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The Infinity CentralStation (ICS) is intended for use by trained health care 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® 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 provided text is a 510(k) premarket notification for the Infinity CentralStation Wide, a medical device for centralized patient monitoring. It describes the device's indications for use, comparison to a predicate device, and performance data from verification and validation testing.

However, the document does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance for such a set.
• Details on experts establishing ground truth, their qualifications, or adjudication methods.
• Information on a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
• Results from a standalone (algorithm-only) performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set or how ground truth for a training set was established.

The document focuses on:

• Cybersecurity modifications and defect fixes as the "significant change modifications" introduced in this submission (page 4).
• Verification and Validation Testing primarily in the context of these cybersecurity enhancements and compliance with design controls (21 CFR 820.30) (page 4). The text states that "results of Verification testing confirm that the modified device continues to meet equivalent criteria demonstrating substantial equivalence to the predicate device" and "Validation test results support the claim of substantial equivalence to the predicate device and do not raise new issues of safety and effectiveness." (page 4).
• Compliance with various medical device standards (e.g., IEC 60601 series), as detailed in the table on page 6.

In summary, this 510(k) pertains to modifications (primarily cybersecurity) to an existing device (Infinity CentralStation Wide VG5 compared to VG4). It leverages the substantial equivalence pathway, meaning it demonstrates that the modified device is as safe and effective as a legally marketed predicate device. This type of submission usually does not require extensive clinical performance studies with acceptance criteria as would be needed for a novel AI/ML-based diagnostic device in a de novo or PMA submission.

Therefore, I cannot extract the requested information from the provided text. The document does not describe the kind of performance study you're asking about (e.g., diagnostic accuracy, reader study) with specific acceptance criteria as if it were a new AI algorithm being tested for diagnostic performance.

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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 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.

Infinity CentralStation (ICS) Wide (MS26800) consists of medical grade software installed and configured on an information technology platform available in one model with configurable software options and optional touch and/or non-touch widescreen displays.
The Infinity CentralStation (ICS) Wide with proposed VG2 modifications is a Central monitoring station capable of real-time display and storage of multi-parameter physiological patient data and alarm annunciation for patient monitors including but not limited to ambulatory and non-ambulatory wireless telemetry monitoring.

The provided text describes a medical device, the Infinity CentralStation Wide, and its regulatory clearance (K151860). However, it does not contain a detailed study proving the device meets specific performance acceptance criteria for an AI or physiological monitoring algorithm.

The document states that the primary modification (VG2 release) is a change in the operating system for enhanced cybersecurity and that "additional proposed modifications do not significantly alter technological characteristics and do not impact the safety or effectiveness of the device." This suggests the focus was on regulatory compliance related to software updates and overall functionality, rather than a new AI-driven feature requiring a specific performance study.

Here's a breakdown of what is and is not provided, based on your requested information:

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

• Not provided in the document. The document mentions "user acceptance criteria was established and assessed based on user feedback obtained in the form of surveys with pre-determined assessment questions and user ratings for the various functionality tested." This refers to user satisfaction and acceptance, not quantitative performance metrics for a specific algorithm.

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

• Not provided. The document mentions "Validation testing was performed in a hospital environment" but does not specify the sample size of patients, data, or source for any performance evaluation. Given the focus on cybersecurity and general functionality updates, it's unlikely a specific "test set" for an algorithm's performance was used in the way implied by your question.

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 provided. There is no mention of expert-established ground truth for an algorithm's performance, as no such algorithm performance study is detailed.

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

• Not provided. No adjudication method is mentioned.

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:

• No, an MRMC study was not done or reported. The device is a central monitoring station, not an AI diagnostic aid that assists human readers.

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

• Not applicable/Not provided. The device is a display and management system for patient physiological data and alarms, not a standalone algorithm. While it handles "arrhythmia detection or alarms" (as per the product code MHX), the document focuses on the system's software update and general functionality rather than detailed performance metrics of these detection algorithms. The primary modification mentioned (VG2) is an operating system change for cybersecurity.

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

• Not provided. No ground truth for an algorithm's performance is detailed.

8. The sample size for the training set:

• Not applicable/Not provided. No AI model training or associated training set details are mentioned.

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

• Not applicable/Not provided. No AI model training or associated ground truth establishment for a training set is mentioned.

Summary of Device Performance and Acceptance Criteria (as reported in the document, albeit for general functionality and user acceptance):

Acceptance Criteria Mentioned:

• Performance/Functional Testing: To confirm effective implementation of proposed modifications and that design outputs satisfy design inputs.
• User Acceptance: Established
• User Satisfaction: Assessed
• User Observations: Obtained

Reported Device Performance / Outcome:

Key Takeaway:

This document is a 510(k) summary for a software update (VG2) to an existing central monitoring station (Infinity CentralStation Wide). The primary focus of the regulatory filing and the "performance data" section is on ensuring that the software modifications (mainly operating system update for cybersecurity) do not negatively impact the device's established safety and effectiveness. It does not detail a study rigorously evaluating the performance of a specific AI or physiological monitoring algorithm against quantitative clinical acceptance criteria, as one might expect for a novel AI diagnostic or classification tool. The "acceptance criteria" and "performance" discussed are largely related to confirming the general functionality, safety, and user acceptance of the updated system.

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