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The PLANET 55 Model 100 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital 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, EtC02, and FiC02 readings.

In addition, PLANET 55 Model 100 has Arrhythmia and ST detection from 3L / 5L ECG measurements. The Arthythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal Patients.

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 Model 100 is a Multi-parameter patient monitoring system for continuous monitoring of the physiological parameter ECG (3/5 lead), Arrhythmia & ST analysis, Respiration, NIBP, Temperature, SpO2 and CO2.

PLANET 55 Model 100 is a 4-channel monitor with 8.4" TFT display capable of displaying ECG, Respiration, Sp02, CO2 digital values of HR/PR, Spo2, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, FiCO2, FCO2, FCO2 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 first 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 i.e. USB, RS232, Infrared remote and Ethernet. The unit comes with adjustable alarm limits as well as visible and audible alarm signals.

The provided text describes the Larsen & Toubro Limited PLANET 55 Model 100 Patient Monitoring System, a multi-parameter device. However, it does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.

The document is a 510(k) summary for premarket notification to the FDA. It primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Missing. The document does not provide a table detailing specific acceptance criteria (e.g., accuracy ranges for heart rate, SpO2, NIBP) or corresponding reported device performance values. It states that the device is "substantially equivalent" to predicate devices, implying similar performance, but quantitative data is not provided.

2. Sample Size for the Test Set and Data Provenance:

• Missing. No specific test set sample size is mentioned for evaluating the new PLANET 55 Model 100.
• Missing. Data provenance (country of origin, retrospective/prospective) is not discussed.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Missing. The document does not describe any expert-established ground truth for a test set. This type of information would typically be found in a detailed performance study.

4. Adjudication Method:

• Missing. No adjudication method is described, as there's no mention of a ground truth establishment process involving multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Missing. There is no mention of an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device described (patient monitor) is not an AI-assisted diagnostic tool in the sense that would typically involve a MRMC study.

6. Standalone (Algorithm Only) Performance Study:

• Missing. While the device has algorithms for Arrhythmia and ST analysis, the document does not present a standalone performance study report for these algorithms with specific metrics (e.g., sensitivity, specificity) against a ground truth. It relies on the substantial equivalence argument to predicate devices which presumably have established performance.

7. Type of Ground Truth Used:

• Missing. As no specific performance study against a defined ground truth for the PLANET 55 Model 100 is provided, the type of ground truth used is not stated. For vital signs monitors, ground truth often involves comparison to reference devices or direct physiological measurements.

8. Sample Size for the Training Set:

• Missing. The document does not mention any training set or its sample size. This would typically be relevant for machine learning-based devices, but the PLANET 55 Model 100 is presented as a traditional vital signs monitor relying on established algorithms rather than novel AI/ML models that require extensive training data.

9. How Ground Truth for the Training Set Was Established:

• Missing. Since no training set is mentioned, the method for establishing its ground truth is also not provided.

Summary of available information:

• Device Name: PLANET 55 Model 100
• Intended Use: Multi-parameter patient monitoring system for continuous monitoring of physiological parameters (ECG, Respiration, NIBP, Temperature, SpO2, CO2), including Arrhythmia & ST analysis. Intended for Adult, Pediatric, or Neonatal patients at bedside or during intra-hospital transport, not for home use. Used by professional healthcare providers.
• Predicate Devices:
  • PLANET 55 Patient Monitoring System (L&T Medical Equipments & Systems) / K071472
  • Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope Corp) / K020550
• Regulatory Status: Substantially Equivalent to predicate devices, Class II, Product Code MHX (Arrhythmia detector and alarm).
• Standards Compliance: IEC 60601-1 (Medical Electrical Safety) and IEC 60601-1-2 (EMC compliance).

Conclusion:

The provided document serves as a 510(k) summary for regulatory submission, focusing on demonstrating substantial equivalence to already marketed devices. It does not contain the detailed performance study information with specific acceptance criteria, sample sizes, ground truth methodologies, or expert involvement that your request specifies for the device itself. Such granular data would typically be found in separate, more detailed technical or clinical performance reports that form part of the full 510(k) submission but are not included in this public summary.

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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.

Study Details (Based on available information)

1. Table of Acceptance Criteria and Reported Device Performance: (Addressed above, largely qualitative based on substantial equivalence.)

2. 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.

3. 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.

4. Adjudication method for the test set:

   • Not applicable/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:

   • No. This is a patient monitoring system, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant and was not conducted.

6. 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.

7. 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.

8. 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.

9. 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.

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