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The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:

· The ICG monitoring is applicable to the adult patients of 122229cm in height and 30159Kg (67~341 pounds) in weight only;

· NIBP measurement continual mode is not applicable to neonates;

· Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;

The monitors are to be used in general healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitors are not intended for home use.

The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index).

All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following:
• The ICG monitoring is applicable to the adult patients of 122229cm in height and 30159Kg (67~341 pounds) in weight only;
• NIBP measurement continual mode is not applicable to neonates;
• Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients;
Those monitors provide patient monitoring capabilities by using corresponding accessories.
The multi-parameter Patient monitor, model: C50 and C80 have same design principle and technical characteristics:
But the software in the host and modules and components are different.
The differences between C50 and C80 are ICG, BIS and size of monitor.

The provided document describes the acceptance criteria and a study proving the C50 and C80 Multi-parameter Patient Monitor meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established through adherence to recognized international standards and clinical performance metrics. The document details a comparison with a predicate device (K170876, Passport Series Patient Monitors). While explicit "acceptance criteria" for each parameter are not always separately listed with a single performance value from the new device, the "Comparison" column in the table below infers if the new device meets or exceeds the predicate's performance or if sufficient justification is provided for differences.

Study that Proves the Device Meets Acceptance Criteria

The essential studies to prove the device meets acceptance criteria are divided into Non-Clinical Performance Data and Clinical Studies.

Non-Clinical Performance Data:

• Software Verification and Validation Testing: Conducted in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Risk analysis was performed, and the software was deemed a "major" level of concern.
• Electrical safety and Electromagnetic Compatibility (EMC): Testing conducted according to:
  • ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012 (IEC 60601-1:2005, MOD)
  • IEC 60601-1-2 Edition 4: 2014-02
• Bench Testing: Functional and system-level tests were performed, showing the devices meet specifications and perform equivalently to the predicate.
• Biocompatibility Testing: Performed for patient-contacting components (ECG cable, SpO2 probes, temperature probes) that were not previously cleared. Cytotoxicity, sensitization, and irritation testing were conducted based on ISO 10993-1 and FDA's 2016 biocompatibility guidance.
• Conformance with Applicable Standards: The device demonstrated compliance with numerous recognized consensus standards, in addition to those listed above for specific modules (e.g., ISO 80601-2-55 for Respiratory Gas Monitors, ISO 80601-2-56 for Thermometers, ISO 80601-2-61 for Pulse Oximeter Equipment, ANSI AAMI EC57:2012 for Cardiac Rhythm and ST-Segment measurement algorithms).

Clinical Studies:

1. NIBP Clinical Study - for adults and children

• Device Parameter: Non-invasive Blood Pressure (NIBP)
• Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
• Sample Size: 25 patients (19 adults, 6 children).
  • Demographics: 10 men, 15 women. 6 patients aged 3-12, 2 aged 12-40, 10 aged 40-60, 7 above 60.
• Data Provenance: Retrospective or Prospective not explicitly stated, but implies prospective data collection from "The Second Affiliated Hospital of Guangzhou Medical University and The First Affiliated Hospital of Guangzhou Traditional Chinese Medical University" from 2012 to 2013 (China).
• Ground Truth: Implicitly referent method (e.g., auscultation by trained observers) as required by ISO 81060-2.
• Adjudication Method: Not specified, but standard practice for NIBP clinical validation involves multiple observers for reference measurements.
• Results: "The results are accurate and reliable, and the repeated measurement consistency is in good condition, within the measurement range. Moreover, No adverse events and side effects were found in clinical trials."

2. NIBP Clinical Study - for neonate and infants

• Device Parameter: Non-invasive Blood Pressure (NIBP)
• Acceptance Criteria/Standard: Complies with ISO 81060-2 Second Edition 2013-05-01 "Non-Invasive Sphygmomanometers - Part 2: Clinical Validation Of Automated Measurement Type."
• Sample Size: 20 subjects.
  • Demographics: 10 males, 10 females. 13 subjects

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The Mennen Medical VitaLogik BIS interface is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EBG signals.

