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The Jawon Upper Arm Automatic Digital Blood Pressure Monitor, Model EX PLUS 1300 is for use by medical professional or home user. The EX PLUS 1300 is a device intended to measure the systolic and diastolic blood pressure, pulse rate and mean blood pressure and inter-arm pressure difference of an adult individual by using a non-invasive oscillometric technique in which one (or two) inflatable cuff(s) is (are) wrapped around the single (or dual) upper arm(s). The cuff size is fit for arm circumference of 23-36 cm.

The EX PLUS 1300 is a blood pressure monitor to non-invasively measure blood pressures and heart rate at the brachial site(s). The device employs oscillometric method. The device is a microprocessor-controlled and includes an air pump, an electronic valve to regulate deflation rate, circuitry to detect and process minute pressure oscillations, LCD display of systolic and diastolic pressure readings and heart rate, and push buttons. The device employs a pressurement algorithm designed to detect, filter, process, and store pressure readings. The electronic deflation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy. The EX PLUS 1300 is an AC adapter-powered.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Jawon Automatic Blood Pressure Monitor, Model EX PLUS 1300:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states compliance with the ANSI/AAMI Voluntary Standard, SP-10:2008. While the specific numerical acceptance criteria for blood pressure monitors according to this standard are not fully detailed in this document, the performance specifications provided are implicitly part of meeting this standard.

Important Note: The stated "Accuracy - pressure: +/- 2mmHg" is often interpreted as the device's inherent precision or resolution. The actual AAMI SP-10 standard for accuracy involves statistical analysis of the difference between device readings and a reference method (auscultation by trained observers), where the mean difference and standard deviation of differences are the key metrics. The document implies compliance with the standard but does not provide these specific statistical results for validation of the EX PLUS 1300 model itself.

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

• Test Set Sample Size: No new clinical test data for the EX PLUS 1300 is provided. The document explicitly states: "The EX PLUS 1300 was not clinically tested because the device uses the identical software codes and pressure detection related hardware as the predicate device to determine systolic, diastolic, and pulse rate." And "As the modified device EX PLUS 1300 comprises of two sets of EASY X 900(R/L) of which are predicate device, no clinical test was conducted."
• Data Provenance: Not applicable as no new clinical data was collected for this specific device. The clinical validation of the predicate device (EASY X 900(R/L)) would have involved data, but its provenance is not detailed here.

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

• Not applicable as no new clinical study was conducted for the EX PLUS 1300. The ground truth method for the predicate device's validation (likely expert auscultation according to AAMI SP-10) is not detailed here.

4. Adjudication Method:

• Not applicable as no new clinical study was conducted for the EX PLUS 1300.

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

• No, an MRMC comparative effectiveness study was not done. The device's validation relies on its substantial equivalence to a predicate device and engineering/non-clinical testing.

6. Standalone Performance Study:

• A standalone clinical performance study was not done for the EX PLUS 1300. The submission argues that because the EX PLUS 1300 uses "identical software codes and pressure detection related hardware" as the predicate device (Jawon Model EASY X 900(R/L)), and is essentially "two (2) sets of model EASY X 900(R/L) in one enclosure," a new clinical test was not required. The performance specifications are given for the EX PLUS 1300, but they are based on the proven performance of the predicate device.

7. Type of Ground Truth Used:

• For the EX PLUS 1300, no new clinical ground truth was established. For the original predicate device validation (EASY X 900(R/L)), the ground truth for blood pressure measurement according to ANSI/AAMI SP-10 typically involves simultaneous auscultation by multiple trained observers using a mercury sphygmomanometer as the reference standard.

8. Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data. It's an oscillometric blood pressure monitor.

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

• Not applicable as this is not an AI/ML device requiring a training set.

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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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Noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or order and arm circumference range between 9" to 14" (23cm to 36cm).

The EASY X 800 (R/L) and EASY 900 (R/L) are blood pressure monitors to non-invalied. The devices of The EAST X 600 (102) and EXS P 500 (102) The devices employ oscillometric method. The devices are airsuing microprocessor-controlled and include an air pump, an electronic valve to regulate deflation and controlled of microprocessor-controlled and included and in and in and in the many of LCD(EASY X 900) display of systolic and diastolic pressure readings and heart rate, and push buttons. Systom and dastone proboard roading of the designed to detect, filter, filter, process, and store The devices employ a probation control valve maintains the deflation rate within limits of 3 to 5 mmHg/sec to optimize measurement accuracy. The EASY X 800 (R/L) and EASY X 900 (R/L) are AC adapter-powered.

The Jawon Medical Automatic Blood Pressure Monitor, Models EASY X 800 (R/L) & EASY X 900 (R/L), is intended for noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or older and arm circumference range between 9" to 14" (23cm to 36cm).

