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The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.

The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.

The Mediana V20, V20a, AVSM3 SNF vital signs monitors are a lightweight and compact device (249 x 211 x 176 (mm) (W×H×D) and 3.1 kg for Standard configuration) powered by AC mains (100-240VAC, 50Hz/60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 8″ TFT-LCD screen.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance for the Mediana V20, V20a, AVSM3 SNF vital signs monitors.

Important Note: The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary. These documents primarily focus on demonstrating substantial equivalence to predicate devices rather than providing detailed, standalone clinical study results for the new device. As such, direct answers to some of your specific questions (like sample sizes for specific new studies, number of experts for ground truth, or MRMC studies) are not explicitly present. The manufacturer is leveraging data from previously cleared devices and relying on the substantial equivalence principle.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for the new devices (V20, V20a, AVSM3 SNF) with corresponding reported performance. Instead, it relies on the concept of substantial equivalence to predicate devices. The implicit acceptance criterion is that the new devices should perform equivalently to the cleared predicate devices according to established standards.

The performance characteristics are stated as:

• Non-Invasive Blood Pressure (NIBP), Pulse Rate (PR), Pulse Oximetry (SpO2), and Temperature (TEMP): The device's specifications and performance for these parameters are stated to be equivalent to the respective predicate devices.

Table of Acceptance Criteria (Inferred from Substantial Equivalence to Predicates):

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not provide specific sample sizes for new clinical test sets for the V20, V20a, AVSM3 SNF devices.
   • It states that for NIBP, "The clinical studies which were carried out by SunTech and AND companies were used to support different NIBP modules of the subject device under their original 510(k) submissions, and that Mediana has licensed the two NIBP modules for use in the subject device." This indicates that clinical data from the original predicate device manufacturers (SunTech and AND) are being leveraged. The provenance of that data would be tied to those original submissions, but it's not detailed here. For other parameters (SpO2, PR, Temp), it simply states equivalence, implying reliance on the predicate device's performance data without necessarily conducting new clinical trials for the Mediana V20 series.
   • The document mentions "system V & V plan #MDR-EG160311-01" for performance testing, which is likely a combination of bench and possibly some limited clinical testing, but specifics are absent.

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

   • This information is not provided in the document. Given the reliance on predicate device data and bench testing, direct ground truth establishment for a new clinical test set (as would be typical for an AI/algorithm-focused submission) doesn't seem to be the primary method for this 510(k).

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

   • This information is not provided as there's no detailed description of a new clinical test where expert adjudication would be relevant for these types of vital signs 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, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic imaging devices. The devices in this submission (vital signs monitors) measure physiological parameters directly and do not involve "human readers" interpreting an AI output in this context.

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

   • The devices perform automated measurements (NIBP, SpO2, PR, TEMP). The "performance" described is inherently standalone, as the device calculates and displays these values. However, "standalone performance" in the context of AI usually refers to the algorithm's output before human review. For these vital signs monitors, the measurement algorithm's performance is the device's performance. The document states the "specifications and performance are equivalent" to predicates, implying their algorithms produce comparable results.

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

   • For such vital signs monitors, the "ground truth" for NIBP, SpO2, PR, and TEMP typically involves direct, invasive, or highly accurate reference measurements (e.g., invasive arterial line for NIBP, co-oximetry for SpO2, EKG for PR, highly accurate reference thermometers for TEMP). The document doesn't explicitly detail the ground truth methods used for the predicate studies it references.

7. The sample size for the training set:

   • This information is not provided and is generally not applicable in the same way it would be for AI/ML-based devices. Vital signs monitors often rely on traditional signal processing algorithms rather than machine learning models that require distinct training sets. Even if there were some adaptive algorithms, training set details are not mentioned.

8. How the ground truth for the training set was established:

   • This information is not provided, as details about a "training set" in the context of this device are absent.

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The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.

The V10 vital signs monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.

The Mediana V10 vital signs monitor is a lightweight and compact device (249 x 211 x 154 (mm) (WxHxD) and 3.0 kg) powered by AC mains (100-240VAC, 50Hz/60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7-segment LED displays.

