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The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. It consists of the SmartLinx Vitals Plus Application (a mobile medical application operating on the SmartLinx Neuron 2 Mobile Platform), SmartLinx Vitals Plus NIBP Module, Masimo uSpO2 Pulse Oximetry Cable, Exergen TAT-5000S Thermometer, Covidien FILAC 3000 Thermometer, SmartLinx Vitals Plus Alarm Hub, SmartLinx Neuron 2 Mobile Platform, and optionally the SmartLinx Early Warning Scoring System (EWSS). The system collects vital signs data from sensors connected to the SmartLinx Neuron 2 Mobile Platform, which serves as the user interface and supports connectivity with the electronic medical record (eMR). The proposed device is identical to the predicate device (K171751) with the addition of the option for Nellcor SpO2 Pulse Oximetry solution and software upgrades.

The provided document is a 510(k) summary for the SmartLinx Vitals Plus Patient Monitoring System. It outlines changes to an already cleared device, primarily the addition of Nellcor SpO2 pulse oximetry solution and software upgrades.

The document explicitly states that "clinical studies to support substantial equivalence" were not required. Therefore, there is no information in this document regarding:

• Acceptance criteria expressed as performance metrics or targets.
• A specific study proving the device met such acceptance criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number of experts or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used or how it was established for training or testing sets.

Instead, the submission relies on:

1. Comparison to a legally marketed predicate device (SmartLinx Vitals Plus Patient Monitoring System, K171751) and a reference device (Zoe Medical's 740 Select, K130411). The core argument is that the modifications (primarily the addition of Nellcor SpO2) do not raise new questions of safety and effectiveness, as the reference device already supports Nellcor SpO2.
2. Performance testing: This is described as "hardware and software verification and validation, as well as testing to FDA recognized consensus standards."
3. Conformance with FDA recognized consensus standards: A table of standards (such as ANSI AAMI ES 60601-1, IEC 60601-1-2, ISO 80601-2-61, IEC 62304, etc.) is provided to demonstrate adherence to established safety and performance requirements for medical electrical equipment, including pulse oximeters and software.

Therefore, the tables and information requested cannot be derived from the provided text, as this 510(k) relies on substantial equivalence through design and standards conformance, rather than new clinical performance data for the specific changes.

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For Software: The Covidien Nellcor™ Respiration Rate Software, when used in conjunction with a Nellcor pulse oximeter and a Nellcor Respiration Rate Sensor, is intended to be used for the continuous, non-invasive monitoring of respiration rate in adults in hospitals and hospital-type facilities.

For Sensor: The Nellcor™ Adult Respiratory Sensor, when used in conjunction with a Nellcor pulse oximeter and the Nellcor Respiration Rate Software Application, is indicated for single patient use when continuous noninvasive arterial oxygen saturation, pulse rate and respiration rate monitoring are required for adult patients weighing more than 30 kg.

The Covidien Nellcor™ Respiration Rate Software allows for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2), pulse rate and respiration rate using a single sensor. The previously cleared Nellcor N-600x pulse oximeter collects the photoplethysmography signal from the patient via the Covidien Nellcor™ Adult Respiratory sensor attached to the patient. This signal is processed by the pulse oximeter to determine SpO2 and pulse rate. Data is then transmitted from the pulse oximeter to a medical grade PC via a data port.

The Respiration Rate Software (RRS) is installed on a medical-grade PC and utilizes data from the pulse oximeter to calculate respiration rate. The RRS also provides an interactive user interface to display respiration rate, trending, system status and alarm information to the user. The RRS also allows for the collection and storage of data on the medical grade PC for subsequent export.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: Not explicitly stated. The text mentions "Clinical validation studies on healthy adult volunteers and on subjects from the hospital general care floor."
• Data Provenance:
  • Country of Origin: Not explicitly stated.
  • Retrospective or Prospective: Prospective, as it refers to "clinical validation studies... were conducted."

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

• Number of Experts: Not specified.
• Qualifications: Not specified. The gold standard is mentioned, but not how experts interacted with it to establish ground truth for the device's assessment.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified.

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

• MRMC Study: No, an MRMC study comparing human readers with and without AI assistance was not done. The study focused on the device's standalone accuracy compared to a gold standard and a predicate device.

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

• Standalone Performance: Yes. The "Respiration Rate Software algorithm" was evaluated for its accuracy. The text states, "The studies demonstrated the accuracy of the Respiration Rate Software algorithm was as good at the predicate, transthoracic impendence measurements, when both were compared a gold standard."

