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The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (O2, N2O and CO2 - in combination with the CO2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

The Fourth Gas Module provides an optional means of delivering carbon dioxide (CO2) into the fresh gas coming from the gas mixer of the anesthesia machine Primus US "Apollo".

The Fourth Gas Module consists of a means of flow and pressure control for CO-; a colorcoded control knob; a means of flow and pressure measurement for CO;; a means to mount a CO2 E-size cylinder; and an enclosure for the various components.

The Fourth Gas Module has been verified to provide the Primus US "Apollo" anesthesia workstation (K042607) with a means of delivering carbon dioxide as a medical gas.

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets those criteria for the "Fourth Gas Module with CO2 for Primus US 'Apollo' Anesthesia machine."

The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices. It states:

• "Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards. The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use."

However, it does not provide details about specific acceptance criteria or the study data that supports this assurance.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

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The Primus US is indicated as a continuous flow anesthesia system. The Primus US may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.

The Primus US, is a continuous flow gas anesthesia system that delivers anesthetic vapor, 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 acceptance criteria and summary of the study for the Primus US Anesthesia Workstation are detailed below based on the provided document.

Acceptance Criteria and Device Performance

The provided document describes a 510(k) premarket notification for the "Primus US Anesthesia Workstation." This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria for a new clinical study. Therefore, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence based on comparisons to predicate devices, and "reported device performance" refers to the features and functionalities of the Primus US that align with or improve upon those of the predicates.

Study Details

The provided document describes a 510(k) premarket notification, which is primarily a regulatory submission demonstrating substantial equivalence to predicate devices. It does not contain details of a de novo clinical study with specific acceptance criteria in the typical sense (e.g., sensitivity, specificity, or reader performance metrics). Instead, the "study" referred to is the process of comparing the new device, Primus US, against several predicate devices to establish that it is as safe and effective as those already on the market.

1. 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 applicable in the context of a 510(k) summary focused on substantial equivalence. There is no "test set" of patient data in the clinical trial sense described for this type of submission. The comparison is feature-by-feature and functionality-by-functionality against established predicate devices.
• Data Provenance: The document does not refer to clinical data. The manufacturer is Dräger Medical AG & Co KGaA, Luebeck, Germany.

2. 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. Ground truth, in the sense of clinical outcomes or expert consensus on clinical findings, is not established for this type of substantial equivalence submission. The "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices.

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

• Not applicable. There is no test set or adjudication process for clinical findings described.

4. 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 not an AI/CADe device or an MRMC study. It is an anesthesia workstation.

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

• Not applicable. This is not an algorithm, but a medical device (anesthesia workstation).

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

• Not applicable in the sense of a clinical ground truth for a new study. The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the legally marketed predicate devices:
  • Fabius GS Anesthesia Workstation (K041622)
  • Julian Anesthesia Workstation (K983635)
  • Narkomed 6400 w/IPM Anesthesia Workstation (NM6400) (K033498)
  • Divan Ventilator (K980208)
  • Vamos w/ Return Sample Gas (Vamos w/ RGS) (K040847)
  • Scio patient gas monitor (K031340)

7. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. No training set is used for this type of device submission.

Summary of the "Study" (Substantial Equivalence Demonstration):

The "study" in this context is the comparison of the Primus US device to several legally marketed predicate devices based on their technological characteristics, indications for use, and performance claims. The manufacturer conducted a risk analysis, system-level qualification, and verification/validation testing to ensure the Primus US met its design specifications and performed as intended. The document highlights similarities in:

• Indications for Use: Both the Primus US and predicates are continuous flow anesthesia systems used for ventilation, gas delivery, and monitoring.
• Technological Characteristics:
  • Integrated electronic monitoring (similar to Fabius GS, Julian).
  • Gas measurement technology (same as Scio patient gas monitor).
  • User interface (similar to NM6400).
  • Battery backup system (similar to Fabius GS).
  • Electronic flow sensor technology (similar to Fabius GS).
  • Oxygen Ratio Controller (ORC) (identical to Fabius GS).
  • Ventilator (electronically controlled, electrically driven piston with fresh gas decoupling, similar to Fabius GS).
  • Integrated breathing system (similar to Fabius GS).
  • Heated breathing circuit (similar to Divan ventilator in NM6400).
  • Gas and agent delivery capabilities.
  • Anesthesia Gas Scavenger compatibility.
  • Automated pre-use checkout (similar to NM6400).
  • Vaporizer compatibility.
• Performance: The document asserts that the Primus US provides comparable functionality and safety features to the predicates. Notably, it also describes an enhancement with the addition of an inspiratory flow sensor, which improves leak detection, inspiratory valve monitoring, and trigger performance.

The FDA's review and clearance (K042607) confirm that the agency found the Primus US to be substantially equivalent to the predicate devices, thereby deeming it safe and effective for its intended use without requiring new clinical performance studies beyond the verification and validation testing performed by the manufacturer.

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