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The Infinity CentralStation (ICS) is intended for use by trained healthcare professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.

Infinity CentralStation with Rest ECG is intended for the production of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

The Infinity M300/M300+ is intended for use with the ICS to monitor ECG and pulse oximetry and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity® CentralStation (ICS) Wide (or widescreen) is a Central monitoring station capable of real-time display and storage of multi-parameter physiological patient data and alarm annunciation for networked devices including but not limited to ambulatory and non-ambulatory wireless telemetry monitoring.

The Infinity M300/M300+ is a wireless telemetry, patient-worn device with rechargeable lithiumion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300/M300+ with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

The provided text is a 510(k) premarket notification summary for the Draeger Medical Systems Infinity CentralStation Wide, Infinity M300, and Infinity M300+ devices. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not explicitly contain detailed acceptance criteria tables with reported device performance or specific study details regarding sample sizes, ground truth establishment for test sets, expert qualifications, or adjudication methods for this specific submission's changes.

The document states that the changes related to cybersecurity and M300+ swappable battery were evaluated through verification and validation testing. It emphasizes that these modifications do not raise new issues of safety and effectiveness and do not change the fundamental scientific technology of the cleared devices, meaning the previous performance characteristics are considered to remain valid.

The key performance data described pertains to compliance with various standards related to electrical safety, EMC, alarm systems, electrocardiographic monitoring, and pulse oximetry. These standards implicitly contain acceptance criteria.

Based on the provided information, I can extract the following, though some requested details related to individual device performance metrics and specific study designs for this particular 510(k) are not explicitly stated in this summary.

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

The document doesn't provide a table of performance acceptance criteria directly. Instead, it refers to compliance with established international and national standards for medical electrical equipment. The "reported device performance" is implicitly that the device meets these standards.

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 detail specific sample sizes for test sets for the verification and validation of the changes in this submission. The testing done refers to internal company verification and validation efforts rather than clinical studies with patient data for assessing core performance metrics like arrhythmia detection accuracy. Data provenance is not specified.

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):

Not applicable/Not provided. The document summarizes the regulatory submission for changes to existing devices, focusing on technical compliance and safety/effectiveness equivalence, not new clinical performance evaluation requiring external expert ground truth establishment for a diagnostic output. The modifications are for cybersecurity and hardware components (swappable battery).

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

Not applicable/Not provided. Adjudication methods are typically used in clinical studies involving interpretation of medical data, which is not the focus of the performance data section for this specific submission's changes.

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 submission is for modifications (primarily cybersecurity and a new battery component) to existing patient monitoring devices, not for a new AI/CAD system. Therefore, an MRMC study is not relevant to the described changes.

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

The performance data focuses on compliance with technical standards for the device's functions (e.g., ECG monitoring, pulse oximetry, alarm systems) and validation of the cybersecurity and hardware changes. These are "standalone" in the sense that the device's technical functions are tested against defined standards. However, it's not "algorithm only" in the context of a new diagnostic algorithm. The monitoring functions (like arrhythmia detection, ST-segment measurement for 12-lead ECG) are inherent to the device and would have been evaluated in prior clearances against ANSI/AAMI EC57.

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

For the specific changes in this submission (cybersecurity, swappable battery), the "ground truth" would be the successful implementation and verification of design requirements and risk mitigations, as tested internally by Dräger. For the underlying physiological monitoring capabilities (ECG, SpO2, arrhythmia, ST-segment), the ground truth for performance evaluation in predicate devices would typically be established through recognized test databases (e.g., MIT-BIH Arrhythmia Database for arrhythmia detection, or similar validated datasets for ST-segment analysis) or expert review against reference standards, as per standards like ANSI/AAMI EC57. The document for this submission does not detail these for the underlying performance.

8. The sample size for the training set:

Not applicable. The described changes and performance data do not relate to machine learning model training.

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

Not applicable. Not a machine learning submission.

