(116 days)
The Disposable Thermometer Probe Sheaths are intended for use as barriers between digital thermometers and users' oral cavities to avoid the possible contamination and infection during temperature measuring. The sheaths are non-sterile and intended for single use only.
The Disposable Thermometer Probe Sheaths are used for oral measurements for digital thermometers. The products and packaging are non-sterile, not made with natural rubber latex, and intended for single patient use only.
The proposed device is a shell-like device, made of PE/EVA, use to cover the oral thermometer as barrier for avoiding possible contamination and infection during measurement of temperature. The device is covered by the paper (Medical Kraft Paper) at the top and bottom which to avoid unnecessary touch with the device before usage and will be removed from the device before use. The outer most packing material is carton box. Each outer packing contains 100 pieces of the device.
Here's a breakdown of the acceptance criteria and study information for the {0} device, based on the provided text:
Device Name: Disposable Thermometer Probe Sheath
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Performance Requirement | Reported Device Performance |
|---|---|---|
| Material/Design | ||
| Basic Design | 3 layer design (Bottom Side Paper + PE/EVA film + Top Side Paper); Removing paper before use; | 3 layer design (Bottom Side Paper + PE/EVA film + Top Side Paper); Removing paper before use; |
| Device Materials Composition | PE/EVA | PE/EVA |
| Thickness | 23.5 um | 23.5 um |
| Density | 0.87-0.88g/cm3 | 0.87-0.88g/cm3 |
| Color | None | None |
| Sterile | No | No |
| Functional Performance | ||
| Strength (ASTM 1104) | Air Pressure of 8.4 kPa (1.2 psi) for 5 seconds | Meets the requirements of ASTM 1104 |
| Accuracy (ASTM E1104/E1112) | ±0.3℃, Less than 38 ℃; ±0.2℃,35.8℃ to less than 37 ℃; ±0.1℃, 37.0 ℃ to 39.0 ℃; ±0.2℃, greater than 39.0 ℃ to 41.0 ℃; | Meets the requirements of ASTM E1104/E1112 (specific values not explicitly re-stated but implied as met) |
| Biocompatibility | ||
| Cytotoxicity (ISO 10993-5) | Meets standard requirements | Complies with ISO 10993-5 |
| Irritation/Sensitization (ISO 10993-10) | Meets standard requirements | Complies with ISO 10993-10 |
(Note: The "Available Dimension" and "Outsider Dimension" are listed as comparative information but not explicitly stated as acceptance criteria with numerical targets in the text beyond simply reporting the device's values.)
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for its performance evaluations (e.g., strength, accuracy, biocompatibility). It mentions "non clinical tests were conducted," but not the number of units tested.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It implies internal testing by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a physical barrier (thermometer probe sheath), and its performance is evaluated against engineering standards and material properties, not through expert interpretation or clinical judgment requiring ground truth establishment by experts.
4. Adjudication Method for the Test Set
This information is not applicable. As explained above, the testing involves objective measurements against predefined standards rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The Disposable Thermometer Probe Sheath is a physical barrier accessory, and its effectiveness is determined by its physical properties and ability to maintain thermometer accuracy, not by human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The non-clinical tests described (strength, accuracy, biocompatibility) are evaluations of the device's inherent properties and performance without human interaction beyond operating test equipment. The device itself does not involve algorithms or AI. The standard tests (ASTM E1104, ASTM E1112, ISO 10993) assess the device's standalone physical and functional characteristics.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the performance of the Disposable Thermometer Probe Sheath is established by internationally recognized engineering and biocompatibility standards. Specifically:
- ASTM E1104-98: Standard Specification for Clinical Thermometer Probe Covers and Sheaths
- ASTM E1112-00: Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
These standards define the acceptable limits and methodologies for testing these types of devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a manufactured medical accessory, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device.
§ 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.