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The devices are intended to be used in a clinical setting, physicians' offices or other alternate care settings. The devices are reusable and are intended for the quantitative detection of body temperature, which can be obtained orally, under the arm (axially) or rectally by trained medical personnel.

AIV's Clinical Electronic Thermometers (also referred to as Temperature Probes) are replacement thermometers for temperature monitoring/measuring systems. The device is reusable. The devices are electronic thermometers using a thermistor temperature sensor. The devices are placed inside a protective sheath (not manufactured or supplied by AIV). Then the thermometer is used on the patient by trained medical personnel. The sensor is displayed on a monitor/measuring system (not manufactured or supplied by AIV). The probe consists of a thermistor located in a metal tipped plastic shaft is attached to a plastic body that allows the protective sheath (not supplied component that actually touches the patient) to be gripped and ejected off the probe. A shielded multi-conductor cable is used to conduct thermistor signals to the connector for the monitor/measuring system. Some a heating resistor that allows a more rapid temperature measurement.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AIV Clinical Electronic Thermometer:

Acceptance Criteria and Device Performance Study for AIV Clinical Electronic Thermometer

The provided document describes a 510(k) Premarket Notification for a replacement clinical electronic thermometer. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide extensive clinical performance data against specific acceptance criteria.

Based on the document, the "acceptance criteria" are primarily implicit in the demonstration of substantial equivalence to existing predicate devices. The study proving this substantial equivalence is limited to bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a replacement device, the "acceptance criteria" are largely derived from the characteristics and performance of the predicate devices. The document explicitly states that the AIV device uses "the same type of construction and have the same technological characteristics" as the predicate devices.

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

The document does not specify a sample size for a test set in the traditional sense of a clinical trial or a structured validation study with a defined dataset. The "study" referenced is bench testing.

• Data Provenance: The data provenance is not specified beyond "bench testing." It is not clinical data (patient data), so concepts like "country of origin" are not applicable in this context. It's an in-house prospective test by the manufacturer.

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

Not applicable. This submission is for a medical device (thermometer) and relies on bench testing and comparison to predicate devices, not on expert clinical interpretation or ground truth establishment in the way an AI diagnostic algorithm would.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" described as the testing is not based on expert review of ambiguous cases.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The AIV Clinical Electronic Thermometer is a direct measurement device, not an AI diagnostic tool that assists human readers.

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

Yes, in spirit, a standalone performance was done, in that the device's performance was evaluated independently through bench testing. However, it's not an "algorithm only" performance as the device is a physical electronic thermometer. The "standalone" evaluation here refers to the device itself performing its intended function (temperature measurement) without a human's interpretative cognitive task being assisted by AI. The human is involved in placing and operating the device, but the temperature reading itself is generated by the device.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing would be established by reference temperature standards and calibrated measurement equipment. While not explicitly detailed, standard engineering and metrology practices dictate that the thermometer's readings would be compared against highly accurate and traceable temperature sources to verify its performance specifications (e.g., accuracy, precision). This is essentially physics/engineering-based ground truth, not clinical or pathology-based.

8. The Sample Size for the Training Set

Not applicable. This device is a physical electronic thermometer; it does not involve machine learning or AI algorithms that require a "training set" of data.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one.

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The DINAMAP® ProCare Series 100N-400N Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

The DINAMAP ProCare Series 100N-400N Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:

• DPC 100N: Non-Invasive Blood Pressure and Pulse Rate .
• DPC 200N: Non-Invasive Blood Pressure and Pulse Rate, Temperature .
• DPC 300N: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry .
• DPC 400N: Non-Invasive Blood Pressure and Pulse Rate. Pulse Oximetry . and Temperature.
  This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.

The provided document is a 510(k) summary for the DINAMAP® ProCare Series 100N-400N Monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study proving specific acceptance criteria in the manner requested (e.g., using a test set, ground truth experts, MRMC studies, or standalone algorithm performance).