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The Infinity M300 is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300 with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity M300 is a wireless telemetry, patient-worn device with rechargeable lithium-ion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300 with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

The provided text is a 510(k) summary from the FDA, detailing the premarket notification for the Draeger Medical Systems' Infinity M300 device. While it mentions "Verification Testing" and "Validation Testing" and refers to meeting criteria and supporting substantial equivalence, it does not provide the specific acceptance criteria, method, or results in a detailed, quantifiable manner that would allow for a comprehensive answer to your request.

The document is a regulatory communication, not a scientific study report. It states that "The results of Verification testing confirm the modified device continues to meet the criteria for substantial equivalence to the predicate device" and that "Validation test results support substantial equivalence to the predicate device." However, it does not disclose what those criteria are or the specific performance metrics achieved.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details on sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. This information would typically be found in the full submission to the FDA, which is not included here.

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The Infinity CentralStation (ICS) is intended for use by trained healthcare professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation. Infinity CentralStation with REST ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

The Infinity M300 is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300 with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

The Infinity CentralStation® (ICS) is an information technology workstation that gathers and displays data for simultaneous central monitoring and critical care management of up to 32 patient monitors connected to the Infinity Network using an optional dual-screen configuration. The ICS system consists of a central processing unit (CPU), one or two displays, a keyboard and a mouse. If an optional second monitoring unit is configured, an additional 32 patients can be monitored, for a total of 64 patients. The ICS acquires and displays waveforms, parameters and alarms from Infinity bedside monitors and Infinity M300.

The Infinity M300® is a patient-worn transceiver that uses the ICS as the primary patient monitoring display and primary alarm source. The M300 provides continuous ambulatory monitoring for the following parameters:

• ECG including heart rate, arrhythmia, and ST segment analysis
• Pulse oximetry including SpO2, pulse plethysmogram waveform, and pulse rate

The M300 has a color display for displaying parameter information, waveforms, and alarms. It also has a rechargeable battery that can be charged using the bedside charger or the central charger. The M300 is restricted to be used on one patient at a time. The M300 also includes the following accessories:

• M300 bedside charger
• M300 central charger
• M300 programming kit

This document is a 510(k) summary for the Draeger Infinity CentralStation with Infinity M300, a physiological patient monitoring system. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the device's intended use and technical specifications. It does not contain information about specific acceptance criteria, study findings, model performance metrics, sample sizes, ground truth establishment, or expert involvement as typically required for evaluating the performance of an AI/ML powered device.

Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the provided text. The document is concerned with regulatory clearance based on substantial equivalence and safety/effectiveness testing against established standards, not a specific performance study for an AI algorithm.

Here's what I can extract from the provided text, highlighting the absence of the requested AI/ML specific information:

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

• Information not provided. The document states: "The modified Infinity CentralStation with Infinity M300 has been tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate devices." This is a general statement of compliance, not a report of specific performance metrics against acceptance criteria. The relevant standards listed are for electromagnetic compatibility (IEC 60601-1-2: 2007).

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

• Information not provided. No details on a test set sample size or data provenance are mentioned.

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)

• Information not provided. The device is a physiological monitor, not an interpretive AI system that would typically require expert-established ground truth in this context.

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

• Information not provided. Not applicable given the nature of the device and information 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

• Information not provided. This device is a monitoring system, 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

• Information not provided. The device performs physiological monitoring, including arrhythmia detection and ST segment analysis, which are algorithmic functions, but the document does not detail specific "standalone performance studies" in the context of an AI/ML algorithm being evaluated. Its performance is evaluated for safety and effectiveness against predicate devices and standards.

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

• Information not provided. For physiological monitoring, ground truth would typically come from standardized simulated signals, known clinical cases validated by other medical equipment, or direct physiological measurements, but the document does not elaborate on how "ground truth" was established for its internal performance evaluations.

8. The sample size for the training set

• Information not provided. There is no mention of a "training set" as this document does not describe an AI/ML model development or validation.

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

• Information not provided. Not applicable.

In summary, this document is a regulatory submission for a medical device that monitors physiological parameters. It does not provide the kind of detailed performance and validation data typically associated with studies proving an AI/ML device meets specific acceptance criteria.

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