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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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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 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 monitor is intended to be used for monitoring, storing, and reviewing of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitor is intended for use by trained healthcare professionals in hospital environments.

Monitored parameters include: NIBP, SpO2, PR (pulse rate), Quick TEMP/Infrared TEMP.

The monitor is not intended for MRI environments. TEMP module is not intended for neonates.

The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP).
• For the Monitor mode, the user can do continuous measurement, monitoring, alarming and manager patient data.
• For the Spot mode, also call spot check mode, the user can measure parameters quickly without creating a patient within the instrument workflow.
• The Round mode is designed to support hospital staff when doing ward rounds. The Round mode is similar as Spot mode. The difference between Round mode and Spot mode is that for one ward round, the iM3 can additionally store one ward round record automatically (the latest measurement) or manually (user can choose the measure results).

iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately.

The iM3can connect with EDAN's MFM-CMS Central Monitoring System to display the iM3 data on a remote work station. The MFM-CMS system received FDA 510(k) clearance on June 21, 2013(K120727)

The provided text is a 510(k) summary for the Edan Instruments iM3 Vital Signs Monitor, seeking FDA clearance based on substantial equivalence to predicate devices. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

The document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm being developed or tested against a ground truth for diagnostic or prognostic performance. Instead, it discusses the performance as it relates to comparison with a predicate device and compliance with established medical device standards.

Therefore, many of the requested details related to AI/ML validation studies (like sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training/test sets) are not applicable to this document as it describes a traditional vital signs monitor seeking 510(k) clearance, not an AI/ML diagnostic or prognostic device.

However, based on the provided text, I can infer and extract information relevant to the device's functional performance criteria and what was demonstrated:

Acceptance Criteria and Reported Device Performance (Inferred from comparison to predicate and standard compliance):

The "acceptance criteria" here are implicitly defined by the performance specifications of the predicate devices and relevant IEC/ISO standards for vital signs monitors. The reported device performance is presented as being "similar" to the predicate and compliant with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• This document does not specify a "test set" in the context of an AI/ML model, but rather refers to performance validation against established standards.
• The comparison data presented in the tables are physical performance specifications of the device modules, not patient data from a clinical trial in the AI/ML sense. Actual human testing for NIBP, SpO2, and TEMP accuracy would have been done to meet the standards (e.g., ISO 81060-2:2013 for NIBP, ISO 80601-2-61: 2011 for SpO2, ISO 80601-2-56 for TEMP), but the specifics (sample sizes, provenance) are not detailed in this summary. These physical performance tests are typically done in controlled lab settings or with human subjects as required by the specific standard.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as this is not an AI/ML diagnostic device requiring expert consensus on image interpretation or similar. The "ground truth" for vital signs monitoring validation is typically measured physiological parameters from reference devices.

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

• Not applicable.

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

• Not applicable.

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

• Not applicable. The device directly measures physiological parameters. Its performance is inherent to its sensors and processing, and the accuracy claims are against reference measurements, not an independent algorithm being evaluated.

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

• The ground truth for the performance claims would be highly accurate reference measurements from precisely calibrated medical devices or established physiological measurement techniques (e.g., intra-arterial blood pressure for NIBP, co-oximetry for SpO2, highly accurate thermometers for TEMP). The document states compliance with relevant ISO/IEC standards which dictate the methods for determining accuracy, including the reference methods.

8. The sample size for the training set:

• Not applicable. This is a vital signs monitor, not a machine learning algorithm that requires a "training set" for its core function.

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

• Not applicable.

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The vital signs monitor is intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters of patients, including Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

This vital signs monitor is used to monitor vital signals for use in hospital environments including out-patient department, wards and NICU. It is not intended for helicopter transport, hospital ambulance or home use. And it is applicable for adult, pediatric and neonatal patients.

The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

The following lists the detailed features of the subject device.

• LCD/LED display
• SpO2, Pulse Rate NIBPCO2 and TEMP measurement
• Infrared ear temp or fast temp module for Temp measurement
• Nellcor or Masimo or BLT SpO2 module
• Display numeric and waveform information simultaneously .
• Nurse call feature
• . Built-in Lithium-ion Battery
• Suitable for adult, pediatric and neonate patients .
• Visual and audible alarm

The document describes a 510(k) premarket notification for the V6 Vital Signs Monitor. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the context of AI/ML devices.

