(89 days)
Intended Use: The Infinity® Acute Care System™ (IACS) Monitoring Solution:
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 healthcare professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network.
Intended Use: Infinity M540 Patient Monitor
The Infinity M540 is intended for the monitoring of multi-parameter, physiological patient information obtained from connected hardware in environments where patient care is provided by trained healthcare professionals. The M540 is intended to monitor one patient at a time.
Indications for Use
The M540 monitors the following parameters:
- Heart rate
- Arrhythmia (adult and pediatric only)
- 12-lead analysis
- ST segment analysis including TruST® (adult and pediatric only)
- 12-lead ST segment analysis (adult and pediatric only)
- Apnea
- Respiration rate
- Invasive pressure
- Non-invasive pressure
- Temperature
- Cardiac output
- Arterial oxygen saturation
- Pulse rate (SpO2)
- Mainstream etCO2
The Infinity® Acute Care System™ (1ACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside and in transport within the hospital setting. The IACS Monitoring Solution is a combination of two devices; Infinity M540 patient monitor with Infinity M500 docking station; and Infinity C500 software with Infinity C500 Medical Cockpit. Infinity C700 software with C700 Medical Cockpit is an option for a larger screen.
The Infinity M540 patient monitor is a light weight hand held portable patient monitor that displays real-time vital signs and provides continuous trending. The Infinity M540 patient monitor is capable of monitoring Heart rate, Arrhythmia (adult and pediatric only), 12-lead monitoring, ST segment analysis including TruST (adult and pediatric only), 12-lead ST segment analysis (adult and pediatric only), Apnea, Respiration rate, Invasive pressure, Noninvasive pressure, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate (SpO2), and Mainstream etCO2. The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. The Infinity M540 patient monitor can be used as a stand alone medical device without any integration with the Infinity C500 Medical Cockpit.
The Infinity C500 software allows the user to extend the viewing capability of the Infinity M540 patient monitor and integrates additional patient information on Infinity C500 Medical Cockpit. The Infinity C500 Medical Cockpit is a medical grade display monitor with limited monitoring control features. The Infinity C500 software is capable of displaying real-time patient data, providing control back to the Infinity M540 and integrating other applications with patient data on the Infinity C500 Medical Cockpit.
The provided 510(k) premarket notification for the "Infinity Acute Care System (IACS) Monitoring Solution" is not a study proving the device meets specific acceptance criteria in the way a clinical study for a new AI diagnostic would. Instead, it is a submission demonstrating substantial equivalence to already legally marketed predicate devices.
Therefore, the document does not contain the specific information requested in the prompt, such as a table of acceptance criteria with reported device performance metrics, sample sizes, expert qualifications for ground truth, or details of a multi-reader multi-case (MRMC) study. The focus is on showing that the new device is as safe and effective as existing ones, primarily through a comparison of technological characteristics and adherence to safety standards.
Here's an analysis of what is available in relation to your request, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics (like sensitivity/specificity for arrhythmia detection). Instead, the acceptance criterion is implicitly "as safe and effective for its intended use as the predicate device(s)" and adherence to applicable standards.
- Reported Device Performance: The document states: "Clinical performance evaluations indicate that the Infinity Acute Care System (IACS) Monitoring Solution is substantially equivalent to the Infinity Alpha patient monitor and Infinity Explorer with MDS III display." This is a qualitative statement of equivalence, not a quantitative report of performance metrics against specific criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not reported.
- Data Provenance: Not reported (e.g., country of origin, retrospective/prospective).
- Context: Because this is a substantial equivalence submission relying on comparison to predicate devices and adherence to standards, a specific "test set" and corresponding sample size for clinical performance evaluation in the way you might expect for an AI diagnostic algorithm is not detailed here. The clinical performance evaluation mentioned is likely a high-level assessment rather than a detailed study generating novel performance metrics for this specific device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not reported.
- Qualifications: Not applicable/not reported.
- Reasoning: Ground truth generation by experts is typically done for diagnostic accuracy studies. This submission focuses on comparing the safety and effectiveness to predicate devices and adhering to standards, not on establishing a new diagnostic accuracy claim requiring expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not reported. (e.g., 2+1, 3+1, none)
- Reasoning: See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned as having been done.
- Effect Size: Not applicable as no MRMC study was performed.
- Reasoning: MRMC studies are common for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission is for a physiological monitoring system and does not describe such a study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Not applicable/not reported as a separate, isolated algorithm performance.
- Reasoning: The Infinity Acute Care System is a monitoring solution, an integrated system that includes hardware and software for displaying physiological parameters. Its "performance" is implicitly tied to its function in continuously acquiring and displaying data, and triggering alarms, rather than a standalone diagnostic algorithm. The monitoring functions (like arrhythmia detection) are part of the integrated system and are implicitly compared to predicate devices.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated for performance evaluation of the IACS itself. The claims are based on "clinical performance evaluations" showing substantial equivalence to predicate devices and adherence to standards. For the predicates, the "ground truth" would have been established through prior regulatory pathways (e.g., device's ability to accurately measure physiological parameters, correctly detect events, etc.).
- Context: For physiological monitors, ground truth often involves calibration against known standards, comparisons to reference devices, or clinical observation by trained professionals to verify correct parameter display and alarm functionality. However, detailed methodology is not in this 510(k) summary.
8. The Sample Size for the Training Set
- Sample Size: Not applicable/not reported.
- Reasoning: The document doesn't describe the development of a novel algorithm using a training set in the way AI/ML models typically do. This seems to be a hardware/software system that performs known physiological monitoring functions.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable/not reported.
- Reasoning: See point 8.
Summary of Device Performance and Equivalence Statement:
The document states:
- "The Infinity Acute Care System (IACS) Monitoring Solution 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 device(s)."
- "Clinical performance evaluations indicate that the Infinity Acute Care System (IACS) Monitoring Solution is substantially equivalent to the Infinity Alpha patient monitor and Infinity Explorer with MDS III display."
This 510(k) submission primarily relies on demonstrating that the new device meets relevant electrical safety standards (IEC 60601-1) and that its technological characteristics and performance are comparable to the previously cleared predicate devices (Infinity Alpha, Infinity Kappa and Delta Series Monitors, Infinity Explorer). It does not present detailed quantitative performance data or specific clinical studies in the format requested.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.