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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 indications for use for the Passport 2® with View 12™ ECG Analysis Module include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3, 5 or 12 lead measurements
• Heart Rate derived from selected sources (SpO2, ECG, IBP, NIBP)
• Blood Oxygenation (SpO2 )* measurement/waveform
• ST Segment Analysis derived from 5 or 12 lead measurements
• Lethal Arrhythmia Detection derived from 5 or 12 lead measurements
• Non Invasive Blood Pressure (NIBP) measurement
• Invasive Blood Pressure (IBP) measurement/waveform measurable at two sites
• Respiration Rate/ waveform derived from ECG or CO2
• CO2, , Inspired and end tidal microstream/waveform
• Temperature measurement via YSI 400/700 series probes
• Interpretation of Resting 12 lead ECG

The target populations are adult, pediatric and neonate with the exception of the:

• Lethal Arrhythmia Detection and ST Segment Analysis, for which the target populations are adult and pediatric only, and
• Interpretation of Resting 12 Lead ECG, for which the target population is adult only.

The monitor is intended for use in the health care facility setting.

The device has the capability of interfacing with Datascope's Gas Module II, displaying the measurements of Anesthetic Gases, O3, N2O, and CO2.

• The device monitors the SpO2 parameter via the Masimo SET® 2000 Pulse Oximeter Technology and Accessories (K990966). The Masimo SET® 2000 Pulse Oximeter Technology and Accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO3) and pulse rate (measured by an SpO3 sensor) and are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

The View 12 ECG Analysis Module provides means for performing diagnostic ECG analysis in conjunction with the monitoring functions of Datascope's Passport 2 Vital Signs Monitor (K993531). The View 12 ECG Analysis Module for the Passport 2 Vital Signs Monitor enables 12-Lead ECG Acquisition. Continuous 12-Lead ST Segment Analysis and Arrhythmia Analysis all with print capabilities. The View 12 ECG Analysis Module consists of a PCMCIA ECG processor card that interfaces with the Passport 2, a front-end electronics cable, and a detachable patient cable with integral leadwire set. The data acquired by this module is interpreted utilizing Mortara Instrument's algorithm (cleared by FDA under notification numbers: K920627, K920626A and K933143) for interpretive electrocardiographs. With the View 12 ECG Analysis Module installed and enabled, the Passport 2 makes interpretive statements on printouts. These statements are categorized into three (3) sections: an interpretive statement, a condition statement, and a rhythm statement.

The provided 510(k) summary (K020532) for the Datascope Passport 2® Vital Signs Monitor with View 12™ ECG Analysis Module does not directly provide acceptance criteria or detailed results from a study specifically conducted for this 510(k) submission to prove the device meets acceptance criteria.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. Here's what can be extracted and inferred regarding the study that proves the device meets acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not contain a specific table outlining acceptance criteria and reported performance for the View 12 ECG Analysis Module itself.

However, the submission states:

• "The diagnostic ECG algorithm used in Datascope's View 12 ECG Analysis Module is identical to that found in the Spacelabs' Integrated Multiparameter Module 90496, as well as in the Mortara Instrument ELI-100 (K920627), ELI-200 (K920626A) and ELI-300 (K933143.)"
• "The functionality of the Passport 2 Vital Signs monitor with View 12 ECG Analysis Module is identical to that of the Spacelabs Ultraview 1050 monitor equipped with Integrated Multiparameter Module 90496."

Therefore, the "acceptance criteria" for the ECG analysis algorithm are implicitly the performance specifications already met and cleared for the predicate Mortara Instrument devices (K920627, K920626A, K933143) and the Spacelabs Module 90496. The reported device performance is, by definition of substantial equivalence in this context, assumed to be identical to these predicate devices. The submission asserts that the Datascope device's algorithm performs as well as the previously cleared Mortara algorithm because it is the Mortara algorithm.

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

The document does not explicitly state the sample size (number of patients/ECGs) for a test set for this specific 510(k) submission to validate the ECG algorithm.

Given the reliance on the predicate Mortara algorithm, the testing data would have been part of the original 510(k) submissions for Mortara Instrument ELI-100 (K920627), ELI-200 (K920626A) and ELI-300 (K933143). Without access to those original submissions, the sample size and data provenance remain unknown from this document. It is highly likely the data would have been retrospective, as is common for established ECG algorithm validation.

