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The anesthesia workstation Perseus is intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.

Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system.

Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents.

Ventilation is accomplished on the patient through a laryngeal mask, a mask, or an endotracheal tube.

The integrated breathing system can be used with partial rebreathing (low-flow or minimumflow).

A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional).

Perseus A500 is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.

The Perseus A500 is a continuous flow gas anesthesia system that delivers anesthetic vapour, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas, and agent identification.

The main functionality of the anesthesia system comprises

• gas delivery for mixing oxygen and carrier gases, -
• anesthetic agent delivery (via vaporizers such as Dräger Vapor 3000),
• anesthesia ventilator (blower based), -
• anesthesia breathing system ABS, -
• airway monitoring (flow, pressure, gas concentrations) .

The Perseus A500 consists of the following main components:

• M3 Blower based Anesthesia Ventilator, electrical driven, supporting the Ventilation . modes
  • o Man/Spont
  • o Volume Controlled
  • Pressure Controlled o
• Embedded control display with touch screen technology and rotary/confirm knob for selecting and confirming parameters.
• . Gas Mixer
• . Heated integrated Anaesthesia Breathing System ABS
• Patient Gas Monitoring with agent mixture detection and Oxygen monitoring .
• Integrated Anesthesia Gas Scavenging System -
• Auxiliary Oxygen Therapy w/ flow indicator -
• Oxygen cylinder support (reserve gas inlet) -

The provided document is a 510(k) premarket notification for the Dräger Perseus A500 anesthesia machine. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results often found for novel devices or AI/ML-driven diagnostics.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy), nor does it describe a study explicitly designed to "prove the device meets the acceptance criteria" in the way one would for a diagnostic or AI algorithm.

Instead, the submission demonstrates compliance with recognized safety, performance, and electromagnetic compatibility standards, and states that the device's functionality and performance are substantially equivalent to its predicate devices.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

Acceptance Criteria and Study for Dräger Perseus A500 Anesthesia Machine

The Dräger Perseus A500 anesthesia machine is a Class II medical device, and its 510(k) submission (K133886) focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant industry standards for safety and performance. This is a different regulatory pathway than for novel diagnostic devices, especially those utilizing AI, which would typically involve detailed performance metrics like sensitivity, specificity, and ROC curves.

1. Table of Acceptance Criteria and Reported Device Performance

As this is an anesthesia machine and not a diagnostic device, the acceptance criteria are based on compliance with harmonized standards, functional equivalence to predicate devices, and safety. Quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are not presented in this 510(k) summary in the way they would be for an AI model.

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

Not applicable in this context. The "test set" here refers to the device itself being tested against standards and its predicate, not a dataset for an algorithm. The evidence presented focuses on engineering verification and validation, and demonstrating equivalence. No specific "data provenance" related to a test set for an algorithm is mentioned.

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

Not applicable. This is not a study requiring expert-established ground truth for an AI algorithm. The "ground truth" for this device's performance is compliance with established engineering and medical device standards, and functional equivalence to legally marketed predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process for a test set in the context of this device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be expected for this type of device (anesthesia machine). This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is being evaluated.

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

Not applicable. The Perseus A500 is an anesthesia machine, not a standalone algorithm. Its performance is inherent to its mechanical and electronic functions.

7. Type of Ground Truth Used

The "ground truth" for this submission is multifaceted:

• Compliance with harmonized standards: The device's performance is measured against the requirements of international and national standards (e.g., IEC 60601 series, ISO 8835 series, ISO 21647, ISO 10993, ISO 15001, ISO 17664).
• Engineering specifications: The device is verified and validated against its own design specifications.
• Functional equivalence to predicate devices: The functionality, indications for use, and general performance are compared directly to previously cleared anesthesia machines.
• Risk analysis: Hazard identification and mitigation are based on established risk management processes.
• Usability evaluation: User feedback validates the intuitiveness and safety of operation.

8. Sample Size for the Training Set

Not applicable. The Perseus A500 is an anesthesia machine, not an AI/ML algorithm that requires a training set.

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

Not applicable, for the same reasons as #8.

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