The provided text describes the Mediana V10 vital signs monitor, which measures non-invasive blood pressure (NIBP), pulse rate (PR), functional arterial oxygen saturation (SpO2), and temperature (Temp). The document is a 510(k) summary for FDA clearance.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the device's ability to demonstrate substantial equivalence to its predicate device (Mediana V10, K152659) and compliance with relevant international standards. The performance is reported in terms of equivalence to the predicate and compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• NIBP Clinical Evaluation: The text states, "To verify the accuracy of measuring, the clinical evaluation was performed on adult, pediatric and neonate." It does not specify the exact sample size (number of patients) within each age group.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether the studies were retrospective or prospective. Given the submitter's location (Republic of Korea), it's plausible the studies were conducted there. The nature of clinical evaluations for device clearance typically implies prospective data collection, but this is not explicitly stated.

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

The document does not provide details on the number of experts or their qualifications for establishing ground truth in the clinical evaluations (NIBP and Temperature).

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical test sets.

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

No, an MRMC comparative effectiveness study was not done. The device is a vital signs monitor, and the performance evaluation is based on the accuracy of its measurements against established standards and predicate device performance, not on a human-in-the-loop diagnostic task that would typically involve MRMC studies.

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

Yes, the primary clinical evaluation for NIBP and Temperature accuracy is a standalone performance assessment of the device's measurement capabilities. The device directly measures these parameters; it is not an AI algorithm assisting human interpretation of images, for instance.

7. The Type of Ground Truth Used

The ground truth for NIBP and Temperature measurements would typically be established using a reference standard method for blood pressure (e.g., intra-arterial measurement or an established oscillometric reference device for NIBP accuracy, and a high-accuracy reference thermometer for temperature) in a clinical setting. While not explicitly stated, compliance with ISO 81060-2 for NIBP implies a rigorous clinical validation against an accepted reference.

8. The Sample Size for the Training Set

The document describes performance testing for a finished device, not a machine learning model that would require a separate "training set." Therefore, there is no mention of a training set or its size.

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

As there is no mention of a machine learning model or a training set, this question is not applicable. The device's performance is based on its underlying hardware and signal processing, validated through the clinical and performance tests described.

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The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The DT-100 infrared thermometer can be used by consumers in household environment.

The DT-100 non-contact infrared thermometer is intended to be used to measure the body temperature using infrared sensors. It can detect the body temperature of all ages from human's face. The operation principle is based on infrared sensor technology. IR sensor can put out different signal when measuring the different object temperature or body temperature. An ASIC can turn the signal from IR sensor to a digital value and display it by LCD. The DT-100 noncontact infrared thermometer can measure body temperature at maximum 40cm between patient and product. The thermometer stores temperature measurement value up to 30, a user can compare prior measurement value and uses an alkaline battery AAA type for operation.

Here's a breakdown of the acceptance criteria and study information for the DT-100 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The exact sample size for the clinical test set is not explicitly stated. The text mentions "all participants" in reference to repeatability, suggesting a cohort of individuals.

• Provenance: The clinical investigation was conducted at Yonsei University Severance Hospital, Republic of Korea. The study was prospective as it involved a clinical investigation to evaluate the device's accuracy and repeatability.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. It states that the clinical investigation was conducted at an "Accredited by IRB" hospital, implying ethical oversight and likely involvement of medical professionals in the data collection process. However, the exact method for determining "ground truth" temperature (e.g., comparison to rectal thermometer, other validated method) is not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "clinical bias" and "clinical repeatability" were calculated based on the measurements obtained during the clinical investigation, implying a direct comparison to a reference standard rather than an adjudicated interpretation of results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a thermometer, and the evaluation focuses on its accuracy and repeatability against a reference, not on how it assists human readers in interpreting images or data.

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

Yes, a standalone performance study was done for the device. The clinical accuracy and repeatability validation test reports, which are part of the listed performance testing, would reflect the device's intrinsic performance. The clinical investigation directly assessed the device's ability to measure temperature.

7. Type of Ground Truth Used

The type of ground truth used was likely a clinical reference standard for temperature measurement, against which the DT-100's readings were compared. While not explicitly stated, in a clinical thermometer validation, this typically involves a highly accurate and validated method (e.g., rectal thermometer, or another established core body temperature measurement technique) as the "truth." The document mentions that the clinical bias and repeatability were evaluated against requirements of the ASTM E1965-98 standard, which specifies reference thermometry.