The BIS Index, a processed parameter may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The Bispectral Index is a complex technology, intended for use only as an adjunct to clinical judgment and training.

In addition, the clinical utility, risk/benefit, and application of this device have not undergone full evaluation in the pediatric population.

The Intended Use of the VitaLogik monitor as indicated above are same as the Indications For Use.

The VitaLogik is a multiparameter physiological patient monitor, capable of monitoring:

• ECG/Heart Rate
• Invasive blood pressure
• Non-invasive blood pressure
• Respiration
• Pulse oximetry
• Two temperature channels
• Cardiac output
• EtCo2
• Spirometry
• BBG
• BIS Interface (new subject of this application)

Main components of the VitaLogik: The VitaLogik system consists of:
(A) a Bed side computer with
(B) Display

(A) The Bed side computer acquires, processes, and converts vital signs from the patient into waveforms and digital signals.

The VitaLogik can acquire the following physiological signals of the patient:

• ECG Waveform and measures Heart Rate, ST and Arrhythmia
• Blood Pressures Waveform and measures Systole, Diastole and Mean Pressure
• Temperature As a numeric value in C or F
• SpO2 Photoplethysmographic waveform and numeric value of the oxygen saturation and pulse rate
• NIBP Systolic, Diastolic and Mean pressure with measuring time stamp
• EtCO2 EtCO2, inCO2 and Respiration Rate
• BIS Index of conciseness and EEG waveform

(B) The Display is used to display the measurement and waveforms, and alarms. With touch screen option it provides also the control functions, replacing the use of hardware keys. Information from each vital sign is presented in a separate portion of the display. Each vital sign is labeled for identification and numeric value. Displayed Vital sign information can include: Primary Vital Sign Name, waveform, Vital Sign Numeric Value, Alarm Status Message.

Operation of the VitaLogik is accomplished by interaction with front panel controls. A quickknob control allows direct interaction with displayed menus for direct parameter selection and setup. Where manual entry of alphanumeric information is required, a menu keyboard menu is displayed.

The VitaLogik is a reusable, software driven, patient monitor, intended for use as part of a physiological monitoring system in a hospital environment. As such it is not a life supporting, nor life sustaining device; nor is it implantable and therefore sterility is not a consideration.

The VitaLogik monitors the patient's vital sign data derived by the VitaLogik are presented on the monitor as waveform and numeric displays. The VitaLogik acquire vital signs data from the patient, and display their waveforms and alarms indications on the VitaLogik display.

The VitaLogik is not a kit and does not contain any drug or biological products. The BIS Interface of the VitaLogik patient monitor is not sold as a stand alone device, but as part of a multiparameter physiological patient monitoring system (VitaLogik).

In chapter 1, page 1-2 of the VitaLogik Operating Manual, the following Prescription Notice appears: "Federal United States law restricts the sale and use of this instrument to qualified medical personnel only"

Functional description of the new VitaLogik BIS Interface:
(Interface to Aspect BISx device cleared in K 040183)

The BIS Interface is used to monitor dual channel EBG waveform and the BIS index, used to estimate the level of conciseness of patient under anesthesia, or patients in the ICU that may be with limited conciseness.

The BIS index together with several quality parameters are displayed and stored by the VitaLogik monitor.

Here's an analysis of the provided text regarding the VitaLogik Patient Monitor with BIS Interface, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission for a device modification, specifically the addition of a BIS Interface to the existing VitaLogik Patient Monitor. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device (Envoy BIS Module). Therefore, the "acceptance criteria" are predominantly framed around matching the specifications and performance of the predicate device, rather than explicit numerical thresholds for clinical outcomes.

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A. Indications for use for BIS EEG Monitor System (VISTA Monitor and BISx4): The BIS EEG VISTA Monitor System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The system, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation. B. Indications for use for BISx device: The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The BISx, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, one of the BISx output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation.

