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The Connex Spot Monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Monitoring respiration rate from photoplethysmogram (Masimo RRp®) is indicated for adult and pediatric patients greater than two years old. The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments.

This product is available for sale only upon the order of a physician or licensed health care professional.

Welch Allyn Connex® Spot Monitor (CSM) is an integrated, configurable vital signs monitor. CSM is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The specific vital sign measurements available are determined by the sensor/processing technology integrated into the base unit including:

• · Noninvasive blood pressure (NIBP) provides measurements of noninvasive blood pressure and pulse rate
• · Spo2 provides pulse rate, respiration rate, and noninvasive functional oxygen saturation of arteriolar hemoglobin
• · Thermometer measures temperature in neonatal, pediatric, and adult patients
• · Respiration rate from photoplethysmogram (RRp)
• The custom scores option provides custom calculations based on patient vital sign values and modifiers determined by the user

The CSM 1.53, in the same manner as the CSM predicate device, can display and transmit patient data that is electronically or manually entered from external and accessory devices, including weight and height data, manually entered respiration rate, barcode scanned patient and clinician data, and other patient or facility information to a connected Host system. Data is transmitted electronically via USB, Wi-Fi, Bluetooth or ethernet communications to electronic record systems, and for remote display and alarming (e.g., at a central station).

This FDA 510(k) summary provides information for the Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM), which is receiving an update to include Masimo RRp® (respiration rate from photoplethysmogram). However, the document does not contain a specific table of acceptance criteria for this new feature nor detailed results of a study proving the device meets said criteria.

Instead, the document states:

• "Non-clinical testing was performed on the CSM to verify safety and efficacy of the device."
• "All updates were implemented through the design control process and verified to not impact safety and efficacy of the device."
• "The non-clinical tests performed confirm that the subject CSM device is substantially equivalent to the legally marketed predicate CSM (K142356)."

Therefore, I cannot provide the specific details requested in your prompt as they are not present in the provided text. The document focuses on regulatory compliance through substantial equivalence, listing general standards applied, rather than specific performance metrics and a detailed study report for the RRp feature.

To answer your request based only on the provided text, the following information is unavailable:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided. The testing is referred to as "non-clinical testing," but no specifics on test data are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not conducted, as this is a medical device for vital sign monitoring, not an AI-assisted diagnostic imaging device requiring human reader improvement studies.
6. If a standalone performance study was done: "Non-clinical testing" was performed, indicating testing of the algorithm/device itself, but specific details of a standalone study (like methodologies, results, and metrics) are not provided.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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The Halo vital signs monitor is a prescription device intended to be used as an adult patient monitor. It is indicated as a single- or multi-parameter vital signs monitor for SpO2 - pulse oximetry, pulse rate, respiratory rate, core body temperature, and skin temperature for spot-check measurements and continuous monitoring from the back of the cavum concha and the neck.

The Halo monitor may be used in hospitals, healthcare facilities, emergency medical transport, home healthcare settings, and other healthcare applications to include medical military settings in the field. The monitor is intended to be used in trauma scenarios, triage, motion, low perfusion, general monitoring, and telemedicine settings. It is reusable, transportable, and for use in all types of ambulances.

The Halo monitor uses wired or wireless communications to transmit vital signs data to a handheld or personal computer. The monitor is intended to be used by trained healthcare providers who are trained to interpret the vital signs readings and make appropriate medical interventions or patients who are und guidance of a medical professional or doctor. Alarms can be set with user-defined thresholds.

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The provided text is a 510(k) clearance letter from the FDA for the "Sempulse Halo Vital Signs Monitor." This document focuses on the regulatory clearance process and does not contain the detailed technical study information (acceptance criteria, test set, ground truth, training set, etc.) that would prove the device meets specific performance criteria.

Therefore, I cannot provide the requested information from the given text.

The typical content of a 510(k) summary (which is a separate document often submitted for public review after clearance) or a detailed performance validation study would include such information. This letter simply confirms that the device has been found "substantially equivalent" to legally marketed predicate devices.

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The device is intended to be used for measuring, storing, and to generate prompts for, multiple physiological parameters of adults and pediatrics (including neonates). The device is intended for use by trained healthcare professionals in hospital environments. Parameters include: NIBP, SpO2, PR (pulse rate), TEMP. The F3000 Quick Temp module is not intended for neonates. The device is not intended for MRI environments.