Therefore, many of the requested categories for acceptance criteria and study details for an AI-powered device are not applicable to this submission. This document describes a traditional medical device (vital signs monitor) which is evaluated based on its compliance with established electrical safety, EMC, and performance standards for each physiological parameter.

Here's an analysis based on the provided document, highlighting applicable information and noting where information for AI/ML performance would typically be found but isn't present here:

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

The document provides a comparison of the proposed device (Vital Signs Monitor V6) and its predicate devices, especially regarding technical specifications and compliance with standards. It does not present specific "accepted criteria" in terms of performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI/ML diagnostic or assistive device. Instead, it demonstrates compliance with recognized medical device standards and equivalence to a predicate.

For the newly added F3000 Temperature Module, a "Clinical Electronic Thermometers testing" was conducted pursuant to guidance. The table below focuses on the reported accuracy of the temperature measurement, which can be interpreted as a performance metric for that specific function.

Note: The "acceptance criteria" here are largely derived from the predicate device's performance or standard requirements that both devices are expected to meet. For NIBP, SpO2, and CO2, the document only states that compliance with relevant IEC standards (IEC80601-2-30 for NIBP, IEC80601-2-61 for pulse oximeter) was demonstrated, but does not provide specific accuracy ranges within the provided text.

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

The document states: "No clinical study is included in this submission." This implies that for the substantial equivalence claim, the manufacturer relied on non-clinical testing and comparison to the predicate device, rather than a clinical study with a dedicated test set on human subjects to evaluate performance like sensitivity or specificity. For the temperature module, it mentions "Clinical Electronic Thermometers testing" but does not detail sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. There is no clinical study data presented for expert-established ground truth.

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

Not applicable. There is no clinical study data presented requiring adjudication.

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

Not applicable. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers.

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

The device is a standalone vital signs monitor. Its "performance" is evaluated by its ability to accurately measure physiological parameters and comply with relevant international standards. The non-clinical tests mentioned demonstrate the device's standalone performance in meeting design specifications and standard requirements.

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

For the non-clinical tests and equivalence claims of the vital signs monitor, the "ground truth" would be established by:

• Reference instruments and calibration standards for objective measurements (e.g., for SpO2, NIBP, temperature).
• Compliance with the technical requirements and performance specifications outlined in international standards (e.g., IEC 60601 series, IEC80601 series).

For the temperature module, "Clinical Electronic Thermometers testing" likely involved comparison to highly accurate reference thermometers in a controlled clinical setting, but specific details are not provided.

8. The sample size for the training set

Not applicable. This device does not appear to involve an AI/ML algorithm that would require a "training set" in the conventional sense for a diagnostic product. Its functionality is based on established hardware and software algorithms for physiological parameter measurement rather than machine learning on a dataset.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The monitor is intended for spot-check monitoring physiologic parameters, including SpO2, PR, NIBP and TEMP, on adult, pediatric, and neonatal patients in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

The Accutorr 3 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. It consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.

The Accutorr 3 Vital Signs Monitor is designed to monitor a fixed set of physiological parameters including Pulse Oxygen Saturation (SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP) and Temperature (TEMP). This monitor provides 3 different SPO2 modules manufactured by Mindray, Masimo or Nellcor.

The provided text describes the regulatory submission for the "Accutorr 3 Vital Signs Monitor." It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies with specific metrics.

The document primarily focuses on:

• Device Description: A compact, easy-to-use vital signs monitor for SpO2, PR, NIBP, and TEMP on adult, pediatric, and neonatal patients.
• Intended Use: Spot-check monitoring of physiological parameters in healthcare facilities.
• Predicated Device: VS-800 Vital Signs Monitor (K072235).
• Non-clinical Tests: Compliance with various international and national safety, biocompatibility, electromagnetic compatibility, and performance standards.
• Clinical Studies: States that NIBP and TEMP modules were "evaluated for clinical accuracy" and "tested and evaluated under applicable clinical standards" (ISO 80601-2-56 for thermometers and ISO 81060-2 for non-invasive sphygmomanometers). However, it does not provide the results of these clinical studies, specific acceptance criteria, or details of the study design.
• Conclusion: Claims the device is "as safe, as effective, and perform as well as the predicate device" based on testing.

Therefore, most of the requested information cannot be extracted from this document because the detailed results of clinical studies and acceptance criteria are not published here.

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

• Cannot be provided. The document only mentions that the NIBP and TEMP modules were evaluated for clinical accuracy against specific standards (ISO 80601-2-56 and ISO 81060-2). It does not list the specific acceptance criteria (e.g., mean difference, standard deviation, accuracy zones) or the reported performance values from those evaluations.

