Search Results

The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) and pulse oximetry (optional) of neonates and infants. The device is designed for use with a body weight up to 10 kg (22 lb).

The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), pulse oximetry (optional), and resuscitation (optional) of neonates and infants.

The purpose of this premarket notification is to activate, for the US market, existing optional functionality which enables the display of SpO2 information by the subject Babyroo TN300 via its graphical user interface (GUI). The SpO2 display functionality is facilitated through connection with existing, cleared pulse oximetry accessories which generate the SpO2 information that is displayed on the subject Babyroo TN300 GUI.

As originally cleared under K230278:
The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat.

The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer.

Infant warming is facilitated via three (3) available thermorequlation modes:

• Manual mode
• Skin temperature mode
• Kangaroo mode

The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatically powered, can be connected to central gas supplies or gas cylinders, and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants:

• Resuscitation module with gas mixer and AutoBreath®.
• Resuscitation module with gas mixer.
• Resuscitation with O2 only.

The optional AutoBreath® function facilitates pneumatically driven, automatic respiratory rate and positive end-expiratory pressure control.

The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray.

The provided text describes a 510(k) premarket notification for a modification to the Babyroo TN300 infant warmer device. The modification involves activating existing optional software functionality to display SpO2 information generated by existing, cleared pulse oximetry accessories. The core device functions for warming, resuscitation, and weighing remain unchanged from the predicate device (K230278).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The submission focuses on demonstrating substantial equivalence for the new functionality (SpO2 display and associated alarms) by relying on existing clearances of the core device and the OEM pulse oximetry accessories, in conjunction with specific non-clinical verification testing of the integrated system. No new clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modification (enabling SpO2 display), the acceptance criteria primarily revolve around demonstrating that the new functionality performs as expected and does not introduce new safety or effectiveness concerns, especially concerning the integration with existing, cleared pulse oximetry technology. The performance is assessed by confirming conformity to relevant standards and effective data transfer.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No human clinical data are included in support of substantial equivalence." This means there isn't a "test set" in the traditional sense of patient data.

The testing relied on non-clinical performance testing:

• Sample Size: Not numerical. The testing involved the Babyroo TN300 device itself, presumably one or more units, integrated with the specific OEM Masimo SET® pulse oximetry accessories. The "sample" here refers to the actual device and integrated components under test in a laboratory/engineering setting.
• Data Provenance: The data comes from laboratory/engineering testing performed by the manufacturer (Draeger Medical Systems, Inc.). It is implicitly prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate the safety and effectiveness of the new functionality. No geographic origin for the test data is specified, but it would typically be conducted at the manufacturer's R&D facilities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no human clinical data or expert evaluations of images/readings were used for the test set (as this is a device modification for display of existing, cleared parameters), there were:

• Number of Experts: N/A.
• Qualifications of Experts: N/A.

The acceptance criteria were demonstrated through objective non-clinical performance testing against recognized standards (e.g., ISO 80601-2-61) and internal verification activities. The "ground truth" for the SpO2 display functionality would be the accurate and reliable transmission and display of the SpO2 and pulse rate data generated by the cleared OEM pulse oximetry accessories themselves, as validated in the OEM integration testing.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. As no human interpretation of data (e.g., images, vital signs patterns) was involved in a "test set" requiring ground truth establishment through expert consensus or adjudication, this is not applicable. The performance was verified through direct measurements and compliance with technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. The document explicitly states: "No human clinical data are included in support of substantial equivalence." This type of study is typically performed to evaluate diagnostic accuracy or human performance with AI assistance, neither of which is the primary focus of this specific device modification (which is display of a physiological parameter).
• Effect Size of Human Readers Improvement with AI vs Without AI Assistance: N/A, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

• Standalone Study: Yes, in a practical sense, the "OEM Integration Validation" is a form of standalone testing. This is described as validating "the effective transfer of pulse oximetry signals generated by a clinical simulator through the cleared OEM Masimo SET® pulse oximetry technology board to the subject Babyroo TN300 device's display." This tests the algorithm's ability (within the Babyroo TN300's software) to receive, process, and display the SpO2 data accurately from the source. The "algorithm" here isn't a complex diagnostic AI but rather the software logic for data handling and display.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for validating the SpO2 display functionality was the known, simulated pulse oximetry signals generated by a "clinical simulator" and then interpreted by the already cleared OEM Masimo SET® pulse oximetry technology board. The test ensured that the Babyroo TN300 accurately displayed what the cleared OEM technology was reporting. Essentially, the ground truth was the output of the "cleared OEM Masimo SET® pulse oximetry technology," and the new device's display was compared directly to that expected output.