The iM3s series vital signs monitors including iM3s\iM3As\iM3Bs\ iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults and pediatrics.

The provided documentation describes the FDA 510(k) clearance for the Edan Instruments Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and software verification/validation, rather than detailing a clinical study with specific acceptance criteria for AI/algorithm performance.

Therefore, many of the requested details regarding acceptance criteria, sample size, expert involvement, and ground truth establishment for a study proving device performance in an AI/algorithm context are not applicable or not provided in this specific FDA clearance document. The device is a vital signs monitor, not explicitly described as incorporating AI for diagnosis or interpretation that would necessitate an MRMC study or detailed ground truth establishment in the context of AI performance.

The document states "Clinical data: Not applicable," further confirming the absence of a clinical study for this clearance.

Here's a breakdown based on the information available in the document:

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

The document refers to compliance with consensus standards for device performance, where the "acceptance criteria" are implied by adherence to these standards and the "reported device performance" is that the device "meets its accuracy specification and meet relevant consensus standards." Specific numerical acceptance criteria are mentioned for the measurement accuracy of SpO2, PR, and NIBP, and various temperature modules.

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

• The document explicitly states "Clinical data: Not applicable." The "test set" for performance was conducted through "Non-clinical data" including "Electrical safety and electromagnetic compatibility (EMC)" and "Performance testing-Bench."
• No specific sample sizes (e.g., number of patients/measurements) for "bench" testing are provided.
• Data provenance (e.g., country of origin, retrospective/prospective) is not applicable given no clinical study.

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

• Not applicable as no clinical ground truth or expert-adjudicated test set was used. Device performance was assessed against established engineering and safety standards.

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

• Not applicable as no clinical test set requiring adjudication was used.

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 performed as this device is a vital signs monitor, not an AI-assisted diagnostic device requiring human reader improvement assessment. Clinical data was deemed "Not applicable."

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

• The performance assessment focused on the device's ability to accurately measure vital signs according to specifications and consensus standards (e.g., IEC 80601-2-30 for NIBP, ISO 80601-2-56 for temperature, ISO 80601-2-61 for pulse oximetry). This is essentially a "standalone" performance evaluation of the measurement algorithms within the device against physical standards, but not in the context of an AI-driven diagnostic algorithm.

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

• For the non-clinical performance testing, the "ground truth" would be the reference measurements from calibrated and traceable sources, as specified by the relevant international standards (e.g., simulated physiological signals/conditions, calibrated temperature sources, etc.).

8. The sample size for the training set:

• Not applicable. This document describes the clearance of a vital signs monitor, not an AI/machine learning algorithm requiring a separate training set.

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

• Not applicable, as no AI training set is described.

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The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, storing, alarming, and transfering of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The VS 9/VS 8/VS 8A Vital Signs Monitor are not intended for helicopter transport, hospital ambulance, or home use.

The subject VS series Vital Signs Monitors includes three monitors:

• VS 9 Vital Signs Monitor
• VS 8 Vital Signs Monitor
• VS 8A Vital Signs Monitor .

The VS series Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. The monitors should only be used by persons who have received adequate training in their use.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Device: Mindray VS Series Vital Signs Monitors (VS 9/VS 8/VS 8A)
Parameter for Analysis: Temperature (Temp) measurement using the new Mindray Temp Module (TrueTemp) in Predictive mode.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for temperature measurement are based on the requirements of ISO 80601-2-56:2017/Amd.1:2018(E). The summary provides statistical results from a clinical investigation.

Note: The document states that the performance of the TrueTemp module "meets the requirements of ISO 80601-2-56:2017/ Amd.1:2018(E) for temperature measurement and meets the acceptance criteria in clinical protocol." While the specific numerical acceptance criteria from the ISO standard are not explicitly listed in the table, the reported performance metrics are the results of testing against those criteria. The predicate device's performance is also included in the table in the full submission, showing similar statistical results.