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

• Cannot be provided. The document states clinical accuracy evaluations were performed for NIBP and TEMP but gives no details about the sample size, data origin, or study design (retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Cannot be provided. This type of information is typically relevant for studies involving subjective interpretation (e.g., medical imaging). For vital signs monitors, ground truth is usually established via reference methods (e.g., invasive blood pressure, rectal temperature, CO-oximetry for SpO2) rather than expert consensus on interpretive tasks. The document does not specify how ground truth was established, beyond referencing the clinical standards.

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

• Not applicable / Cannot be provided. Adjudication methods are typically used in studies where multiple human readers assess data and discrepancies need resolving (e.g., image interpretation). This is not relevant for the type of clinical accuracy evaluation performed for a vital signs monitoring device.

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. This is not an AI-assisted diagnostic device, but a vital signs monitor. MRMC studies or AI assistance are not applicable in this context.

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

• Partially applicable. The NIBP and TEMP modules underwent "clinical accuracy" evaluations. For a vital signs monitor, these evaluations inherently test the device's "standalone" performance against a reference standard. However, no performance metrics are given.

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

• Inferred, but not explicitly stated with details. For NIBP, the standard (ISO 81060-2) typically requires comparing the device's readings against simultaneous readings from a reference method (e.g., intra-arterial blood pressure). For temperature, the standard (ISO 80601-2-56) usually involves comparison against a highly accurate reference thermometer measurement (e.g., rectal or tympanic probe depending on the device's site). The document does not explicitly state these methods were used, only that the device was evaluated under these standards.

8. The sample size for the training set

• Not applicable / Cannot be provided. This device is not described as using machine learning or AI that would involve a "training set." Its core functionality relies on established physiological measurement principles.

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

• Not applicable / Cannot be provided. See point 8.

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The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:

• noninvasive blood pressure,
• pulse rate,
• noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
• body temperature in normal and axillary modes.

The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.

The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.

The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Optional compatible weight scales (e.g., Health o meter") can be used for height, and BMI input.

The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.

The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition.

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

The Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) is designed to provide a scalable, modular system of components which can be configured to address the needs for vital signs spot checking and continuous monitoring.

The Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing modules installed into the base unit including;

• NIBP Module provides measurements of noninvasive blood pressure and pulse rate.
• SpO2 Modules from Nellcor and Masimo provide pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin.
• The Masimo SpO2 Module can also provide hemoglobin measurements (SpHb, SpHbv) and acoustic respiration rate (RRa),
• The Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients.
• The Oridion Capnography Module equipped systems are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI) measurements,
• The EarlySense Module provide users the option of continuous and contact-less monitoring of respiration rate, heart rate and patient movement. The addition of this Module is the subject of this 510(k).

The CVSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner. IR temperature, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications, including, for example, to electronic record systems and for remote display and alarming (e.g., central station).

This looks like a 510(k) summary for the Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) that focuses on the addition of the EarlySense module. The submission claims substantial equivalence to a previously cleared device (K121013), not necessarily claiming novel performance that requires significant clinical studies.

Here's an analysis of the provided text regarding acceptance criteria and studies:

Key Takeaway from the Document:

The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." (Page 8). This means that for the subject device (the CVSM with the integrated EarlySense module), there wasn't a new clinical study to establish its performance. Instead, it relies on substantial equivalence to a predicate device and bench testing for the integration of the EarlySense module. The EarlySense module itself was previously cleared in a separate 510(k) (K120465), and the performance claims for respiration rate, heart rate, and patient movement from that clearance are what are being incorporated.

Therefore, the acceptance criteria and performance data for the overall device are generally based on the predicate device's performance, as well as the previously cleared EarlySense module's performance, and the current submission primarily addresses the safety and effectiveness of the integration via non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since no new clinical studies were performed for this specific 510(k), the "reported device performance" for the subject device (CVSM with EarlySense module) relies on the performance characteristics inherited from the predicate device and the previously cleared EarlySense module.

Note: The acceptance criteria for the EarlySense module's measurements (Respiration Rate, Heart Rate, Patient Movement) are those from its original 510(k) clearance (K120465), which are being appended to the CVSM's indications for use.

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

As explicitly stated: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data."

Therefore, there is no "test set" in the context of new clinical performance data generated for this 510(k) submission.

