(81 days)
The ACON™ Digital Thermometer Probe Covers are intended for use as a barrier that is used as an accessory to oral or rectal measurements for digital thermometers, including the ACON 30 Second Reliable Digital Thermometer. These probe covers are non-sterile and intended for single use only.
The disposable digital thermometer probe covers are plastic coverings used for either oral or rectal measurements for digital thermometers. The product is non-sterile and contains latex.
The provided text is a 510(k) summary for ACONTM Digital Thermometer Probe Covers. It outlines the device's description, intended use, and comparison to a predicate device. The information primarily focuses on substantial equivalence for regulatory approval rather than a detailed performance study with acceptance criteria and results in the format requested.
Here's an analysis based on the provided text, addressing your questions to the best extent possible given the information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the probe covers. Instead, it relies on demonstrating substantial equivalence to a predicate device and qualitative performance verification through "probe cover leakage test and probe cover validation test."
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Leakage | Not explicitly stated, but implied to be "robust" and "satisfactory" to prevent cross-contamination. | Satisfactory performance based on "probe cover leakage test." |
| Validation | Not explicitly stated, but implied to be "robust" and "satisfactory" for the intended use. | Satisfactory performance based on "probe cover validation test." |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10. | Compliance to applicable voluntary standards including ISO 10993-5 and ISO 10993-10 biocompatibility testing. |
| Compliance to Standards | Compliance with ASTM E1104. | Compliance to applicable voluntary standards including ASTM E1104. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the "probe cover leakage test" or the "probe cover validation test."
The data provenance is not explicitly stated beyond being "laboratory testing results." It is implied to be prospective testing conducted by the manufacturer (ACON Laboratories, Inc.) given it's part of a 510(k) submission for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The testing for a digital thermometer probe cover typically involves objective physical and material tests (e.g., leakage, material compatibility, strength) rather than expert interpretation of data or images.
4. Adjudication method for the test set
This information is not applicable for the reasons stated above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical probe cover, not an algorithm or AI system.
7. The type of ground truth used
The concept of "ground truth" in the context of expert consensus, pathology, or outcomes data is not applicable to this device. The "truth" for a probe cover is its ability to physically perform its barrier function and protect against contamination, which is assessed through direct physical testing (leakage, structural integrity, material properties).
8. The sample size for the training set
This information is not applicable as the device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as 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.