(239 days)
The Actherm Digital Clinical Thermometer Probe Covers medACCU1010, medACCU1010-1 and medACCU1020 are accessories for digital thermometers, including the models of Actherm Digital Clinical Thermometers. They are indicated for use as barriers between digital thermometers and users' rectum or oral cavities to avoid the possible contamination and infection during temperature measuring. These probe covers are intended for single use when temperature taking.
The Digital Clinical Thermometer Probe Covers medACCU1010 and medACCU1010-1 are manufactured in the same shapes and sizes. The only difference between them is medACCU1010-1 coated with lubrication; therefore it is only used for rectal measurements for digital thermometers. The Digital Clinical Thermometer Probe Covers medACCU1020 are manufactured in different shapes and sizes from medACCU1010 and medACCU1010-1. The disposable digital thermometer probe covers medACCU1010 and medACCU1020 are used for either oral or rectal measurements for digital thermometers.
The provided text describes the 510(k) summary for Actherm Digital Clinical Thermometer Probe Covers. However, it does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and a specific study proving the device meets those criteria. The document states that the device "meet the ASTM Standard Specification for Clinical Thermometer Probe Covers and Sheaths (ASTM E 1104-98), as well as ISO 10993-1 biocompatibility testing," but does not explicitly provide the acceptance criteria or the specific performance results from a study.
Based on the provided text, here's what can be extracted and what is missing:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|
| ASTM Standard Specification for Clinical Thermometer Probe Covers and Sheaths (ASTM E 1104-98): Specific performance metrics such as barrier integrity, material strength, thermal conductivity impact, etc. (Details not provided in the document). | "Actherm Digital Clinical Thermometer Probe Covers... meet the ASTM Standard Specification for Clinical Thermometer Probe Covers and Sheaths (ASTM E 1104-98)" |
| ISO 10993-1 Biocompatibility Testing: Biocompatibility requirements to ensure no adverse biological reactions (e.g., cytotoxicity, sensitization, irritation). (Details not provided in the document). | "Actherm Digital Clinical Thermometer Probe Covers... meet the... ISO 10993-1 biocompatibility testing" |
Note: The document states that the device "meets" these standards, implying compliance with their respective acceptance criteria. However, the specific quantitative acceptance criteria (e.g., "must have a barrier integrity greater than X") and the actual device performance values (e.g., "device achieved Y for barrier integrity") are not detailed in this 510(k) summary. It only confirms adherence to the standards.
Study Details
The provided document refers to compliance with standards (ASTM E 1104-98 and ISO 10993-1) as "Performance Data," which implies studies were conducted. However, it does not provide details about these studies.
Therefore, the following information is not available in the provided text:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This information is not provided in the 510(k) summary. The document only confirms compliance with standards, not the specifics of the testing methodology or data origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This type of expert review or ground truth establishment is typically associated with studies involving diagnostic interpretation (e.g., medical imaging). For a device like a thermometer probe cover, the "ground truth" would be established by the physical testing methods defined within the ASTM and ISO standards (e.g., passing a leak test, material characterization). There would not be "experts establishing ground truth" in the diagnostic sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable to the type of device and testing described. Adjudication methods are used for resolving discrepancies in expert interpretations, which is not relevant for physical and biocompatibility testing of a probe cover.
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 is not applicable. MRMC studies and AI assistance relate to diagnostic software or tools, not physical medical devices like thermometer probe covers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable, as the device is a physical accessory and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance data cited (ASTM E 1104-98 and ISO 10993-1), the "ground truth" would be the defined specifications and test methods within those standards. For example, for barrier integrity, the ground truth would be that the cover successfully prevents fluid penetration under specified conditions. For biocompatibility, the ground truth would be the absence of cytotoxic effects, irritation, or sensitization as defined by the ISO 10993 series of tests.
8. The sample size for the training set:
- Not applicable. There is no concept of a "training set" for a physical device like this, as it does not involve machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 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.