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The Vital Signs device is intended for noninvasive spot measurement of pulse rate and breathing rate when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

The system is intended for use by appropriately trained staff and should not be used by untrained users.

The Vital Signs device is indicated for use on subjects 12 years of age or older who do not require critical care or continuous vital signs monitoring.

The device is not intended to be the sole method of checking the physical health of a subject.

The subject device is the next generation device of the predicate (K211906).

Vital Signs is a software-only medical device (SaMD) that provides retrospective monitoring of non-contact pulse rate and respiratory rate data derived from video, without the need for contact devices to be attached to the patient or bed.

The device consists of custom-designed software assessing video footage collected using off-the-shelf cameras installed within single occupancy rooms within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient spot heart rate and respiratory rate data from the analysis of this video data, once the user has followed a workflow to initiate the system's data analysis.

Improvements to the device compared to the predicate are as follows:
• 24 hour trends
• Expansion of intended population from 18 years and older → 12 years and older
• Widened respiratory rate range from 8-31 bpm → 8-39 bpm

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) Clearance Letter for the Oxehealth Vital Signs Device:

1. Table of Acceptance Criteria and Reported Device Performance

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The PanopticAl Vital Signs device is intended for noninvasive spot measurement of pulse rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera.

The PanopticAl Vital Signs device is intended for use by healthcare professionals. The device is only intended to be used in healthy subjects.

The PanopticAl Vital Signs device is indicated for use on humans 18 to 60 years of age who do not require critical care or continuous monitoring.

The PanopticAl Vital Signs device is not intended to be the sole method to assess a subject's physical health condition. The pulse rate measurements it provides should complement, not replace, professional medical care and/or medication.

PanopticAl Vital Signs is a medical software device that uses remote photoplethysmography (rPPG) to measure a person's pulse rate. The app utilizes the surrounding light as the light source and works by capturing and measuring the subtle color changes on the skin caused by light absorption and reflection by the blood vessels beneath the skin. The app uses the front camera of an iPhone or iPad to capture videos of the subject. Then, the algorithm in the app detects and tracks the subject's face to capture the subtle light changes reflected in the changes in RGB pixel values. This information is sent to PanopticAl's cloud server for further processing to calculate the pulse rate. The pulse rate value is then returned to the PanopticAl Vital Signs app, and the result is displayed on the app.

Here's a breakdown of the acceptance criteria and study details for the PanopticAI Vital Signs 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

• Sample Size (Clinical Validation Study): N=107
• Data Provenance: The document does not explicitly state the country of origin. It describes participants based on gender, age, BMI, facial shape, history of hypertension, race/ethnicity (Asian, Black, Hispanic, White), and Fitzpatrick Skin Type Scale. The study appears to be prospective since it's a clinical validation study aiming to assess agreement between the device and a "standard pulse rate measurement by a clinician."

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

The document mentions "standard pulse rate measurement by a clinician" as the ground truth. It does not specify the number of clinicians or their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth. The ground truth was based on "standard pulse rate measurement by a clinician."

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

No. The document describes a clinical validation study comparing the device's performance to a clinician's standard measurement. It does not mention an MRMC study or the effect size of human readers improving with AI assistance. The device is a standalone measurement tool.

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

Yes, a standalone study was performed. The clinical validation study directly assesses the PanopticAI Vital Signs app's accuracy against a clinical standard, demonstrating its performance without human interpretation of its outputs beyond what is displayed by the app itself. The device is intended for "non-invasive spot measurement of pulse rate," implying a direct output from the algorithm.

7. Type of Ground Truth Used

The ground truth used was expert consensus / clinical measurement from a "clinician" performing "standard pulse rate measurement."

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set. It focuses solely on the clinical validation (test) set.

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

Since the training set sample size is not provided, how its ground truth was established is also not described in this document.

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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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The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users.

The Oxehealth Vital Signs device is indicated for use on humans 18 years of age or older who do not require critical care or continuous vital signs monitoring.

The device is not intended to be the sole method of checking the physical health of a subject.

The modified Oxehealth Vital Signs device uses custom-designed software to read data collected using off-the-shelf cameras. Data collected in this manner can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Video is collected through video cameras installed in each room. When run through proprietary software- controlled algorithms, the software will allow a user to make spot checks for pulse and breathing rates of the individual in the room. Validation testing has demonstrated that the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates.

Based on the provided text, the Oxehealth Vital Signs device is a software-only medical device used for noninvasive spot measurement of pulse rate and estimated breathing rate. The document (K220899) is a Special 510(k) Notice, indicating modifications to a previously cleared device (Oxehealth Vital Signs version 1.47.0, K211906), rather than an initial submission. Therefore, the detailed clinical study data with sample sizes for test and training sets, ground truth establishment methods, expert qualifications, and detailed statistical results (like MRMC study effect sizes) are not explicitly present in this document, as it refers back to the original DEN200019 submission for clinical evidence.

However, based on the provided text, we can extract the following information regarding acceptance criteria and general study approach:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "no change" in performance for the modified device compared to the predicate, K211906, which in turn relied on clinical evidence from DEN200019. Therefore, the acceptance criteria and reported performance for the modified device are the same as its predicate.

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

• Test Set Sample Size: This specific 510(k) submission (K220899) does not provide new sample sizes for a test set. It states: "Clinical evidence was supplied and reviewed in DEN200019. The proposed modifications discussed in this Special 510(k) submission do not affect any of the fundamental principles of operation or performance of the device in measuring pulse rate and estimating breathing rate (chest wall movements). ... The original clinical evidence is still considered applicable now, no new clinical evidence is required..." To find the specific sample sizes, one would need to refer to the DEN200019 submission.
• Data Provenance: Not specified in this document. It would be in the original DEN200019 submission.

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

• Not specified in this document. This information would be in the original DEN200019 submission.

4. Adjudication Method for the Test Set

• Not specified in this document. This information would be in the original DEN200019 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

• This device is a standalone measurement device, not an AI-assisted diagnostic tool for human readers, so an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance is not applicable to its stated function. The primary comparison is to "conventional methods and technology" for vital sign measurement (as stated in Device Description, page 5 of 11).

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

• Yes, this is a standalone device. The "Validation testing has demonstrated that the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates." (Device Description, page 5 of 11). The performance data listed in the table (50-130 ± 3 bpm, 8-31 ± 2 bpm) refers to the algorithm's direct output compared to a reference.

7. The Type of Ground Truth Used

• The ground truth for the clinical evidence (from DEN200019) was established by comparison with "a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner." (Clinical data requirement, page 6 of 11). This implies direct physiological measurement using established medical devices.

8. The Sample Size for the Training Set

• Not specified in this document, as it refers back to the original DEN200019 submission for clinical evidence.

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

• Not specified in this document, as it refers back to the original DEN200019 submission for clinical evidence. However, given that it's a device that measures vital signs by assessing video footage, it's highly probable that the ground truth for training would have been established by simultaneously recording vital signs using "clinically accurate patient-contacting relevant comparator devices" while the video footage was collected.

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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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