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

This information is not provided in the K020532 document, as the ECG algorithm itself was cleared in prior 510(k)s (Mortara Instrument devices). The original Mortara submissions would contain this detail. Typically, expert cardiologists or electrophysiologists with significant experience would be used for manual adjudication of ECGs to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not provided in the K020532 document. It would have been part of the original Mortara submissions. Standard adjudication methods for ECGs often involve a consensus of multiple cardiologists (e.g., 2-out-of-3 agreement, or a tie-breaker by a senior expert).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is mentioned for the View 12 ECG Analysis Module in this 510(k) summary. The submission's argument is that the algorithm is the predicate algorithm, thus no new large-scale comparative study is required for algorithm performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, implicitly. The performance of the diagnostic ECG algorithm (Mortara's algorithm) was assessed in a standalone manner when it was originally cleared under K920627, K920626A, and K933143. This 510(k) leverages that prior clearance.

7. The Type of Ground Truth Used:

For ECG interpretation algorithms, the ground truth is almost exclusively expert consensus by qualified cardiologists or electrophysiologists. This would have been the case for the underlying Mortara algorithm.

8. The Sample Size for the Training Set:

This information is not provided in the K020532 document. The training data for the Mortara algorithm would have been developed prior to its initial 510(k) clearances.

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

This information is not provided in the K020532 document. For ECG algorithms, ground truth for training data would also typically be established through expert consensus, often with a similar process to, but distinct from, the ground truth establishment for the independent test set.

Summary of Device Acceptance Rationale (based on the provided text):

The Datascope Passport 2® Vital Signs Monitor with View 12™ ECG Analysis Module's acceptance is based on its substantial equivalence to legally marketed predicate devices. Specifically:

• Functionality: The overall device functionality (Passport 2 with View 12) is stated to be identical to the Spacelabs Ultraview 1050 monitor with Integrated Multiparameter Module 90496.
• ECG Algorithm: The diagnostic ECG algorithm itself is identical to one already cleared and used in several Mortara Instrument devices (K920627, K920626A, K933143) and the Spacelabs module. These predicate devices have already demonstrated compliance with performance standards and safety through their own clearance processes.
• Safety and Performance Testing: The Datascope device underwent "extensive safety and performance testing" and complies with various industry and safety standards (e.g., ANSI/AAMI EC11, EC13, IEC 60601 series, ISO 10993-1, EN 1441). This testing would focus on the integration of the module, electrical safety, EMC, and ensuring that the overall device still meets general performance requirements, not necessarily re-validating the intrinsic accuracy of the ECG interpretation algorithm, which is assumed from its predicate status.

In conclusion, the "study that proves the device meets the acceptance criteria" for the ECG analysis algorithm refers to the studies conducted for the original Mortara Instrument devices (K920627, K920626A, K933143) because the Datascope device uses the identical, previously cleared algorithm. This 510(k) primarily establishes that the integration of this already cleared algorithm into a new monitor platform does not raise new questions of safety or effectiveness.

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Monitoring of stable patients, not at high risk for life-threatening anthythmias, after discharge from hospital stay, such as patients with compensated congestive heart failure, patients whose myocardial infarction is not recent, or patients with a stabilized heart condition following open heart surgery or coronary artery disease

Monitoring of patients in out-of-hospital convalescence settings

Monitoring of patients by physicians, clinics, or skilled care facilities

Any time a health care professional desires monitoring, measuring or recording of a patient's ECG, SpO2, and/or blood pressure in an out of hospital residence setting