7. The Type of Ground Truth Used:

• Ground Truth: "Gold standard." While the specific nature of this gold standard is not detailed, in the context of respiration rate monitoring, it typically refers to direct observation, capnography, or a highly accurate clinical measurement method.

8. The Sample Size for the Training Set:

• Sample Size: Not provided. The document focuses on performance testing rather than algorithm development/training data.

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

• Ground Truth Establishment: Not provided. As with the training set size, the document does not detail the specifics of the algorithm's development or the ground truth used for its training.

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The T-105 Series Vital Signs Monitor is intended to monitor a single patient's vital signs in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition. The patient populations include adult, pediatric and neonatal. The device is capable of monitoring:

• . Pulse rate (via oximetry data)
• . Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP)
• . Temperature
• . Blood Oxygen Saturation (SpO2 via finger oximeter)
  This device is intended for use by qualified healthcare personnel trained in its use.

The Omron HBP T-105 Series is a modification of the Colin Press-Mate PM-2100 and is intended to monitor a single patient's vital signs. The device is capable of monitoring:

• . Pulse rate (via oximetry data):
• Non-invasive pressure (systolic, diastolic and mean oscillometric (NIBP); .
• . Temperature; and
• . Blood Oxygen Saturation (SpO2 via finger oximeter)

The provided document is a 510(k) premarket notification for the Omron HBP T-105 Series Vital Signs monitor. This type of submission relies on demonstrating substantial equivalence to pre-existing legally marketed predicate devices, rather than presenting a full de novo study with detailed acceptance criteria and performance data as might be found in a clinical trial report for a novel AI device.

Therefore, the requested information, particularly regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (especially for AI systems), is largely not present in this document. The document focuses on demonstrating that the new device's specifications are similar to or the same as those of the predicate devices.

However, I can extract what is available and highlight what is missing based on your request.

Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" here are implicitly the specifications of the predicate devices, as the new device claims "same as predicate device" for most performance metrics. The "Reported Device Performance" is also stated in relation to these predicate device specifications.

Missing Information from the Document:

1. Sample sizes used for the test set and the data provenance: This information is not provided. A 510(k) submission for a vital signs monitor often relies on performance data collected during design verification and validation, but detailed sample sizes and population demographics are not routinely included in the public summary. Given the device is a technical modification of existing technology, the "testing" would likely involve demonstrating compliance with recognized standards (e.g., ISO 81060-1 for NIBP, ISO 80601-2-61 for Pulse Oximetry) rather than a novel clinical study for equivalence, and the results are summarized as "same as predicate."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. For device performance, the "ground truth" would be established by reference measurement devices or established clinical protocols, not by expert consensus on, for example, image interpretation.

3. Adjudication method for the test set: Not applicable/not provided. Adjudication is typically relevant for subjective assessments, which is not the primary mode of evaluation for a vital signs monitor.

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. This device is a vital signs monitor, not an AI-powered diagnostic imaging system. There are no "human readers" or "AI assistance" in the context of interpretation of complex medical cases.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of AI. The device's algorithms (e.g., for oscillometric NIBP, SpO2) operate intrinsically. Performance is assessed against reference standards.

6. The type of ground truth used: For vital signs monitors, the ground truth is typically established using independent, highly accurate reference measurement equipment/methods. For example, for NIBP, this might involve simultaneous intra-arterial pressure measurements, or non-invasive methods validated against such standards. For SpO2, it might involve co-oximetry measurements from arterial blood samples. This document does not detail the specific ground truth methods employed in its validation studies, but it is implied that standard validation procedures were followed for each parameter.

7. The sample size for the training set: Not applicable. This device does not employ machine learning/AI in a way that requires a distinct "training set" in the context of general-purpose vital signs monitoring. Its algorithms are based on established physiological principles.

8. How the ground truth for the training set was established: Not applicable, as no AI training set is described.

Summary of Study that Proves the Device Meets Acceptance Criteria

The document states that the Omron HBP T-105 Series is a modification of the Colin Press-Mate PM-2100. The primary method for proving the device meets acceptance criteria in a 510(k) submission like this is demonstrating substantial equivalence to a previously cleared predicate device.

The "study" in this context is not a standalone clinical trial in the sense of a drug or novel AI device, but rather a series of verification and validation (V&V) tests to confirm that the modified device performs according to its specifications and is at least as safe and effective as the predicate.

