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The Star 50N multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatric and neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unpin Vital signs parameters include ECG (3 lead / 5 lead), SpO2, Respiration, Temperature, external optional Capnography (CO₂). It can also display the digital values of HR/PR, SPO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, EyCO2, and FiCO2.

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.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

STAR 50N is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, SpO2 and external CO2 (optional).

STAR 50N is a 6-channel monitor with 10.4" TFT 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, Diastolic and Mean), Temperature, EtCO2 and FiCO2 readings. It has 168 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. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It has got optional communication features - USB, Wi/Fi (optional) and Ethernet. This monitor can also be connected to L&T Central Nursing Station (Skyline 55) and an external LCD-TFT display

This document is a 510(k) summary for the STAR 50N Patient Monitoring System. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested.

Therefore, many of the requested fields cannot be filled directly from the provided text, as the document describes a regulatory submission based on comparison to existing devices, not a de novo study proving new acceptance criteria.

Here's an analysis based on the provided text, highlighting what information can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance for the STAR 50N in the traditional sense of a clinical or technical validation study with specific metrics (e.g., accuracy, sensitivity, specificity). Instead, it states that the device is substantially equivalent to predicate devices.

The acceptance criteria are implicitly met by demonstrating that the STAR 50N shares the "same" technological characteristics and principles of operation, and performs "as well as" or "no worse than" the predicate devices. The document explicitly states:

Reported Device Performance: The only "performance" reported is that the characteristics are "Same" as the predicate devices. No specific numerical performance metrics are provided for the STAR 50N itself from a new study within this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a new clinical test set or data collection for the STAR 50N. The basis for comparison is the performance of the predicate devices.

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)

Not applicable. No ground truth establishment for a new test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No new test set or 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 device is a patient monitoring system, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is an integrated patient monitoring system. Its primary "performance" is the accurate capture and display of physiological parameters, which is implicitly standalone in its function once calibrated. However, the exact type of "standalone" study (e.g., specific accuracy tests against reference standards) is not detailed in this summary; instead, compliance with standards (IEC 60601-1, IEC 60601-1-2) which would involve such testing, is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated for the STAR 50N in a new study. For the predicate devices' prior approvals, the ground truth for vital sign measurements (ECG, SpO2, NIBP, etc.) would typically be reference standards (e.g., skilled manual blood pressure readings, reference ECG machines, oximeter simulators) according to recognized medical device standards.

8. The sample size for the training set

Not applicable. This device is not described as involving machine learning or AI models with a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set is described.

Summary of what the document does provide regarding acceptance criteria and study:

The document serves as a 510(k) summary, which is a submission to the FDA demonstrating substantial equivalence to legally marketed predicate devices. The "study" in this context is primarily a comparison of technological characteristics and intended use between the new device (STAR 50N) and already approved predicate devices (STAR 55 and Stellar 300).

Implicit Acceptance Criteria: The primary acceptance criterion for a 510(k) is that the new device is substantially equivalent to a predicate device in terms of:

• Intended Use: The STAR 50N shares the same intended use (monitoring vital signs for adult, pediatric, and neonatal patients at the bedside or during intra-hospital transport) as its predicates.
• Technological Characteristics: The document asserts that the parameters (ECG, Respiration, Temperature, SpO2, IBP, Capnography, NIBP) are "Same" as those of the predicate devices. This implies that the underlying technology for measuring these parameters is similar enough not to raise new questions of safety or effectiveness.
• Safety and Effectiveness: L&T believes the device "doesn't pose any additional risk on safety & effectiveness" when compared to the predicates, supported by compliance with international standards IEC 60601-1 (Medical Electrical safety) and IEC 60601-1-2 (EMC compliance).

"Study" Proving Acceptance: The "study" that proves these criteria are met is the comparison document (mentioned as "Substantial Equivalence Equipment comparison" document, though not fully provided) that systematically details the technological characteristics of the STAR 50N against those of the predicate devices (STAR 55 and Stellar 300). The conclusion is that because the device is "substantially equivalent," it meets the regulatory requirements for market clearance without requiring a new, comprehensive clinical trial for performance metrics beyond what the predicate devices already established.

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The STELLAR 300 - three parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric and neonate patient's vital signs at the benside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameter includes Plethysmograph. It can also disolay the digital wallus 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 Meen of PR, SpO2, Non-Invasive Blood Pressure (Systolic, Displays Mean) and Temperatire 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.

This document is a 510(k) summary for the STELLAR 300 Patient Monitoring System, seeking clearance for a neonate mode addition. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a new AI/software-as-a-medical-device.