The device is not intended to sound real time alarms

This device does not replace physician's care

The LifeSigns!™ Cardiac Monitoring System collects vital signs data for diagnostic monitoring of stabilized patients, not at high risk for life-threatening arrhythmias, in an out-of-hospital environment. The monitored vital signs include ECG, SpO2, heart rate, and blood pressure. The LifeSigns System is comprised of a monitor (LifeSigns™Shuttle), a cradle (LifeSigns144 Commander), and central station software (LifeSigns™ Central Station). The Shuttle is a portable device, that acquires the patient ECG (one to 12 leads) using ECG electrodes, and the photometric SpO2 data, and heart rate. The Commander provides the non-invasive oscillometric blood pressure measurement (as an option), and connects the Shurtle to a telephone line. The Central Station software operates on an IBM compatible personal computer, coupled by a DSVD (digital simultaneous voice and data) modem to a telephone line. The software provides support for data collection from the monitor and cradle, and supports display, editing, reporting and management of the collected vital signs data, patient demographics, and other associated data. The DSVD capability allows simultaneous voice and data communications between the patient and the central station personnel and between the cradle and the PC. The device is not intended to sound real time alarms. The LifeSigns System does not replace physician's care.

The Instromedix LifeSigns™ Cardiac Monitoring System is a device designed for diagnostic monitoring of stabilized patients in out-of-hospital environments. The FDA has cleared this device through the 510(k) pathway (K964408), signifying its substantial equivalence to predicate devices. The provided document focuses more on the regulatory submission and equivalence to predicate devices rather than a detailed performance study with explicit acceptance criteria and corresponding results in a table format.

However, based on the information provided, we can infer the approach taken for demonstrating performance and regulatory acceptance.

Inferred Acceptance Criteria and Reported Device Performance

While explicit numerical acceptance criteria for accuracy, sensitivity, or specificity are not provided in the document, the core assertion for 510(k) clearance is substantial equivalence to legally marketed predicate devices. This implies that the LifeSigns System's performance for vital signs measurements (ECG, SpO2, heart rate, blood pressure) meets a level comparable to these established devices.

Study Details from the Provided Document:

Due to the nature of a 510(k) summary, specific details regarding sample size, data provenance, expert qualifications, and detailed study methodologies are not extensively provided as they would be in a clinical trial report. However, based on the text:

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "performance testing of vital signs measurements." It can be inferred that a test set of data was used to demonstrate equivalence, but the size and specifics (e.g., retrospective/prospective, country of origin) are absent. This would typically be detailed in a separate test report referenced in the 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For vital signs monitoring devices, ground truth is typically established by comparing the device's readings against a recognized standard (e.g., another FDA-cleared device, a calibrated reference instrument, or manual measurements by trained professionals). The document does not specify the number or qualifications of experts involved in this ground truth establishment, if any were required beyond technical calibration.

3. Adjudication method for the test set: Not applicable based on the information provided. Adjudication methods like "2+1" are typically used in studies involving subjective interpretations (e.g., image reading), where multiple experts provide opinions that need to be reconciled for ground truth. For objective vital signs measurements, direct comparison to a reference standard is more common.

4. 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. The LifeSigns System is a vital signs monitoring device, not an AI-powered diagnostic tool requiring human interpretation improvement studies. It collects and displays objective physiological data.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the system as collecting and displaying vital signs data. The "algorithm" here would pertain to the signal processing for ECG, SpO2, heart rate, and blood pressure calculation. The performance testing would inherently be standalone in terms of the device's ability to accurately measure these parameters before human interpretation of the trends or values.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The specific type of ground truth is not detailed. For vital signs, ground truth would typically come from:

   • Calibrated reference equipment: For blood pressure and SpO2, direct comparison to highly accurate and calibrated reference devices or invasive measurements.
   • Simultaneous recordings/manual verification: For ECG and heart rate, comparison to simultaneously acquired gold standard ECGs or manual heart rate calculation from rhythms.
     The document mentions performance testing, implying direct measurement and comparison, rather than subjective expert consensus, pathology, or outcomes data, which are more common for diagnostic imaging or disease progression studies.

7. The sample size for the training set: Not applicable and not provided. The LifeSigns System predates the common approach of using large training sets for deep learning or AI algorithms. Its functions for acquiring ECG, SpO2, heart rate, and blood pressure are based on well-established signal processing and measurement principles, not machine learning trained on large datasets.

8. How the ground truth for the training set was established: Not applicable, as no training set in the modern AI sense is described or implied for this device.