The provided table itself serves as the core of this proof, by showing that:

• Many key specifications (measurement method, patient target, accuracy of pressure indicator, accuracy of pulse rate for NIBP, SpO2 measurement method and accuracy for Nellcor, temperature measurement method and accuracy) are "same as predicate device."
• Where changes exist (e.g., power source, display, operating/storage conditions, dimensions, weight, BP module, SpO2 module, addition of Masimo sensors, use of an Omron algorithm for quick BP measurement), these changes are either presented as minor design updates (e.g., battery type, display technology) or by referencing other legally marketed predicate devices for the specific component/feature (e.g., Omron HEM907 for Air Control Valve/Applicable Cuff, Omron HEM-757 for Quick BP algorithm, Nellcor N-595 and Masimo RAD-5 with their respective sensors for SpO2).

The conclusion of the FDA (as shown in pages 4-6) is that the device is "substantially equivalent" to the predicate devices, which signifies that the manufacturer successfully demonstrated that the changes do not raise new questions of safety or effectiveness and that the performance meets acceptable standards, usually through bench testing, engineering analysis, and potentially limited clinical testing if deemed necessary for specific changes (though not detailed here).

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The Fusion™ System and accessories blood pressure measurement system is intended to be used on patients with wrist circumference of 11 cm - 22 cm by trained medical personnel to continually monitor systolic, diastolic and mean blood pressure and pulse rate.

The Fusion System module option of Nellcor OxiMAX Option (K012891), is indicated for the continuous non-invasive monitoring of a patient's functional oxygen saturation of arterial hemoglobin (SpO2) by trained medical personnel.

The Fusion System module option of Kendall Genius Thermometer (K920713) is indicated for the measuring of a patient's body temperature.

This device is prescription use only.

The Fusion™ System is a non-invasive blood pressure monitor that uses a pressure sensor placed directly on top of the radial artery. This sensor is noninvasive and eliminates the need for an occlusive inflatable cuff. This device is intended to be used on patients by trained medical personnel to continually monitor systolic, diastolic and mean blood pressure, and pulse rate.

The Fusion™ System uses a patented "sweep technique" which applies a varying force on the radial artery. The counterpressure in the artery produces a signal which is digitized and used to calculate blood pressure parameters.

The sensor measures the pulse at the point of maximum energy transfer; the wave shapes are analyzed by Medwave's proprietary algorithms. Parameters are extracted from the waveforms and a set of coefficients are applied to them yielding systolic, mean, and diastolic pressures approximately every 15 heart beats. These algorithms have been tested and validated in clinical studies by synchronized comparisons to arterial line pressure waveforms.

Patient pressures can be monitored visually by viewing the screen and audibly entering limits into the Fusion™ System alarm menu. Patient measurements above or below the limits will be automatically brought to the attention of the caregiver through these visual and audible alarms. A Start/Stop key provides the operator with an option to cancel operation at anytime.

The Fusion™ System can be ordered with additional module options:

• · Tyco Healthcare Nellcor OxiMax Pulse Oximetry System (K012891) provides monitoring of a patient's functional oxygen saturation of arterial hemoglobin.
• · Kendall Genius Thermometer (K920713) provides patient's body temperature readings.
• · Seiko Thermal Printer SII providing hardcopy of readings selected to print.

The Medwave, Inc. Fusion™ System is a non-invasive blood pressure monitor. Here's an analysis of its acceptance criteria and the supporting study:

1. Acceptance Criteria and Reported Device Performance

The device's performance claims are based on meeting industry standards for non-invasive blood pressure monitors.

2. Sample Size and Data Provenance

The document indicates that clinical data supporting the performance claims is "on file at Medwave, Inc." However, it does not specify the sample size used for the test set or the country of origin. It also doesn't explicitly state whether the data was retrospective or prospective.

3. Number of Experts and Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method

The document does not specify an adjudication method for the test set.

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

An MRMC study was not conducted as this is a medical device for automated measurements, not an AI diagnostic imaging system that would typically involve human readers. The device is intended to provide automated measurements.

6. Standalone Performance Study

Yes, a standalone study was performed. The device's algorithms were "tested and validated in clinical studies by synchronized comparisons to arterial line pressure waveforms." This indicates that the algorithm's performance was evaluated independently against a gold standard.

7. Type of Ground Truth Used

The ground truth used for validating the blood pressure measurements was the intra-arterial line pressure waveforms. This is considered a highly accurate and invasive "gold standard" for blood pressure measurement.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set of the proprietary algorithms.

9. How Ground Truth for the Training Set Was Established

The document states that "Parameters are extracted from the waveforms and a set of coefficients is applied to them, yielding systolic, mean and diastolic pressures. The algorithms have been tested against intra arterial line pressure waveforms and proven to meet industry standards..." This implies that the ground truth for training (or at least for validation) was established using intra-arterial line pressure waveforms.

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The device is for use on individual adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport. These indications were previously cleared under K030931 and K041434.

