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The A7 Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

The A7 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.

The A7 Anesthesia System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor and provides for automatic and manual modes of ventilation. The A7 incorporates 02, CO2, N2O and Agent concentration monitoring (Desflurane, Isoflurane, Enflurane, Sevoflurane and Halothane). The A7 consists of a main unit (includes an anesthetic ventilator and flow meter monitor assembly) and a detachable breathing system.

The provided document is a 510(k) premarket notification for a medical device, the A7 Anesthesia System. It aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a clinical study involving experts and ground truth as might be expected for an AI/ML device.

Therefore, much of the requested information (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, and how training set ground truth was established) is not applicable or available in this type of document, as it describes a traditional medical device and its performance is validated through engineering and safety standards, not AI-centric clinical studies.

However, I can extract information related to "acceptance criteria" in the context of this device's regulatory pathway, and the "study" (testing) that proves it meets these criteria, which are primarily engineering standards and performance specifications.

Here's the breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

For an anesthesia system, "acceptance criteria" are typically defined by recognized consensus standards for safety and performance, and the "reported device performance" demonstrates adherence to these standards and documented specifications. The document provides a detailed comparison to a predicate device, which implicitly defines performance targets.

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

• Sample Size: Not applicable. For this type of device, "testing" refers to verification and validation against engineering specifications and standards, often conducted in a laboratory or simulated environment, not a clinical "test set" in the sense of patient data.
• Data Provenance: Not applicable. The testing described is functional and safety testing to standards, not based on patient data.

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

• Not applicable. Ground truth in the context of device performance is established by metrology, engineering specifications, and adherence to recognized standards, not by expert consensus on patient data.

4. Adjudication method for the test set

• Not applicable. There is no "adjudication method" in the sense of reconciling disagreements among experts for a clinical dataset. Device performance is objectively measured against predefined engineering and safety criteria.

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 an anesthesia system, not an AI/ML-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This device is a traditional medical apparatus, not an algorithm, and is designed for human operation within a clinical workflow.

7. The type of ground truth used

• Engineering specifications and recognized consensus standards. The device's "performance data" describes compliance with several IEC, ISO, ASTM, and CGA standards (e.g., IEC 60601 series for safety and essential performance, ISO 14971 for risk management, ISO 5356-1 for connectors, ISO 21647 for respiratory gas monitors, ASTM F1101-90 for ventilators, etc.). Biocompatibility testing (ISO 10993 series) also constitutes a "ground truth" for material safety.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML system that requires a "training set" of data.

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

• Not applicable. As it's not an AI/ML system, there is no training set or ground truth established for one.

Summary of Acceptance Criteria and Proving Compliance for this Device:

The "acceptance criteria" for the A7 Anesthesia System are primarily defined by:

1. Safety and Performance Standards: The device must meet the requirements of a comprehensive list of international and national standards (e.g., IEC 60601 series, ISO 10993 series, ISO 14971, ASTM F1101, etc.).
2. Functional Specifications: The device must perform according to its design specifications (e.g., flow ranges, accuracy of gas monitoring, alarm functionalities, ventilation modes, etc.) as demonstrated through comparison with a legally marketed predicate device (the A5 Anesthesia System).
3. Biocompatibility: Materials in patient or gas path contact must comply with ISO 10993 requirements.
4. Software Validation: The software must be fully verified and validated in accordance with FDA guidance.

The "study that proves the device meets the acceptance criteria" consists of:

• Biocompatibility Testing: Conducted per ISO 10993-1, 5, 10, and 18 for cytotoxicity, irritation, sensitization, and volatile organic compound testing.
• Software Verification and Validation: Documentation provided to FDA in accordance with relevant guidance.
• Performance Testing: Demonstrated compliance with its product specifications and intended use by adhering to the listed standards (e.g., IEC 60601-1, IEC 60601-2-13, ISO 21647, etc.). This involves engineering tests, measurements, and simulations to confirm that the device's functional characteristics match its design and meet the safety and performance requirements set by the standards and predicate device's established performance.
• Substantial Equivalence Comparison: A detailed technical comparison to the predicate A5 Anesthesia Delivery System (K123211) showing that any differences do not raise new questions of safety or effectiveness. The comparison table explicitly lists how the A7's performance metrics align with or, in some cases (like individual gas flow accuracy), improve upon the predicate's. New features (Fresh Gas Control System, Negative Pressure Suction Device, Agent Consumption Calculation, Auxiliary Common Gas Outlet, Sample Gas Return, Quick Release APL Valve, Auxiliary Work Surface) were also subjected to performance testing to ensure safety and effectiveness.

In essence, for this type of traditional medical device, "acceptance criteria fulfillment" is a demonstration of engineering rigor, adherence to recognized safety and performance standards, and functional equivalence (or justifiable differences) to a predicate device, rather than a clinical trial with patient data interpreted by experts.

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