Based on the provided text, the following information can be extracted, with significant limitations for aspects related to "acceptance criteria" and "study" in the context of detailed performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds (e.g., accuracy, sensitivity, specificity) for vital sign monitoring. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device, STELLAR 404T. The "reported device performance" is essentially that its parameters are "similar" to the predicate.

The statement on page 3, "The range and accuracy of the parameters & method of sensing are similar to the predicate devices," is the closest the document comes to defining performance. A detailed comparison would likely be contained in the "Substantial Equivalence Equipment comparison" document, which is referenced but not provided here.

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

The document does not specify a sample size for a test set or any performance studies with human subjects for the NIBP, Pulse Oximetry, or Temperature parameters, nor does it describe data provenance (e.g., country of origin, retrospective/prospective). The claim of similarity to the predicate likely relies on engineering testing and comparison of technical specifications, rather than a clinical performance study with a distinct test set.

For the addition of the "Neonate mode," the document states, "STELLAR 300 device with Adult & Pediatric mode is already FDA approved -K093017. In this submission, Neonate mode is added to STELLAR 300." This suggests that the extension to neonates might be justified based on established technology and potentially bench testing or comparisons to standards without a new clinical study in neonates described in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. As there's no mention of a clinical performance study with a test set requiring ground truth established by experts, this detail is absent.

4. Adjudication Method

This information is not provided in the document. There is no mention of a study involving expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

MRMC studies are typically performed for imaging devices or AI algorithms where human interpretation is involved. The STELLAR 300 is a patient vital signs monitor. Therefore, an MRMC comparative effectiveness study was not done as it is not applicable for this type of device. The concept of "human readers improve with AI vs without AI assistance" does not apply to a vital signs monitor.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The STELLAR 300 is a hardware device that measures vital signs. Its core function is to produce quantitative measurements (NIBP, SpO2, Temperature). Its performance is inherently standalone in the sense that the device measures and displays these parameters directly. It's not an AI algorithm that provides an輔助 diagnosis needing "human-in-the-loop" interaction in the described context. Therefore, the device operates in a standalone capacity by providing raw vital sign data.

7. The Type of Ground Truth Used

Given the nature of a patient monitor, the ground truth for vital sign parameters would typically be established using reference standard measurement devices (e.g., a calibrated sphygmomanometer for NIBP, a co-oximeter for SpO2, a calibrated thermometer for temperature). The document does not explicitly state the type of ground truth used, but it implies that performance is evaluated against established standards or a predicate device.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is because the STELLAR 300 is a traditional medical device (patient monitor) and not an AI/Machine Learning device that undergoes a "training" phase in the computational sense. Its design and validation rely on engineering principles, compliance with standards (IEC 60601-1, IEC 60601-1-2), and comparison to a predicate device.

9. How the Ground Truth for the Training Set was Established

As there is no training set in the AI/ML sense, this question is not applicable to the STELLAR 300 device as described in this 510(k) summary.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes the "study" (or rather, the justification for substantial equivalence) as a comparison to a legally marketed predicate device, STELLAR 404T (K060058). The core argument is based on the technological characteristics of the STELLAR 300 being "similar" to the predicate device regarding primary parameters (NIBP, Pulse Oximetry, Temperature), their range, accuracy, and method of sensing. Other features like display, recorder, alarm functionality, and battery type are also cited as similar. The addition of the neonate mode to the STELLAR 300 is an extension to an already FDA-approved device for adult and pediatric use (K093017).

The document states, "Comparison of all the parameters of STELLAR 300 to that of the predicate devices is given in the 'Substantial Equivalence Equipment comparison' document." This implies that a detailed technical comparison, likely including bench testing against specifications or established standards, was performed to support the claim of similarity in range and accuracy.

Compliance with international standards (IEC 60601-1 for safety and IEC 60601-1-2 for EMC) further supports the device's acceptable performance and safety. The conclusion is that the device "doesn't pose any additional risk on safety & effectiveness of the device" compared to the predicate.

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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.

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The Skyline55 Ver 1 is Central Nursing System Software that is loaded in a PC, which in turn is connected to a listed patient monitor via an Ethernet communication (wired or wireless). The system software will enable a user to simultaneously monitor 8/16 beds. The system software will make available to the user, patient information in the form of continuous monitoring along with extended features in which 72-hour trend data can be stored for each patient and displayed in the form of Waveform recall, Graphical and Tabular Trends. Alarm records for 72-hours too are recorded and stored for each patient connected to the system software.