8. Sample Size for the Training Set

The document does not provide information about a training set since this is a medical device (thermometer) and not a machine learning/AI algorithm that requires a separate training phase. The discussion focuses on the validation of the device's performance through clinical and bench testing.

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

Not applicable as there is no mention of a training set for this device.

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The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V10 is suitable for continuous operation.

The V10 vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.

The Mediana V10 vital signs monitor is a lightweight and compact device (298 × 218 × 172 (mm) (W×H×D) and 3.4 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7-segment and LED displays.

The Mediana V10 device is a vital signs monitor designed to measure non-invasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), and temperature (Temp) in adult, pediatric, and neonatal patients across various healthcare settings.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria with specific thresholds for each vital sign measurement or detailed performance data for the V10 device itself. Instead, it states that the V10's specifications and performance are equivalent to predicate devices that comply with specific standards.

Therefore, the table below will reflect this equivalence statement. The "Acceptance Criteria" are implied by the standards and performance of the predicate devices, and "Reported Device Performance" is stated as being equivalent.

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

The document states: "The Mediana vital signs monitor, Model V10 substantially has been tested in accordance with the system V & V plan #MDR-EG140718-01 included with the submission using production equivalent units prior to release to market."

• Sample Size for Test Set: Not specified. The document mentions "production equivalent units" but does not provide a number or range for the test set sample size.
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the study was retrospective or prospective.

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

There is no information provided regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set within the provided text. The assessment relies on equivalence to devices that already comply with established standards.

4. Adjudication Method for the Test Set

There is no information provided regarding an adjudication method for the test set.

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

• No evidence of a MRMC comparative effectiveness study. The document focuses on the technical equivalence of the V10 to predicate devices, not on the improvement of human readers with or without AI assistance. The V10 is a standalone vital signs monitor, not an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study (Algorithm Only)

• Yes, a standalone performance assessment was conducted, but it's framed as equivalence testing. The document states: "The Mediana vital signs monitor, Model V10 substantially has been tested in accordance with the system V & V plan #MDR-EG140718-01 included with the submission using production equivalent units prior to release to market." This indicates that the device itself underwent testing to demonstrate its performance, which was then compared to that of predicate devices to establish substantial equivalence. However, the exact performance metrics or detailed results of this standalone testing are not provided, only the conclusion of equivalence.

7. Type of Ground Truth Used

• The "ground truth" for the V10's performance is implicitly tied to the performance established by the predicate devices and their adherence to recognized standards (e.g., AAMI SP10 for NIBP). For example, if the predicate device's NIBP measurements were validated against an invasive arterial line (a common ground truth for NIBP), then the V10's "equivalence" implies it meets similar accuracy standards. However, the document does not directly state the specific ground truth used for the V10's own testing.

8. Sample Size for the Training Set

• Not applicable / Not specified. The V10 is described as a vital signs monitor, which typically relies on established measurement principles and calibrated sensors, not a machine learning algorithm requiring a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not relevant to this device as described.

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

• Not applicable / Not specified. As the device does not appear to be an AI/ML-based system requiring a training set, this question is not relevant.

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The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric a nd neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist.

The YM6000 patient monitor is to monitor electrocardiography (ECG), Arrhythmia, ST segment, heart rate (HR), pulse rate, noninyasive blood pressure (systolic, diastolic and mean arterial pressures); functional arterial oxyge n saturation, invasive b lood pressure, respiration, capnography (EtCO2 and InCO2) and temperature for adult, pediatric and neonate in patients in general hospital and alternate ca re facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.

The YM6000 patient monitor is a lightweight and compact device (341 × 305 × 172 (mm) (W × H × D) and 5.5 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays.

The provided text is a 510(k) summary for a patient monitor. It focuses on establishing substantial equivalence to predicate devices rather than presenting detailed performance studies with specific acceptance criteria and detailed study results in the format requested.

