(11 days)
The Galaxy 55 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HRPR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA readings.
The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
GALAXY 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead). Respiration, NIBP. TBP. Temperature. SpO2. CO2 & Gas monitoring.
GALAXY 55 is a 8-channel monitor with 15"/17"/19" external monitor display capable of displaying ECG. Respiration. SpO2, CO2. digital values of HR/PR. SpO2, RR. Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolie and Mean), Temperature, EiCO2. FiCO2. NoO. On, EiAA and FiAA readings. It has selective 24148172 Hours tabular and graphical trends. It has special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facility with last 24 patient alarms details. It has a two-channel thermal array recorder for printing of Tabular trends & waveforms. It has got optional communication features -USB. RS232, Infrared remote and Ethernet. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.
The provided 510(k) summary for the Larsen & Toubro Limited GALAXY 55 Patient Monitoring system primarily focuses on its substantial equivalence to a predicate device (STAR 55 Patient Monitoring System). Therefore, the study described is a comparison study against a predicate device, rather than a standalone performance study with specific acceptance criteria for diagnostic metrics.
Based on the provided documents, I can extract information related to the comparison with the predicate device and the general intended use. However, explicit acceptance criteria with specific performance metrics and a detailed study report proving these criteria are met are not present in this type of 510(k) summary. This document typically asserts substantial equivalence based on technological characteristics and compliance with standards, without presenting detailed clinical performance data in the same way a clinical trial report would.
Here's a breakdown of what can be inferred and what is not available:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to the predicate device based on technological characteristics and compliance with standards, rather than defining specific performance acceptance criteria for diagnostic metrics (e.g., sensitivity, specificity, accuracy) and then reporting the device's performance against them.
The "Conclusion" states:
"Based on the Technological characteristics of GALAXY 55 and its comparison with that of predicate devices Star 55, Larsen & Toubro Limited believes that their device is substantially equivalent to this predicate Monitor and doesn't pose any additional risk on safety & effectiveness of the device."
This implies that the "acceptance criteria" were met by demonstrating similar technological characteristics and compliance with general medical device standards to the legally marketed predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document does not describe a test set or a clinical study with patient data. The comparison is based on the device's technological characteristics.
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/provided. No expert review or ground truth establishment for a test set is mentioned, as no clinical study on patient data is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No adjudication method for a test set 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
This information is not applicable/provided. This device is a patient monitoring system, not an AI-assisted diagnostic tool, and the document does not describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. As above, this is a patient monitoring system, and its performance is evaluated in comparison to a predicate device's technological characteristics, not through a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. No ground truth for specific diagnostic outcomes is discussed. The "ground truth" for the substantial equivalence claim is the functional and safety profile of the predicate device, against which the new device's technological characteristics and standards compliance are compared.
8. The sample size for the training set
This information is not applicable/provided. The document does not describe an AI/algorithm that would require a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. The document does not describe an AI/algorithm or a training set.
Summary of the Study described in the 510(k) Summary:
The study described is a comparison of technological characteristics of the GALAXY 55 Patient Monitoring System to a legally marketed predicate device, the STAR 55 Patient Monitoring System (K080173), also manufactured by L&T Medical Equipments & Systems.
- Objective: To establish substantial equivalence to the predicate device.
- Methodology: A detailed comparison of all parameters available in the GALAXY 55 system with those of the STAR 55 system, presented in a "Predicate device comparison table" (which is referenced but not included in these provided pages). The document also states compliance with international standards IEC 60601-1 (Medical Electrical safety) and IEC 60601-1-2 (EMC compliance).
- "Acceptance Criteria" implicitly met: The new device must possess similar technological characteristics and performance specifications to the predicate device to be considered substantially equivalent. It must also comply with relevant safety and EMC standards. The document asserts that based on this comparison, the GALAXY 55 "doesn't pose any additional risk on safety & effectiveness of the device" compared to the predicate.
- Study Type: A comparative analysis of device specifications and documented compliance to recognized standards, rather than a clinical performance study.
- Data Provenance: Not human or patient data, but rather device specifications and engineering data.
Therefore, while the document confirms the device's regulatory pathway and the basis for its market clearance, it does not provide the detailed performance metrics and study design typically associated with demonstrating performance against specific, quantitative acceptance criteria for diagnostic accuracy.
§ 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).