(280 days)
The intended use for the IVAC Models 2082/2087 Thermometers is to measure oral, rectal and axillary temperatures in clinical practice.
The IVAC Models 2082/2087 Thermometers are thermistor-based electronic thermometers that are used in clinical practice for measuring oral, rectal and axillary temperature. A thermistor located at the tip of the probe is placed in contact with tissue at the desired measurement site. A microprocessor measures resistance in the circuit and converts the resistance measurement to a temperature, which is then displayed.
This 510(k) summary describes a thermistor-based electronic thermometer, the IVAC Models 2082/2087 Temp Plus III. The primary change in these new models is an improved algorithm that allows for predictive temperature readings in approximately 10 seconds, compared to 30 seconds in the previous models (2080/2085 Temp Plus II).
The document does not provide a study to prove acceptance criteria in the traditional sense of a clinical trial with specific performance metrics and statistical analysis. Instead, it relies on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria with numerical targets (e.g., accuracy +/- X degrees) or reported performance data for the new algorithm are provided. The submission focuses on substantial equivalence based on the functionality remaining the same and the predictive mode speed improvement.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Measure oral, rectal, and axillary temperatures | Meets this functionality |
| Technological characteristics are the same | Deemed substantially equivalent |
| Do not raise new questions of safety/effectiveness | Deemed substantially equivalent |
| Predictive mode display time (new algorithm) | Approximately 10 seconds |
| Predictive mode display time (previous algorithm) | Approximately 30 seconds |
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. There is no mention of a dedicated "test set" in the context of a clinical performance study for the new algorithm. The document explains that NASA "tested" a modified hydrogen sensor system (which was adapted for the medical thermistor), but no details on this testing (sample size, data provenance) are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No "test set" and no establishment of ground truth by experts are described.
4. Adjudication Method for the Test Set
Not applicable. No "test set" or adjudication method is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This document does not describe a MRMC comparative effectiveness study. The device is a thermometer, not an imaging or diagnostic device that typically involves human readers interpreting results.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The document mentions that NASA "developed a microprocessor and electronics package employing novel predictive technology for accelerating the response time of slowly responding sensors" and that the "hydrogen sensor system was modified to accept input from a medical type thermistor and was tested by NASA." This implies some form of testing of the algorithm and hardware in a standalone capacity by NASA, but no details of this testing, its methodology, or results are provided in the 510(k) summary.
7. The Type of Ground Truth Used
The ground truth for a thermometer would typically be a reference temperature measurement method (e.g., a highly accurate, calibrated thermometer in a controlled environment). However, the document does not describe how ground truth was established for any specific performance testing of this device's predictive algorithm. The focus is on demonstrating substantial equivalence in function.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" in the context of machine learning model development. The algorithm discussed here is a predictive algorithm for temperature measurement, not a deep learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no mention of a "training set."
Summary of the Study:
The provided document describes a substantial equivalence claim rather than a study proving specific acceptance criteria. The manufacturer, IVAC Corporation, asserts that the new Models 2082/2087 Thermometers are substantially equivalent to their previous models (2080/2085) and the Diatek SureTemp 4 Thermometer. The primary justification for this equivalence is that the devices perform the same primary function (measuring oral, rectal, and axillary temperatures) and share similar technological characteristics, with the key difference being an improved algorithm for faster predictive temperature readings. The document alludes to NASA's involvement in developing and testing the predictive technology, but it does not provide details of these tests, specific performance metrics, or clinical study results for the new algorithm.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.