8. The Sample Size for the Training Set

• Training Set Sample Size: N/A. This device modification does not involve a machine learning or AI algorithm that requires a "training set" in the traditional sense. The software functionality being activated is to display existing, cleared data.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: N/A, as no training set was used.

Ask a specific question about this device

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.

Ask a specific question about this device

The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite is a suite of software applications that are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including:

• Server Software Health Level seven (HL7) Interface Software Options -
• -American society for testing and materials (ASTM) Stat Lab interface
• -Developer Tools
• Pager Interface -
• -Alarm history database
• -Time master functions
• -12-lead electrocardiogram (ECG) export

Infinity Gateway Suite is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application.

The Infinity Gateway Suite facilitates the exchange of important clinical information between the Infinity protocol and existing hospital and patient care systems. The Infinity Gateway Suite is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer Tools and/or Interface Options to create a seamless flow of information tailored to support clinical workflow.

Infinity Gateway Developer Tools and Interface Options are licensed or unlocked by using option passwords associated with a dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway Developer Tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine technology, which facilitates software deployments.

Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Infinity Network and other hospital systems.

The subject device is compatible with Infinity Central Station Wide version VG5.0

This document is a 510(k) Premarket Notification from the FDA granting clearance for the Infinity Gateway Suite (VF9.1.1) from Draeger Medical Systems, Inc. It primarily addresses cybersecurity updates and other software improvements to an existing device.

Based on the provided text, the device is software only and does not involve AI/ML capabilities or diagnostic imaging. Therefore, most of the requested information regarding acceptance criteria, study methodologies (like multi-reader multi-case studies, standalone performance), ground truth establishment, expert adjudication, and sample sizes for training/test sets is not applicable in the context of typical AI/ML medical device submissions.

Here's a breakdown of the relevant information from the document as it pertains to the device's performance given its nature:

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

Since this is a software update primarily focused on cybersecurity and feature removal/modernization, traditional performance metrics like sensitivity, specificity, or accuracy (as seen in diagnostic AI devices) are not presented. The acceptance criteria relate to the successful implementation of the software updates and ensuring the device still functions as intended.

• ANSI AAMI ISO 14971:2019 (Risk Management)
• ANSI AAMI IEC 62304:2015 (Software Life Cycle Processes)
• ANSI AAMI IEC 62366-1:2020 (Usability Engineering) |

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

• Sample Size for Test Set: Not explicitly stated in terms of patient data or specific number of test cases, but the document mentions "All test cases were determined to meet their respective requirements," implying a set of defined test cases were executed.
• Data Provenance: Not applicable in the context of patient data as this is a software update for network communication and data exchange, not a device that processes or analyzes patient-derived data for diagnostic purposes. The testing is functional and performance testing of the software itself. The document does not specify country of origin for testing, nor whether it was retrospective or prospective, as these are not relevant to this type of software update.

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 is not applicable. Ground truth, in the sense of clinical annotations by experts, is not established for this type of software. The "ground truth" here is the expected behavior and functional requirements of the software, verified through standard software V&V processes.

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

• This is not applicable. Adjudication is typically used for ambiguous cases in clinical data annotation (e.g., differentiating between expert opinions on an image). For software functional testing, results are typically binary (pass/fail) based on predefined requirements.

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:

• This is not applicable. The Infinity Gateway Suite is a data exchange and remote viewing software, not an AI/ML diagnostic or assistive device that would be used by human "readers" (e.g., radiologists, pathologists) to interpret medical images or data. Therefore, an MRMC study is irrelevant to this device.