Skyline 55 Ver1 is intended to conduct centralized monitoring for adult, pediatric and neonatal patients' vital sign information from multiple monitors in a hospital, the monitoring parameters include ECG, NIBP, SPO2, RESP, IBP, TEMP, CO2 and Anesthesia agents.

The user, responsible to interpret the monitored data made available, will be a professional health care provider. The system software permits patient monitoring with adjustable visible and audible alarm signals. The system software is not intended for home use.

Central Nursing Station is a kind of medical information system widely applied in clinical monitoring, whose operation requires specific hardware environment such as a PC loaded with an Operating System and a software application. The loaded PC system is connected with multiple individual bedside monitors through a communication channel (In Skyline55 case wired Ethernet 802.3 and wireless 802.11bg). It can collect the monitoring information of the patient transferred via interface from the bedside monitor. It can also display and export the integrated information from bedside monitors so as to free-up doctors from clinical monitoring work and create centralized monitoring management.

The Skyline55 Ver1 is such Central Nursing Station software which is loaded in a PC of recommended specifications. The system set-up includes a FCC approved highperformance PC hardware system, the application software and Windows operation system (Windows XP). Through applying Larsen & Toubro specified protocol, the Central Monitoring System receives physiological information from cleared bedside monitors manufactured by Larsen & Toubro, includes: Planet 50, Star 50, Galaxy, Planet 55, Star 55 and Galaxy 55.

Skyline 55 Verl can maximally support the simultaneous interfacing of 16 bedside monitors. TCP/IP protocol is applied to ensure reliable transmission of data between the bedside monitors and the Central Nursing Station using Cat5e cable.

Skyline 55 Ver1 offers centralized display of physiological information of many patients who are monitored simultaneously. The software can support one display with display information from up to 16 bedside monitors. If any of the bedside monitors gives off a patient vital sign parameter alarm (also referred as Red Alam), prompt information will be immediately displayed by means of audible and visual alarm for medical personnel attention.

The physiological waveforms displayed on Skyline 55 Ver1 include: ECG, RESP, CO2, SPO2, IBP and Anesthesia agents. The physiological parameters displayed on the central monitoring system include: HR, RR, SPO2, SysDia/Mean NIBP and IBP, TEMP and CO2, Archythmia, ST indications and Anesthesia agents. The software also performs notification directly for Red alarms from the bedside monitor. Moreover database technology is applied to store these from the bedside monitor.

Skyline 55 Ver1 is used to provide a secondary display/announcement for the physiological parameters based on the bedside monitor and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions.

The provided document is a 510(k) summary for the Skyline 55 Version 1 Central Nursing Station software. It compares the device to predicate devices and states its intended use. However, it does not include detailed information regarding specific acceptance criteria, test methodologies, sample sizes for test sets, expert qualifications, adjudication methods, or separate training set details, which are typical for studies proving device performance.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a detailed performance study with acceptance criteria in the manner often seen for novel algorithms or diagnostic devices. Substantial equivalence relies on comparing the technological characteristics and intended use of the new device to a predicate.

Based on the provided text, here's what can be extracted and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit "acceptance criteria" and "reported device performance" in a quantitative, metrics-based format typically used for evaluating the diagnostic performance of a device (e.g., sensitivity, specificity, accuracy against a gold standard).

Instead, the conclusion of the 510(k) summary acts as the overarching "acceptance," stating:
"The conclusions drawn from testing and validation of Skyline 55 Ver1 demonstrates that the device is as safe, as effective, and performs as well as the legally marketed predicate devices Skyline55 Ver0 (K081552) and the Hypervisor VI Central Monitoring System (K062194, by Shenzen Mindray Bio-Medical Electronics Co., Ltd, China)."

This is a qualitative statement of equivalence, not a quantitative performance report against a set of statistical criteria. The "performance" is implicitly deemed equivalent to the predicate devices through functional comparison and validation.

Instead of a criteria table, the document provides a "Technological Characteristics" comparison with predicate devices:

2. Sample size used for the test set and data provenance

The document states "testing and validation of Skyline 55 Ver1" was performed, but does not specify any sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typical for performance studies of diagnostic or AI-driven systems, but less so for substantial equivalence evaluations of monitoring software which rely more on functional verification and validation.

3. Number of experts used to establish the ground truth for the test set and their qualifications

This information is not provided in the document. The concept of "ground truth" established by experts is usually relevant for diagnostic devices where accuracy is assessed against expert opinion or definitive diagnostic methods. For a central nursing station software, the primary "truth" is the data transmitted from the bedside monitors, and the software's performance is gauged by its ability to accurately receive, display, and manage this data.