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

• Sample Size for Test Set:
  • 106 valid cases for oral temperature.
  • 110 valid cases for axillary temperature.
  • 109 valid cases for rectal temperature.
• Data Provenance: The study was a clinical investigation conducted by Mindray. The country of origin is not explicitly stated in the provided abstract, but Mindray is a Chinese company (Shenzhen, Guangdong, P.R. China), suggesting the study likely took place in China. It was a prospective clinical investigation as it aimed to meet specific requirements for validity and accuracy of the new module.
• Subject Demographics: The study included subjects in three age groups: infants (newborn to one year), children (greater than one to five years), and adults (greater than five years old). The age of subjects ranged from 4 days to 67 years old. The total number of febrile subjects constituted not less than 30% and not greater than 50% of all subjects in each selected age group and body site.

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

This information is not explicitly provided in the summary. The ground truth (reference temperature) was established by comparing the TrueTemp module's measurements to the "direct mode of WelchAllyn SureTemp PLUS 690." It's likely that a trained clinical professional operated the reference thermometer, but the specific number and qualifications of experts involved in establishing the "ground truth" are not detailed.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. Given that the ground truth was established by a comparative measurement against a reference device (WelchAllyn SureTemp PLUS 690), it implies a direct comparison rather than an expert consensus requiring an adjudication process.

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 applicable. The device is a vital signs monitor that directly measures physiological parameters like temperature. It is not an AI-assisted diagnostic tool that involves human readers or interpretation of medical images/data in a way that would necessitate an MRMC comparative effectiveness study to assess human improvement with AI assistance.

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

Yes, a standalone performance evaluation was done for the temperature measurement function. The clinical investigation directly assessed the accuracy and validity of the "new Mindray Temp Module (TrueTemp)" in its predictive mode compared to a reference standard (WelchAllyn SureTemp PLUS 690). This evaluation focused on the device's intrinsic measurement capabilities without assessing human interaction or interpretation as part of the core performance metrics discussed here.

7. The Type of Ground Truth Used

The ground truth used was comparison to a legally marketed reference device: the "direct mode of WelchAllyn SureTemp PLUS 690," which is itself a clinical thermometer. This is a form of comparative measurement against a recognized standard in the field.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set for the Mindray TrueTemp module's temperature measurement function. Given that this is a hardware module (thermal resistance technique) with associated algorithms for predictive mode, its development and calibration would typically involve internal technical specifications and potentially laboratory testing, but "training set" in the context of machine learning is not directly applicable or reported for this type of device in the provided summary.

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

As no training set information is provided, how its ground truth was established is not discussed in this document.

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The Accutorr 3/Rosebud Vital Signs monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non-Invasive Blood Pressure (NIBP) and Temperature (TEMP) on adult, pediatric, and neonatal patients in healthcare facilities by physicians or appropriate medical staff under the direction of physicians.

The subject Vital Signs Monitors includes two monitors: Accutorr 3 Vital Signs Monitor and Rosebud Vital Signs Monitor. The Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by physicians or appropriate medical staff under the direction of physicians.

This FDA 510(k) summary describes the Accutorr 3/Rosebud Vital Signs Monitor, which includes two devices: the Accutorr 3 Vital Signs Monitor and the Rosebud Vital Signs Monitor. The key change in this submission is the introduction of a new Mindray Temperature Module (TrueTemp) with updated temperature measurement capabilities.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the temperature module are based on the requirements of ISO 80601-2-56:2017 and ASTM E1112-00 for temperature accuracy. The performance data is specifically for the "Predictive mode" of the new TrueTemp module.

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

• Sample Size: The clinical accuracy study for the TrueTemp module evaluated:
  • 106 valid cases for oral temperature
  • 110 valid cases for axillary temperature
  • 109 valid cases for rectal temperature
• Data Provenance: The document does not explicitly state the country of origin. It is a prospective clinical investigation conducted to meet ISO 80601-2-56 requirements. The age of subjects ranged from 4 days to 67 years old. The study ensured that the total number of febrile subjects was not less than 30% and not greater than 50% of all subjects in the selected age group and body site.

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

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the clinical temperature study. However, the ground truth was established by comparing the device's readings to those of a WelchAllyn SureTemp PLUS 690 in direct mode, which is a legally marketed and presumably accurate reference thermometer. This implies the "experts" were the established accuracy of this reference device.

4. Adjudication Method for the Test Set

The document does not mention an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" was established by a comparative measurement against a reference device (WelchAllyn SureTemp PLUS 690 in direct mode) rather than an interpretation requiring multiple human adjudicators.

