(42 days)
The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children.
The Basis® Baby-Temp Pacifier Digital Thermometer is a clinical thermometer intended for the determination of oral body temperature determination in infants and young children. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The pacifier digital thermometer also meets Safety Standards for Baby Pacifiers.
This 510(k) summary for the K962991 Basis® Baby-Temp Pacifier Digital Thermometer provides very limited information regarding performance studies and acceptance criteria, as it predates the adoption of more rigorous clinical study expectations for many device types.
Based on the provided text, here's what can be extracted and what remains unknown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature" | The device conforms to ASTM E1112. |
| Meets Safety Standards for Baby Pacifiers | The device meets Safety Standards for Baby Pacifiers. |
Explanation: The summary states the device conforms to ASTM E1112 and meets Safety Standards for Baby Pacifiers. It does not provide specific numerical performance metrics (e.g., accuracy +/- X degrees, or specific safety test results). The general statement of conformity is the reported performance against these high-level criteria.
Further Information Based on the Provided Text:
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2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Unknown. The document does not mention any specific clinical or performance testing data, sample sizes, or data provenance. It only states conformity to standards.
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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)
- Not Applicable / Unknown. This type of device (digital thermometer) typically relies on metrology standards and physical testing rather than expert-established ground truth in the way a diagnostic imaging device would. The document does not describe any such expert involvement.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Unknown. No information on adjudication methods is provided, as typical for this type of device and submission era.
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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 is a standalone digital thermometer, not an AI-powered diagnostic device. MRMC studies are irrelevant.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable (or inherently standalone by definition). As a digital thermometer, its "performance" is inherently standalone. The document states it conforms to standards but doesn't detail performance studies in terms of an "algorithm" or "human-in-the-loop," as would be described for, say, an AI-powered diagnostic tool. The device itself is the "standalone" component.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Metrological Standards. For a digital thermometer, the "ground truth" for accuracy would be established by reference thermometers and metrological standards as outlined or referenced in ASTM E1112. The document doesn't explicitly state how this was done, just that the device conforms.
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8. The sample size for the training set
- Not Applicable / Unknown. This device is not described as using machine learning or AI, so there would be no "training set."
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9. How the ground truth for the training set was established
- Not Applicable. As no training set is indicated, this question is not applicable.
Summary of Study (as described in the 510(k) summary):
The "study" described in this 510(k) summary is not a traditional clinical trial or comparative effectiveness study. Instead, the basis for clearance is:
- Conformance to ASTM E1112: This standard specifies requirements for electronic thermometers, including accuracy limits, display resolution, and other physical/electrical properties. The "study" implies that the device underwent testing to ensure it met these specifications.
- Conformance to Safety Standards for Baby Pacifiers: This indicates the device's physical design, materials, and overall safety as a pacifier were tested against relevant standards.
- Substantial Equivalence: The primary "study" for 510(k) devices often revolves around demonstrating substantial equivalence to a legally marketed predicate device. In this case, the device is stated to be substantially equivalent to the Questech International, Inc. WeeCare™ Pacifier Thermometer and the Intelligent Product Limited Company Paci-Temp Pacifier with Digital Thermometer. This implies that the design, intended use, and performance characteristics (as demonstrated by conformity to standards) are similar enough to the predicate devices that no new questions of safety or effectiveness are raised.
The 510(k) summary provided offers very high-level statements of conformance rather than detailed study results.
§ 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.