(123 days)
The Philips AVENT Digital Thermometer Set is intended for determination of temperature. The set contains three items:
- A pacifier thermometer to detect baby's oral temperature.
- . An ordinary pacifier that can be used as a daily used regular pacifier.
- A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.
The Philips AVENT Digital Thermometer Set contains three items:
- A pacifier thermometer to detect baby's oral temperature.
- . An ordinary pacifier that can be used as a daily used regular pacifier.
- A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.
The provided text is related to a 510(k) premarket notification for a medical device: Philips Avent Digital Thermometer Set, Model SCH540. It is a clearance letter from the FDA, and as such, it does not contain the detailed study information or acceptance criteria specifications that would typically be found in a clinical study report or a more comprehensive regulatory submission.
The document primarily focuses on the FDA's determination of substantial equivalence to predicate devices and outlines general regulatory compliance requirements.
Therefore, I cannot fulfill all parts of your request based on the provided text. Specifically, the following information is not available in the given document:
- A table of acceptance criteria and the reported device performance: This document does not specify any performance metrics or acceptance criteria used in testing.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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 device is a thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant, and no information about it is provided.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not relevant for a thermometer.
- The type of ground truth used: For a thermometer, "ground truth" would typically refer to a reference temperature measurement method, but the details are not provided.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Based on the available text, here's what can be inferred or stated:
The document confirms that the Philips Avent Digital Thermometer Set, Model SCH540, has received 510(k) clearance from the FDA. This indicates that the manufacturer submitted data demonstrating that their device is substantially equivalent to legally marketed predicate devices. The "substantial equivalence" determination implies that the device performs as safely and effectively as a predicate device.
The intended uses of the device are explicitly stated in the "Indications for Use" section:
- Indications for Use: The Philips AVENT Digital Thermometer Set is intended for determination of temperature. The set contains three items:
- A pacifier thermometer to detect baby's oral temperature.
- An ordinary pacifier that can be used as a daily used regular pacifier.
- A digital flexible-tip thermometer that measures the oral, rectal, and axillary body temperature of humans.
Without the full 510(k) submission (which includes performance data, test protocols, and acceptance criteria), it is impossible to provide the specific details requested in your prompt regarding the study and acceptance criteria.
§ 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.