A. BIS EEG VISTA Monitor System: The BIS EEG VISTA Monitor System, is comprised of the BISx4, the VISTA Monitor, and associated cables. When the System is connected to a BIS Sensor (which is applied to the patient's forehead, acquires EEG signals from the brain, and is 510(k) cleared) the monitor displays 2 channels of EEG. When the System is connected to a BIS Bilateral Sensor (also 510(k) cleared), the monitor displays 4 channels of EEG. The BISx4 houses the digital signal converter as well as the BIS algorithm (it has no display or user interface), and it performs the computations necessary to produce the Bispectral Index (BIS). It also calculates SQI, EMG, Burst count and Suppression Ratio. The BISx4 may be distributed to business partners that have the ability to display BIS on their patient monitors. The Monitor displays a maximum of 4 channels of EEG, as well as SQI, EMG, Burst Count, Suppression Ratio and a BIS value. The BIS value is acquired using 2 channels of EEG. The Monitor has secondary trend and trend review screens, as well as results of self tests. In addition to the above, when connected to a Bilateral Sensor, the System provides additional capability as follows: BISx4 calculates DSA, Asymmetry, sBIS, and sEMG. The Monitor displays DSA, Asymmetry, sBIS, and sEMG numerically and graphically. B. BISx device: The BISx is a component that processes up to 2 channels of EEG and computes BIS and other EEG parameters (same as the cleared BISx device). The BISx connects to Aspect sensors on one side and the Aspect Monitor or OEM patient monitoring systems on the other, allowing them to display BIS on their integrated patient monitoring systems. The OEMs are responsible for the regulatory pathway to integrate the BISx in their systems. The software is a moderate level of concern. This submission is updating the indications for use statement for the BISx device, to reflect the addition of clinical benefits added at FDA request to the BIS EEG VIEW Monitor, 510(k) (K#062613, recently cleared on 6/18/07). No change is being made to the cleared BISx device (#K040183).

The provided text does not contain detailed information about specific acceptance criteria, device performance metrics, or a study that rigorously proves the device meets those criteria in a quantitative sense suitable for a table. The submission is a 510(k) summary, which focuses on substantial equivalence to predicate devices rather than independent performance validation against predefined clinical acceptance criteria.

The "Summary of Testing" section (in {3}) states: "The following tests/analyses have been completed for the BIS EEG VISTA Monitor System: Software Validation, Hazard Analysis and Risk Assessment. Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use."

This statement confirms that internal tests were conducted to ensure the device performs as intended and is safe, but it does not provide details on:

• Specific performance specifications or acceptance criteria.
• Quantitative results from these tests.
• Methodology of how these criteria were established or evaluated.
• Any clinical study (e.g., MRMC, standalone) involving human readers or a comparison against a clinical ground truth.

Therefore, I cannot provide the requested table or detailed study information based on the given text.

Here's an assessment of the other requested points based on the provided document:

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

   • Not provided in the document. The document states "Results indicate the device meets its performance specifications and validation test requirements," but does not list these specifications or the corresponding performance outcomes.

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

   • Not provided in the document. The document mentions "Software Validation" and "Hazard Analysis and Risk Assessment" as completed tests, but does not specify any test set size or data provenance for these. This typically implies internal engineering and software testing rather than a clinical trial with patient data.

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

   • Not provided in the document. Since no clinical test set is detailed, information about experts and ground truth establishment is absent.

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

   • Not applicable/Not provided. No clinical 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:

   • No, an MRMC study was not described. The document focuses on substantial equivalence and safety/performance specifications, not on comparative effectiveness with human readers.

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

   • Implied, but details not provided. The BISx4 and BISx calculate the Bispectral Index (BIS) and other parameters algorithmically. The "Software Validation" mentioned implies testing of this algorithm's performance against its specifications, which is a form of standalone testing. However, no specific metrics, methods, or results of this standalone performance are given beyond a general statement of meeting specifications.

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

   • Not provided in the document. Without details on specific performance tests, the type of ground truth used to validate the algorithms (e.g., against reference EEG signals or clinically established states of anesthesia) is not mentioned.