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

• The device is a "standalone" algorithm in a sense that it performs its functions (data exchange, remote viewing) automatically. However, "standalone performance" usually refers to the diagnostic accuracy of an AI model on its own. Since this device doesn't perform diagnoses or predictions, this concept isn't directly relevant in the typical sense for AI. Its performance is about its functionality and interoperability.

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

• This is not applicable in the clinical sense. The "ground truth" for this software is its documented functional and cybersecurity requirements, against which the software's performance is verified.

8. The sample size for the training set:

• This is not applicable. The Infinity Gateway Suite is described as a software suite with specific functionalities (HL7 interface, Pager interface, data exchange, etc.) and cybersecurity updates. It is not an AI/ML model that undergoes a "training" phase with a dataset.

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

• This is not applicable for the same reason as point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) of neonates and infants. The device is designed for use with a body weight up to 10 kg (22 lb).

The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants.

The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat.

The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer.

Infant warming is facilitated via three (3) available thermoregulation modes:

• Manual mode
• Skin temperature mode
• Kangaroo mode

The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatic powered, can be connected to central gas supplies or gas cylinders and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants:

• Resuscitation module with gas mixer and AutoBreath®.
• Resuscitation module with gas mixer.
• Resuscitation with O2 only.

The optional AutoBreath® function facilitates pneumatically-driven, automatic respiratory rate and positive end-expiratory pressure control.

The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray.

The Babyroo TN300 device has an expected service life of 10 years.

The provided text is a 510(k) summary for the Dräger Babyroo TN300 infant radiant warmer. It details the device's indications for use, its comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding reported device performance values in a single, clear format as typically expected for specific performance metrics (e.g., a specific temperature range, with a specific accuracy requirement, and the measured accuracy).

Instead, the "7. Substantial Equivalence Comparison and Discussion" section (pages 6-7) serves as the de-facto presentation of performance characteristics and how they compare to the predicate device. For the characteristics where the proposed device differs, the "Comment" column often implies the acceptance criteria (i.e., that the performance meets safety and effectiveness requirements, even if different from the predicate).

Here's a partial reconstruction of a table based on the provided comparison, focusing on performance-related aspects and inferring acceptance criteria where possible:

Ask a specific question about this device

The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

The Infinity Gateway Suite is a suite of software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.

Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including:

• Server Software Health Level seven (HL7) Interface Software Options -
• -American society for testing and materials (ASTM) Stat Lab interface
• -Developer's Tools
• -Remote View Applications
• । Pager Interface
• -Alarm history database
• -Time master functions
• -12-lead electrocardiogram (ECG) export
• Service-Oriented Device Compatibility (SDC) interface with encryption -

Infinity Gateway is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application.

The Infinity Gateway Server facilitates the exchange of important clinical information between the Infinity/SDC protocol and existing hospital and patient care systems. The Infinity Gateway Server is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer's Tools and Interface Options to create a seamless flow of information tailored to support clinical work flow.

Infinity Gateway Developer's Tools and Interface Options are licensed or "unlocked" by using option passwords that are associated with a USB license dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway developer's tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine technology, which facilitates cost-effective software deployments and reduces the total cost of ownership.

Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Draeger Infinity Network and other hospital systems.

The provided text describes the regulatory clearance of Draeger Medical Systems, Inc.'s Infinity Gateway Suite (K203579) based on its substantial equivalence to a predicate device (K043549). This type of submission (510(k)) focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials typical of novel devices.

Therefore, the document primarily details the Device Description, Comparison of Technological Characteristics with Predicate Device, and Verification and Validation Testing necessary to establish substantial equivalence. It does not contain information about a diagnostic AI algorithm study with the typical acceptance criteria and study design details (e.g., sample sizes for test/training sets, blinding, expert adjudication, MRMC studies, ground truth establishment) that would be present in a submission for a novel AI/ML-driven diagnostic device.

The "Performance Data" section specifically states: "The verification and validation that was conducted confirmed the Infinity Gateway product performs according to intended use with no adverse effects upon other medical devices in the Infinity system to which it is connected. Testing confirmed that identified Product Risk mitigations functioned with the new code, with all test cases passing without exception." This refers to software engineering and functional integrity testing, not a diagnostic performance study as outlined in your request.

