(115 days)
The PLANET 55 multi-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 parameters include ECG (3 lead /5 lead), SpO2, Respiration, Temperature and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 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.
PLANET 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, and CO2.
PLANET 55 is a 4-channel monitor with 8.4" TFT display capable of displaying ECG, Respiration, SpO2, CO2, digital values of HR/PR, SpOz, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has selective 24\48\72 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, RS485 Infrared remote and Ethernet.
Here's an analysis of the provided documents regarding the Larsen & Toubro Limited PLANET 55 Patient Monitoring system.
Please note: The provided documents (510(k) summary and FDA clearance letter) primarily focus on establishing "substantial equivalence" to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics in the way a new, novel AI/software medical device might. Therefore, some of the requested information (like specific performance metrics, sample sizes for test sets, expert qualifications, and MRMC studies) is not present in these documents as it wasn't the focus of this type of submission.
Acceptance Criteria and Reported Device Performance
The documents do not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the PLANET 55 monitor's various parameters. Instead, the "acceptance criteria" are implied by the process of demonstrating substantial equivalence to legally marketed predicate devices, meaning it performs as safely and effectively as those devices for its intended use.
The reported "device performance" is primarily qualitative, stating that the device offers the same parameters and functionality as the predicate devices.
| Parameter Monitored | Implied Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (Qualitative) |
|---|---|---|
| ECG (3/5 lead) | Performs as safely and effectively as predicate devices for ECG monitoring. | Capable of displaying ECG, HR/PR. |
| Respiration | Performs as safely and effectively as predicate devices for respiration monitoring. | Capable of displaying Respiration, RR. |
| NIBP | Performs as safely and effectively as predicate devices for non-invasive blood pressure monitoring. | Capable of displaying Non-Invasive Blood Pressure (Systolic, Diastolic, Mean). |
| Temperature | Performs as safely and effectively as predicate devices for temperature monitoring. | Capable of displaying Temperature. |
| SpO2 | Performs as safely and effectively as predicate devices for SpO2 monitoring. | Capable of displaying SpO2. |
| CO2 (Capnography) | Performs as safely and effectively as predicate devices for CO2 monitoring. | Capable of displaying CO2, EtCO2, FiCO2. |
| General Functionality | Meets safety and essential performance standards. | 4-channel monitor with 8.4" TFT display, tabular/graphical trends (24/48/72 hours), NIBP trend (240 readings), Alarm Recall (24 patient alarms), 2-channel thermal array recorder, optional communication (USB, RS232, RS485, Infrared, Ethernet). |
Study Details (Based on available information)
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Table of Acceptance Criteria and Reported Device Performance: (Addressed above, largely qualitative based on substantial equivalence.)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided documents. Substantial equivalence claims often rely on engineering testing and comparison to predicate device specifications rather than a distinct "test set" of patient data for performance validation in the way software algorithms use for efficacy.
- Data Provenance: Not applicable in the context of this submission, as it's not a study involving patient data to prove a novel performance claim. The submission relies on compliance to international standards and direct comparison of features and specifications with predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/mentioned. Ground truth establishment with experts is typical for diagnostic algorithms, not for monitoring systems seeking substantial equivalence based on technical specifications and established technology.
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Adjudication method for the test set:
- Not applicable/mentioned.
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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. This is a patient monitoring system, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant and was not conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a "patient monitoring system" with a human user (professional health care provider) responsible for interpreting the data. It is not an "algorithm only" device in the sense of AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of this submission. The "ground truth" for demonstrating substantial equivalence for a vital signs monitor typically involves:
- Conformance to standards: Meeting established performance requirements detailed in relevant IEC standards (e.g., IEC 60601-1 Medical Electrical safety, IEC 60601-1-2 EMC compliance).
- Bench testing: Verifying accuracy and functionality of individual parameters against calibrated reference equipment.
- Comparison to predicate device specifications: Ensuring that the technical specifications and performance characteristics are equivalent.
- Not applicable in the context of this submission. The "ground truth" for demonstrating substantial equivalence for a vital signs monitor typically involves:
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The sample size for the training set:
- Not applicable/mentioned. This is not an AI/machine learning device that requires a "training set" of data.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied.
Summary of the Study provided in the 510(k) Summary:
The "study" presented in this 510(k) summary is a comparative analysis demonstrating substantial equivalence to predicate devices rather than a traditional clinical efficacy study.
- Objective: To show that the PLANET 55 Patient Monitoring System is substantially equivalent to legally marketed predicate devices (PLANET 50 Patient Monitoring System and STAR 50 Patient Monitoring System).
- Methodology:
- Direct comparison of technological characteristics (parameters monitored, features) of the PLANET 55 with the identified predicate devices.
- Stated compliance to international standards: IEC 60601-1 (Medical Electrical safety) and IEC 60601-1-2 (EMC compliance).
- The submission includes a "Substantial Equivalence Equipment comparison" document, which would detail feature-by-feature and specification-by-specification comparisons, but this document itself is not provided here.
- Conclusion: Larsen & Toubro Limited believes that the PLANET 55 is substantially equivalent to its predicate monitors and "doesn't pose any additional risk on safety & effectiveness of the device."
In essence, the "study" for this type of device is a comprehensive engineering and regulatory comparison to show that the new device is as safe and effective as existing, legally marketed devices for the same intended use.
§ 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).