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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 Accutorr 7 Vital Signs Monitor is intended for 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 7 Vital Signs Monitor is a compact, easy-to-use vital signs monitor designed to satisfy basic monitoring needs. This patient monitor consists of a main unit, parameters measurement accessories, peripheral equipments or accessories.

The provided 510(k) summary for the Accutorr 7 Vital Signs Monitor (K132038) does not contain the detailed acceptance criteria or a specific study that proves the device meets those criteria in the typical format of a clinical or performance study with numerical endpoints.

Instead, the submission states:

"The Accutorr 7 Vital Signs Monitor comply with the recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. Mindray's product development process required that the following activities be completed during the development of those patient monitors:

Requirements specification review
Hardware and Software testing
Code design and code reviews
Environmental EMC testing
Wireless testing
Safety testing
Performance testing
Hardware and Software validation"

And concludes:

"The results of all testing demonstrate that the Accutorr 7 Vital Signs Monitor is as safe, as effective, and perform as well as the predicate devices."

This indicates that the device's performance was evaluated against internal requirements, recognized standards, and by demonstrating substantial equivalence to its predicate devices (VS-800 Vital Signs Monitor, K072235). The document does not provide a table of acceptance criteria with specific numerical targets or a study report detailing specific performance metrics (e.g., accuracy, precision) for SpO2, PR, NIBP, and TEMP, nor does it describe the methodologies for such studies.

Therefore, most of the requested information cannot be extracted from this document.

However, I can populate the table and answer the questions based on the general information provided, highlighting what is not explicitly stated as "N/A" (Not Applicable from this document) or "Not specified".

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document primarily refers to "Hardware and Software testing," "Performance testing," and "Hardware and Software validation" without detailing the sample sizes (e.g., number of patients, number of measurements) or the specific data used.
• Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective).

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

• Not applicable. The document does not describe a study involving expert-established ground truth for a test set in a clinical context. The "testing" mentioned appears to be engineering and performance verification against standards and internal requirements, rather than a clinical trial with expert adjudication.

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

• Not applicable. No expert-based adjudication is described.

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 performance described is for the device as a standalone vital signs monitor. However, the exact methodology for this standalone performance (e.g., specific accuracy metrics against a reference standard) is not detailed in this summary. It states "Performance testing" was done, indicating some form of standalone evaluation.

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

• Not explicitly stated. For vital signs monitors, the "ground truth" for performance testing typically involves comparison against a reference standard device (e.g., a calibrated pressure manometer for NIBP, a co-oximeter for SpO2, a calibrated thermometer for TEMP, ECG for PR). The document does not specify these reference standards.

8. The sample size for the training set

• Not applicable. This vital signs monitor is not described as an AI/ML-based device that would typically involve a "training set."

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

• Not applicable, as it's not an AI/ML-based device with a "training set."

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The Passport M Series patient monitors including models Passport 17M and Passport 12M are intended to be used for monitoring, displaying, reviewing, alarming and transferring of multiple physiological parameters including ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, ST segment analysis, heart rate(HR)), respiration rate(RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure(IBP), cardiac output (C.O.), continuous cardiac output (CCO), mixed/central venous oxygen saturation(SvO2/ScvO2), carbon dioxide (CO2), Oxygen(O2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM).

All the parameters can be applied for single adult, pediatric and neonatal patients with the exception of the follows: the arrhythmia detection, ST Segment analysis (Mortara algorithm), BIS, RM, CCO, SvO2/ScvO2 and PAWP monitoring are intended for adult and pediatric patients only. ST Segment analysis (Mindray algorithm) is intended for adult patients only. C.O. is only for use on adult patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. It must only be used by persons who have received adequate training in its use. It is not intended for helicopter transport, hospital ambulance, or home use.

The Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) are the developed new series based on the technical platform of the BeneView T Series patient monitors. The new series, much more compact and flexible with the appearance changes, are the sub-configuration models of the BeneView T Series patient monitors by adding some parameters monitoring functions, such as continuous cardiac output (CCO) and mixed /central venous oxygen saturation (SvO2/ScvO2) monitoring.

And comparing with the cleared BeneView T Series Patient Monitors using Mortara ECG algorithm, the subject patient monitors adopt Mindray Monitoring ECG Algorithm as an optional ECG algorithm to implement ECG monitoring, arrhythmia detection, and ST Segment Analysis.

The provided text is a 510(k) summary for the Mindray Passport M Series Patient Monitors. It describes the device, its intended use, and its classification, and states that it complies with recognized safety, performance, and electromagnetic compatibility standards. However, it does not include specific acceptance criteria or an explicit study describing how the device meets those criteria.

The "Test Summary" section states: "The Passport M Series Patient Monitors (including models Passport 17M and Passport 12M) comply with the recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. Mindray's product development process required that the following activities be completed during the development of those patient monitors: Requirements specification review, Hardware and Software testing, Code design and code reviews, Environmental EMC testing, Safety testing, Performance testing, Hardware and Software validation."

While this indicates that performance testing and validation were conducted, it does not provide details on the specific acceptance criteria, the methodology of the studies, or the reported device performance against those criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies from the provided text.

To answer your request, a more detailed performance study report would be needed.

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