The purpose and function of the LIFEGARD II Family is to monitor:

• ECG
• Heart rate
• Non-invasive blood pressure (NIBP)
• Functional arterial oxygen saturation (SpO2)
• Respiration rate
• Temperature and
• End-tidal carbon dioxide (EtCO2)
• Impedance Cardiography (ICG)
• Arrhythmia with ST segment detection
• Continuous non-invasive blood pressure (CNIBP)

The Impedance Cardiography (ICG) is intended for use on individual adult patients that meet the limits specified below:

• Height: 4 ft - 7 ft - 6 in (122 - 229 cm)
• Weight: 67 - 350 lbs (30 - 159 Kg)

The CNIBP is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This device is intended to be used on patients by trained medical personnel to continuously monitor systolic, diastolic and mean blood pressure and pulse rate. This pressure information is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequent updated blood pressure information in a safe, non-invasive, easily obtained and comfortable manner.

The LIFEGARD II Family is a compact, lightweight device for measuring, processing, printing, and displaying information derived from nine physiological measurements:

• Electrocardiogram (ECG). A three lead or five lead ECG is acquired and a waveform can be displayed real-time on the LCD screen or permanently recorded on the optional printer. The design of the ECG function is derived directly from the predicate devices, the parent C3 Family of patient monitors.
• Respiration. Waveform and numeric respiration rate value from ECG. Airway respiration rate from EtCO2 if available. The design of the respiration parameter is derived directly from the predicate devices, the parent C3 Family of patient monitors.
• Arrhythmia with ST segment analysis software performs five distinct operations: beat detection, lead selection, beat classification, ventricular tachyarrhythmia detection, and ST segment measurement. The design of arrhythmia with ST segment function provides VF and ST segment deviation functionality similar to the predicate device, M3046A (M2/M3/M4) Compact Portable Patient Monitor
• Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses software and firmware that is used in the OxiMAX Pulse Oximetry System and Sandman SD20 Amplifier patient monitor and system.
• The temperature is measured using thermistor probes for continuous temperature measurements. These are pre-amendment devices.
• Blood pressure is measured non-invasively (NIBP) by the oscillometric method. This is the same as in the predicate devices, parent C3 Family of patient monitors.
• Continuous non-invasive blood pressure (CNIBP) is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This is the same technology as in the predicate device, Vasotrac APM205A.
• End-tidal CO2 (EtCO2) This method pulls a constant sample flow of exhaled breath from the patient, and analyzes it with a remote CO2 sensor built into the measurement system. This is the same as in the predicate devices, parent C3 Family of patient monitors.
• Impedance Cardiograph (ICG). This mode uses Thoracic Electrical Bioimpedance (TEB). This is identical in all aspects to the predicate device, the C3 ICG.
• An internal thermal printer records waveforms, hemodynamic parameters and tabular trends on a 50-mm wide strip chart.
• External USB printing identical to the parent C3 Family.

The LIFEGARD II Family is powered by internal sealed lead-acid batteries or from the mains supply via a battery eliminator. A fully charged battery will power the monitor for three hours.

The provided text describes a 510(k) summary for the Analogic Corporation LIFEGARD II Family of patient monitors. It extensively details the device's characteristics, intended use, and comparison to predicate devices, focusing on regulatory equivalency rather than specific detailed clinical study results to demonstrate acceptance criteria performance.

Therefore, much of the requested information regarding a detailed study proving the device meets acceptance criteria, including sample sizes, expert qualifications, adjudication methods, and ground truth establishment for AI performance, is not present in this document. This document primarily outlines non-clinical tests and regulatory compliance to establish substantial equivalence with predicate devices.

However, based on the information available, I can construct the table of acceptance criteria (as inferred from the non-clinical tests) and indicate the reported device performance in a general sense where mentioned.

Here's the breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

The document lists various non-clinical tests and standards that the device will be subjected to. These standards implicitly define the acceptance criteria for various aspects of the device's safety and performance. The "reported device performance" is generally stated as "will be conducted" or "demonstrates that the performance... is substantially equivalent."

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

• Not provided. The document focuses on non-clinical testing and regulatory compliance rather than detailed clinical study results with specific sample sizes. The "AAMI EC 57 tests already performed" implies some test data exists, but details are absent.

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

• Not provided. This information would typically be found in a clinical study report, which is not part of this 510(k) summary.

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

• Not provided. This information is absent.

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 / Not provided. The LIFEGARD II Family device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results in a comparative effectiveness study. The "Arrhythmia with ST segment analysis software" is an algorithm within the device, not an AI for human interpretation enhancement. The document primarily focuses on the device's technical specifications and equivalency, not its impact on human reader performance.

