(185 days)
These devices are indicated for use as a barrier accessory to digital thermometers while taking rectal temperature measurements. These sheaths are non-sterile and intended for single use only. This accessory is contraindicated for use with broken skin.
The Medline Digital Rectal Thermometer Sheath is an accessory to a clinical electronic (digital) thermometer, a Class II device in the US, intended to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning and display unit. The sheath covers the transducer and is a single-use disposable device. Digital Thermometer Sheaths may not be suitable for clinical thermometers which employ rigid plastic sheaths.
The provided document is a 510(k) summary for the Medline Digital Rectal Thermometer Sheath. This device is a Class II medical device used as a barrier accessory to digital thermometers for rectal temperature measurements. The document outlines a substantial equivalence argument to a predicate device (SaniTherm Thermometer Sheaths, K983406), rather than a study demonstrating a specific performance metric against clinical acceptance criteria for an AI-powered diagnostic device.
Therefore, many of the requested details regarding acceptance criteria, study design for AI algorithms, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this 510(k) submission for a non-AI accessory device.
However, I can extract the information that is relevant to the product's performance and testing for substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria (Implied by regulatory standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet appropriate sections of ISO 10993-5 and ISO 10993-10 for cytotoxicity, sensitization, and irritation. | Evaluated for: Cytotoxicity, Sensitization, Irritation. The document states "Biocompatibility testing according to ISO 10993-5 & 10" and later "Biocompatibility in accordance with appropriate sections of ISO 10993-5 and ISO 10993-10 evaluated all materials...". This implies acceptance criteria were met. |
| Strength | Meet acceptance criteria as defined by ASTM E1104:98 (2016). | "Testing for tensile strength and lubricity (coefficient of friction) of the lubricated sheath met acceptance criteria." |
| Accuracy | Meet acceptance criteria as defined by ASTM E1104:98 §5.4 (2016). | "Testing showed that the sheath and lubricant materials met acceptance criteria." |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample size for the test sets used in the biocompatibility, strength, or accuracy testing. It also does not provide details on data provenance (e.g., country of origin, retrospective/prospective). These are typically detailed in the full test reports, which are not included in this summary document.
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. The device is a thermometer sheath, and its performance testing (biocompatibility, strength, accuracy of temperature transmission) does not involve expert-established ground truth in the way a diagnostic imaging device would. The "ground truth" for these tests would be the established performance standards of the ASTM and ISO documents.
4. Adjudication method for the test set:
Not applicable. The tests performed are objective physical and chemical evaluations against established standards, not subjective assessments requiring adjudication.
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:
Not applicable. This device is not an AI-powered diagnostic tool, and therefore, an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
For biocompatibility, the "ground truth" is compliance with ISO 10993 standards. For strength and accuracy, the "ground truth" is compliance with ASTM E1104:98 (2016) specifications. These are objective engineering and material science standards, not medical ground truth derived from pathology, outcomes, or expert consensus in a clinical diagnostic sense.
8. The sample size for the training set:
Not applicable. This device does not involve a training set as it is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a 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.