual measurement), not on how humans using AI assistance improve their performance.

5. Standalone Performance:

   • Yes, a standalone performance study was done. The study directly compared the accuracy of the automated Non-Invasive Blood Pressure (NIBP) monitor (the algorithm/device) against a manual blood pressure measurement (the ground truth).

6. Type of Ground Truth Used:

   • Expert Consensus (Implicit): The ground truth was established by "manual blood pressure measurement" using a mercury manometer and stethoscope. While not explicitly stated as "expert consensus," this method inherently relies on trained human observers performing the measurement, which can be considered an expert-derived ground truth. The text states: “InBody has compared the accuracy between mercury manometer using the stethoscope and the non-invasive automatic sphygmomanometers.”

7. Sample Size for the Training Set:

   • The document does not provide details about a specific training set for the device's algorithm. It focuses on the clinical testing for regulatory clearance. Given that the software "Most of the measurement software has been re-used from our predicate device," it's likely previous data or general engineering principles informed the algorithm, rather than a specific, new training set for these models.

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

   • As no specific training set is mentioned for these new models, the method for establishing its ground truth is not described. The re-use of software from a predicate device suggests that the core algorithm was developed and validated previously.

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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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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 Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Body Shape Graph

Actual: Weight [except for Model InBodyS10, which requires the manual entry of weight], Body Mass Index (BMI) and Impedance Values, Height [except for Model InBody S10 and InBody H20/InBody H20® which requires the manual entry of Height], Resistance Values [only for InBody770, InBody S10], Reactance Values [for InBody 510], Phase Angle [for InBody770, InBody S10] The InBody H20 and the InBody H20(B) are identical except that the (B) model has Bluetooth capability for data transfer.

InBody770, InBody570, InBody H20/InBody H20%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 InBody H2O and the InBody H20() are identical except that the (5) model has Bluetooth capability for data transfer.

The provided 510(k) summary describes a comparative performance study rather than a study with pre-defined acceptance criteria against a ground truth. The primary goal of these studies was to demonstrate substantial equivalence to predicate devices, not to meet specific performance targets with absolute metrics like sensitivity or specificity.

Here's a breakdown of the available information based on your request, with explicit notes where the requested information is not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document does not explicitly state numerical acceptance criteria for performance metrics. Instead, the "acceptance" was based on demonstrating comparable performance to the predicate devices (InBody J30, InBody 170, InBody 3.0) through comparison tests. The conclusion states: "As compared to our predicate devices (our own brand) these new models have very similar technological characteristics and performed comparably to our predicates."

Reported Device Performance:
The document does not provide quantitative performance results (e.g., accuracy, precision measurements) for the new devices or their comparison to the predicate devices. It simply states that "comparison performance tests" were conducted and that the new devices "performed comparably."

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

• InBody570 vs. InBody J30: 68 examinees for the comparison test.
• InBody770 vs. InBody J30: 40 examinees for the comparison test.
• InBody S10 vs. InBody3.0: 43 examinees for the comparison test.
• InBody H20/InBody H20(B) vs. InBody J30: 40 examinees for the comparison test.

Data Provenance: The document does not specify the country of origin of the data nor whether the study was retrospective or prospective.

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

Not applicable. The studies described are comparison performance tests against a legally marketed predicate device (InBody J30, InBody 170, InBody 3.0), not against an independently established "ground truth" using experts. The predicate device itself acts as the reference for comparison.

4. Adjudication Method for the Test Set

Not applicable. Since the studies are comparison performance tests against a predicate device, there is no mention of an adjudication method in the context of expert consensus or labeling of cases, as would be common in diagnostic imaging studies.

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 an Impedance Plethysmograph (Body Composition Analyzer) that directly measures and estimates body composition parameters. It is not an AI-assisted diagnostic imaging device that human readers would interpret. Therefore, an MRMC study with human readers and AI assistance is not relevant to this device.

