(42 days)
The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans.
The Basis® Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans. 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".
Here's an analysis of the provided K971045 510(k) summary, aiming to extract the requested information, with the understanding that a 510(k) summary often provides limited detail on extensive clinical studies:
Assessment of Provided Information:
The provided 510(k) summary for the Basis® Flexible Tip Digital Thermometer is very brief and focuses on regulatory classification, intended use, and substantial equivalence to predicate devices. It explicitly states that the device conforms to "ASTM E1112, 'Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature'". This standard itself contains the acceptance criteria for such devices, and conformity to it is the proof of meeting those criteria.
Therefore, many of the requested details about specific study design, sample sizes, expert involvement, and ground truth establishment are not present in this summary because the primary evidence for this type of device is typically performance testing against a recognized standard (ASTM E1112), rather than a clinical trial involving expert adjudication of diagnostic images or outcomes.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Since the K971045 summary explicitly states conformity to ASTM E1112, the acceptance criteria are those defined within that standard. Without access to the full ASTM E1112 standard, I cannot list every specific criterion and a numerical "reported device performance" against each. However, I can describe the nature of the criteria and how the device implicitly "meets" them by conforming to the standard.
| Acceptance Criteria (Based on ASTM E1112 principles) | Reported Device Performance (Implied by "conforms to ASTM E1112") |
|---|---|
| Accuracy: Error limits for specified temperature range (e.g., ±0.1°C or ±0.2°F). | The device's measurement accuracy falls within the allowed error limits specified by ASTM E1112 for the intended measurement range (oral, rectal, axillary). This is typically demonstrated through calibration and comparison to a traceable reference standard. |
| Response Time: Time to reach stable temperature reading. | The device reaches a stable temperature reading within the maximum time specified by ASTM E1112 for intermittent thermometers. |
| Repeatability/Reproducibility: Consistency of readings. | When repeatedly measuring a stable temperature, the device provides consistent readings within the variability limits set by ASTM E1112. |
| Environmental Conditions: Performance under varying temperature/humidity. | The device maintains its accuracy and performance characteristics within the specified environmental operating and storage conditions outlined in ASTM E1112. |
| Electrical Safety: Conformity to relevant safety standards. | The device meets electrical safety requirements applicable to medical devices as referenced by ASTM E1112 or other relevant standards. |
| Biocompatibility: Materials in contact with patients are safe. | Materials used in the flexible tip and other patient-contacting parts are biocompatible according to relevant standards (though ASTM E1112 primarily focuses on performance, this is a general requirement for such devices). |
| Durability/Mechanical Integrity: Withstand normal use. | The device is mechanically robust and durable enough to withstand typical handling and use, as implicitly covered by various sections of ASTM E1112 (e.g., resistance to cleaning agents, drop tests, etc.). |
| Display Characteristics: Readability, units, low battery indicator. | The digital display is clear, shows temperature in appropriate units (e.g., °F or °C), and includes features like a low battery indicator as required by ASTM E1112. |
Study Details (Based on available info and typical device regulatory pathways for this type of device)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in the 510(k) summary. For compliance with ASTM E1112, this would involve a set of physical thermometers tested in a laboratory setting against calibrated reference thermometers under controlled conditions. It's not a "data set" in the typical AI/diagnostic sense.
- Data Provenance: Not specified. Testing would typically be conducted in a laboratory, likely within the manufacturer's facilities or by a certified testing house. It is not "patient data" provenance.
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)
- Number of Experts: Not applicable in the context of device performance testing against a physical standard. The "ground truth" for temperature measurement is established by highly accurate and calibrated reference thermometers traceable to national or international standards. It does not involve human expert interpretation or consensus.
- Qualifications of Experts: N/A (as above).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The performance is objectively measured against a standard, not interpreted or adjudicated by human reviewers.
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
- MRMC Study: No. This type of study is not relevant for a digital thermometer as it does not involve human "readers" interpreting diagnostic images or data, nor does it involve AI assistance in the diagnostic sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in a sense. The "standalone performance" of the thermometer algorithm is its ability to accurately measure and display temperature according to the ASTM E1112 standard. This is precisely what conformance to the standard demonstrates. There isn't typically a "human-in-the-loop" for interpreting a thermometer reading, beyond reading the displayed number.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for digital thermometers is established by physical reference standards (e.g., highly accurate and calibrated reference thermometers or temperature baths) that are traceable to national or international metrology standards. It is an objective physical measurement, not a subjective interpretation.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This device does not use machine learning or AI in a way that requires a training set in the typical sense. Its performance is based on its hardware and firmware design, not on being "trained" on data.
9. How the ground truth for the training set was established
- Ground Truth (Training Set): 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.