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

• Yes, implicitly. The context of the "Arrhythmia with ST segment analysis software" and other measurement parameters (SpO2, NIBP, EtCO2, etc.) indicates these perform their functions as standalone algorithms within the device. The document states: "Arrhythmia with ST segment analysis software performs five distinct operations: beat detection, lead selection, beat classification, ventricular tachyarrhythmia detection, and ST segment measurement." Similarly, SpO2 calculates saturation, and NIBP measures blood pressure. These are inherent functions of the device's algorithms.

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

• Not explicitly detailed, but inferred from testing standards. For parameters like ECG, NIBP, SpO2, and EtCO2, ground truth would typically be established by established reference methods or highly accurate (often invasive or laboratory-grade) measurement devices during testing against the standards mentioned (e.g., AAMI EC 57 for ECG, ANSI/AAMI SP10 for NIBP, EN 865 for SpO2, EN 864 for EtCO2). The document suggests that the performance of these integrated modules is evaluated against these industry-accepted standards, implying that the "ground truth" is defined by such reference methods.

8. The sample size for the training set:

• Not applicable / Not provided. This device pre-dates the widespread use of deep learning and large-scale training sets for medical devices, particularly for a summary from 2005. The mention of "design of the ECG function is derived directly from the predicate devices" and "SpO2 subsystem uses software and firmware that is used in the OxiMAX Pulse Oximetry System" points to established, possibly rule-based or conventional signal processing algorithms, rather than models requiring large training sets in the modern AI sense.

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

• Not applicable / Not provided. As mentioned above, the concept of a "training set" with ground truth in the current AI/ML context is likely not relevant to this device's development as described in a 2005 510(k) summary. The algorithms' development would have relied on engineering principles, signal processing, and testing against known physiological signals and reference measurements, rather than ground truth established for a statistical learning model.

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The PRO₂ Pulse Reflectance Oximeter System is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR). The PRO₂ is intended to monitor arterial saturation on the back or forehead locations in pediatric and adult populations. The PRO₂ is for use in hospitals, hospital-type facilities and intra-hospital transport environment.

The Pro2® Pulse Reflectance Oximeter System consists of a reusable sensor that emits red and infrared light, a disposable sensor holder to attach the Sensor and detect red and infrared light, and a monitor incorporating control, processing, and display units. The Pro2® Monitor contains an internal battery to power the unit when AC power is not available. The Monitor displays the percentage of oxygen saturation in the blood, pulse rate, signal quality, and alarms. The Pro2 Sensor geometry includes light sources that emit light in three different wavelengths, and detection areas defined by two photodetector rings arranged concentrically with a photodetector in the center. The rings constitute an annular shape, which allow a multi-path acquisition of signals from a larger tissue area. The Monitor calculates the oxygen saturation based upon specific wavelengths of light detected by its sensor. The Pro2® device has a disposable sensor holder; Model # AHL-200 for adults and pediatric use. The Pro2 Sensor Holder provides optical isolation for external light and is attached to the patient with adhesive that is incorporated as part of the Sensor Holder.

The provided text describes the PRO2 Pulse Reflectance Oximeter System. Here's a breakdown of the requested information based on the text:

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

The provided document states: "The Pro2® Pulse Reflectance Oximeter System performance was tested with clinical data and the results met the acceptable criteria." However, it does not specify what those "acceptable criteria" were nor does it provide a numerical breakdown of the reported device performance against those criteria. It only makes a general statement of compliance.

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

The document mentions "clinical data" was used for testing but does not provide the sample size of the test set nor its provenance (e.g., country of origin, retrospective or prospective nature).

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 text.

4. Adjudication method for the test set:

This information is not provided in the text.

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 device is a Pulse Reflectance Oximeter System, which is a medical device for measuring oxygen saturation and pulse rate. It is not an AI-assisted diagnostic imaging system, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable in this context.

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

The device is inherently a standalone measurement device. It continuously monitors and displays physiological parameters (SpO2 and pulse rate) without requiring human interpretation for its primary function. The "clinical data" testing would have evaluated the device's accuracy in autonomously deriving these measurements, thus representing standalone performance. However, specific details of this testing are not provided beyond the general statement of meeting acceptable criteria.

7. The type of ground truth used:

The document explicitly states the device measures "functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." For oximetry devices, the gold standard for ground truth for oxygen saturation is typically arterial blood gas (ABG) analysis. While not explicitly stated, it is a standard practice in oximeter validation to compare the device's readings against ABG measurements.