Therefore, many of the requested categories cannot be directly extracted from the provided text. The document primarily describes the device, its intended use, and argues for its equivalence based on shared modules and compliance with industry standards.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not provide a table of explicit acceptance criteria with corresponding reported device performance values in a quantifiable manner for each parameter. Instead, it states that various modules (ECG, NIBP, SpO2, Respiration, Thermometry, Capnography) used in the YM6000 are identical to those in predicate devices and comply with relevant standards (AAMI SP-10, IEC60601-2-30, ISO9919, IEC60601-2-34). For example, it says: "all devices comply with the AAMI performance standard SP-10 & IEC60601-2-30 and have same measurement technology" for NIBP.

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

This information is not explicitly stated in the document. The text mentions "The Mediana patient monitor, Model YM6000 substantially have been tested in accordance with the system V & V plan (#P AA00-00005) and summary included with the submission using production equivalent units prior to release to market." This indicates testing was performed, but details about sample size, data type (retrospective/prospective), or origin are not provided.

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. The document focuses on technical equivalence and compliance with standards rather than human-expert-based ground truth establishment.

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

This information is not provided.

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 is not an AI-powered device, but a physiological patient monitor. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

The device is a patient monitor. Its performance is inherent to its functional modules, which operate "standalone" in recording physiological parameters. The document primarily focuses on the technical specifications and standards compliance of these modules.

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

The "ground truth" for a patient monitor like the YM6000 would generally be based on:

• Reference measurement devices/standards: For parameters like NIBP, SpO2, ECG, etc., the accuracy is typically verified against highly accurate reference devices or simulated signals that meet specific industry standards.
• Compliance with performance standards: The document frequently refers to compliance with standards like AAMI SP-10, IEC60601-2-30, ISO9919, IEC60601-2-34. These standards define the acceptable range of error and performance characteristics.

The document does not explicitly state "expert consensus," "pathology," or "outcomes data" as ground truth methods for the device's fundamental physiological measurements.

8. The sample size for the training set

This information is not provided. For a patient monitor, there isn't typically a "training set" in the machine learning sense. The device's algorithms for physiological parameter measurement are developed based on established physiological principles and signal processing, and then validated against a range of inputs/patients.

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

As there's no mention of a "training set" in the AI/machine learning context, this question is not applicable. The ground truth for developing and testing the device's measurement algorithms would be based on established medical and engineering principles, known physiological ranges, and comparison with highly accurate reference equipment under controlled conditions.

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The FM20 is a Fetal Monitor for measuring and recording maternal contraction and fetal heart rate. Data is displayed on a front panel LCD(7") Display, recorded on a strip chart recorder and may be transmitted over RS232 port to a remote data receiver. Single/Twin fetal heart rates may be measured by means of Doppler Ultrasound. Uterine Activity is measured with an external TOCO transducer. The FM20 is intended to be used during the antepartum periods on pregnant woman.

FM20 is the fetal monitor that measures uterine contractions and fetal heart rate (FHR) which may be used to predict fetal status. To detect the Doppler frequency signal reflected from the heart of the fetus, FM20 irradiates ultrasound wave to the abdomen of a pregnant woman. FM20 analyzes this signal and displays the heart rate by LCD. Also, FM20 provides the sound from the heart of fetus. FM20 measures the uterine contraction of a pregnant woman by pressure sensors and displays the numerical values. And FM20 prints the heart rate of the fetus and the values of uterine contraction. FM20 records the heart rate of the fetus, the uterine contraction of a pregnant woman. and basic information of the equipment with a provided thermal orinter. FM20 is capable of Twin Monitoring with two pulsed Ultrasound Transducers. FM20 has a free voltage(100 - 240VAC input) power adaptor. FM20 has Fetal movement detection function. To extract fetal movement signal, FM20 uses a circuit and digital filter. FM20 has Event marker function so that the patient can record the time of important events. FM20 has the capability to alert the caregiver in the event a heart rate goes above or below limit for a preset time delay.

The provided text describes a 510(k) submission for the Mediana FM20 Fetal Monitor, focusing on its substantial equivalence to predicate devices. The document highlights the device's technical characteristics, indications for use, and safety testing but does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria with quantitative performance metrics. It primarily states that "All test results were satisfactory" for safety, EMC, and performance testing according to standards EN/IEC 60601-1 and EN/IEC 60601-1-2.