The section "Clinical Performance Data" directly states this lack of new clinical studies. The performance of the EarlySense module for respiration rate, heart rate, and patient movement was established in its prior 510(k) (K120465), and the current submission is for the integration of this already-cleared module into the CVSM.

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

Not applicable, as no new clinical studies were conducted for this submission that would require establishing a ground truth with experts. The performance data for the EarlySense module itself would have been established during its original K120465 clearance process.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical studies were conducted for this submission.

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

No, an MRMC comparative effectiveness study was not done as part of this 510(k) submission. The submission explicitly states "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." This type of study would be classified as a clinical study.

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

The document indicates that the "EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner." This implies a standalone algorithm for these measurements. However, no new standalone performance study was done for this submission. The performance characteristics of the EarlySense module were presumably established during its original K120465 clearance. This 510(k) focuses on the integration of this already-cleared module into the Welch Allyn CVSM.

The "Non-Clinical Tests" section lists several bench tests (e.g., Electromagnetic Compatibility, Shock and Vibration, Thermal Shock, Operating Environmental Test, Battery Use Cycles, Electrical Safety, Industrial Design Specification Analysis, Shipping Container Labeling, BOM Verification, Design Validation, Directions For Use Validation). These are engineering and usability tests to ensure the integrated system functions safely and effectively, but they are not standalone performance studies of the measurement algorithms themselves.

7. The type of ground truth used

Not applicable for this 510(k) submission, as no new clinical studies were conducted. The ground truth for the EarlySense module's measurements (Respiration Rate, Heart Rate, Patient Movement) would have been established during its original K120465 clearance, likely using reference methods or gold standards for vital sign measurement.

8. The sample size for the training set

Not applicable for this 510(k) submission, as no new clinical studies were conducted. Any training data for the EarlySense algorithms would have been part of its original development and clearance (K120465).

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

Not applicable for this 510(k) submission. This information would pertain to the original development and clearance of the EarlySense module (K120465).

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The Vital Signs Monitor models M3 and M3A (hereinafter called monitor) is intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).

The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.

The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.

The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement.

The following lists the detailed features of the subject device.

• LCD or LED display
• SpO2, Pulse Rate NIBP and TEMP measurement
• T2 or TH or F3000 module for Temp measurement
• Nellcor or EDAN SpO2 module
• Display numeric and waveform information simultaneously
• Nurse call feature
• Built-in Lithium-ion Battery
• Suitable for adult, pediatric and neonate patients
• Visual and audible alarm

Here's an analysis of the provided text regarding the acceptance criteria and study for the Edan Instruments Vital Signs Monitor Models M3 and M3A:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and corresponding reported device performance values are not explicitly stated in a clear, tabulated format for the SpO2, NIBP, or TEMP measurements. The submission focuses on substantial equivalence to predicate devices and adherence to general safety standards rather than detailed performance metrics.

The document states:

• "The differences between the subject devices and predicate devices do not affect the basic design principle, usage, effectiveness and safety of the subject devices. And no question is raised relating to the safety and effectiveness." (Page 3)
• "Verification and validation testing were conducted on the Vital Signs Monitor Models M3 and M3A. This premarket notification submission demonstrates that Vital Signs Monitor Models M3 and M3A is substantially equivalent to the predicate device, and without any changes of the intended use compared to the predicate version." (Page 3)

The key acceptance criterion mentioned is substantial equivalence to predicate devices (Edan Instruments Inc.: M3 and M3A Vital Signs Monitor K120144, and The Kendall Company: K003313). The performance is implied to be at least equivalent to these predicate devices.

The only specific performance testing mentioned with regard to a standard is:

• "Clinical Electronic Thermometers testing for the newly added F3000 Temperature Module pursuant to the guidance 'Guidance on the Content of Premarket Notification [510(K)] Submission for Clinical Electronic Thermometers' dated Mar. 1993." (Page 2)

Without the detailed results of this thermometer testing, a quantitative table cannot be constructed from the provided text.

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

The provided text does not explicitly state a specific sample size used for a test set or the data provenance (e.g., country of origin, retrospective/prospective).

The document mentions "Verification and validation testing were conducted," but details on these tests, including sample sizes, subjects, or data sources, are absent. The "Clinical test: Clinical testing is not required" statement indicates that no human subject clinical trials were deemed necessary for this 510(k) submission, relying instead on non-clinical testing and equivalence to predicates.

