(212 days)
The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult or Pediatric patient's vital signs at the bedside or during intra-hospital 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 300 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 300 have 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 module and 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 300 Patient Monitoring System. It describes the device, its intended use, and its technological characteristics compared to a predicate device. However, it does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria. A 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results or acceptance criteria and their fulfillment.
Therefore, I cannot provide the requested information from the given text as it is not present. Based on the document, the device received 510(k) clearance (K093017) based on its substantial equivalence to the Stellar 404T Patient Monitoring System (K060058), meaning it was deemed as safe and effective as the predicate device.
To answer your request, here's what the document does state, and what it does not state:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance: The document only states that "The range and accuracy of the parameters & method of sensing are similar to the predicate devices." No specific performance metrics (e.g., accuracy, precision) for NIBP, SpO2, or Temperature are provided for the Stellar 300 or its predicate.
2. Sample size used for the test set and the data provenance
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).
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 in the document.
4. Adjudication method
- This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- This document describes a patient monitoring system, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This document describes a hardware patient monitor. Performance data from standalone algorithm testing, if any, is not included.
7. The type of ground truth used
- This information is not provided in the document.
8. The sample size for the training set
- This information is not provided in the document.
9. How the ground truth for the training set was established
- This information is not provided in the document.
Summary of Device and Regulatory Submission (from the document):
- Device: STELLAR 300 Patient Monitoring System
- Manufacturer: Larsen & Toubro Limited
- Type: 3-parameter patient monitor (NIBP, Pulse oximetry, Temperature)
- Intended Use: Monitoring a single Adult or Pediatric patient's vital signs at the bedside or during intra-hospital transport. Not for home use. Professional healthcare providers are responsible for interpreting data.
- Predicate Device: STELLAR 404T Patient Monitoring System (K060058)
- Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "The parameters available with the Larsen & Toubro Limited make STELLAR 300 Patient monitoring system (NIBP, Pulse oximetry and Temperature) are also available with the predicate device. The range and accuracy of the parameters & method of sensing are similar to the predicate devices."
- Compliance: Refers to IEC 60601-1 and IEC 60601-1-2 for safety and EMC requirements.
§ 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).