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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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This device is capable of monitoring:

• Heart Rate .
• Respiration Rate .
• Invasive Pressure .
• Non-Invasive Pressure .
• . Arrhythmia
• Temperature ◆
• Arterial oxygen saturation .
• Pulse rate .
• (central) apnea .
• end-tidal CO2 .
• ST Segment Analysis .

This device 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.

The VF4 release of the INFINITY GammaXL (SC 6802XL) supports the "look and feel" of the Draeger Medical product line, including the Draeger logo, colors, menu structure, and physical form. An alarm indicator has been added to the top center of the device that illuminates in red or yellow for the purpose of displaying both life threatening and serious alarms respectively.

The provided documents describe a 510(k) submission for modifications to the INFINITY GammaXL physiological patient monitor. The submission asserts that the modified device is as safe and effective as its predicate device (SC 6802XL, K030313 / K993974). However, the documents available do not contain detailed acceptance criteria, reported device performance data in a tabular format, or information about specific studies that prove the device meets such criteria.

The submission states: "Testing in accordance with internal design control procedures has verified that the INFINITY GammaXL with VF4 modifications is as safe and effective as the SC 6802XL as submitted in 510(k) K030313." It also mentions "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Not applicable." This suggests that the modifications were primarily related to user interface ("look and feel"), mechanical design, and the addition of an alarm indicator, and that extensive new clinical performance data (beyond what was established for the predicate device) was not deemed necessary for this particular 510(k) submission.

Since the provided text does not contain the information requested, I cannot complete the table or answer most of the questions.

Here's a breakdown of what is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states that testing was done to verify equivalence but doesn't detail performance metrics or acceptance criteria for those tests.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 a physiological monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI-driven algorithm, as this is a physiological monitor. The device's performance would be assessed on its ability to accurately measure and alarm on physiological parameters.
7. The type of ground truth used: Not specified, beyond the general statement of "testing in accordance with internal design control procedures." For physiological monitors, ground truth typically involves calibrated reference devices.
8. The sample size for the training set: Not applicable and not provided, as this is not an AI/ML device requiring a training set in that sense.
9. How the ground truth for the training set was established: Not applicable and not provided.

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