The "Testing" section (I) states that "Several bench studies were conducted which demonstrate safety and effectiveness of the DINAMAP® ProCare Series 100N-400N Monitor." These studies are listed as:

• Electromagnetic Compatibility
• Electrical Safety
• Mechanical and Environmental

These types of studies typically involve engineering or regulatory compliance testing against pre-defined standards, not clinical performance evaluation with a test set of patient data, ground truth, or expert review as would be relevant for AI/software-as-a-medical-device (SaMD) clearances.

The document emphasizes that the device has the "same technological characteristics as the predicate device" and that "There are no new technologies used" (Section G). Specifically, for the key physiological parameters, it states:

• NIBP algorithm as implemented on the ProCare Series Monitor (predicate device)
• Alaris IVAC Turbo thermometry technology as implemented on the ProCare Series Monitor (predicate device)
• Wholly implemented Nellcor N-595 SpO2 technology (predicate device)

This indicates that the performance of these technologies relies on the clearance of the existing predicate devices rather than new performance studies for this specific submission.

Therefore, it is not possible to provide the requested information because the document does not describe the kind of study that would typically generate such data for a device with potentially new algorithms or performance claims. The submission is based on substantial equivalence to existing technologies and components.

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The DINAMAP® ProCare Series Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature. The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/ surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

The DINAMAP ProCare Series Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:

• DPC XXX: Non-Invasive Blood Pressure and Pulse Rate ●
• DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry o
• . DPC XXX: Non-invasive Blood Pressure and Pulse Rate, Temperature
• DPC XXX: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry ● and Temperature.
  This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.

The GE Medical Systems Information Technologies DINAMAP® ProCare Series Monitor relies on substantial equivalence to predicate devices rather than a standalone study demonstrating specific acceptance criteria. This means the device is deemed safe and effective because it operates with the same underlying technology and performs comparably to devices already legally marketed.

Here's an breakdown based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria or quantifiable performance metrics for the DINAMAP® ProCare Series Monitor in a specific table. Instead, it relies on the "substantial equivalence" of its underlying technologies to predicate devices. The study proving the device meets "acceptance criteria" (implicitly, the performance of the predicate devices) is primarily based on:

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

The document does not mention a "test set" in the context of human patient data with a specific sample size. The testing primarily involved bench studies to confirm adherence to engineering and performance standards (e.g., AAMI/ANSI SP10, mechanical, electrical safety).

There is no information provided on the country of origin of data or whether the data was retrospective or prospective as no human patient data test set is described.

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

Since there isn't a described "test set" and a process of establishing ground truth with experts in the human data sense, this information is not applicable and therefore not provided in the document.

4. Adjudication Method for the Test Set

As there is no described test set involving human data and expert review, an adjudication method is not applicable and not mentioned.

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

No MRMC comparative effectiveness study is mentioned. The device's approval is based on substantial equivalence to predicate devices and bench testing, not on human reader performance improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The NIBP algorithm is stated to be "wholly implemented from the DINAMAP Pro Series 100-400 Monitor or an NIBP auscultatory algorithm tested according to the ANSI/AAMI SP10 standard." The Masimo SpO2 and Alaris thermometry technologies are also "wholly implemented." This indicates that the algorithms themselves were likely evaluated in a standalone manner as part of the predicate device's original testing and by adherence to standards like ANSI/AAMI SP10 for NIBP. However, a dedicated standalone study for this specific device with performance metrics is not detailed beyond the statement of implementation and standard adherence.

7. Type of Ground Truth Used

The "ground truth" for the performance of the NIBP algorithm, for example, would have been established historically for the predicate devices or by the ANSI/AAMI SP10 standard, which specifies requirements for accuracy of non-invasive blood pressure monitors. For SpO2 and temperature, the "ground truth" would be inherent in the established performance and accuracy of the "wholly implemented" Masimo and Alaris technologies, respectively, likely validated by their own regulatory submissions. This would primarily be objective measurements against established reference methods or standards, rather than expert consensus, pathology, or outcomes data in the context of this submission.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The device relies on established algorithms from predicate devices (DINAMAP Pro Series 100-400 for NIBP, Masimo for SpO2, Alaris for Temperature). Therefore, information on a training set size is not applicable.