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

The device itself is a standalone measurement system. The clinical performance tests conducted were effectively "standalone" in the sense that they evaluated the device's output against a reference device, without human interpretation as part of the primary output. The device generates estimated body composition parameters directly.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the described clinical performance tests, the "ground truth" was the measurements obtained from the legally marketed predicate devices (Biospace Body Composition Analyzer Model InBody J30, InBody 170, InBody 3.0). The study aim was to demonstrate "comparable performance" to these predicates, not to an independent gold standard like DEXA or hydrostatic weighing.

8. The Sample Size for the Training Set

Not applicable. The document describes clinical performance validation studies performed to demonstrate substantial equivalence, not the development or training of an algorithm. There is no information provided about a "training set" for the underlying bioelectrical impedance analysis (BIA) algorithms used by the InBody devices. These algorithms are based on scientific principles and likely developed over time, not typically "trained" on a dataset in the way a modern machine learning model would be.

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

Not applicable. As mentioned in point 8, the document does not describe a training set or the establishment of ground truth for it. The BIA technology relies on established physiological models and electrical properties of tissues. The derivation of "Segmental Body Water" is mentioned as being "based on a computation that is Segmental Body Water is calculated using Segmental Lean Mass supported by reference papers: that is already submitted in InBody J30 (K110689). Body Water can be calculated by Lean Body Mass (= Fat Free Mass) according to fact which is founded in the attached reference papers. As in papers they tell body water/fat free mass is 0.73." This indicates reliance on scientific literature and prior device approvals rather than a new "training set" with established ground truth.

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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, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity, Visceral Fat Area (VFA). Actual : Weight [except for model S10, which requires the manual entry of weight], Body Mass Index (BMI), Impedance Values, height [only for model InBodyJ30, which has height-meter function].

InBodyS10, InBodyl70, and InBodyJ30 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 bighly 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.

This 510(k) summary (K110689) indicates that the Biospace Body Composition Analyzers (InBodyS10, InBody170, InBodyJ30) are substantially equivalent to predicate devices based on "bench and software testing." However, it does not provide details about specific acceptance criteria or the study that definitively proves the device meets those criteria. The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed performance study with explicit acceptance criteria and results for the new devices.

Here's a breakdown of what is and isn't present in the provided text regarding your request:

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

• Not provided. The document states, "The results of bench and software testing indicates that the new devices are as safe and effective as the predicate device," but it does not present a table of specific acceptance criteria (e.g., accuracy +/- X%, precision Y%) or the quantitative performance measurements of the new devices against those criteria. The comparative table primarily focuses on features and measured parameters rather than performance metrics.

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

• Not provided. Neither the sample size nor the data provenance (country, retrospective/prospective) for any test sets are mentioned.

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 provided. There is no mention of experts or their qualifications for establishing ground truth. The document indicates that for "Visceral Fat Area (VFA)," evaluation was done "with CT," implying CT scans were used as a reference, but it doesn't describe the process of establishing ground truth from these CT scans or involving human experts.

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

• Not provided. As no details of a test set or ground truth establishment by experts are given, no adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not provided. This device is a body composition analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this type of device.

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

• Implied but not detailed. The device is an impedance plethysmograph body composition analyzer. It "determines body composition parameters based on bioelectrical impedance analysis (BIA)." This implies a standalone algorithm (the BIA analysis) calculates the parameters. However, no specific standalone performance study details (metrics, datasets) are provided beyond the general statement of "bench and software testing."

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

• Implied for VFA, otherwise not specified. For "Visceral Fat Area (VFA)," the document states "Evaluation with CT." This suggests CT scans were used as a reference standard (ground truth) for VFA measurements. For other parameters (e.g., Skeletal Muscle Mass, Body Fat, Total Body Water), the type of ground truth used for validation is not specified.

8. The sample size for the training set

• Not provided. There is no mention of a training set or its sample size. The document's purpose is a 510(k) summary for substantial equivalence, which often doesn't require detailed descriptions of training data for such devices unless significant machine learning or AI algorithm development is a core differentiating factor.