4. Adjudication method for the test set

This information is not provided. Given the nature of the device (central monitoring software, not a diagnostic algorithm requiring interpretation), an adjudication method for a test set (e.g., 2+1, 3+1) is unlikely to be applicable or described in this type of submission.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and effect size of human readers improving with AI vs without AI assistance

An MRMC study was not conducted or described. This type of study is typically performed for AI or CAD devices where the AI is intended to assist human readers in making a diagnosis or improving efficiency. The Skyline 55 is a central monitoring system, not an AI-assisted diagnostic tool. Its purpose is to aggregate and display data from bedside monitors, not to interpret or assist in interpretation in a manner that would be assessed via MRMC.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The document does not describe a standalone performance study for an algorithm. The Skyline 55 is described as software for a "Central Nursing Station" which provides a "secondary display/announcement" for physiological parameters, emphasizing that it is "NOT a patient monitoring device" and clinicians should "always reference the primary bedside monitor." This implies the device's role is inherently "human-in-the-loop" as a data display and alert system, rather than a standalone diagnostic algorithm.

7. The type of ground truth used

The "ground truth" for verifying the functionality of the Skyline 55 Ver1 is implicitly the physiological data transmitted from cleared bedside monitors. The software's performance is validated by its ability to accurately receive, display, and store this information, as well as correctly generate alarms based on parameters from these primary sources. There's no indication of 'pathology' or 'outcomes data' being used as ground truth for this device's performance.

8. The sample size for the training set

This information is not provided. As this is software for a central monitoring system, designed for data display and management rather than a machine learning or AI algorithm, the concept of a "training set" in the context of model development is not directly applicable in the typical sense. The software would have undergone standard software development, verification, and validation, which might involve testing with simulated or captured data, but not a "training set" for an algorithm.

9. How the ground truth for the training set was established

This information is not provided, and as explained above, the concept of a "training set" for this type of software is not explicitly detailed or applicable in the way it would be for an AI device.

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The STAR 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/ 12 lead), SpO2, Respiration, Temperature, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HR/PR, 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.

In addition, Star 55 Model 100 has got Arrhythmia and ST detection from 3L/5L/12L ECG measurements. The Arrhythmia 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.

STAR 55 Model 100 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5/12 lead), Arrhythmia & ST analysis, Respiration, NIBP, IBP, Temperature, SpO2, CO2 & Gas monitoring,

STAR 55 Model 100 is a 8-channel monitor with 12.1" TFT display capable of displaying ECG, Respiration, SpO2, CO2, digital values of HR/PR. SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blond Pressure (Systolic. Diastolic and Mean), Temperature, EtCO2, FiCO2, NoO. O2, EtAA and FiAA readings. It has selective 2448172 Hours tabular and graphical trends. It han special feature of NIBP having a trend of storing last 240 readings. It has Alarm Recall facilius 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 fratures . USB, RS232, Infrared remote and Ethernet. The device permits patient monitoring with adjustable aların limits as well as visible and audible alarm signals.

The provided document K090172 is a 510(k) summary for the STAR 55 Model 100 patient monitoring system. However, it does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria with reported performance metrics, sample sizes, ground truth establishment, or expert qualifications.

The document primarily focuses on establishing substantial equivalence to predicate devices, describing the device's technical characteristics and intended use, and listing compliance with general safety and EMC standards.

Based on the provided text, I can only provide the following limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding reported device performance for specific physiological parameters. It states that the device is intended for "continuous monitoring of the physiological parameters ECG (3/5/12 lead), Arrhythmia & ST analysis, Respiration, NIBP, IBP, Temperature, SpO2, CO2 & Gas monitoring." It also mentions "Arrhythmia and ST detection," implying these are functions of the device.

The only specific performance mention is:

• "The data acquired by 12L ECG Module is interpreted utilizing Mortara Instruments algorithm (cleared by FDA under notification numbers: K920627, K933143)." This indicates that the core algorithm for 12-lead ECG interpretation is a previously cleared algorithm, implying its performance has been deemed acceptable in its prior clearances. However, no specific performance metrics for this device using that algorithm are provided in this document.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified in the provided document.

4. Adjudication method for the test set:

• Not specified in the provided 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 type of study is not mentioned in the provided document. The device is a patient monitoring system, not primarily an AI-assisted diagnostic tool for human readers in the context of an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The document mentions that the 12L ECG module uses "Mortara Instruments algorithm (cleared by FDA under notification numbers: K920627, K933143)." This implies that the algorithm itself had standalone performance evaluated for its initial clearance. However, this document does not present a standalone performance study specifically for the STAR 55 Model 100 using this algorithm; it relies on the predicate algorithm's prior clearance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not specified in the provided document. For patient monitoring systems, ground truth typically involves reference devices (e.g., a known accurate ECG machine for rhythm analysis, a calibrated thermometer for temperature).

