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V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.

V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.

V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.

V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.

V80 Anesthetic Vaporizer is used to provide desflurane vapour with controllable concentration.

The provided text is a 510(k) Summary for the Mindray V80 Anesthetic Vaporizer. It focuses on demonstrating substantial equivalence to a predicate device (D-Vapor Anesthetic Vaporizer) by comparing technical characteristics and performance data, mainly through bench testing and compliance with various standards.

Crucially, this document does not describe a study that uses a test set, ground truth established by experts, or measures human reader performance with or without AI assistance. The device in question is an anesthetic vaporizer, which is a piece of hardware, not an AI/software device that interprets medical images or diagnoses conditions. Therefore, many of the requested elements of your query (e.g., sample size for test set, number of experts, MRMC study, standalone performance for an algorithm, training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information from the document regarding its acceptance criteria and the type of studies conducted to prove it meets those criteria, specifically concerning its performance and other safety/effectiveness aspects.

Here's a breakdown of the requested information based on the provided document:

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

The document presents a comparison table between the subject device (V80 Anesthetic Vaporizer) and the primary predicate device (D-Vapor Anesthetic Vaporizer), essentially demonstrating that the acceptance criteria for the subject device are met by matching or exceeding the performance and specifications of the predicate.

Note: The differences in battery type and bridging time are addressed by stating, "The differences in technological characteristics do not raise new questions of safety and effectiveness," implying these differences meet safety and effectiveness criteria.

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

• Sample Size for Test Set: Not applicable as this is a hardware device where performance is evaluated through bench testing and compliance with standards rather than a test set of data samples. The functional and system level testing was conducted on the "subject device" (V80 Anesthetic Vaporizer). The exact number of units or test cycles for the bench testing is not specified in the summary, but it implies a sufficient number to validate performance.
• Data Provenance: The testing was conducted by "Mindray" (Shenzhen Mindray Bio-Medical Electronics Co., LTD. which is based in China). The document does not specify if these were retrospective or prospective tests, but for bench testing of hardware, it would inherently be prospective (testing a new device).

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

Not applicable. Ground truth as typically defined for AI/imaging devices (e.g., expert radiologist annotations) is not relevant for an anesthetic vaporizer's performance which is measured by objective physical parameters (e.g., concentration output, flow rate, warm-up time). The "ground truth" for these tests are the established specifications and consensus standards.

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

Not applicable. No expert consensus or adjudication method for medical interpretations is involved. Performance is measured against predefined engineering specifications and international standards.

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

Not applicable. This is a hardware device, not an AI-assisted diagnostic tool.

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

Not applicable in the context of an algorithm. However, the performance data presented is "standalone" in the sense that it measures the device's intrinsic performance characteristics (e.g., concentration delivery, flow rate) against engineering specifications, independent of human interaction other than setting up and operating the test itself.

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

The "ground truth" for this device's performance evaluation is based on:

• Engineering Specifications: The design specifications the device is intended to meet.
• Predicate Device Performance: The established performance characteristics of the legally marketed predicate device (K042276 – D-Vapor Anesthetic Vaporizer).
• Consensus Standards: Compliance with recognized international standards (e.g., ISO 80601-2-13, ISO 5360, IEC 60601 series, ISO 10993 series, ISO 18562 series) which define acceptable performance and safety limits for medical devices.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

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

Not applicable.

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The indications for use of the BeneVision Central Monitoring System include:

• Real time viewing of patient clinical data and alarms .
• . Storage and Historical review of patient clinical data and alarms
• Printing of real time and historical patient data
• Configuration of local settings as well as synchronizing settings across the network to a remote device
• Transfer of patient clinical data and settings between several CentralStations
• Provides a Resting 12 Lead interpretation of previously stored data

The BeneVision Central Monitoring System is a networked patient monitoring system intended for use in a fixed location, installed in professional healthcare facilities to provide clinicians remote patient monitoring. The network connections between the various devices can be any combination of Ethernet (Wireless WIFI (WLAN), and Wireless WMTS. The BeneVision Central Monitoring System supports one or more Mindray compatible physiological monitors and will display, store, print, and transfer information received from the compatible monitors. The Bene Vision Central Monitoring System supports bi-directional configuration of the compatible monitors.

The telemetry monitoring systems are designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The BeneVision Central Monitoring System supports Telemetry Systems: TMS-6016, Telepack-608, TMS60, TM80 and TM70.

The TMS-6016 transmitter is intended for use on Adult and Pediatric patients to monitor ECG and SpO2 physiological data.

The Panorama Telepack-608 transmitter is intended for use on Adult patients to monitor ECG and SpO2 physiological data.

The TMS60 transmitter is intended for use on Adult and Pediatric patients over three years old to monitor ECG, . SpO2, NIBP and Resp physiological data. The physiological data can be reviewed locally on the display of the transmitter. The CentralStation will support ECG, Heart Rate, SpO2, NIBP, Resp, Pulse Rate, Arrhythmia analysis, QT monitoring, and ST Segment Analysis for the TMS60.

. The TM80/TM70 telemetry monitor is intended for use on Adult and Pediatric patients over three years old to monitor ECG. SpO2. NIBP and Resp physiological data. The physiological data can be analyzed, alarmed, stored, reviewed locally on the display of the monitor, and the CentralStation can config and display the physiological parameters from the TM80/TM70.

The BeneVision Central Monitoring System is intended for use in professional healthcare facilities under the direct supervision of a licensed healthcare practitioner.

The BeneVision Central Monitoring System (CMS) is a networked patient monitoring system intended for use in healthcare settings by, or under the direction of, a physician to provide clinicians remote patient monitoring. The target patient population is adult patients and pediatrics.

The provided text is a 510(k) premarket notification summary for the BeneVision Central Monitoring System. It details the device, its intended use, comparison to predicate devices, and various testing performed to demonstrate substantial equivalence.

However, the document does not contain information about an AI/algorithm where acceptance criteria and specific performance metrics (like sensitivity, specificity, or AUC) or information related to multi-reader multi-case (MRMC) comparative effectiveness studies would typically be found. The changes describe modifications to the software for an existing central monitoring system, primarily related to operating system compatibility, supported monitors, and the addition of a "Resting 12 Lead interpretation of previously stored data" feature.

The document discusses "Software Verification and Validation Testing" and "Bench Testing" to ensure the device meets its specifications, but these tests are for the overall system's functionality and accuracy, not for an AI component that would require the level of detail requested in the prompt.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance for an AI model, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device, as this information is not present in the provided text.

The information that is available in the document regarding testing is general:

• Software Verification and Validation Testing: Conducted "as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This ensures the product "works as designed" and validates its "design and performance."
• Bench Testing: Conducted "functional and system level testing to validate the performance of the devices." The results "show that the subject device meets its accuracy specification, and is substantially equivalent to the predicate device."
• Consensus Standards: The device meets relevant consensus standards, specifically mentioning IEC 60601-2-25:2011 for electrocardiographs.

The document explicitly states:

• Animal Testing: "Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device."
• Clinical Data: "Not applicable. Clinical testing is not required to establish substantial equivalence to the predicate device."

Without an AI/ML component described with specific performance criteria and a study demonstrating its meeting those criteria, the detailed information requested in the prompt cannot be extracted from this document.

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