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

• Not provided. As no training set is mentioned, naturally, how its ground truth was established is also not provided.

In summary:

This 510(k) summary establishes substantial equivalence by comparing the new devices' features and measurement capabilities to previously cleared predicate devices. It states that "bench and software testing indicates that the new devices are as safe and effective as the predicate device," but it lacks detailed performance study information, including specific acceptance criteria, quantitative results, sample sizes, expert qualifications, or detailed ground truth methodologies that would typically be associated with a "study that proves the device meets the acceptance criteria." For devices like these, the substantial equivalence argument often relies on the proven safety and effectiveness of the existing predicate device and demonstrating that the new device operates on the same principles and provides comparable measurements.

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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, Segmental Body Fat mass, % Segmental Body Fat, and Energy expenditure of activity. Actual : Weight, Body Mass Index (BMI),and Impedance Values

Models InBody 270, InBody R20, and InBody R20B 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.

The provided FDA 510(k) summary for the Biospace Body Composition Analyzers (Models InBody 270, InBody R20, and InBody R20B) focuses on demonstrating substantial equivalence to a predicate device (Biospace Body Composition Analyzer Model InBody 230, K062603) rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new devices being cleared.

The core of the submission relies on the assertion that "The results of bench and software testing indicates that the new devices are as safe and effective as the predicate device." and "After analyzing bench testing data, software validation, and the risk analysis, it is the conclusion of Biospace that the Models InBody 270, InBody R20, and InBody R20B, BODY COMPOSITION ANALYZERS are as safe and effective as the predicate devices, and have few technological differences, thus rendering them substantially equivalent to the predicate device."

This means the submission does not contain the level of detail requested for a typical study that proves acceptance criteria based on direct performance measurements. It's a comparison study, arguing the new device is sufficiently similar to an already cleared device. Therefore, a direct table of acceptance criteria and reported device performance for the new devices is not explicitly provided in the document.

However, we can infer the "acceptance criteria" through the lens of substantial equivalence: the new devices must perform similarly and as safely and effectively as the predicate device for all shared indications. Any new indications (Segmental Body Fat mass, % Segmental Body Fat-Energy expenditure of activity) would implicitly have an acceptance criterion of accurate measurement, but no specific performance targets are given.

Here's an attempt to address your questions based on the provided text, acknowledging the limitations inherent in a 510(k) summary focusing on substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the 510(k) summary does not provide a table of explicit numerical acceptance criteria for the new devices and their direct performance. The acceptance criterion is primarily substantial equivalence to the predicate device (Biospace Body Composition Analyzer Model InBody 230, K062603) in terms of safety and effectiveness for shared indications, and the ability to accurately measure the new indications.

The 'reported device performance' is therefore a general statement of equivalency.

No information is provided regarding:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) The document does not specify a separate "test set" in the context of clinical performance data for the new devices, as the primary assessment is substantial equivalence through bench and software testing.

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, as detailed clinical performance data using expert-established ground truth is not presented for the new devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set Not applicable.

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, as this device is a body composition analyzer, not an AI-assisted diagnostic tool requiring human reader studies.

6. 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 "bench and software testing" mentioned would apply to the algorithm's performance, but no details of such a standalone performance study (e.g., accuracy against a gold standard like DEXA) are provided in this summary. The substantial equivalence argument often relies on the predicate device already having demonstrated acceptable standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not specified for the new devices. For the predicate device, ground truth for body composition analysis typically involves methods like DEXA (Dual-energy X-ray absorptiometry) or hydrostatic weighing, but these details are not in this summary.

8. The sample size for the training set Not applicable, as this is not an AI/machine learning device that involves a "training set" in the typical sense. Any internal algorithm development for the predicate or the new devices would have used internal data, but details are not provided.