8. The sample size for the training set:

• Not specified in the provided document. As the device utilizes a previously cleared algorithm for specific functions (e.g., Mortara Instruments algorithm for ECG), the training data for that algorithm would have been part of its original clearance, but no details are provided here.

9. How the ground truth for the training set was established:

• Not specified in the provided document. Similar to point 8, this would pertain to the original clearance of any algorithms incorporated, but is not detailed here.

Summary of available information related to acceptance and study:

The submission highlights compliance with international standards:

• IEC 60601-1 Medical Electrical safety
• IEC 60601-1-2 EMC compliance

The fundamental claim for clearance is substantial equivalence to predicate devices:

• STAR 55 Patient Monitoring System (L&T Medical Equipments & Systems) / K080173
• Passport 2 Vital signs monitor with View 12 ECG Analysis Module (Datascope Corp.) / K020550

The core argument for substantial equivalence relies on:

• The parameters available with the STAR 55 Model 100 being available with the predicate devices.
• The 12L ECG Module utilizing a previously FDA-cleared algorithm (Mortara Instruments algorithm: K920627, K933143).

Therefore, this 510(k) submission does not provide the detailed study results and acceptance criteria as outlined in your request. It rather demonstrates that the device's technological characteristics and intended use are similar to those of legally marketed predicate devices, and that it adheres to general safety and EMC standards.

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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 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.

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The STAR 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 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, Capnography (CO2) & optional Gas module unit. It can also display the digital values of HR/PR, 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.

STAR 55 is a multi-parameter patient monitoring system for continuous monitoring of the physiological parameters ECG (3/5 lead), Respiration, NIBP, IBP, Temperature, Sp02, CO2 & Gas monitoring.

STAR 55 is a 8-channel monitor with 12.1" TFT 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, Diastolic and Mean), Temperature, EtCO2, FiCO2, N2O, O2, EtAA and FiAA 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, Infrared remote and Ethernet. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

This 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. The provided document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and compliance with general safety standards, rather than presenting a specific performance study with detailed acceptance criteria.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a dedicated study for the STAR 55. Instead, it relies on demonstrating that "The parameters available with the aLarsen & Toubro Limited make STAR 55 Patient monitoring system are available with the predicate devices - aLarsen & Toubro Limited make STAR 50 patient monitoring system & Mindray Co., Ltd. PM 9000 patient monitor for Gas monitoring."

The "Conclusion" states: "Based on the Technological characteristics of STAR 55 and its comparison with that of predicate devices Star 50 and PM 9000 Express for gas monitoring, Larsen & Toubro Limited believes that their device is substantially equivalent to this predicate Monitors and doesn't pose any additional risk on safety & effectiveness of the device."

This implies that the acceptance criterion for the STAR 55's performance is that it performs similarly to the predicate devices across all measured parameters, and the reported device performance is that it meets this unstated, but implied, substantial equivalence.

Without explicit values from the document, a table cannot be fully constructed. However, if we interpret "acceptance criteria" as "compliance with predicate device functionality," then the table would look something like this:

2. Sample Size for the Test Set and Data Provenance

The document does not provide details of a specific clinical performance study with a test set, sample size, or data provenance. The assessment is based on a comparison of technological characteristics with predicate devices.

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

Not applicable, as no clinical study with ground truth established by experts is described. The assessment is based on comparison to existing legally marketed devices.

4. Adjudication Method

Not applicable, as no clinical study requiring adjudication is described.

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

Not applicable. The document describes a comparison to predicate devices, not a study evaluating human reader performance with and without AI assistance.

6. Standalone Performance Study

A standalone performance study, as typically understood for an algorithm or AI, is not described. The document focuses on the device as a whole system and its equivalence to other patient monitors. However, the compliance to standards like IEC 60601-1 Medical Electrical safety and IEC 60601-1-2 EMC compliance implies that standalone technical performance evaluations (e.g., accuracy of parameter measurements, electrical safety) were conducted, but the details of these tests are not provided in this summary.

7. Type of Ground Truth Used

The concept of "ground truth" in the context of clinical images or advanced algorithms is not applicable here. The "truth" for this submission is the established performance and safety of the predicate devices. The claim is that the new device's technological characteristics are equivalent, implying its performance is also equivalent.

8. Sample Size for the Training Set

Not applicable, as this device is a hardware patient monitoring system, not an AI/ML algorithm that typically requires a training set.

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

Not applicable for the same reason as point 8.

Ask a specific question about this device

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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