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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 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.

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