9. How the ground truth for the training set was established Not applicable.

In summary, this 510(k) submission successfully argued for substantial equivalence based on technical similarities and general statements of safety and effectiveness derived from bench and software testing, without providing granular clinical study data with specific acceptance criteria and performance metrics for the new devices.

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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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For use only in healthy subjects for Measurement Of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Body Water, (TBW), ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Actual : Weight, (except for model S20, which requires the manual entry of weight) Body Mass Index (BMI),and Impedance Values

Models Inbody 520, Inbody 720, and Inbody S20 are body composition analyzers. The 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.

The provided K052646 document for Biospace Corporation Limited's InBody Body Composition Analyzers (Models 520, 720, and S20) does not contain detailed acceptance criteria, specific study designs, or reported device performance metrics as requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Biospace Body Composition Analyzer Model InBody 3.0, K042528) to obtain 510(k) clearance from the FDA.

The document indicates that "bench and clinical testing indicates that the new device is as safe and effective as the predicate devices," but it does not provide the quantitative results or specific acceptance criteria for these tests. The comparison table primarily highlights the features and indications for use, including the different frequencies used for impedance measurements, between the new devices and the predicate.

Therefore, many of the requested details cannot be extracted directly from this document. Below is an attempt to address the points based on the available information and what can be inferred about a 510(k) submission for substantial equivalence.

Acceptance Criteria and Study for Biospace Body Composition Analyzers (Models InBody 520, InBody 720, and InBody S20)

The provided submission primarily focuses on demonstrating "substantial equivalence" to a predicate device, as opposed to establishing specific performance acceptance criteria and proving them through detailed studies with quantitative results. The core of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily that it meets pre-defined acceptance criteria for novel performance claims.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, explicit quantitative acceptance criteria and reported device performance metrics (e.g., accuracy, precision, correlation coefficients against a gold standard) are not detailed. The document generally states: "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices."

The comparison table (Section 6) focuses on functional equivalence, listing the Indications for Use and Analysis Method as identical to the predicate device, but expands the Operating parameters (Frequency) for the new models (InBody 720 and S20) compared to the predicate and InBody 520. This suggests that the "acceptance criteria" were likely related to demonstrating similar measurements and safety profiles to the predicate, rather than meeting specific numerical performance targets against a true gold standard.

Missing Information: The document does not provide actual numerical data for accuracy, precision, bias, correlation coefficients, or any other specific performance metrics from the bench or clinical testing mentioned.

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

This information is not provided in the document. For a 510(k) submission based on substantial equivalence, clinical data might involve healthy volunteers to demonstrate comparable measurements to the predicate device, but specific sample sizes and data provenance (e.g., country of origin, retrospective/prospective nature) are not disclosed in this summary.

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

This information is not provided. Body composition analysis, especially with BIA, usually relies on reference methods (e.g., DEXA, hydrodensitometry) or other validated BIA devices rather than expert consensus on images. The "ground truth" for the test set would likely be measurements from the predicate device or a clinical gold standard, if such a study was performed.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided. As the device measures quantitative physiological parameters rather than interpreting images or clinical signs, an adjudication method for "test set" interpretation is generally not applicable in the same way it would be for diagnostic imaging.

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

This information is not provided. MRMC studies are typically used in diagnostic imaging to assess human reader performance with and without AI assistance. This device is a quantitative measurement tool (body composition analyzer), not an imaging interpretation aid, so an MRMC study is highly unlikely to have been performed or relevant for this type of submission.

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

The device itself is a standalone algorithm/device for body composition analysis. The "performance" described would inherently be the algorithm's performance in providing measurements. The document generally states "bench and clinical testing," which implies direct performance evaluation of the device in a standalone capacity. No human-in-the-loop component is mentioned or suggested for the primary function of body composition measurement.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The specific type of "ground truth" used for any clinical testing (if conducted beyond direct comparison to the predicate) is not explicitly stated. However, for body composition analyzers like the InBody series, the ground truth typically involves:

• Validated Reference Methods: Such as Dual-energy X-ray Absorptiometry (DEXA), hydrodensitometry (underwater weighing), or isotope dilution for water compartments.
• Comparison to a Predicate Device: In a 510(k) context, a common approach is to demonstrate agreement with the legally marketed predicate device (Biospace Body Composition Analyzer Model InBody 3.0, K042528) through correlation studies or Bland-Altman analysis.

