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This devices are 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 presel linits and I mo do roo alarin recordings. The devices will connect to R50 recorders either directly or via the Infinity network.

When a GammaXL is 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 anestheic agents, Halothane, Isoflurane, Enflurane, Sevoflurane in any mixture and communicates real time and derived gas information to the GammaXL.

The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The devices are intended for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonatal population.

• not available with Infinity Vista

The intent of this 510(k) is to describe modifications for the Infinity Gamma/GammaXL and Vista monitors, including Pacer Fusion mode, three new versions of the Scio gas module, and Draeger's Masimo SET pod.

The provided text is a 510(k) summary for a medical device (Infinity Gamma Series VF6 Monitors) and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The submission is for modifications to an existing device, and it states: "Verification and validation testing performed indicates that the modifications implemented in the VF6 release of the Gamma series monitors are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)."

However, it does not provide details of what "verification and validation testing" entailed, what the acceptance criteria for that testing were, or what the reported performance was against those criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance from the given text.

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This devices are 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.

When a GammaXL is connected to a SCIO module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of CO2, N20, 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 GammaXL.

The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The devices are intended for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonatal population.

• not available with Infinity Vista

Software version VF5 is the latest release of the INFINITY Gamma/GammaXL and the Infinity Vista monitor (a variant of the Infinity GammaXL with fewer options). It supports a new serial connection to the Scio gas module, as well as other minor software modifications. Testing in accordance with internal design control procedures has verified that the INFINITY Gamma/GammaXL and Vista with VF5 modifications are as safe and effective as submitted in 510(k) K040188, K041087 and K033600.

The provided text describes a Special 510(k) for device modifications to the INFINITY Gamma/GammaXL and Vista with VF5 software. This submission focuses on verification and validation testing to demonstrate that the software modifications do not alter the fundamental technology and the device remains as safe and effective as previous versions.

Here's a breakdown based on your requested information:

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

The submission does not provide specific acceptance criteria or reported device performance metrics in a quantitative manner. It states:

• Acceptance Criteria (Implied): The modifications implemented with software version VF5 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s). This is a qualitative statement of equivalence.
• Reported Device Performance: "Verification and validation testing performed indicates that the modifications implemented with software version VF5 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." This is also a qualitative statement, indicating successful completion of internal testing without providing granular results or specific performance metrics.

2. Sample size 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 the sample size used for the test set or the data provenance. It only mentions "Verification and validation testing performed."

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 in the document. The text does not describe an expert-driven ground truth establishment process for the testing. The testing appears to be internal verification and validation against design specifications and previous versions of the device, rather than a clinical study with expert ground truth.

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

This information is not provided. There is no mention of an adjudication process for the testing performed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device in question is a physiological patient monitor with software modifications, not an AI-assisted diagnostic tool that would typically involve human readers.

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

The document does not explicitly describe a "standalone" performance study in the context of an algorithm's performance without human intervention. The testing performed was "Verification and validation testing" to ensure the modifications were safe and effective, implying functional and performance testing of the device itself.

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

The document does not specify the type of ground truth used. Given the nature of the device (physiological monitor) and the reported testing (verification and validation of software modifications), the "ground truth" would likely be based on:

• Engineering specifications and requirements: Ensuring the device functions as designed and meets its technical parameters.
• Comparison to previous versions: Confirming that the modified software performs equivalently to the predicate devices.
• Internal reference standards: Using calibrated equipment or established reference values for physiological parameters.

8. The sample size for the training set

This is not applicable and therefore not provided. The submission describes modifications to existing software for a physiological monitor, not the development of a new AI/machine learning algorithm that requires a training set.

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

This is not applicable and therefore not provided, as there is no training set for an AI/machine learning algorithm described in this submission.

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The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea is accomplished through impedance plethysmography and apnea through capnography, end-tidal carbon dioxide, and 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 INFINITY Gamma, like the INFINITY GammaXL, supports the "look and feel" of the Draeger Medical product line, including the Draeger logo, colors, menu structure, and physical form. The Infinity Gamma also has an alarm at the top center that illuminates in red or yellow for the purpose of displaying both life threatening and serious alarms respectively. The primary difference between the INFINITY GammaXL and the new INFINITY Gamma is the smaller size.

The provided document is a 510(k) summary for the INFINITY Gamma, a patient physiological monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device (INFINITY GammaXL) and does not contain detailed acceptance criteria or a study that specifically proves the device meets such criteria in the way typically expected for a new, novel AI/ML medical device.

Instead, the document states performance has been verified through "internal design control procedures" and refers to the predicate device's established safety and effectiveness.

Therefore, for almost all the requested information, the answer will be "Not Applicable" or "Not Provided in this document" because the submission is for a device modification of an existing device, not a new device requiring extensive clinical or standalone performance studies against defined acceptance criteria.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in this document. The submission states: "Testing in accordance with internal design control procedures has verified that the INFINITY Gamma is as safe and effective as the INFINITY GammaXL as submitted in 510(k) K033600." Specific performance metrics and acceptance criteria for these metrics are not detailed.

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

• Sample Size: Not provided.
• Data Provenance: Not provided. The document mentions "internal design control procedures," implying testing was likely conducted internally, but no specifics on data origin (e.g., country, retrospective/prospective) are given for any test set.

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

Not applicable / Not provided. This type of information is typically relevant for studies involving subjective interpretation (e.g., image analysis) where expert consensus is needed. For a physiological monitor, ground truth would likely be established through calibrated instruments or established clinical values, not expert consensus on interpretations. No details are given.

4. Adjudication method for the test set:

Not applicable / 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 involving human readers.

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

Not applicable. The "device" itself performs the monitoring; there isn't a separate "algorithm" being tested in a standalone fashion distinct from the hardware and embedded software. The document states "Testing in accordance with internal design control procedures has verified that the INFINITY Gamma is as safe and effective as the INFINITY GammaXL". This implies comprehensive device testing, not an isolated algorithm evaluation.

7. The type of ground truth used:

Not provided. For physiological monitors, ground truth would typically come from reference devices or established physiological standards for accuracy validation, but no specifics are mentioned in this document.

8. The sample size for the training set:

Not applicable / Not provided. This document describes a traditional medical device, not a machine learning model, so there isn't a "training set" in the sense of AI/ML development.

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

Not applicable / Not provided.

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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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