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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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