Given this, I cannot extract the specific information requested in your prompt as it pertains to a diagnostic AI study. However, I can summarize the closest relevant information from the provided text regarding the device's performance and verification:

Summary of Device Performance and Verification based on Substantial Equivalence (510(k) pathway):

The Infinity Gateway Suite (K203579) demonstrated its performance and met acceptance criteria through verification and validation testing confirming substantial equivalence to its predicate device (K043549).

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Not Applicable / Not Stated: This document describes functional and software interface testing, not a diagnostic study requiring a "test set" of patient data in the typical sense. No mention of data provenance (country of origin, retrospective/prospective) is made.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable: The "ground truth" here is the functional correctness and safety of the software and its interfaces, validated through engineering tests against specified requirements and standards, not through expert clinical interpretation of diagnostic data.

4. Adjudication Method for the Test Set:

• Not Applicable: There was no "test set" requiring clinical adjudication. Software test cases either pass or fail based on predefined expected outcomes.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No: This was not an MRMC study. The device is a data gateway and communication system, not a diagnostic AI intended to assist human readers in interpreting medical images or signals.

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

• Yes (in a functional sense): The verification and validation testing confirms the standalone functional performance of the software. However, this is not a diagnostic "algorithm only" performance as would be applicable to an AI model detecting disease. The device’s function is to facilitate data viewing and exchange among existing systems.

7. The Type of Ground Truth Used:

• Software Requirements and Engineering Specifications: The "ground truth" for this clearance is the device's adherence to its functional requirements, safety specifications, and relevant industry standards. Testing confirmed that the software met its intended functional specifications and that risk mitigations were effective.

8. The Sample Size for the Training Set:

• Not Applicable: This is not an AI/ML-driven diagnostic device that undergoes training on a data set.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable: As there's no training set for an AI model, this is not relevant.

In conclusion, the provided text details a 510(k) submission for a medical device software system focused on data connectivity and exchange. The "acceptance criteria" and "study" described are in the context of software verification and validation, ensuring functional integrity and safety for its intended use, rather than a diagnostic performance study of an AI algorithm.

Ask a specific question about this device

Intended Use

Infinity® Acute Care System™ (IACS)

The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals.

The IACS obtains the physiologic, multi-parameter data from the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network.

The IACS and optional connected hardware are not intended for use in the following hospital environments:

• Hyperbaric chambers
• Environments containing MRI equipment

Indications for use

The IACS, in connection with the M540 Patient Monitors the following parameters:

• Heart rate
• Arrhythmia (adult and pediatric patients only)
• 12-lead Rest ECG analysis (adult and pediatric patients only)
• ST segment analysis including TruST (adult and pediatric patients only)
• Apnea
• Impedance respiratory rate RRi
• Invasive blood pressure IBP
• Non-invasive blood pressure NIBP
• Temperature
• Cardiac output (adult and pediatric patients only)
• Carbon dioxide etCO2, inCO2, RRc
• Arterial oxygen saturation SpO2
• Pulse rate
• Perfusion index PI
• Total hemoglobin SpHb, (adult and pediatric patients only)
• Total oxygen content SpOC, (adult and pediatric patients only)
• Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
• Methemoglobin saturation SpMet
• Pleth variability index PVI

The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network.

Intended Use

The Infinity Medical Cockpits, consisting of the C500, and the C700 are monitoring and control displays for the Infinity Acute Care System (IACS).

Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings.

The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.

Indications for Use

As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use.

Intended Use

The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient information in environments where patient care is provided by trained health care professionals.

The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multiparameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time.