The device's acceptance criteria and performance are based on compliance with the ANSI/AAMI SP10 standard. The submission indicates that the modified devices (EASY X 800 (R/L) and EASY X 900 (R/L)) were deemed substantially equivalent to the predicate devices (FT-500 (R/L) and FT-700 (R/L)) due to similarities in intended use, technology, and software/pressure detection hardware. No new clinical trials were conducted for the modified devices.

Here's a breakdown of the requested information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Note: The document only specifies compliance with standards as the acceptance criteria, and the reported performance is the device meeting these standards. Specific numerical performance metrics (e.g., mean difference and standard deviation between device and reference measurements) as typically found in AAMI validation studies are not explicitly detailed in this summary, but are implicitly met if the device complies with the standard.

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

The document states: "The modified devices... are not clinically tested because the devices use the identical software codes and pressure detection related hardware as the predicate devices to determine systolic, diastolic, and pulse rate." This implies that no new test set was used for the modified devices for clinical performance evaluation. The substantial equivalence relies on the established performance of the predicate devices. The document does not provide details of the predicate device's test set or data provenance.

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

As no new clinical testing was performed for the modified devices, this information is not applicable to the current submission for the EASY X 800 (R/L) & EASY X 900 (R/L) devices. The ground truth for the predicate devices would have been established through clinical validation studies, likely involving trained healthcare professionals, but these details are not provided in this summary.

4. Adjudication Method for the Test Set

Since no new clinical testing was conducted for the modified devices, the adjudication method for a new test set is not applicable.

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

No (N/A). This type of study investigates the improvement of human readers with AI assistance. The device in question is an automatic blood pressure monitor, which does not involve human readers interpreting images or data for diagnosis, therefore, an MRMC study is not relevant.

6. Standalone Performance Study

Yes, implied. The statement "The modified devices... meet the requirements of ANSI/AAMI SP10, IEC 60601-1-2, and EN 60601-1" suggests that the standalone performance of the device (or its predicate) was evaluated against these recognized standards for automated sphygmomanometers. ANSI/AAMI SP10 outlines requirements for accuracy of automated blood pressure devices compared to a reference standard. However, detailed results of such a standalone study for the modified devices are not provided, as they relied on the predicate's performance.

7. Type of Ground Truth Used

For blood pressure monitors, the "ground truth" for clinical validation (as required by standards like ANSI/AAMI SP10) is typically established using simultaneous auscultatory measurements by trained observers (experts) using a mercury sphygmomanometer or another validated reference method. This is the standard method for establishing the accuracy of automated blood pressure devices.

8. Sample Size for the Training Set

The document explicitly states that the modified devices use "identical software codes and pressure detection related hardware as the predicate devices." This means there was no separate training set for algorithm development for these modified devices, as the algorithm was already developed and validated with the predicate devices. The details of the training set (if any, as traditional machine learning "training" might not apply in the same way to this type of device at that time) for the predicate devices' algorithm are not provided.

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

As noted in point 8, there was no separate "training set" for these modified devices. For the predicate devices, if an algorithm involved learning, its ground truth would have been established through clinical measurements against a reference standard, as described in point 7. However, the exact methods or criteria for establishing ground truth for any potential algorithm training for the predicate devices are not detailed in this summary.

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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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Noninvasive measurement of systolic and diastolic blood pressure and determination of heart rate in adult patients with age 16 or older and arm circumference range between 9" to 14"(23cm to 36cm).

Models FT-500 and FT-700 of the Jawon system are compact, automatic sphygmomanometers intended for measurement of blood pressure at the brachial site. Models FT-500 and FT-700 employ oscillometric method. All models are microprocessor controlled and include an air pump, an electronic valve to regulate deflation rate, circuitry to detect and process minute pressure oscillations, an LCD display of systolic and diastolic pressure readings and heart rate, and push button controls.

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

Acceptance Criteria and Device Performance Study for Jawon Medical FT-500(R,L) and FT-700(R,L) Noninvasive Blood Pressure Measurement System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that the measurement performance of the Jawon systems has been evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-2002 and was "found to comply fully with the accuracy criteria established in the standard."

However, the specific numerical acceptance criteria (e.g., mean difference, standard deviation) from ANSI/AAMI SP10-2002 are not explicitly detailed in the provided text. The text only states that the device complies with the standard.

To illustrate, typical ANSI/AAMI SP10 criteria for accuracy usually involve:

• Mean difference: The absolute mean difference between the device reading and the reference standard should typically be less than or equal to 5 mmHg.
• Standard deviation: The standard deviation of the difference between the device reading and the reference standard should typically be less than or equal to 8 mmHg.

Since the document doesn't provide the exact numerical performance metrics of the device against these criteria, the table below reflects what is stated in the document.

Note: Without the explicit numerical criteria from ANSI/AAMI SP10-2002 and the specific performance data from the study, a more detailed table is not possible based on the provided text.