8. The sample size for the training set:

Pulse oximeters are typically developed through engineering and calibration processes, not machine learning training sets in the modern sense. Therefore, the concept of a "training set" as understood in AI/ML is not applicable to this device.

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

As mentioned above, the concept of a "training set" in the AI/ML context is not applicable. The device's algorithms for calculating SpO2 and pulse rate would be based on established physiological principles of light absorption by oxygenated and deoxygenated hemoglobin, and these would be validated through engineering and clinical testing against reference methods (like ABG) rather than "training" on a dataset with established ground truth in the AI sense.

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The CAS 740 Series Vital Signs Monitor is indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adult, pediatric and neonatal patients, in the care of health professionals.

The CAS 740 Monitor is a replacement monitor based on the existing 9303 Vital Signs Monitor, and the CAS 9001 or 9002 EMS monitors. The 740 are primarily a repackaging of these monitors. The primary parameter is non-invasive blood pressure, which is included in all models. Blood pressure measurement is based on oscillometric technology. The additional two parameters are pulse oximetry and temperature. A purchaser has pulse oximetry choices that include modules manufactured by Masimo, Nellcor or Nonin. The temperature parameter utilizes predictive technology from SureTemp (Welch Allyn Inc.). The monitor is a rugged, portable and lightweight unit widely adaptable for many applications and mounting schemes. Used for spot-checking or continuous monitoring, features include an easily replaceable Nickel Metal Hydride rechargeable battery pack, wireless infrared printer communication, and many more.

The provided document describes the CAS 740 Series Monitor, a vital signs monitor, and details its equivalence to predicate devices, not an AI/ML powered device. Therefore, the questions related to AI/ML specific studies, such as multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment for training sets, are not applicable.

However, the document does provide information regarding acceptance criteria and a study for the Non-Invasive Blood Pressure (NIBP) component.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that the clinical studies for NIBP were conducted in accordance with AAMI SP10:2002. The AAMI SP10 standard (now ISO 81060-2) typically requires a minimum of 85 subjects for clinical validation to ensure a statistically robust evaluation of NIBP device accuracy. The document does not specify the exact number of subjects or the country of origin, nor whether the data was retrospective or prospective, beyond stating "clinical studies."

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

For Non-Invasive Blood Pressure measurements validated against a standard like AAMI SP10, the "ground truth" is typically established by simultaneously taken reference blood pressure measurements (e.g., intra-arterial measurements or trained auscultatory measurements using a mercury sphygmomanometer) by qualified healthcare professionals. The document does not specify the exact number or qualifications of these professionals beyond implying adherence to the AAMI SP10 standard, which mandates specific protocols for reference measurements.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method in the context of expert consensus, as this is not typically applicable for NIBP accuracy studies where direct physiological measurements serve as the reference. Adherence to AAMI SP10 implies a standardized method for obtaining reference measurements.

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

No. This is not applicable as the CAS 740 Series Monitor is a vital signs monitor and not an AI/ML powered device requiring interpretation of medical images or data by multiple readers.

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

Yes, for the Non-Invasive Blood Pressure component, standalone performance was assessed. The document states: "CAS has tested and demonstrated ND Plus performance equivalent to the NB module in bench test simulations." This refers to the algorithm's performance in simulation without human interaction to interpret the NIBP readings. Additionally, the clinical studies, while involving patients, assess the device's ability to accurately measure blood pressure on its own.

7. The Type of Ground Truth Used

For the Non-Invasive Blood Pressure (NIBP) component, the ground truth was based on reference blood pressure measurements obtained according to the AAMI SP10:2002 standard during clinical studies. These are direct physiological measurements.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/ML algorithm. The NIBP measurement relies on oscillometric technology and algorithms that were likely developed and refined using physiological data, but the term "training set" with specific size is not mentioned for this type of device.

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

As there is no mention of a "training set" in the AI/ML context, this question is not directly applicable. The underlying algorithms for oscillometric NIBP would have been developed and validated against a combination of empirical data and theoretical models of blood pressure oscillations, with accuracy verified through extensive testing against established reference methods.

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Use of the Fukuda Denshi Model DS-7100 series Portable Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive and or invasive blood pressure, temperature and pulse oximetry. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-7100 series is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-7100 is also indicated where a hard copy record of the physiological parameters, the alarmed conditions or the trended values may be required.

The DS-7100 Series Patient Monitor is a pre-configured monitor meant to acquire and monitor physiological signals from patients. The system is design to be used in ICU. CCU. OR or recovery areas of the hospital or clinic. An optional Battery Pack Operation allows the DS-7100 series to be used to monitor patients during intra-hospital transport. Patient ages from neonates to adults can all be monitored. Waveforms, numeric and trend data from these patients are available to the clinician on the systems display or may be printed on the systems recorder.