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

No, an MRMC comparative effectiveness study was not done. This device is a vital signs monitor, and the clinical study focused on the accuracy of temperature measurement against a reference standard, not on human interpretation or decision-making aided by AI.

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

Yes, the clinical accuracy study for the temperature module can be considered a standalone performance evaluation of the device's temperature measurement capabilities. It directly compared the device's readings to a ground truth established by a reference thermometer, without human interpretation of the device's output as the primary endpoint.

7. The Type of Ground Truth Used

The ground truth for the temperature accuracy study was established by comparison to a legally marketed and accurate reference device, specifically the WelchAllyn SureTemp PLUS 690 in direct mode. This can be categorized as a form of reference standard measurement.

8. The Sample Size for the Training Set

The document does not provide information about a training set size. This is typical for vital signs monitors, where the device's algorithms for parameters like temperature (e.g., predictive mode calculations) are developed and then validated through bench and clinical testing against established standards, rather than requiring large labeled clinical datasets for typical machine learning training.

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

As no training set is described, information on how its ground truth was established is not applicable here. The development of the TrueTemp module's algorithm would have involved engineering and calibration against known temperature standards and thermometry principles.

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Vital Signs Monitor MD2000C is a portable device indicated for measuring physiological parameters, such as NIBP, SpO2, PR, and Pulse waveform of adult and three years old and older pediatric patients in hospitals, community hospitals and medical facilities. Vital Signs Monitor is intended for spot-checking and/or continuous monitoring of patients.

The proposed device Vital Signs Monitor MD2000C is a device powered by internal electrical power source and external electrical power source. The MD2000C is used in hospital,community hospitals and medical facilities. It can measure and record functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Non-invasive measurement of blood pressure (NIBP) of adult and pediatric patients. Its accessories include SpO2 probe, NIBP cuff for adult, NIBP cuff for pediatric, and power adapter. It has data storage,display,alarm.

Here's a breakdown of the acceptance criteria and study information for the Vital Signs Monitor MD2000C based on the provided text:

Acceptance Criteria and Device Performance

The direct acceptance criteria for the Vital Signs Monitor MD2000C are not explicitly stated as a separate table within the document in terms of specific performance targets for NIBP, SpO2, and PR beyond accuracy ranges. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (MD2000B and MD300M for SpO2, and Multi-parameters health Examination System for NIBP).

The performance data available relates to the MD300M (for SpO2) and Multi-parameters health Examination System (for NIBP), which the new device MD2000C claims to be identical to in those modules.

Table of Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance:

Note: The "Implied Acceptance Criteria" are based on the performance of the predicate devices which the new device is seeking equivalence to. The direct acceptance criteria for the specific device are not explicitly listed in a regulatory numerical format but are demonstrated through equivalence to these predicate performances.

Study Information:

2. Sample sizes used for the test set and the data provenance:

• SpO2 Accuracy Study (MD300M):
  • Sample Size: 12 healthy adult volunteer subjects (6 females, 6 males)
  • Demographics: Ages 21-43 years, 47-82 kg, 155-185 cm, with a representative range of pigmentation.
  • Data Provenance: Conducted in Yue Bei People's Hospital. Prospective study. Country of origin not explicitly stated but implied to be China (as the manufacturer is Beijing Choice Electronic Technology Co., Ltd.)
• NIBP Accuracy Study (Multi-parameters health Examination System):
  • Sample Size: 85 subjects (35 child subjects aged 3-12 years, 50 adult subjects)
  • Data Provenance: Conducted in PLA Rocket Force Characteristic Medical Center. Prospective study. Country of origin not explicitly stated but implied to be China.

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

• The document does not specify the number or qualifications of experts used to establish ground truth for either the SpO2 or NIBP studies.
  • For SpO2, ground truth is typically established using a co-oximeter in controlled desaturation studies (e.g., fractional oxyhemoglobin measurement compared to pulse oximeter readings).
  • For NIBP, ground truth is typically established simultaneously with a reference auscultatory or invasive blood pressure measurement taken by qualified personnel.

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

• The document does not provide details on any adjudication methods used for the test sets. The studies appear to be direct performance comparisons against a reference standard rather than assessments requiring multiple human interpretations.

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 performed. This device is a vital signs monitor, not an AI-assisted diagnostic imaging or interpretation tool for human readers. It provides physiological parameters directly.

