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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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The EGM gas monitor is indicated for measuring and monitoring CO2 concentration and the concentrations of N2O, O2, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane. Federal Law restricts this device to sale by or on the order of a physician.

The M1013A Essential Gas Module provides a nondispersive infrared measurement of respiratory and anesthetic gases and a paramagnetic measurement of oxygen (Fast O2). It is designed to work with the Philips IntelliVue MP20/30/40/50/60/70/90 Anesthesia option #H30 through a digital interface (RS232). It is intended for measuring the airway gases of #1100 through a dignal interrace (1020) maintenance of, and emergence from anesthesia. The module produces display waves for O2, CO2, N2O, and anesthetic agents, together with The module produces display waves for O2, CO2, N2O, anesthetic agents, and airway respiration rate. An anesthetic agent must be selected manually for measurement. An automatic zero calibration is performed by the Essential Gas Module as required to maintain measurement accuracy.

The provided text is a 510(k) summary for the Essential Gas Module (EGM) and a clearance letter from the FDA. It does not contain a detailed study description with specific acceptance criteria, reported performance, sample sizes, expert qualifications, or adjudication methods.

This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and validation data.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document states:
"Information provided in the 510(k) Premarket Notification supports the determination of substantial equivalence. Design, development verification and validation of the device was carried out in accordance with applicable standards and company internal procedures. The results provide assurance that the device meets its specifications and is safe and effective for its intended use."

This indicates that internal verification and validation were performed to meet specifications, but the specifics of these studies (acceptance criteria, sample sizes, etc.) are not detailed in this public 510(k) summary.

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This device is capable of monitoring: Heart Rate, Respiration Rate, Invasive Pressure, Non-Invasive Pressure, Arrhythmia, Temperature, Arterial oxygen saturation, Pulse rate, central apnea accomplished through impedance plethysmography, apnea accomplished through capnograpy, end-tidal CO2, ST Segment Analysis. This Infinity GammaXL and SC 6802XL will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network. When connected to a SCIO module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.

The INFINITY GammaXL and SC 6802XL with software version VF3 and above are capable of displaying gas-monitoring data received from a Scio gas module (K031340). Anesthetic gas monitoring is available when a GammaXL or SC 6802XL is attacted via a specific cable to a Scio gas module. This is a password protected locked optical. The GammaXL and SC 6802XL with Scio are similar to the Infinity Modular Monitors with Scio (K031340) in that they display gas-monitoring parameters received from the Scio gas module.

The provided text is a 510(k) summary for the INFINITY GammaXL and SC 6802XL with Scio, which is a device for physiological monitoring with integrated gas monitoring capabilities. The document details the device's modifications from previous versions and its intended use. Here's a breakdown based on your request, highlighting that this document outlines regulatory approval rather than a detailed study report:

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

The document does not provide a table with specific, quantifiable acceptance criteria and corresponding reported device performance metrics in the way one would expect from a clinical performance study for a diagnostic AI device.

Instead, the submission states:

• Acceptance Criteria (Implied): Equivalence to legally marketed predicate devices, with "no new issues of safety and efficacy" and operating "as intended with no adverse affects." The General Controls provisions of the Act (annual registration, listing, GMP, labeling, prohibitions against misbranding and adulteration) also serve as broad acceptance criteria for regulatory compliance.
• Reported Device Performance:
  • "Verification and validation testing of the Infinity GammaXL and SC 6802XL with SCIO, indicates no new issues relative to safety and efficacy."
  • "The review of clinical data indicates that the GammaXL/SC 6802XL with Scio operates as intended with no adverse affects."

The focus here is on demonstrating that the modified device maintains the safety and efficacy profile of its predicate devices, particularly regarding the display of gas-monitoring data from the Scio module, rather than presenting a performance study against novel acceptance targets.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" with a particular sample size in the context of a performance study. The evaluation appears to be a systems-level verification and validation process for a device modification, focusing on functional performance and safety. Therefore, information about data provenance (country of origin, retrospective/prospective) is not provided.

3. 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)

This information is not provided. The nature of the device (physiological monitor displaying gas data) means that "ground truth" would likely be established through calibrated sensing equipment and established physiological principles, rather than expert human interpretation of complex data for diagnostic purposes.

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

This information is not applicable and not provided. The evaluation described is for a physiological monitoring device's functional and safety performance, not for a diagnostic device requiring adjudication of expert interpretations.

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

An MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic tools where human readers interpret medical images or complex data. The INFINITY GammaXL and SC 6802XL with Scio is a physiological monitoring device that displays data directly, not an AI diagnostic assistant for human interpretation.

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

This document describes a medical device that includes software for displaying physiological parameters and gas-monitoring data. While the device's internal algorithms process data from sensors (e.g., for arrhythmia detection or calculating end-tidal CO2), the "standalone performance" in the context of diagnostic AI algorithms is not applicable here. The device itself operates autonomously to monitor and display, but it's not an "algorithm only" product for diagnostic interpretation. Its performance is evaluated as an integrated system.

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

The document does not explicitly state the type of ground truth used. However, given the device's function, it is highly probable that the "ground truth" for verification and validation would involve:

• Reference gas analyzers/simulators: For accurate measurement of CO2, N2O, O2, and anesthetic agents, against which the Scio module's measurements would be compared.
• Calibrated physiological simulators: For heart rate, respiration rate, pressure, temperature, SpO2, etc., to ensure the device accurately measures and displays these parameters.
• Physical testing and engineering verification: To confirm signal integrity, alarm functionality, and system integration.

8. The sample size for the training set

This information is not applicable and not provided. The INFINITY GammaXL and SC 6802XL with Scio is a physiological monitoring device that processes sensor data using established algorithms, not a machine learning or AI-based system that requires a "training set" in the context of modern AI development.

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

This information is not applicable and not provided, as there is no mention of a "training set" in the context of this device.

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