8. The sample size for the training set:

   • Not applicable/Not provided. This device calculates physiological parameters based on established algorithms (e.g., for EEG signal processing, Bispectral Index). It's unlikely to be a machine learning model that requires a distinct "training set" in the modern sense. The algorithms are likely fixed based on biomedical engineering principles and prior research.

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

   • Not applicable/Not provided. (See point 8).

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The Spectrum Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Spectrum Monitor 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 (ECG, SpO2, IBP, NIBP)
• Pulse Oximetry (SpO2)
• ST Segment Analysis derived from 3, 5 or12 ECG lead measurements
• Arrhythmia Detection derived from 3, 5 or 12 ECG lead measurements
• Interpretation of Resting 12 lead ECG
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP) - up to four (4) channels
• Cardiac Output
• Respiration Rate/waveform derived from ECG or CO2
• CO2, inspired and end tidal microstream/waveform
• Temperature - up to two (2) channels
• Hemodynamic Calculations
• IV Drug Calculations
• Bispectral Index (BIS)

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

• Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations, Pulmonary Artery Wedge Pressure measurements, and
• Interpretation of Resting 12 Lead ECG and IV Drug Calculations, for which the target population is adult only.
• Bispectral Index. The BISx is intended for use under direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. Note: The clinical utility, risk/benefit, and application of the device have not undergone full evaluation in the pediatric population.

The Bispectral Index from available information is a complex technology, intended for use only as an adjunct to clinical judgment and training.

The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The Spectrum Monitor has the capability of interfacing with Datascope's Intra Aortic Balloon Pumps, Central Stations, and Gas Module products.

The Spectrum Monitor, which is the subject of this submission, is a modified version of the Datascope Spectrum Monitor, which was previously cleared by FDA under K031849, on September 9, 2003. There have been no significant changes to the Spectrum Monitor since its clearance. At this time, Datascope Corp. has added a new parameter to the device's monitoring capabilities, the measurement of Bispectral Index (BIS) via an interface to the Aspect Medical System's BISx™ module (K040183).

The Spectrum Monitor is a device that is used to monitor, display, trend and print a patient's physiological parameters. The device has a 12.1 inch color display and has a standard configuration of 3 or 5 lead ECG, Masimo SET® SpO2, Non-Invasive Blood Pressure (NIBP), Respiration, Continuous Temperature and IV Drug Calculations. Optional software includes ST and Arrhythmia Analysis. Optional hardware features include View12 ECG Analysis Module (which includes ST Arrhythmia and 12 Lead interpretation), up to 4 Invasive Blood Pressure Channels, Microstream® CO2, Anesthetic Gases, Nellcor Oxismart® and Oximax® SpO2, a second temperature source, dual trace recorder, and Cardiac Output.

A comprehensive calculation package, including Hemodynamic Calculations, is available if the Spectrum is equipped with an External Parameter Module.

Digital displays are provided for Heart Rate, NIBP, SpO2, Respiration Rate, and Temperature. Optional digital displays are provided for up to four Invasive Blood Pressure, Anesthetic Agents, O2, and N20, ST, CO, CO2, and BIS. The optional internal recorder provides hard copies of all digital data and waveforms, as well as trend information.

Bispectral Index (BIS) is continuous measure of the effects of certain anesthetic and sedative agents on a patient's brain. The Aspect BISx module monitors the hypnotic state of the brain based on acquisition and processing of EEG signals. It processes the raw EEG signal to produce Aspect's proprietary BIS Index, a single value that is correlated with the patient's level of hypnosis. The BISx mates on one side with a patient interface cable, which attaches to Aspect's BIS sensors, and on the other side with the Spectrum Monitor, where the BIS Index is displayed on the integrated display.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Datascope Spectrum™ Monitor, dated February 2, 2007. It describes a modified version of an existing monitor with the addition of Bispectral Index (BIS) monitoring capabilities via an interface to Aspect Medical System's BISx™ module.

However, the document does not contain specific acceptance criteria or performance data in terms of quantifiable metrics (e.g., sensitivity, specificity, accuracy, error rates) for any of the monitored parameters, including the newly added BIS. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to design control processes.