Therefore, many of the requested details cannot be extracted directly from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the specifications and performances (FHR monitoring, UC monitoring, Transducer type, ultrasound frequency, FHR range, FHR accuracy, Detection of fetal movement via ultrasound transducer) of Mediana Model FM20 are equivalent to the predicate devices (Bistos Co.,Ltd. Model BT-300, and BiOSYS Co.,Ltd, Model IFM-500). However, it does not explicitly list numerical acceptance criteria or the specific performance values achieved by the FM20.

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

The document does not specify any sample size used for a test set or the data provenance (e.g., country of origin, retrospective or prospective) for a clinical study. The information provided heavily relies on the equivalence to predicate devices and adherence to electrical/EMC standards, rather than new clinical performance data.

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

Not applicable. The document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. The document does not describe a study with an adjudication method.

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

No, an MRMC comparative effectiveness study is not mentioned. The submission focuses on substantial equivalence based on technical characteristics and safety standards, not on direct comparison of human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document describes the device as a "Fetal Monitor," implying it's a standalone monitoring device. However, it doesn't detail performance studies for the algorithm in isolation. Its performance is stated as "equivalent" to predicate devices, which are also standalone fetal monitors. The device does have features like "Fetal movement detection function. To extract fetal movement signal, FM20 uses a circuit and digital filter" and "capability to alert the caregiver in the event a heart rate goes above or below limit for a preset time delay," which represent algorithm-driven functions. However, quantitative standalone performance metrics for these functions are not provided.

7. The Type of Ground Truth Used:

Ground truth, in the context of clinical performance evaluation (e.g., pathology, outcomes data, expert consensus), is not explicitly mentioned or used in this submission. The "ground truth" for the device's acceptable performance appears to be its adherence to established electrical, mechanical, and environmental safety standards (EN/IEC 60601-1, EN/IEC 60601-1-2) and its technical equivalence to previously cleared predicate devices.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe a machine learning algorithm that would require a training set in the conventional sense. The device's "Fetal movement detection function" uses a "circuit and digital filter," suggesting a more traditional signal processing approach rather than a machine learning model requiring a large training dataset.

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

Not applicable, as a training set for a machine learning algorithm is not described.

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The F10 Fetal Doppler measures heart rate, which is displayed on a LCD display and provides fetal heart sounds. The fetal heart rate is measured using Doppler ultrasound.

F10 is a pocket-size fetal Doppler that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker. By measuring fetal heart rate(FHR), you are able to predict fetal well-being. F10 irradiates fetal wave to the abdomen of a pregnant woman to detect the Doppler frequency signal and analyze, and displays the heart rate on LCD screen. The device also provides the heart sound from the heart of fetus

The provided text is a 510(k) summary for the Mediana F10 Fetal Doppler. It does not describe a clinical study with acceptance criteria and device performance in the way typically seen for AI/ML medical devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and adherence to safety and performance standards.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted directly from this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance in terms of metrics like sensitivity, specificity, or FHR accuracy. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices and compliance with relevant safety and performance standards.

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance from a study evaluating device performance metrics is described. The comparison is primarily based on technical specifications and adherence to standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described for a test set.

3. Adjudication method for the test set: Not applicable. No clinical test set requiring adjudication is described.

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: Not applicable. This device is a fetal Doppler for measuring heart rate, not an AI/ML imaging or diagnostic aid. There is no mention of human readers or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hardware product that directly measures and displays FHR. There is no "algorithm only" performance reported in the context of an AI/ML device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The validation focuses on technical specifications and regulatory compliance rather than clinical ground truth for diagnostic accuracy. The "ground truth" for its function would be derived from physical measurements (e.g., of sound waves corresponding to heartbeats) rather than expert consensus on images or pathology.

7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.

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The P10 pulse oximeter is intended to be used to monitor functional arterial oxygen saturation (SpO2) and pulse rate in all areas of a hospital, hospital, hospital-type facilities, intra-hospital transport and home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist.

Note: The continuous monitoring and Spot check mode are user-selectable. The mode of operation is the continuous monitoring except when the Spot Check Mode (03) is enabled.

