(84 days)
The Omron electronic thermometer Models MC-245, MC-341, MC-341, MC-343, and MC-344 are intended to measure the body temperature either oral, axillaries (under arm) and rectal and Model - MC-247 measure the body temperature oral (basal) and to be used by medical professionals in clinical and hospital environments and consumers in a home environment. It is intended for use on people of all ages.
These are simple electronic thermometer which is a thermistor to measure temperature. All the functions, except posture symbol, are the same as the predicate device, MC-3B, K881446. Power source battery operated. Calculation method (system) is the same and identical to the predicate, K881449. The differences between the various models are: Some models have a flexible or rigid or rigid / flexible tip. Offered with a probe cover. Temperature scale offered in C° & F° or F° only. Readout time is different.
The Omron Thermometers (Models MC-245, MC-246, MC-247, MC-341, MC-343, MC-344) are clinical electronic thermometers.
Here's an analysis of the provided information regarding their acceptance criteria and supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for this device is primarily its accuracy, as compared to a predicate device (MC-3B K881446).
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (New Device) |
|---|---|
| Accuracy: ±0.2 °F (for Celsius, not explicitly stated for predicate but implied by equivalence) | Accuracy: ±0.2 °F, ±0.1 °C |
| Measurement Range: 89.6 °F to 107.6 °F | Measurement Range: 89.6 °F to 107.6 °F, 32.0 °C to 42.0 °C |
| Display Resolution: 4 Digits (0.1 °F increments) | Display Resolution: 4 Digits (0.1 °F / 0.1 °C increments) |
Note: The document states that the new devices are "substantially equivalent" to the predicate device K881446 due to "identical algorithms and means of measuring temperature," and "Operating specifications - Identical to predicate K881446." This implies that the performance characteristics of the new devices meet or are identical to those of the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for a test set for performance evaluation. It primarily relies on demonstrating substantial equivalence to a predicate device.
For the materials testing (ISO 10993), the document states: "The materials have been tested in accordance to ISO 10993." However, specific sample sizes or data provenance for these material tests are not detailed in this summary.
Given the nature of a 510(k) summary for simple thermometers, detailed performance studies with dedicated test sets (as might be expected for complex AI/imaging devices) are often not presented if substantial equivalence can be demonstrated through other means (e.g., identical technology, components, and operating principles).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For simple electronic thermometers, the "ground truth" for temperature measurement is typically established using calibrated reference thermometers, not human experts.
4. Adjudication Method for the Test Set
An adjudication method is not applicable or mentioned because the performance assessment described primarily relies on direct measurement and comparison to a predicate device's specifications, rather than subjective interpretation requiring multiple expert opinions.
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 information is not applicable to this device. The Omron Thermometers are simple electronic thermometers and do not incorporate AI or involve human readers in interpreting results in a way that would necessitate such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of the "algorithm only" in the context of AI is not applicable here, as the device is a simple electronic thermometer. Its performance is inherent to its physical components (thermistor) and calculation method, which is stated to be "identical" to the predicate device. The accuracy specification of ±0.2 °F (±0.1 °C) can be considered a standalone performance metric for the device.
7. The Type of Ground Truth Used
The ground truth for a clinical electronic thermometer's accuracy is typically established using traceable, calibrated temperature standards or reference thermometers. This involves comparing the device's readings against these known, precise temperature values. The document doesn't explicitly detail the methodology for establishing ground truth but implies it through the stated accuracy specifications.
8. The Sample Size for the Training Set
This information is not applicable to this device. As a simple electronic thermometer, there is no "training set" in the context of machine learning or AI. The device's functionality is based on established physical principles and calibrated components, not learned data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
§ 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.