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The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option provides a means for performing diagnostic ECG analysis in conjunction with the monitoring functions of the SpaceLabs Medical Model 90492 ECG module. Diagnostic ECG analyzes detailed ECG waveforms in each cardiac cycle and the beat-to-beat variability in order to determine the cardiac rhythm. When used in conjunction with a SpaceLabs Medical Patient Care Management System (PCMS) monitor the SpaceLabs Medical Model 90492 ECG module provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events.

The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is a softwareonly option added to the 90492 module software, and is designed to acquire, analyze and display up to twelve ECG vectors in a standard diagnostic ECG analysis format and to work exclusively within the SpaceLabs Medical 90492 12lead ECG module. The diagnostic analysis algorithm is that used in the Mortara Instruments ELI 100 (K920627), ELI 200 (K920626A) and ELI 300 (K933143) and is provided by Mortara Instruments as object code. There is no additional hardware required for this option.

The SpaceLabs Medical Model 90492 ECG module is designed to acquire, process and display up to twelve ECG leads and one respiratory effort signal using standard ECG electrodes. The twelve ECG leads consist of the standard twelve ECG leads, I, II, III, aVR, aVL, aVF, V1 - V6. The 90492 ECG module is used to monitor patients in the operating room, recovery rooms, intensive care units, in the emergency room, in research settings, or other units where additional ECG leads are desired.

ECG data is displayed as an analog moving waveform or as various static waveforms. The analog ECG is passed through digital filters to eliminate unwanted signals. Standard ECG electrodes are used to interface the patient to the 90492 ECG module. Clinicians will position the electrodes in the customary locations. The electrodes are connected to shielded leadwires which are connected to a shielded cable. The cable is connected to the front of the 90492 module.

Unfortunately, the provided text does not contain the detailed information needed to fully answer your request. The document is a 510(k) summary for a medical device and primarily focuses on describing the device, its intended use, and its equivalence to a predicate device.

Here's what I can extract and what's missing:

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

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds for ECG interpretation). The document generally states that "extensive safety and performance testing" was done and that the device "meets all of its functional requirements and performance specifications."
• Reported Device Performance: Not provided. The summary confirms that the diagnostic ECG algorithm is identical to those found in the Mortara Instrument ELI300 (K933143), ELI 100 (K920627), and ELI 200 (K920626A). To find performance, one would need to consult the 510(k) summaries or supporting documentation for those predicate devices, as this document asserts identical performance due to using the same algorithm.

Missing Information for a comprehensive table: Specific metrics (e.g., detection rates for specific arrhythmias, accuracy of QRS duration measurement, etc.) and quantitative results against those metrics.

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

• Sample Size: Not mentioned for any test set.
• Data Provenance: Not mentioned.
• Retrospective or Prospective: Not mentioned.

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):

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

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

• Not 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:

• MRMC Study: Not mentioned. The device is described as a "Diagnostic ECG Analysis Option" which implies an algorithm that provides the analysis, but it doesn't describe a study comparing human readers with and without this algorithm's assistance.

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

• The document implies this is a standalone algorithm's performance inherited from the predicate devices. It states, "The SpaceLabs Medical 12-Lead Diagnostic ECG Analysis Option is a software-only option... The diagnostic analysis algorithm is that used in the Mortara Instruments ELI 100 (K920627), ELI 200 (K920626A) and ELI 300 (K933143) and is provided by Mortara Instruments as object code." This suggests the algorithm's performance itself was assessed (or accepted based on predicate devices) without necessarily involving human-in-the-loop studies for this specific submission. However, the details of that standalone performance are not present here.

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

• Not mentioned. For ECG analysis, ground truth often involves expert cardiologist consensus readings.

8. The sample size for the training set:

• Not mentioned.

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

• Not mentioned. Given that the algorithm is described as "identical to those found in the Mortara Instrument ELI300," the training and ground truth establishment would have occurred during the development and clearance of those earlier Mortara devices.

In summary: This 510(k) summary primarily focuses on regulatory equivalence to predicate devices, asserting that the device is "as safe and effective as the predicate device and raises no new issues" because it uses an identical, previously cleared algorithm. It does not provide the detailed performance study information typically requested for new algorithm submissions or when demonstrating specific performance against acceptance criteria. To obtain such details, one would need to review the K933143, K920627, or K920626A submissions for the Mortara Instrument devices.

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