The M540 and any connected hardware are not intended for use in the following hospital environments:

• Hyperbaric chambers
• Environments containing MRI equipment

Indications for use

The M540 monitors the following parameters:

• Heart rate
• Arrhythmia (adult and pediatric patients only)
• 12-lead Rest ECG analysis (adult and pediatric patients only)
• ST segment analysis including TruST (adult and pediatric patients only)
• Apnea
• Impedance respiratory rate RRi
• Invasive blood pressure IBP
• Non-invasive blood pressure NIBP
• Temperature
• Cardiac output only available when the M540 is docked in an IACS configuration (adult and pediatric patients only)
• Carbon dioxide etCO2, inCO2, RRc
• Arterial oxygen saturation SpO2
• Pulse rate
• Perfusion index PI
• Total hemoglobin SpHb, (adult and pediatric patients only)
• Total oxygen content SpOC, (adult and pediatric patients only)
• Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
• Methemoglobin saturation SpMet
• Pleth variability index PVI

The Infinity® Acute Care System™ (IACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside. The IACS is a combination of the following devices: Infinity M540 Patient Monitor (Model #MS20401) with the Infinity M500 Docking Station (Model #MS20407) integrated with the Infinity Medical Cockpit (Model #MK31501 - 17" screen or Model MK31701 - 21" screen) and respective software, powered by the Infinity P2500 power supply (Model #MS22277).

The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 Patient Monitor and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 Patient Monitor is a lightweight hand-held patient monitor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and transmits the data over the network. The Infinity M540 Patient Monitor can be used as a stand-alone medical device without integration with the Infinity Medical Cockpits.

Associated accessories may include:

• Infinity MCable Masimo SET Model #MS20667
• Infinity MCable Masimo SET Rainbow Model #MS27900 / MS27003
• Infinity MCable – Nellcor OxiMax – Model #MS20668
• Infinity MPod Quad Hemo Model #MS20725
• Infinity MCable Dual Hemo Model #MS20783
• Infinity MCable Mainstream CO2 Model #6871950
• Infinity MCable - Analog/Sync - Model #MS20662
• Infinity MCable – Nurse Call – Model #8417370
• PS120 Desktop Power Supply - Model #2606270
• Y-Adapter (for PS120) Model #MS29702

The IACS, Monitoring Solution is a software driven device that is supplied and used non-sterile in a hospital environment by trained personnel. The IACS, Monitoring Solution is capital equipment.

The provided document is a 510(k) summary for the Draeger Infinity Acute Care System (IACS) Monitoring System. It details changes and improvements to an existing device rather than a new AI-powered diagnostic device. Therefore, it does not contain the typical acceptance criteria and study information aligned with the questions.

Specifically:

• It appears to be an update (VG4.1.1) to existing Infinity Acute Care System (IACS) Monitoring System software and associated components.
• The document indicates that clinical studies were not performed or required for the device modifications. This means there isn't a study that "proves the device meets the acceptance criteria" in the context of typical AI diagnostic device studies involving ground truth from experts or pathology.

However, based on the information provided, here's what can be extracted and inferred, addressing as many points as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, performance metric table for an AI algorithm. Instead, it focuses on compliance with standards and verification testing for functions.

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

• Test Set Sample Size: Not applicable in the context of an AI-powered diagnostic study with a discrete test set. The document indicates "Verification testing was conducted to confirm the new requirements... based on the differences between the subject and predicate devices." This implies various specific tests against functional requirements and standards, not a single patient-level test set for an algorithm's diagnostic performance.
• Data Provenance: Not applicable for this type of submission which focuses on verification of software and hardware changes against established standards, rather than analyzing patient data for a diagnostic algorithm.

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

• This information is not provided because the submission does not involve external "experts" establishing ground truth for a diagnostic algorithm's test set. The ground truth for this device's performance is based on compliance with electrical safety, EMC, and specific physiological parameter standards (e.g., EC57 for cardiac rhythm and ST segment algorithms).

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

• Not applicable, as there is no diagnostic image/signal interpretation dataset requiring expert adjudication.

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. The document explicitly states: "Clinical studies were not performed or required for the device modifications subject of this 510(k)." The device is a patient monitoring system, not an AI-assisted diagnostic tool that would typically undergo such a study.

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

• While the system has algorithms (e.g., for arrhythmia, ST segment), the submission does not detail standalone performance testing in the manner of an AI diagnostic algorithm. The "Major Level of Concern" for software indicates that the algorithms directly drive clinical decisions and thus misapplication could cause serious injury or death, suggesting the critical nature of their standalone accuracy. However, formal standalone performance metrics (e.g., sensitivity, specificity) with a defined dataset for these specific algorithms are not reported in this summary beyond compliance with standards like EC57.

