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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.

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The Sigma Alpha Vaporizer vaporizes a specific anaesthetic agent - Suprane®, also know as Desflurane - and delivers controlled concentrations of the vaporized anaesthetic agent into a fresh gas that is then breathed by the patient. The Sigma Alpha Vaporizer is indicated for use by both adult and pediatric patients. The Sigma Alpha Vaporizer is not intended to be used with Enflurane, Halothane, Isoflurane or Sevoflurane, or for use in a breathing circuit. The Sigma Alpha Vaporizer is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. It is supplied as a prescription device, and the labeling indicates this.

The Sigma Alpha Vaporizer is an electronic calibrated vaporizer that is designed to enrich the fresh gas flow of a continuous flow anaesthesia machine, when the vaporizer is connected directly between the flowmeter and the common gas outlet of the machine. The device has been developed in close co-operation with clinicians and the anaesthetic agent manufacturer.

This document is a 510(k) summary for the Sigma Alpha Vaporizer. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics typically associated with AI/ML-based medical devices.

Therefore, many of the requested items related to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established) are not applicable or not present in this document.

Here’s an analysis based on the provided text, addressing what can be extracted:

Acceptance Criteria and Device Performance Study for Sigma Alpha Vaporizer

This 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria and proving performance against them in a detailed clinical study with quantifiable metrics as one would expect for a novel AI/ML device.

The "study" in this context refers to the comparison of the Sigma Alpha Vaporizer's technological characteristics, intended use, and indications for use against predicate devices. The implicit acceptance criterion is that the new device is "as safe and effective" as the predicates, and that its technological characteristics are "very similar" without any "minor differences" making it "any less safe and effective."

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion (Implicit)	Reported Device Performance (as per 510(k))
   Substantial Equivalence (Overall Safety & Effectiveness to Predicates): The device must be "as safe and effective" as analogous legally marketed predicate devices. This implies meeting performance standards for anesthetic vaporizers in terms of vaporizing specific agents and delivering controlled concentrations.	The document concludes: "From the above information it is concluded that the Penlon Sigma Alpha Vaporizer is substantially equivalent to the above named predicate devices." It explicitly states that "any minor differences do not make the Sigma Alpha any less safe and effective than the predicate devices."
   Intended Use & Indications for Use Match Predicates: The device's intended use and indications for use should align with the predicate devices.	"The intended use and indications for use apply equally to the above named predicate devices." The device is intended to vaporize Suprane® (Desflurane) and deliver controlled concentrations to patients (adult and pediatric).
   Technological Characteristics Similarity: The device's technological characteristics must be very similar to predicate devices.	"The technological characteristics of the Sigma Alpha and the predicate Devices... are very similar."

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

   • N/A. This is a 510(k) for a medical device (anesthetic vaporizer), not an AI/ML diagnostic or predictive tool. There is no "test set" of observational data in the AI/ML sense mentioned in this document. The evaluation is based on device design, engineering specifications, and comparison to predicate devices.

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

   • N/A. No "ground truth" establishment in the AI/ML sense. The approval process relies on regulatory review by FDA experts based on the device's documentation and demonstrated substantial equivalence, rather than expert consensus on a dataset.

4. Adjudication method for the test set:

   • N/A.

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:

   • N/A. This device is an anesthetic vaporizer, not an AI-assisted diagnostic tool.

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

   • N/A. This device does not involve an algorithm with standalone performance.

7. The type of ground truth used:

   • N/A. For this type of device, "ground truth" would relate to engineering measurements verifying the vaporizer's output accuracy against its calibrated settings under various operating conditions. Such detailed test results are typically presented in the full 510(k) submission, but only the summary is provided here, which focuses on substantial equivalence. The summary does not provide specific performance data beyond the claim of substantial equivalence.

8. The sample size for the training set:

   • N/A. There is no "training set" in the AI/ML sense for this device.

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

   • N/A.

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