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

• Yes, standalone performance was evaluated. The studies described for SpO2 and NIBP accuracy directly measure the device's performance against a reference standard, without human interpretation of the device's output influencing the accuracy metrics. The device itself is designed to provide direct physiological measurements.

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

• SpO2: The ground truth for SpO2 accuracy studies is typically established by fractional oxyhemoglobin measurement using a co-oximeter during controlled hypoxia conditions. This is considered the reference standard for pulse oximetry.
• NIBP: The ground truth for NIBP accuracy studies is established by simultaneous measurements using a reference auscultatory method (e.g., mercury sphygmomanometer with stethoscope by trained observer) or an invasive arterial line, compared to the device's oscillometric readings.

8. The sample size for the training set:

• The document does not specify sample sizes for training sets. It describes the device's performance through validation studies (test sets) for specific modules that were adopted from previously cleared devices. It's implied that the algorithms within these modules were developed and potentially trained using proprietary datasets not detailed in this 510(k) summary.

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

• The document does not specify how ground truth was established for any potential training sets. This information would typically be part of the internal development process for the SpO2 and NIBP algorithms, which predates this 510(k) application (as the modules are reused from previously cleared devices).

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The VS 9/VS 8/VS 8A Vital Signs Monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon Dioxide (CO2). All the parameters can be monitored on single adult, pediatric, and neonatal patients.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The VS 9/VS 8A Vital Signs Monitors are not intended for helicopter transport, hospital ambulance, or home use.

The subject VS series Vital Signs Monitors includes three monitors:

• VS 9 Vital Signs Monitor
• VS 8 Vital Signs Monitor
• VS 8A Vital Signs Monitor

The VS series Vital Signs Monitors are for use for adult, pediatric, and neonatal patients. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. The monitors should only be used by persons who have received adequate training in their use.

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., LTD VS Series Vital Signs Monitors. It describes the device, its intended use, comparison to predicate devices, and the performance data submitted to demonstrate substantial equivalence.

However, the provided document does not describe an AI/ML software device or a study validating its performance. The "Product Code: MWI, CCK, DQA, DXN, FLL" and "Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm)" indicate traditional vital signs monitors. The 'software verification and validation testing' mentioned refers to general software engineering practices for medical devices, not specific performance criteria for an AI/ML algorithm.

Therefore, I cannot provide the requested information because the document does not contain details about:

• Acceptance criteria for an AI/ML algorithm.
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test sets used for AI/ML validation.
• Ground truth establishment methods for AI/ML datasets.
• MRMC studies for AI/ML.
• Standalone performance for AI/ML algorithms.
• Training set details for AI/ML.

The document discusses validation for a physical medical device (vital signs monitor) including:

• Biocompatibility Testing: For NIBP cuffs due to an ink change.
• Software Verification and Validation Testing: General software V&V for the device's embedded software, not an AI/ML algorithm.
• Electrical safety and electromagnetic compatibility (EMC): Compliance with relevant standards.
• Bench Testing: Functional and system level testing to validate device performance.
• Clinical Data: NIBP measurement accuracy validated according to ISO 81060-2:2018 in neonate, infant, child, and adult populations.

If you have a document describing an AI/ML medical device, please provide that, and I will be able to answer your questions.

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The MouthLab Vital Signs Monitoring System is a hand-held, wireless device intended to record, transfer, store and display single lead electrocardiography (ECG), heart rate variability (HRV), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), respiration pattern (RP), oral temperature (TEMP) and basic lung function measurements: peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1).

This system is for spot checking and does not have continuous monitoring capability or any alarm features. The device comes in contact with the user for approximately 60 seconds at each use and the captured medical parameters shall be displayed on a mobile application.

It is intended for use by adults in the home environment and in healthcare facilities. This system makes no specific diagnosis. Respiration rate is not intended for adults with underlying or suspected medical conditions. The device is for single user use.

It is intended for use with users who are well perfused and during no motion condition. Users with implanted pacemakers and/or implanted cardioverter-defibrillators (ICDs) are not recommended to use the device.