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

• For the performance data mentioned (e.g., EC57 testing for cardiac rhythm and ST segment measurement algorithms), the "ground truth" would be established by reference standards or simulated physiological signals that mimic known conditions, against which the device's measurements are compared for accuracy and adherence to a recognized standard. It is not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.

8. The sample size for the training set

• Not applicable. This is not an AI algorithm trained on a dataset of patient cases. The software updates involve improvements and corrections to existing functionalities and compliance with standards.

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

• Not applicable, as no training set for an AI algorithm is mentioned or implied.

Ask a specific question about this device

Intended Use

Infinity® Acute Care System™ (IACS)

The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals.

The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network.

The IACS and optional connected hardware are not intended for use in the following hospital environments:

• Hyperbaric chambers
• Environments containing MRI equipment

Indications for Use

The IACS, in connection with the M540 Patient Monitor, monitors the following parameters:

• Heart rate
• Arrhythmia (adult and pediatric patients only)
• 12-lead Rest ECG analysis (adult and pediatric patients only)
• ST segment analysis including TruST (adult and pediatric patients only)
• Apnea
• Impedance respiratory rate RRi
• Invasive blood pressure IBP
• Non-invasive blood pressure NIBP
• Temperature
• Cardiac output (adult and pediatric patients only)
• Carbon dioxide etCO2, inCO2, RRc
• Arterial oxygen saturation SpO2
• Pulse rate
• Perfusion index PI
• Total hemoglobin SpHb, (adult and pediatric patients only)
• Total oxygen content SpOC, (adult and pediatric patients only)
• Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
• Methemoglobin saturation SpMet
• Pleth variability index PVI

The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network.

Intended Use

The Infinity Medical Cockpits, consisting of the C500, and the C700 are monitoring and control displays for the Infinity Acute Care System (IACS).

Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings.

The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.

Indications for Use

As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use.

Intended Use

The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient in environments where patient care is provided by trained health care professionals.

The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multi-parameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time.

The M540 and any connected hardware are not intended for use in the following hospital environments:

• Hyperbaric chambers
• Environments containing MRI equipment

Indications for Use

The M540 monitors the following parameters:

• Heart rate
• Arrhythmia (adult and pediatric patients only)
• 12-lead Rest ECG analysis (adult and pediatric patients only)
• ST segment analysis including TruST (adult and pediatric patients only)
• Apnea
• Impedance respiratory rate RRi
• Invasive blood pressure IBP
• Non-invasive blood pressure NIBP
• Temperature
• Cardiac output - only available when the M540 is docked in an IACS configuration (adult and pediatric patients only)
• Carbon dioxide etCO2, inCO2, RRc
• Arterial oxygen saturation SpO2
• Pulse rate
• Perfusion index PI
• Total hemoglobin SpHb, (adult and pediatric patients only)
• Total oxygen content SpOC, (adult and pediatric patients only)
• Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
• Methemoglobin saturation SpMet
• Pleth variability index PVI

The Infinity® Acute Care System™ (IACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside. The IACS is a combination of the following devices Infinity M540 Patient Monitor (Model # MS20401) with the Infinity M500 Docking Station (Model #MS20407) integrated with the Infinity Medical Cockpit (Model # MK31501 - 17" screen or MK31701 - 21" screen) and respective software, powered by the Infinity P2500 power supply (Model #MS22277).

The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 Patient Monitor and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 Patient Monitor is a lightweight hand-held portable patient monitor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and transmits the data over the network. The Infinity M540 Patient Monitor can be used as a stand-alone medical device without any integration with the Infinity Medical Cockpit.

