(11 days)
The STELLAR 404T - three parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Plethysmograph. It can also display the digital values of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device, which can also be used as a portable device, permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
This STELLAR 404T unit is a 3 parameter Patient monitor System (TFT color monitor) with NIBP, Pulse oximetry and Temperature with an inbuilt two channel thermal array recorder for printing of Tabular trends & waveforms.
STELLAR 404T has waveform display capability for Plethysmograph. It also displays the digital values of PR, SpO2. Non-Invasive Blood Pressure (Systolic, Diastolic and Mean) and Temperature readings. It has graded and color coded alarms It has 2 hours and 12 hours tabular and graphical trends for SpO2 and Temperature. It has special tabular trend for NIBP to store the last 100 readings. Alarm recall feature offers last 16 alarm conditions.
The provided document is a 510(k) summary for the STELLAR 404T Patient Monitoring System. It does not contain information about specific acceptance criteria or an explicit study proving the device meets said criteria in the format typically used for AI/ML device evaluations. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and validation data.
However, I can extract information related to the device's characteristics and the comparison study used for substantial equivalence.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a performance report with numerical results like sensitivity, specificity, or F1-score. Instead, it states that the "range and accuracy of the parameters & method of sensing are similar to the predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of an AI/ML device evaluation. The assessment is based on comparing the technological characteristics of the STELLAR 404T with its predicate devices. There's no mention of sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document does not describe an evaluation where experts established ground truth for a test set. The comparison is based on the device's design and specifications against existing, legally marketed devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or expert adjudication process is described.
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 is a traditional medical device submission, not an AI/ML device, and therefore, no MRMC study or human reader improvement analysis is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a patient monitoring system, not an algorithm. Its performance is inherent in its measurement capabilities, which are asserted to be similar to predicate devices.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The ground for "substantial equivalence" is based on comparing the device's design, intended use, and technological characteristics to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/ML device that requires training data.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
Summary of available information from the document that loosely relates to your request:
- Device Name: STELLAR 404T Patient Monitoring System
- Predicate Devices:
- Comparison Focus: "The range and accuracy of the parameters & method of sensing are similar to the predicate devices."
- Parameters Monitored: NIBP (Non-Invasive Blood Pressure), Pulse oximetry (SpO2, PR), and Temperature. Also displays Plethysmograph.
- Key Design Similarities to Predicate:
- Available parameters (NIBP, Pulse oximetry, Temperature)
- Range and accuracy of parameters
- Method of sensing
- Audible & visual alarms
- TFT color display (like PLANET)
- Thermal array recorder (similar to PLANET)
- Key Design Difference from Predicate:
- Battery type: Lithium-ion in STELLAR 404T vs. Lead-acid in PLANET. The submission states this difference does not pose additional risk.
- Compliance to Standards: IEC 60601-1, IEC 60601-1-2.
Conclusion stated by the submitter: Based on the technological characteristics and comparison to the predicate device, Larsen & Toubro Limited believes their device is substantially equivalent and "doesn't pose any additional risk on safety & effectiveness of the device."
This 510(k) summary provides a comparison for regulatory purposes to demonstrate substantial equivalence, not a detailed performance study with explicit acceptance criteria and corresponding results as one would typically find for an AI/ML device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).