The MouthLab Vital Signs Monitoring System is a non-invasive, battery-powered, handheld, wireless, personalized single-user, vital sign measuring apparatus. The device is intended to intermittently monitor the user vitals through the use of an integrated SpO2 sensor, ECG electrodes, microphones and thermistor, which measures the users' functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), oral temperature (TEMP), ECG, heart rate (HR) and heart rate variability (HRV). The users' respiration rate (RR) measurements, respiration pattern (RP) and the basic lung functions (FEV1 and PEF) measurements are obtained are obtained through the acoustic measurement of air turbulence. The vital signs data are transferred to the Aidar Cloud™ Application via a cellular network for processing and storage. This processed data is then displayed on the Aidar Care™ Mobile Application.

The provided document, a 510(k) Summary for the MouthLab Vital Signs Monitoring System (K201635), outlines the device's acceptance criteria and the studies conducted to demonstrate its performance. The device measures multiple physiological parameters, and therefore, different studies were conducted for each.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• SpO2 Measurements: "a controlled desaturation study with adults." The specific sample size is not provided. The data provenance is implied to be prospective clinical testing, likely conducted in a controlled environment as it refers to a "controlled desaturation study." The country of origin is not specified.
• Respiration Rate Measurements: "20 healthy adults." The data provenance is prospective clinical testing. The country of origin is not specified.
• For other parameters (ECG/HR, Pulse Rate, Temperature, PEF/FEV1), bench testing was performed, meaning synthetic data or physical test equipment was used. No human subject sample size is applicable.

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

• Respiration Rate Measurements: Ground truth was established by "a clinician's manually scored capnography (EtCO2) waveforms." The number of clinicians is not specified, and their specific qualifications beyond "clinician" are not detailed.
• SpO2 Measurements: Ground truth was established by "reference co-oximeter analysis of arterial blood gas." This implies laboratory analysis rather than human expert interpretation of raw data. No human experts were explicitly stated to establish this ground truth in the provided text.

4. Adjudication Method for the Test Set:

• For SpO2, and Temperature, the comparison was against a reference standard (co-oximeter, calibrated thermometer) implying direct comparison, not a human adjudication process.
• For Respiration Rate, the comparison was against "a clinician's manually scored capnography waveforms." This suggests a single clinician's scoring was used as ground truth, implying no adjudication method (e.g., 2+1 or 3+1) was employed for establishing this ground truth.

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 comparative effectiveness study was done involving human readers with and without AI assistance (the MouthLab system). The studies described are validation studies comparing the device's measurements to reference standards, not studies on human reader performance improvement.

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

• Yes, the performance data provided describes the standalone performance of the MouthLab Vital Signs Monitoring System in measuring various physiological parameters. The clinical and bench tests evaluate the device's ability to accurately capture and report these values.

7. The type of ground truth used:

• ECG and Heart Rate: Bench testing compliant with IEC 60601-2-27:2012. (Simulated physiological signals)
• Pulse Rate: Bench testing compliant with ISO 80601-2-61:2017. (Simulated physiological signals)
• Temperature: Bench agreement study as per ISO 80601-2-56:2017. (Reference temperature measurements)
• Peak Flow Measurements (FEV1 and PEF): Bench testing according to the ATS Standardization of Spirometry, 2005 Update. (Reference flow/volume measurements)
• SpO2 Measurements: Reference co-oximeter analysis of arterial blood gas. (Objective clinical reference standard)
• Respiration Rate Measurements: Clinician's manually scored capnography (EtCO2) waveforms. (Expert interpretation of surrogate physiological data)

8. The sample size for the training set:

• The document does not explicitly mention a training set sample size. The performance data section focuses on "bench testing" and "clinical testing" for validation, not on the training of machine learning models. If the device uses algorithms trained on data, that information is not detailed in this summary.

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

• As the document does not mention a training set, the method for establishing its ground truth is not provided.

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The device is intended to be used for measuring, storing, and to generate prompts for, multiple physiological parameters of adults and pediatrics. The device is intended for use by trained healthcare professionals in hospital environments.

Parameters include: NIBP, SpO2, PR (pulse rate), TEMP.

The F3000 Quick TEMP module is not intended for neonates.

The device is not intended for MRI environments.

The iM3s series vital signs monitors including iM3s\iM3As\iM3Bs\ iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults, pediatrics and neonates.

Here's an analysis of the provided text regarding the acceptance criteria and study data for the Vital Signs Monitor (iM3s, iM3As, iM3Bs, iHM3s).