Given the 510(k) pathway, it is most probable that comparability to the predicate device was the primary "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This information is not provided. BIA devices typically use mathematical models and equations to convert impedance values into body composition parameters. While these models might be "trained" or derived from large population datasets, the details of such training sets (size, characteristics, data provenance) are not part of this 510(k) summary. This submission focuses on the performance of the device (applying its algorithms) rather than the development of the algorithms themselves.

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

This information is not provided. If mathematical models within the device's software were derived from population data, the ground truth for establishing those models would typically come from a combination of gold-standard body composition methods (e.g., DEXA, hydrodensitometry) applied to a diverse cohort. However, this level of detail is beyond the scope of this 510(k) submission, which assumes the underlying BIA principles and algorithms are already established or sufficiently similar to a predicate.

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For use only in healthy subjects for Measurement Of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Actual : Weight, Body Mass Index (BMI),and Impedance Values

InBody 3.0 is an impedance plethysmograph body composition analyzer. The 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 does not contain specific acceptance criteria or a study that directly proves the device meets such criteria in a quantitative sense (e.g., sensitivity, specificity, accuracy targets). Instead, it's a 510(k) summary for a medical device (InBody 3.0 Body Composition Analyzer) seeking substantial equivalence to existing legally marketed devices.

The "study" referenced in the document is a comparison to predicate devices, where the new device is deemed "as safe and effective as the predicate devices" based on "bench and clinical testing." However, the details of these tests, including specific performance metrics and acceptance criteria, are not provided.

Here's an attempt to answer the questions based on the available information, noting where information is missing:

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

No explicit quantitative acceptance criteria (e.g., specific accuracy ranges, correlation coefficients, or sensitivity/specificity thresholds) and corresponding reported performance values for the InBody 3.0 are provided in the document. 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," implying that its performance is comparable to the predicate devices, but without specifying how that "safety and effectiveness" was measured or what values constitute "safe and effective."

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

This information is not provided in the document. The filing mentions "clinical testing" but does not detail the sample size, study design (retrospective/prospective), or data provenance.

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)

This information is not provided in the document. Given that the device measures body composition parameters, the "ground truth" would likely involve reference methods for body composition (e.g., DEXA, hydrostatic weighing), rather than expert interpretation of images.

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

This information is not provided in the document.

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

This type of study is not applicable to the InBody 3.0 Body Composition Analyzer. This device is an automated measurement tool for body composition, not an AI-assisted diagnostic imaging tool that would involve human readers.

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

The InBody 3.0 is a standalone device that performs measurements directly. Its performance would inherently be "standalone." However, specific quantitative performance metrics (e.g., accuracy against a gold standard) are not reported in this summary. The assessment of "safety and effectiveness" against predicate devices implies standalone comparison.

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

The document does not explicitly state the type of ground truth used for "clinical testing." For body composition analyzers, common ground truth methods include:

• Dual-energy X-ray absorptiometry (DEXA)
• Hydrostatic weighing (underwater weighing)
• Isotope dilution
• Air displacement plethysmography (Bod Pod)

It is highly probable that one or more of these established methods were used, but the document does not specify.

8. The sample size for the training set

This information is not provided in the document. The device uses Bioelectrical Impedance Analysis (BIA), which relies on established physiological models and algorithms. While these models are developed and potentially trained on various populations, the specific training set size for this particular device's algorithms is not disclosed in the 510(k) summary.

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

This information is not provided in the document. Similar to the test set, any "training" (model development) for the BIA algorithms would have utilized established bodily composition measurement techniques, but the specifics are not detailed.

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