The P10 Pulse Oximter is to monitor non-invasive functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate for adult, pediatric and neonate patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.

The Mediana P10 Pulse Oximeter is a lightweight and compact device (58×105×21mm and 90g) powered by 3 Alkaline AAA batteries. The monitor provides patient data and monitoring status on LCD displays. MD1 module is used for SpO2 module, and YM-1 reusable sensor is used for SpO2 sensor.

Here's a breakdown of the acceptance criteria and the study details for the Mediana P10 Pulse Oximeter, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting explicit numerical acceptance criteria for a new device. However, the core performance metric for a pulse oximeter is its accuracy in measuring functional arterial oxygen saturation (SpO2). The clinical testing was conducted to support the device's accuracy claims.

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

• Sample Size for Test Set: 10 human adult volunteers.
• Data Provenance: Clinical hypoxia testing was performed in the context of an institutionally approved protocol, indicating a prospective study. The subjects were described as a mix of White, Hispanic, and African American individuals. The location of the study is not explicitly stated, but Mediana Co.,Ltd. is based in Korea and the 510(k) submission was processed in the US, suggesting the study could have been conducted in either region or internationally.

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

The ground truth for arterial oxygen saturation (SaO2) was established by a co-oximetry reference method on radial arterial blood samples. This method itself (co-oximetry) is the gold standard for measuring SaO2. While not explicitly stated as "experts," the performance of this co-oximetry method and the collection of arterial blood samples would necessitate highly skilled medical professionals (e.g., physicians, nurses, lab technicians) with expertise in arterial blood sampling and operating co-oximeters. The number of such professionals involved is not specified.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by direct measurement using a co-oximetry reference method, not by expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the standalone accuracy of the pulse oximeter against a reference standard, not on how human readers' performance would improve with AI assistance. Pulse oximeters are typically standalone measurement devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The clinical hypoxia testing evaluated the accuracy of the P10 pulse oximeter against the co-oximetry reference method. This assesses the device's inherent measurement capabilities.

7. The Type of Ground Truth Used

The ground truth used was outcomes data / reference standard measurement in the form of arterial oxygen saturation (SaO2) obtained by the co-oximetry reference method from radial arterial blood samples. This is considered a highly accurate and direct measure for assessing pulse oximeter performance.

8. The Sample Size for the Training Set

The provided 510(k) summary does not explicitly mention a "training set" or "training data" in the context of a machine learning or AI algorithm. Pulse oximeters operate on well-established physiological principles and signal processing, rather than requiring extensive machine learning training sets in the same way an AI diagnostic imaging device would. The "clinical validation report" for the SpO2 module (MD1) mentioned in section 17-O might contain more details about any internal data used for calibration or algorithm refinement, but it's not detailed in this summary.

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

As no specific "training set" is mentioned in the context of machine learning, this question is not directly applicable. If the device uses algorithms that were developed using internal data, the ground truth for that development would typically be established through similar methods (e.g., comparison to co-oximetry) during the R&D phase of the SpO2 module.

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The Lucon M-series (M20, M30) is intended to be used to monitor for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician. The device is capable of monitoring:

• Electrocardiography (ECG)
• Heart rate (HR)
• Noninvasive blood pressure (NIBP)
• Functional arterial oxygen saturation (SpO2)
• Pulse rate (PR)
• Respiration rate (RR)
• Temperature (Temp)
• Arrhythmia/ST segment (M30 only)
• Capnography (M30 only)
  Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgical centers, and sub acute care centers.
  Note: The medically skilled and trained user can be clinicians like doctors and nurses who know to take and interpret a patient's vital signs. These clinicians must take direct responsibility for the patient's life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient's life. This equipment should only be operated by trained users who can adjust the settings of the patient monitor.

The Mediana Lucon M-series (M20, M30) patient monitor is a lightweight and compact device (250 × 210 × 170 (mm) and 3.2 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on TFT-LCD displays.

• Electrocardiography (ECG)
• Heart rate (HR)
• Noninvasive blood pressure (NIBP)
• Functional arterial oxygen saturation (SpO2)
• Pulse rate (PR)
• Respiration rate (RR)
• Temperature (Temp)
• Arrhythmia/ST segment (M30 only)
• Capnography (M30 only)

The provided text does not contain specific acceptance criteria with numerical performance targets or a detailed study demonstrating that the device meets these criteria. Instead, it focuses on establishing substantial equivalence to predicate devices for a patient monitor (Mediana Lucon M-series M20, M30).