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

• Sample Size: The document does not specify the exact sample size (number of subjects/measurements) used in the clinical studies. It only mentions "clinical studies."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only mentions that the studies were "conducted in accordance with ANSI/AAMI Standard SP10-2002."

3. Number of Experts and Their Qualifications for Ground Truth

• The document does not provide information on the number of experts used to establish ground truth or their qualifications. For blood pressure measurement, ground truth typically involves a trained observer (often a physician or specially trained technician) using a mercury sphygmomanometer with a stethoscope in a double-blinded fashion according to a standardized protocol.

4. Adjudication Method for the Test Set

• The document does not provide any information on the adjudication method used for the test set. In clinical blood pressure validation studies, ground truth is often established by multiple trained observers, and if there are discrepancies, a third observer might adjudicate. However, this is not mentioned.

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

• No MRMC study information is provided. The device is a non-invasive blood pressure monitor, not an imaging or diagnostic device that typically involves human readers interpreting results. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not applicable in this context.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance study was done. The "measurement performance of the Jawon systems has been evaluated in clinical studies" directly assesses the algorithm's accuracy in measuring blood pressure against a reference standard. This is inherently a standalone performance evaluation of the device's core function.

7. Type of Ground Truth Used

• Based on the statement "evaluated in clinical studies conducted in accordance with ANSI/AAMI Standard SP10-2002," the ground truth used would be simultaneous, direct auscultatory blood pressure measurements performed by trained observers using a reference standard (e.g., mercury sphygmomanometer) in a clinical setting. ANSI/AAMI SP10 is a standard for verifying the accuracy of automated sphygmomanometers, which involves comparing the device's readings against validated manual measurements.

8. Sample Size for the Training Set

• The document does not provide information on the sample size for the training set. For established medical devices like blood pressure monitors, the "training" of the internal algorithm is often a part of the initial design and development process, which may not involve a separate "training set" in the same way machine learning models do. If the device uses machine learning, this information is not disclosed.

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

• The document does not provide information on how the ground truth for any training set was established. As with the training set sample size, this information is not disclosed in the provided text.

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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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The Infrared Ear Thermometer, Model DX-707 is intended for the intermittent measurement of human body temperature in home care environment. It is intended for use on people of all ages.

The DX-707 Infrared Ear Thermometer is a hand-held, non-sterile, reusable clinical thermometer using an infrared sensor that measures patient body temperature through the opening of the auditory canal. Its operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces. The DX-707 Infrared Ear Thermometer consists mainly of five parts with the associated circuit: (1) IR sensor, (2) Micom IC, (3) LCD module, (4) an ambient temperature sensor (thermistor), and (5) Keys, "I/O", "Measure". The DX-707 thermometer is powered by internal DC 3V battery, size CR2032 and it is supplied with probe cover.

The provided text describes the 510(k) submission for the "Instant Infrared Thermoscanner, DX-707" (also referred to as Infrared Ear Thermometer, Model DX-707).

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 submission refers to compliance with established standards rather than specific numerical acceptance criteria for a novel device. The performance is reported in terms of equivalence and meeting these standards.

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

• Test Set Sample Size: "Approximately 39% of the patients participating in the study were considered febrile." This indicates a study population, but the absolute number of patients in the study (test set) is not explicitly stated.
• Data Provenance: The study involved different age groups: 0-3 years, 4-10 years, 11-65 years, and >65 years. No specific country of origin is mentioned for the clinical study data, but the submitter Jawon Medical Co., Ltd. is based in South Korea. The study is prospective as it's a "comparison study and clinical repeatability testing was performed".

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 given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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 MRMC study was done. This device is an infrared ear thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, questions regarding "human readers improve with AI vs without AI assistance" are not applicable.

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

• Yes, a standalone performance assessment was done. The entire submission pertains to the standalone performance of the DX-707 Infrared Ear Thermometer. The performance summary and clinical results section focus on the device's ability to measure temperature directly, complying with established standards and demonstrating equivalence to predicate devices.

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

• The ground truth for the clinical comparison study was based on the measurements obtained from the "predicate devices". The text states: "...demonstrated that the DX-707 Infrared Ear Thermometer measured ear temperature equivalently to the predicate devices..." This implies comparison against the established accuracy of the legally marketed predicate devices. For clinical repeatability, the ground truth would be the repeated measurements themselves to assess consistency. The ultimate ground truth for temperature measurement, in general, is considered core body temperature, but here, the comparison is against another device.

8. The Sample Size for the Training Set

• Not applicable. This device is a medical device for temperature measurement, not a machine learning/AI algorithm that requires a separate "training set" in the context of supervised learning. Its design and validation rely on engineering principles, compliance with technical standards, and clinical comparison.

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

• Not applicable. (See point 8).

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