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

Given that "Clinical testing is not required," the concept of "ground truth established by experts" for a test set using patient data is not applicable in this context. The evaluation was primarily based on non-clinical performance against standards and comparison to predicate devices.

4. Adjudication Method for the Test Set

As there was no explicit clinical test set requiring expert ground truth, an adjudication method is not applicable and not mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical testing is not required" and focuses on substantial equivalence and non-clinical testing. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

The device is a vital signs monitor, which is inherently a standalone measurement device that provides physiological parameters (SpO2, NIBP, TEMP). It collects and displays data directly. The provided text, however, focuses on its safety and performance relative to predicate devices and standards, rather than a specific "standalone performance study" in the context of an AI algorithm. If we interpret "standalone" as the device operating independently to deliver its intended measurements, then the entire submission implicitly supports its standalone performance. However, there's no separate study specifically labeled as "standalone performance" for an AI algorithm, as this device does not appear to primarily be an AI-driven diagnostic.

7. Type of Ground Truth Used

The primary "ground truth" implicitly relied upon for this submission is:

• Standards: Adherence to established non-clinical electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and thermometer testing standards.
• Predicate Device Performance: The demonstrated safety and effectiveness of the legally marketed predicate devices (K120144 and K003313). The new device's performance is asserted to be "the same or similar performance specifications" as these predicates.

8. Sample Size for the Training Set

The provided text does not mention or imply the existence of a training set. This is consistent with the device being a vital signs monitor primarily evaluated through non-clinical testing and comparison to predicates, rather than a machine learning or AI-driven diagnostic device that would typically involve a training set.

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

Since there is no mention of a training set, there is no information on how its ground truth would have been established.

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The Vital Signs Monitor M900 is used to monitor patient's physiological parameters such as Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), and Temperature (TEMP) continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department.

The Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Oxygen Saturation (SpO2), Carboxyhemoglobin Saturation (SpCO), Methemoglobin Saturation (SpMet), Total Hemoglobin Concentration (SpHb), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

It is intended to be used in outpatient departments and emergency treatment rooms of hospitals, community clinics, private clinics and other medical institutions. It is not intended for helicopter transport, hospital ambulance or home use.

The proposed device, Vital Signs Monitor M900 is used to monitor patient's physiological parameters such as SpO2, PR, NIBP and TEMP continuously. It is intended to be used in health care unit or department, such as out-patient department, emergency department, internal ward, and nursing department.

The proposed device, Vital Signs Monitor V6 is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters of patients, including Oxygen Saturation (SpO2), Carboxyhemoglobin Saturation (SpCO), Methemoglobin Sathemoglobin Saturation (SpMet), Total Hemoglobin Concentration (SpHb), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Carbon dioxide (CO2) and Temperature (Temp).

The Vital Signs Monitor V6 is intended to be used in outpatients and emergency treatment rooms of hospitals, community clinics, private clinics and other medical institutions. It is not intended for helicopter transport, hospital ambulance or home use.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not explicitly state the specific sample size used for the clinical test of the Vital Signs Monitor V6. It only mentions that the clinical test was conducted "per ASTM E1965-98(reapproved 2009)."
• Data Provenance: The clinical test was conducted in People's Hospital in Zhuhai, indicating the data is from China. The document does not specify whether the data was retrospective or prospective, but clinical tests are typically prospective studies.

3. Number of Experts and their Qualifications for Ground Truth

The document does not provide information on the number of experts used or their qualifications to establish ground truth for the temperature measurement test. For a clinical study following ASTM E1965-98, ground truth usually relies on highly accurate reference thermometers used by trained clinical personnel, but specific details are not provided here.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method used for the test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device performance against a standard, not on human reader improvement with AI.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done for the temperature measurement of the Vital Signs Monitor V6. The clinical test evaluated the device's performance against the ASTM E1965-98 standard. This standard typically defines the accuracy requirements for infrared thermometers, meaning the device's temperature measurement algorithm and hardware were tested as a standalone system.

7. Type of Ground Truth Used

The ground truth for the temperature measurement test would have been established by comparing the device's readings to those of a highly accurate reference thermometer as mandated by the ASTM E1965-98 standard. This is a form of empirical measurement comparison against a validated reference.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This type of device (vital signs monitor for temperature) typically undergoes calibration and validation against standards rather than machine learning-style training using a distinct training set.

9. How Ground Truth for the Training Set Was Established

As no training set is described, there is no information on how its ground truth was established.

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