The DS-7100 series consist of two models. The base model DS-7010L allows for the monitoring of ECG, RESP, SpO2, BP NIBP and Temp. Model DS-7101LT offers all the monitoring features of the base model and adds an integrated WMTS 600 MHz telemetry transmitter, which uses the same basic design and control mechanism which was previously cleared, for use with the predicate device, as the Fukuda Denshi DS-5000 series telemetry model HLX-501 (K980728)

The DS-7100 series are self contained monitors which include an 8.4 inch TFT color LCD display which can display up to 6 waveforms. All input operation is performed on the monitors touch screen controls. Additional standard features include an Ethernet LAN for connection to Fukuda Denshi Central Stations, a built- in dot matrix thermal printer that can print up to 3 wave forms simultaneously and an alarm pole feature on the top of device that alerts to alarm conditions through 9 corresponding flashing patterns.

The device is small and lightweight at 5.2 kg. The physical dimensions of the device are 260mm (W) x 264 mm (H) x 196 mm (D). Because there is no need for a cooling fan operation is extremely quite. The AC power supply includes the battery charger for the optional battery operation to allow intra-hospital transport of patients. Use of low power, high speed flash memory allows for easy software upgrades though a standard PMCIA compatible IC card.

The provided text is a 510(k) summary for a medical device (Fukuda Denshi DS-7100 Series Portable Patient Monitor) being modified. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlining the device's description and intended use.

Crucially, this document does NOT contain information about specific acceptance criteria or a study designed to prove the device meets those criteria.

510(k) submissions, especially "Special 510(k)" for device modifications, often refer to performance standards and specifications that the device meets, but they don't always detail the specific studies and acceptance criteria in the summary document intended for public release. The focus of this type of submission is typically on showing that the modified device performs as safely and effectively as its predicate, adhering to existing performance specifications rather than establishing new ones through a detailed performance study described in this summary.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The document states that any safety issues for software-controlled medical devices are either "the same issues already addressed by the predicate devices or are addressed the system hazard analysis, or in the system validation." This implies that the current submission relies on previous clearances and internal validation documentation rather than presenting new, detailed performance study data in this summary.

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The Nellcor OxiMax SoftCare adult oxygen sensor, model SC-A, is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for adults weighing more than 40 kg.

The Nellcor OxiMax SoftCare preterm infant oxygen sensor, model SC-PR, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 1.5 kg.

The Nellcor OxiMax SoftCare neonatal oxygen sensor, model SC-NEO, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing 1.5 kg to 5 kg.

The Nellcor OxiMax SoftCare neonatal oxygen sensor, model SC-N, is indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonates weighing less than 3 kg.

The OxiMax SoftCare Sensors are indicated for single-patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required.

The OxiMax SoftCare sensors are sterile, latex-free, single patient use, non-adhesive Sensors. These sensors have a noon and soft and soft as a more is eliminated.

These sensors contain a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in-sensor data, Advanced Signal Evaluation, lot code and data set revision, and sensor model. The OxiMax SoftCare sensors are compatible with OxiMAX monitors.

The provided text is a 510(k) summary for the Nellcor OxiMax SoftCare Sensors. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the typical format for a medical device's performance study.

Based on the information provided, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." However, it does not provide a specific table of acceptance criteria or the reported device performance metrics (e.g., accuracy, precision values, specific thresholds for SpO2 or pulse rate) during these evaluations. This is common for 510(k) summaries which often refer to conformance to established standards or predicate device performance without detailing the exact numbers.

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

• Sample Size for Test Set: Not specified. The document only mentions "Human oxygenation evaluations."
• Data Provenance: Not specified, but likely from a clinical setting, given "human oxygenation evaluations." It does not clarify if it was retrospective or prospective.

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

This information is not provided. For oxygen saturation sensors, ground truth for human oxygenation evaluations is typically established by arterial blood gas analysis performed by trained medical professionals, but the document does not elaborate on this.

4. Adjudication Method for the Test Set:

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:

This is not applicable to this device. The OxiMax SoftCare Sensors are an oxygen sensor (hardware) designed for continuous noninvasive arterial oxygen saturation and pulse rate monitoring, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

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

This is not applicable in the context of device performance as typically understood for AI/software devices. The device itself is a sensor that outputs data, not an algorithm that interprets complex inputs for diagnosis. Its performance is measured by its accuracy and precision in measuring SpO2 and pulse rate. The document states "human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," implying a standalone performance assessment against a clinical reference standard.