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

Since there is no described "training set" for a new machine learning algorithm, how its ground truth was established is not applicable. The ground truth for the underlying algorithms would have been established during the development and validation of the predicate devices or the implemented technologies (Masimo, Alaris) using methods appropriate for physiological measurements (e.g., comparison to invasive gold standards for BP, co-oximetry for SpO2, calibrated thermometers for temperature).

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The DINAMAP® Pro Series 110-410 Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

The DINAMAP Pro Series 110-410 Monitor is a prescription device intended for use only by health care professionals. Four configurations of the monitor-all with integrated printer-will offer the following vital signs parameters:

• DINAMAP 110: Non-Invasive Blood Pressure and Pulse Rate
• DINAMAP 210: Non-Invasive Blood Pressure and Pulse Rate, Temperature .
• DINAMAP 310M: Non-invasive Blood Pressure and Pulse Rate, Pulse Oximetry
• DINAMAP 410M: Non-Invasive Blood Pressure and Pulse Rate, Pulse Oximetry . and Temperature.
  This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery.

The provided document is a 510(k) Premarket Notification for the DINAMAP® Pro Series 110-410 Monitor. This document is primarily focused on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a clinical study with acceptance criteria and device performance as typically expected for complex AI/ML devices.

However, based on the information provided, here's what can be extracted and what is NOT available:

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

The document mentions several "bench studies" for safety and effectiveness, but it doesn't provide specific acceptance criteria values or the quantitative results of these tests for the DINAMAP Pro Series 110-410 Monitor itself. Instead, it relies on the substantial equivalence to predicate devices and the transfer of existing, proven technologies.

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

This information is not provided in the document. The document primarily refers to "bench studies" and "wholly implemented" technologies from predicate devices. There is no mention of a clinical test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there is no description of a clinical study involving experts establishing ground truth. The device is a physiological monitor, where the "ground truth" for its measurements (e.g., blood pressure, temperature, SpO2) would typically be established through comparison with a reference standard (e.g., invasive blood pressure, rectal thermometer, co-oximetry), not via expert consensus on an image or diagnostic data.

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

This information is not provided. There is no description of a test set requiring adjudication.

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 is not applicable to this device. The DINAMAP® Pro Series 110-410 Monitor is a vital signs monitor, not a diagnostic imaging device that involves human readers or AI assistance in interpretation. The "AI" mentioned in the input query is not relevant to this type of device.

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

The device itself is a standalone vital signs monitor. Its "performance" is its ability to accurately measure physiological parameters. The document states that the NIBP ASAP algorithm, Alaris IVAC Turbo thermometry, and Masimo SpO2 SET technologies were "wholly implemented" from predicate devices. This implies that the algorithms, as part of the integrated system, operate without human-in-the-loop performance for the measurement itself, though healthcare professionals interpret and act on the displayed values. However, no specific standalone performance study results for these specific integrated components of the 110-410 monitor are provided beyond the statement of implementation.

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

For the underlying technologies (NIBP, temperature, SpO2), the ground truth would typically be established by a universally accepted reference standard for each parameter (e.g., arterial catheter for NIBP, highly accurate thermometer for temperature, co-oximeter for SpO2). However, this document does not describe how the ground truth was established for the development or validation of the implemented technologies for the 110-410 monitor, as it relies on the predicate devices' prior approvals.

8. The sample size for the training set

This information is not provided. The document makes no mention of a training set as it describes the integration of existing, proven technologies rather than the development of entirely new algorithms for this specific device.

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

This information is not provided, as there is no mention of a training set.

In summary, the provided document is a regulatory submission for a vital signs monitor based on substantial equivalence. It describes the integration of existing, proven technologies but does not detail the specific performance studies, acceptance criteria, or ground truth establishment processes for these technologies as applied to the new device, instead leveraging the prior approvals of the predicate devices.

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