However, based on the information provided, we can infer the approach used to demonstrate performance and substantial equivalence:

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the performance specifications of the predicate devices. The document repeatedly states that the Mediana Lucon M-series has "identical" or "similar" specifications and uses "identical technology" or "same technology" as the predicate devices. It also mentions compliance with relevant performance standards.

• ECG and heart rate specifications are identical to Omron HBP-2070.
• ECG measurement performance is similar to Philips SureSigns VM6.
• Uses identical technology as predicate devices. |
  | Noninvasive Blood Pressure (NIBP) | - NIBP module (M3200) is identical to that in Omron HBP-2070.
• NIBP specifications are identical to Omron HBP-2070.
• Complies with AAMI performance standard SP-10 & IEC60601-2-30.
• Uses same technology as predicate devices (Omron HBP-2070 and Philips SureSigns VM6). |
  | Functional Arterial Oxygen Saturation (SpO2) | - SpO2 module (NELL-3) is used in Spacelabs mCARE 300, 91220 and Omron HBP-2070.
• SpO2 specifications are identical to Omron HBP-2070 and Spacelabs 91220.
• Complies with performance standard ISO9919. |
  | Respiration Rate (RR) | - Algorithm of Impedance measurement is identical to Omron HBP-2070.
• Respiration specification is identical to Omron HBP-2070.
• Respiration measurement (Thoracic Impedance) for Lucon M-series and Spacelabs 91220 are from the same ECG module (designed and manufactured by Mediana). |
  | Capnography (EtCO2) | - Algorithm of Airway Measurement has identical performance to Spacelabs 91220.
• Airway Measurement is from Capnography module (Philips Respironics Inc.).
• Operation theory of Airway Measurement in Welch Allyn Propaq Encore 200 series is same as Lucon M-series (M30 only) and Spacelabs 91220.
• Uses Capnostat 5 and Lo Flo C5 modules (already FDA registered: K042601, K053174) which are identical to modules used in Spacelabs 91220.
• Minor differences in Capnography specification between Lucon M-series (M30 only) and identified predicate devices; all three devices have identical technology and operation theory for Capnography. |
  | Temperature (Temp) | - Thermometry MDT-1 module is identical to that in Omron HBP-2070 and Spacelabs 91220.
• Temperature measurement technology is equivalent to Omron HBP-2070 and Spacelab 91220.
• Uses YSI 400 and 700 probes/probe covers, identical to predicate devices. |
  | Pulse Rate (PR) | - Derived from NIBP channel (M3200 module), identical to Omron HBP-2070.
• Derived from SpO2 channel (NELL-3 module), identical to Omron HBP-2070 and Spacelabs 91220. |
  | General Device Functionality | - Internal power source (rechargeable lead acid battery and AC power) is similar to predicate devices.
• Overall safety and effectiveness, and compliance with appropriate medical device standards, stated to be substantially equivalent to predicate devices. |

Study Details:

The submission highlights a "Summary of Performance Testing" but provides very limited details about the actual studies conducted to prove the device meets acceptance criteria.

1. Sample size used for the test set and the data provenance:

   • The document states that the device "substantially have been tested... with the system V & V plan (#MDR-YW071202-02) and summary included with the submission using production equivalent units prior to release to market."
   • No specific sample size for a test set is mentioned.
   • No information on data provenance (e.g., country of origin, retrospective or prospective) is provided. The testing seems to be internal verification and validation (V&V) against design specifications and predicate device performance.

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

   • Not applicable/Not mentioned. The testing described involves technical performance characteristics, not clinical interpretation that would require expert ground truth.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Given the nature of the technical performance testing described, an adjudication method like 2+1 or 3+1 would not be relevant.

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 MRMC study was done. This device is a patient monitor, not an AI-assisted diagnostic tool.