Please note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily presents performance specifications and shows that the new device meets those, often by referencing existing standards or previous clearances. It does not typically include detailed experimental setups for clinical or performance studies in the way a research paper would. Therefore, some information requested (like sample size for training sets, specific adjudication methods, MRMC studies, or detailed ground truth establishment for training data) is not present in this type of regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the predicate device's specifications and compliance with relevant ISO/IEC standards. The "Reported Device Performance" for the subject device is stated as meeting these same specifications.

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

• Sample Size for Test Set: Not specified in the document. The performance is validated through "functional and system level testing" and compliance with standards, not a clinical trial with a specified patient sample size for device comparison.
• Data Provenance: The studies are described as "non-clinical data" and "bench testing." No country of origin is mentioned for patient data, as no clinical studies with human subjects are detailed. The nature of the testing implies it's retrospective, based on existing standards and validation procedures, rather than prospective clinical data.

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

• This information is not provided in the document. The "ground truth" for these performance tests would typically be established by highly calibrated reference instruments or simulated physiological signals according to the requirements of the cited ISO/IEC standards, rather than expert human interpretation in a clinical context.

4. Adjudication Method for the Test Set

• This information is not applicable and not provided. As no clinical studies with human subjects or interpretation tasks are described, there is no need for an adjudication method. The assessment is against technical specifications and standards.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical data: Not applicable." The focus is on the device's standalone performance against engineering and international standards.

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

• Yes, the performance reported is essentially standalone. The "bench testing" and "software verification and validation testing" assess the device's accuracy and functionality in isolation, without an explicit human-in-the-loop component for interpreting outputs in the context of the device's core physiological measurements (NIBP, SpO2, PR, TEMP).

7. The Type of Ground Truth Used

• The ground truth for the performance testing is based on:
  • Reference measurements from calibrated equipment: For parameters like SpO2, NIBP, and TEMP, the "ground truth" would be simulated physiological signals or measurements from highly accurate, traceable reference devices as mandated by the respective ISO/IEC standards.
  • Compliance with international standards: The device is tested against the specific requirements and accuracy tolerances defined in standards such as IEC 80601-2-30 (NIBP), ISO 80601-2-56 (thermometers), and ISO 80601-2-61 (pulse oximeters).

8. The Sample Size for the Training Set

• This information is not provided and is not applicable in the context of this device and document. This device is a vital signs monitor, not typically an AI/machine learning diagnostic device that relies on "training sets" in the conventional sense of machine learning algorithms. Its parameters are measured directly through hardware and firmware, validated against physical standards.

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

• This information is not provided and is not applicable as there is no "training set" for an AI algorithm described for this device. The device's fundamental operational principles are based on established physiological measurement techniques, not on learning from a dataset.

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The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2, with an optional accessory for capnography (ETCO2, RR). It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer.

The monitor is intended to be used by trained healthcare providers.

The WVSM Patient Monitor is a device that monitors physiological parameters associated with Electrocardiogram, Non-invasive Blood Pressure, pulse oximetry and carbon dioxide gas. The WVSM Patient Monitor is a multi-patient use non-sterile device. It utilizes embedded firmware. Patient applied parts are needed for physiological measurement and are provided via FDA cleared OEM accessories to the WVSM monitor. The modification to the WVSM includes: Adding an indication for capnography by interfacing with a FDA cleared accessory. Adding the capability to use the device while connected to the AC power adapter instead of only using the device on battery power.

This document provides information about the Athena GTX Wireless Vital Signs Monitor (WVSM) RWC + miniCap, which is a modified version of a previously cleared device. The primary modifications are the addition of capnography functionality and the ability to operate while connected to an AC power adapter.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding performance results for each parameter. Instead, it states that "Key performance specifications are listed in the table in section VI below," which refers to the comparative table between the modified device and the predicate device. This table primarily highlights differences and similarities in technological characteristics.

However, based on the text, the acceptance criterion for this 510(k) submission appears to be demonstrating that the modifications (capnography and AC power mode) do not adversely affect the safety and effectiveness of the device and that the new functionalities (capnography parameters) meet established standards.

The document implicitly refers to compliance with industry standards for safety, EMC (Electromagnetic Compatibility), and essential performance as the main performance metric for the modified device.

Implicit Acceptance Criteria and Reported Performance (Based on the provided text):

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