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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 EntraCare Thermometer, Model 1000, is intended to be used under a physicians orders when an accurate temperature measurement is required. The device is intended to be used orally or rectally in the human body temperature range of 92°F to 108°F. It may be used with infants, children, or adults in all settings under the order of a physcian. The heart rate timer is also provided to aid in establishing a patients approximate heart rate.

The EntraCare Thermometer, Model 1000, is a hand-held, battery powered thermometer. This thermometer is capable of measuring and displaying temperatures over the entire human body temperature range (92.0° to 108.0° F or 33.0° to 42.0° C). This device also is capable of calculating a persons approximate heart rate through the use of a stopwatch type function and will display the rate simultaneously with temperature. This feature acts like a stop watch and does not attempt to directly measure a patients pulse.

Here's an analysis of the provided text regarding the EntraCare 1000 Thermometer's acceptance criteria and studies:

Based on the provided 510(k) summary, the device is a thermometer and the safety and efficacy are primarily demonstrated through substantial equivalence to predicate devices, rather than a clinical study with specific acceptance criteria in the traditional AI/medical imaging sense.

However, we can infer performance characteristics based on the device's function and the comparison to predicate devices. The primary "performance" would relate to its ability to accurately measure temperature and its features.

Here's a breakdown of the requested information, acknowledging that the format of the provided text is for a thermometer and not an AI or imaging device, so some categories might not apply or will be interpreted based on the available information:

Acceptance Criteria and Device Performance for EntraCare 1000 Thermometer

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary for a thermometer, the "acceptance criteria" are implied by its technological characteristics being "the same" as the predicate devices, and its ability to measure within the specified human body temperature range. The core performance is accurate temperature measurement within a defined range.

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

• Sample Size for Test Set: Not applicable or not explicitly mentioned in this 510(k) summary. For a thermometer, the "test set" would typically refer to the number of measurements taken to validate accuracy, bias, and precision against a reference standard. This information is not provided.
• Data Provenance: Not applicable or not explicitly mentioned. Clinical studies with data provenance (e.g., country of origin, retrospective/prospective) are not detailed in this summary.

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

• Number of Experts: Not applicable. For a basic medical device like a thermometer, "ground truth" would be established by validated reference temperature standards (e.g., traceable to NIST) and potentially by expert medical supervision during usability/performance testing, but not in the sense of expert image interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., interpreting medical images), not for objective measurements like temperature.

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

• Not applicable. An MRMC study is relevant for interpretive tasks, often with AI assistance for human readers. This device is a standalone measurement tool.

6. Standalone Performance Study

• Was a standalone study done? Yes, implicitly. The document states that "The new device has the same technological characteristics (i.e., design, material, energy source) as the predicate devices." This implies that the device's technical specifications and performance were evaluated to ensure they meet the expected standards for a clinical thermometer, equivalent to the predicate devices. While a detailed study report isn't here, the regulatory pathway based on substantial equivalence requires demonstrating that the device performs as intended and is safe and effective on its own merits, relative to the predicates. The ability to measure and display temperatures within the specified range is its standalone performance.

7. Type of Ground Truth Used

• Ground Truth Type: For a thermometer, the ground truth would be objective reference standards. This would involve traceable temperature standards (e.g., calibrated baths, reference thermometers) used to verify the accuracy and precision of the EntraCare 1000 across its operating range.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/machine learning model, so there is no training set in that context. The device's design and calibration are based on established engineering principles for temperature measurement.

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

• Not applicable, as there is no "training set." The "ground truth" for the device's design and calibration would be established through engineering specifications, metrology standards, and validation processes used in the manufacturing of clinical thermometers.

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