(337 days)
The B-D Assure Ear Thermometer is designed for home use to measure body temperature from the tympanic membrane.
The B-D Assure Ear Thermometer is designed for measuring body temperature in a home setting.
The Becton Dickinson Infrared Thermometer is a device that measures patient body temperature by quantifying the infrared emission from the tympanic membrane.
In clinical application the end of the infrared thermometer is placed in the outer portion of the auditory canal, where the sensor can get a good view of the tympanic membrane. Placing the probe is very similar to the maneuver used to visualize the ear drum using an otoscope. There is no risk of eardrum injury because the probe is not long enough or small enough to be inserted too deep into the ear canal.
The most advantageous feature of infrared tympanic thermometry is that it takes very little time. Readings can be taken in a few seconds.
This looks like a 510(k) submission, not a study report. 510(k) submissions demonstrate substantial equivalence to a predicate device rather than explicitly defining and meeting acceptance criteria through a standalone study.
Therefore, many of the requested fields cannot be directly extracted as they would be for a typical clinical or performance study report. The document primarily focuses on demonstrating that the B-D Assure Ear Thermometer has the "same technological characteristics" and functions "in an equivalent manner" to the predicate device, the Thermoscan® Instant Thermometer.
Here's an attempt to answer the questions based on the provided text, flagging where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate device (Thermoscan® Instant Thermometer) in functionality and safety. | "The B-D Assure Ear Thermometer has been bench tested and has proven to function in a equivalent manner as the predicate device." "Based on the results of the bench testing the B-D Assure Ear Thermometer is considered safe and effective when used as intended." |
| Technological characteristics: measure patient body temperature by quantifying infrared emission from the tympanic membrane. | "The B-D Assure Ear Thermometer and the predicate device (the Thermoscan® Instant Thermometer) have the same technological characteristics." |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document only mentions "bench testing."
- Data provenance: Not specified. The nature of "bench testing" suggests it was likely internal testing by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. "Bench testing" typically refers to laboratory or engineering tests, not human expert assessment for ground truth.
4. Adjudication method for the test set
- Not applicable/Not specified.
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
- No. This is a medical device (thermometer), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The "bench testing" mentioned can be considered a standalone performance evaluation of the device itself. The device is not an algorithm, but a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but for bench testing of a thermometer, the "ground truth" would likely be a highly accurate reference thermometer or calibrated temperature source.
8. The sample size for the training set
- Not applicable. This is a traditional medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.