(21 days)
These devices are indicated for use as a barrier that is used as an accessory to oral or rectal, digital or mercury thermometers. These sheaths are non-sterile and are intended for single patient use only.
SaniTherm Disposable Thermometer Sheaths are plastic coverings used for either oral or rectal, mercury or digital thermometers. Digital Thermometer Sheaths may not be suitable for use with all clinical thermometers. Example - Clinical thermometers which employ rigid plastic sheaths. Banta Thermometer Sheaths are made from ethylene methyl acrylate copolymer film.
The provided document is a 510(k) premarket notification for "SaniTherm Disposable Thermometer Sheaths". This document outlines the general information about the device and its substantial equivalence to other devices already on the market.
Crucially, this document does not describe specific acceptance criteria and a study demonstrating the device meets those criteria, as it focuses on establishing substantial equivalence rather than reporting on a specific performance study with defined metrics.
Therefore, I cannot provide the requested information in the format specified because the source material does not contain it. The document affirms the device's substantial equivalence to existing predicate devices (Abco Dealers, K871465 and Mediine Industries, Inc., K772385) in terms of materials, construction, and manufacturing process. It also states its intended use as a barrier for thermometers.
Based on the provided text, the following information is either not present or not applicable in the context of a performance study:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence to existing devices, not unique performance claims with specific metrics.
- Sample size used for the test set and the data provenance: Not provided. No specific performance study is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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 a thermometer sheath, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
Summary of what is available in the document related to the device:
- Device Name: SaniTherm Disposable Thermometer Sheaths
- Proprietary Name: SaniTherm Themometer Sheaths, Oral and Rectal, Digital and Mercury
- Common Name: Thermometer Sheaths
- Intended Use/Indications for Use: These devices are indicated for use as a barrier that is used as an accessory to oral or rectal, digital or mercury themometers. These sheaths are non-sterile and are intended for single patient use only.
- Material: Ethylene methyl acrylate copolymer film.
- Sterilization: Not sold sterile.
- Latex Content: Latex-free.
- Substantial Equivalence: To Abco Dealers, K871465 and Mediine Industries, Inc., K772385. Identical in materials, construction, and manufacturing process. Size may vary for different thermometer types.
For a device like a thermometer sheath, the "acceptance criteria" and "performance study" would typically relate to physical properties (e.g., tear strength, barrier effectiveness against liquids/pathogens, compatibility with thermometers) rather than diagnostic accuracy or AI performance. This 510(k) document indicates that such performance characteristics are implicitly met because the device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.
§ 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.