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

   • Yes, implicitly. The "Performance Testing" refers to the device's technical specifications and how it performs in measuring various physiological parameters. This would be standalone performance of the device's modules and algorithms. The core argument for substantial equivalence relies on the identical/similar technology and specifications to the predicate devices, which suggests an evaluation of the device's intrinsic measurement capabilities.

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

   • The ground truth for this type of device would typically be reference standards or highly accurate measurement equipment used to validate the accuracy and precision of each physiological parameter (ECG, NIBP, SpO2, Temp, RR, EtCO2). For example, NIBP accuracy might be validated against an invasive arterial line or a calibrated simulator. The document also mentions compliance with specific performance standards (e.g., AAMI SP-10, IEC60601-2-30, ISO9919), which define test methods and acceptance criteria.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device does not appear to use a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on established physiological measurement technologies, often implemented as modules from reputable manufacturers (Omron, Nellcor, Philips Respironics).

8. How the ground truth for the training set was established:

   • Not applicable/Not mentioned. As there's no mention of a traditional training set for an AI algorithm, this question is not relevant. The performance is validated against established medical device standards and the performance of predicate devices.

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The purpose and function of the Mediana ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate for adult, pediatric and neonate patients and temperature for adult and pediatric patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.

• Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acutecenters.
• Note: Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.

The ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure, pulse rate, non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) for adult, pediatric and neonate patients and body temperature for adult and pediatric patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.
The Mediana ARGUS VCM vital signs monitor is a lightweight and compact device (180×278×130 mm and 2.7 kg) powered by AC mains (100-240VAC, 50-60Hz) and also powered by internal battery. The monitor provides patient data and monitoring status on 7segment and LED displays.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Mediana ARGUS VCM series, Vital Signs Monitor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and performance metrics of the new device itself.

Therefore, much of the requested information cannot be extracted directly from this document. Here's what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with numerical targets and the Mediana ARGUS VCM series' specific performance against these targets. Instead, it relies on demonstrating substantial equivalence to predicate devices by stating that its specifications and performance are equivalent to those predicate devices.

Explanation: The "acceptance criteria" here are implied to be the performance characteristics of the predicate devices. The "reported device performance" is a statement of equivalence rather than specific numerical results. The document explicitly states that the Mediana device uses the same NIBP module (Welch Allyn NIBP module POEM), the same SpO2 module (Nellcor Oximetry module MP506), and the same temperature module (Welch Allyn thermometry module SureTemp®) as its predicate devices, which is the primary basis for claiming equivalence in these specific areas.

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

• Sample Size: Not specified. The document mentions "system V & V plan (#PA300-09000) and summary (#PA300-09013)" were used, but details on sample size for testing are not included in this summary.
• Data Provenance: Not specified. The context suggests that the testing would have been conducted by Mediana Co., Ltd. in Korea, but no details on the origin of any clinical data (e.g., country of origin, retrospective or prospective) are provided. The testing primarily appears to be technical verification and validation, rather than a clinical study with patient data.

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

Not applicable. The document does not describe a study involving expert-established ground truth for the device's performance. The "ground truth" for demonstrating equivalence is based on the specifications and performance of the predicate and the use of the same core measurement modules.

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

Not applicable. This type of adjudication method is typically used in AI/diagnostic imaging studies for establishing ground truth, which is not the nature of the testing described here.

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 is not an AI/diagnostic imaging device. It is a vital signs monitor, and the studies mentioned are focused on demonstrating technical performance and equivalence, not comparing human reader performance with or without AI assistance.

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

Yes, in a way. The "performance testing" described ("system V & V plan (#PA300-09000) and summary (#PA300-09013)") would assess the device's functional performance in isolation, independent of human interaction beyond operating the device. However, this is not in the context of an "algorithm only" as typically understood in AI devices. It refers to the performance of the integrated vital signs monitor.

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

The "ground truth" implicitly used for the claim of substantial equivalence is the established and legally marketed performance of the predicate devices, particularly when the same core measurement modules are utilized. For technical verification and validation, the ground truth would be precise reference measurements from calibrated equipment (e.g., for blood pressure, SpO2, and temperature).

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set. Its design is based on established vital signs monitoring technologies, some of which are explicitly stated to be the same modules as in the predicate devices.

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

Not applicable, as there is no training set for this type of device.

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