7. The Type of Ground Truth Used:

For "human oxygenation evaluations," the most common ground truth for pulse oximeters is arterial blood gas (ABG) analysis. The document does not explicitly state this, but it is the standard method for establishing ground truth for SpO2 accuracy.

8. The Sample Size for the Training Set:

This information is not provided. The device is a physical sensor, and while it contains a "memory chip carrying information about the sensor" and uses "Advanced Signal Evaluation," the document doesn't discuss a "training set" in the context of a machine learning algorithm. If there are internal calibration or signal processing algorithms, the training data for those are not described.

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

This information is not provided and likely not applicable in the context of device training as understood for AI systems. Any internal calibration data or signal processing optimization would have associated ground truth, but this is not detailed.

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The Welch Allyn Vital Signs Monitor is intended for monitoring of blood pressure, pulse rate, temperature and oxygen saturation (SpO2) of adult and pediatric patients. The device is not designed, sold or intended for use except as indicated.

• The Welch Allyn Vital Signs Monitor is not designed for use with neonates. To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn Small Child cuffs are the smallest cuffs approved for use with young children and infants. The circumference of the child's arm must fit within the range markings on the cuff.
• The Welch Allyn Vital Signs Monitor should not be used on patients who are linked to heart/lung machines.

The Welch Allyn Vital Signs Monitor is designed to non-invasively and automatically measure systolic and diastolic blood pressure, pulse rate, temperature and oxygen saturation (SpO2) for adult and pediatric patients. THE WELCH ALLYN VITAL SIGNS MONITOR IS NOT INTENDED TO BE USED ON NEONATAL PATIENTS. All blood pressure, pulse, temperature and SpO2 values are displayed on large, easy-to-read displays, and may be printed via an integrated thermal printer, as desired. The rechargeable battery and wide variety of mounting accessories make the Welch Allyn Vital Signs Monitor convenient for many locations. The operator may choose any combination of simultaneous measurement modalities. This flexibility, combined with features such as programmable alarms and automatic blood pressure cycles, makes the Welch Allyn Vital Signs Monitor ideal for a wide variety of patient monitoring needs.

The provided document describes the Welch Allyn Vital Signs Monitor, an updated version of a previously cleared device, primarily focusing on the change of the SpO2 module.

Here's an analysis of the acceptance criteria and the study justifying the device's performance, based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document mentions "Accuracy test" as a validation test. However, it does not explicitly state specific numerical acceptance criteria (e.g., within X mmHg for blood pressure, within Y% for SpO2) or the quantitative reported device performance against such criteria. The submission states that the device "passed all the safety and effectiveness testing," implying that any implicit acceptance criteria for these tests were met.

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

The document does not explicitly state the sample sizes used for the "Accuracy test" or "Usage test" for the Welch Allyn Vital Signs Monitor with the new MP506 module. It also does not specify the provenance (e.g., country of origin, retrospective/prospective) of any data collected during these tests.

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

The document does not mention the use of experts to establish ground truth for any of the described tests. The testing described appears to be focused on device functionality, safety, and compliance with manufacturing/module-specific standards rather than a clinical performance study requiring expert adjudication of patient data for ground truth.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as there is no indication that expert review of patient data was part of the testing described.

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

No MRMC comparative effectiveness study is mentioned in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device through verification and validation of changes (specifically the SpO2 module).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

The "Accuracy test" and "Nellcor compliance testing" performed on the SpO2 module can be considered standalone performance evaluations of that component. The overall device testing (software functional, basic functional) also assesses the device's inherent performance. There's no mention of a human-in-the-loop performance study in the context of its accuracy, but rather general "usage test" which might involve human interaction.

7. The Type of Ground Truth Used:

For the SpO2 module, the "Nellcor compliance testing" implies that the ground truth would be based on the established gold standards and methodologies used by Nellcor for validating pulse oximetry, which typically involves controlled desaturation studies against arterial blood gas measurements (co-oximetry). However, this is inferred, not explicitly stated regarding the data collected for this submission. For other metrics like blood pressure, temperature, and pulse rate, the ground truth for an "Accuracy test" would typically involve comparison against a reference standard device. The document does not explicitly detail these ground truth methods.

8. The Sample Size for the Training Set:

The document describes verification and validation testing for the updated device, not the development of an algorithm that would require a training set. The device is a measurement instrument, and the core technology for SpO2, blood pressure, etc., relies on established physical principles and algorithms, not a machine learning model that requires a distinct training/test split in the way AI/ML devices do. Therefore, a "training set" is not applicable in the context described.

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

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable.

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