Therefore, many of the requested items cannot be extracted from this document.

Here's an analysis of what information is available and what is missing:

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

Missing. The document states that "Datascope's product development process required that the following activities be completed during the development of the Spectrum Monitor: Requirements specification review, Software testing, Code design and code reviews, EMC testing, Safety testing, Software validation." And concludes that "The results of all testing demonstrate that the Spectrum Monitor is as safe, as effective, and performs as well as the predicate devices."

However, it does not provide any specific performance metrics or acceptance criteria that were used to evaluate the device and compare it to predicate devices. For example, it does not state "BIS accuracy must be +/- X points" or "Arrhythmia detection sensitivity must be Y%."

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

Missing. No details on sample size, data provenance, or study design (retrospective/prospective) are provided for any testing 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)

Missing. No information on experts or ground truth establishment for testing is included.

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

Missing. No adjudication methods are 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 multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" or be evaluated in an MRMC comparative effectiveness study in the context of improving human interpretation. The BIS functionality is presented as an aid to clinical judgment, but not as an AI system that improves human "reading" of data in a comparative effectiveness study.

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

Missing. The document does not provide performance data for any component, standalone or otherwise. The BISx module is described as providing a "single value that is correlated with the patient's level of hypnosis," but no performance metrics for this correlation are given.

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

Missing. No ground truth types are described for any testing.

8. The sample size for the training set

Missing. There is no mention of a "training set" as this is a medical device submission based on substantial equivalence, and the new BIS parameter is integrated via Aspect Medical System's BISx™ module, which is a previously cleared device (K040183). The submission for the Spectrum Monitor's modification primarily focuses on the integration and safety/effectiveness of the combined system, rather than de novo algorithm development and training.

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

Missing. As no training set is mentioned, naturally, its ground truth establishment is also not discussed.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices and adherence to design control processes. It does not present detailed performance data, acceptance criteria, or clinical study results in the format requested, which would be typical for a submission involving novel algorithms or significant performance claims for a new diagnostic or assistive AI feature. The addition of BIS is achieved by integrating a pre-cleared module, and the focus of this submission is on the safety and effectiveness of the combined system.

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Indicated for use by health care professionals monitoring the physiological parameters whenever there is a need for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in hospital environment and during transport within hospital environments. Models MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within hospital environments. ST Segment monitoring is restricted to adult patients only. The transcutaneous gas measurement (tcp0₂ / tcpCO₂) is restricted to neonatal patients only.

The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors.

The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 IntelliVue Patient Monitors underwent verification, validation, and testing activities to establish their performance, functionality, and reliability characteristics. The study that proves the device meets the acceptance criteria is described as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The 510(k) summary explicitly states that "Pass/Fail criteria were based on the specifications cleared for the predicate device." However, the exact quantitative metrics for these specifications are not provided in the summary.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It generally refers to "system level tests, performance tests, and safety testing."

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

This information is not provided in the 510(k) summary. The testing appears to be based on engineering and predefined specifications rather than expert adjudicated ground truth on clinical data.

4. Adjudication Method for the Test Set:

This information is not provided. The testing described appears to be based on objective pass/fail criteria derived from predicate device specifications, rather than a clinical adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The submission focuses on substantial equivalence to predicate devices through technical testing.

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

The testing described appears to be standalone performance testing of the device's hardware and software against predefined specifications. The summary does not describe any human-in-the-loop performance evaluation in the context of this submission.

7. The type of Ground Truth Used:

The "ground truth" for the device's performance was based on the "specifications cleared for the predicate device." This implies a comparison to established technical and performance requirements of previously approved devices, rather than clinical outcomes data or pathology.

8. The Sample Size for the Training Set:

This information is not applicable or provided. The submission describes a medical device update (software release and new models) and does not suggest the use of machine learning algorithms that would require a distinct "training set" for model development.

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

This information is not applicable or provided, as the submission does not detail the use of a training set for machine learning. The device's performance validation is based on adherence to the specifications of predicate devices.

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