Associated accessories may include:

• · Infinity MCable Masimo SET Model #MS20667
• •Infinity MCable Masimo SET Rainbow Model #MS27900 / MS27003
• ·Infinity MCable Nellcor OxiMax Model #MS20668
• · Infinity MPod Quad Hemo Model #MS20725
• •Infinity MCable Dual Hemo Model #MS20783
• •Infinity MCable Mainstream CO2 Model #6871950
• ●Infinity MCable Analog/Sync Model #MS20662
• •Infinity MCable Nurse Call Model #8417370
• •PS120 Desktop Power Supply Model #2606270
• •Y-Adapter (for PS120) Model #MS29702

The IACS, Monitoring Solution is a software driven device that is supplied and used non-sterile in a hospital environment by trained personnel. The IACS, Monitoring Solution is capital equipment.

Here's a breakdown of the acceptance criteria and study information for the Draeger Medical Systems, Inc. Infinity Acute Care System (IACS) Monitoring Solution, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or a direct table comparing them to reported device performance. It focuses on demonstrating equivalence to a predicate device and adherence to recognized standards. However, it does highlight areas where "verification testing was conducted to confirm the new requirements."

Based on the information, the implicit acceptance criteria are compliance with relevant safety and performance standards, and successful verification of new software requirements and algorithms.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for test sets in relation to patient data or specific parameters. It references "verification testing" and "EC57 testing" but does not provide details on the number of cases or data points used.

The data provenance is also not explicitly stated. The studies mentioned appear to be internal performance bench testing rather than studies involving external clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish a ground truth for any test set or their qualifications. The testing described appears to be technical verification against standards and internal requirements.

4. Adjudication Method

No adjudication method is described, as there is no mention of expert review of test set results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or conducted. The submission is for a monitoring solution, and the focus is on technical performance and equivalence to a predicate, not on human-AI assistive improvement.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone (algorithm only) performance was indirectly assessed through the "Performance Bench Testing" and "EC57 testing conducted for performance of cardiac rhythm and ST segment measurement algorithms." This testing evaluates the device's algorithms and functions independent of human interpretation in a clinical setting.

7. Type of Ground Truth Used

The ground truth for the performance bench testing and EC57 testing would implicitly be:

• Established Standards: Compliance with the requirements of relevant IEC and ISO standards (e.g., IEC 60601 series, ISO 80601-2-55, EC57 for ECG performance).
• Engineering Specifications/Reference Values: For internal verification, ground truth would be against predetermined engineering specifications, simulated inputs, or known reference signals.

There is no mention of ground truth established via expert consensus, pathology, or direct outcomes data from human patients for the clearance of this device.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This device is a multi-parameter patient monitoring system, which typically involves rule-based algorithms, signal processing, and established physiological measurement techniques, rather than machine learning models that require extensive training data.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned as being used for machine learning, this point is not applicable. The device's functionality is based on established medical device engineering principles and adherence to regulatory standards.

Ask a specific question about this device

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.

Ask a specific question about this device

The Isolette® 8000 plus is indicated for thermoregulation and controlling oxygen (optional), and humidity (optional) for both premature and full-term infants up to a maximum of 10 kg (22lbs).

The Isolette® 8000 plus is not intended for home use.

The Isolette® 8000 plus is a neonatal incubator that provides a controlled environment for both premature and full-term infants up to a maximum of 10 kg (22lbs). It controls temperature, oxygen and humidity (both are optional).

The predicate device as cleared in K172154 is offered with the hood and shell assembly of the incubator mounted on a variable high adjustable (VHA) trolley. All components and accessories for the device were cleared as part of the system.

The modification of the device is the replacement of the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. All other components and accessories of the device are identical to those cleared under K172154.

The modification does not change the intended use or alter the fundamental scientific technology of the currently approved predicate device.

This document is a 510(k) premarket notification for a modification to an existing medical device, the Isolette® 8000 Plus Neonatal Incubator. The modification involves replacing the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. No AI/ML components are involved in this device, therefore, many of the requested fields are not applicable.

Here's a summary based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document focuses on demonstrating that the modified device remains substantially equivalent to its predicate device (Isolette® 8000 plus, K172154) despite the change in the trolley. The acceptance criteria essentially align with the predicate device's established performance and safety standards. The performance of the modified device is reported as "Same" for nearly all specifications, with "Different – No impact on effect on safety and effectiveness" for the few physical attribute changes.

Ask a specific question about this device