(131 days)
YLS-01 is intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. This sheath is non-sterile and is intended for single patient use only.
The Yu Long Sheng Disposable Thermometer Sheath(model YLS-01) is a plastic covering used for oral/rectal digital thermometer. This device is not made with natural rubber latex
The provided text describes a 510(k) premarket notification for a medical device, the Yu Long Sheng Disposable Thermometer Sheath (Model YLS-01). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a diagnostic or therapeutic AI medical device.
Therefore, many of the requested sections below, particularly those related to AI-specific study designs, reader studies, and ground truth establishment, cannot be directly addressed from the provided text. The device in question is a simple medical accessory, not an AI-powered system.
However, I can extract the acceptance criteria (performance tests) and the reported performance as described for this type of device, as well as information about the testing conducted.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
For the Yu Long Sheng Disposable Thermometer Sheath (Model YLS-01), the "acceptance criteria" are implied by the standards and tests performed to demonstrate safety and performance for this type of accessory. The reported performance is that the device has undergone these tests.
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| Material Safety Test | Conducted by SGS (results not detailed, but implied to be acceptable for 510(k) clearance) |
| Biocompatibility (ISO 10993-5) | Conducted by SUPERLAB (implied to be acceptable) |
| Biocompatibility (ISO 10993-10) | Conducted by SUPERLAB (implied to be acceptable) |
| Product Characteristics (ASTM E1104:03 / F1104-98(2003)) | Conducted by Wincent Consultant (implied to be acceptable) |
Note: For medical accessories like a thermometer sheath, "performance" typically refers to meeting material safety, biocompatibility, and physical characteristic standards, ensuring it functions as intended without harming the patient or altering thermometer accuracy. The document states these tests were conducted, implying successful completion.
Study Details (Limitations apply as this is not an AI study)
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not specify sample sizes for the material safety, biocompatibility, or product characteristics tests. These tests are typically conducted on a limited number of device samples according to the respective standard's requirements for characterization.
- Sample Size: Not specified.
- Data Provenance: The tests were conducted by SGS and SUPERLAB (for biocompatibility) and Wincent Consultant (for performance test, likely in Taiwan or China given the submitter's location). This would be considered prospective testing of manufactured samples.
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 is not applicable. The device is a thermometer sheath, not an AI diagnostic tool. Ground truth in this context refers to the chemical, biological, and physical properties of the material and device determined through standardized laboratory tests, not expert interpretation of medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The tests mentioned (material safety, biocompatibility, product characteristics) are objective laboratory assessments based on established quantitative and qualitative methods defined by international standards (ISO, ASTM). They do not involve expert adjudication in the clinical sense.
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. The device is a disposable thermometer sheath, not an AI or imaging device requiring MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical accessory, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is based on objective measurements and assessments against established international standards for material safety, biocompatibility (cytotoxicity, irritation, sensitization), and physical characteristics. This includes:
- Chemical analysis: To ensure material components are safe.
- Biological assays: For biocompatibility (e.g., cell cultures for cytotoxicity, animal models for irritation/sensitization as per ISO 10993 standards).
- Physical measurements: To confirm product dimensions and integrity as per ASTM E1104.
8. The sample size for the training set
This is not applicable. The device is a physical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for a physical device like a thermometer sheath.
§ 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.