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510(k) Data Aggregation
(57 days)
COCET Digital Thermometer measures body temperature. This digital thermometer is used in the armpit (axillary) to take temperature measuring results. The device is for adult use.
COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-03/KFT-04/ KFT-05/KFT-06/ KFT-07/KFT-08/ KFT-09/KFT-10) is a hand-held electronic thermometer, it comprised of an electronic thermo resistor (thermistor) sensor connected to printed circuit board(PCB) with liquid crystal display(LCD) user readout. The outer material of thermometer is made of ABS and the measuring tip is stainless steel. The thermometer using a temperature sensor to output an electrical signal, and then converting the current signal into a liquid crystal digital display temperature. The thermometers are powered by LR41 battery. The battery can be replaced.
The provided text describes the 510(k) summary for the COCET Digital Thermometer. It outlines a comparison to a predicate device and details non-clinical tests performed. However, it does not contain the specific information required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop study.
The document is for a digital thermometer, which is a fairly straightforward medical device. The "study" described is primarily bench testing to demonstrate performance according to recognized standards, rather than a clinical trial involving a large number of human subjects and complex ground truth establishment as would be seen for an AI diagnostic device.
Here's what can be extracted and what is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance
Acceptance Criteria (from text, implied by standards adherence) | Reported Device Performance (from text) |
---|---|
Accuracy: +/- 0.1 °C (±0.2°F) from 35.5 °C to 42 °C (95.9°F-107.6°F) | +/- 0.1 °C (±0.2°F) from 35.5 °C to 42 °C (95.9°F-107.6°F) |
Accuracy: +/- 0.2 °C (± 0.4 °F) in the rest measuring range | +/- 0.2 °C (± 0.4 °F) in the rest measuring range |
Biocompatibility: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 | Device passed cytotoxicity, skin irritation, and sensitization testing. |
Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2 | Performed in accordance with IEC 60601-1:2005 and IEC 60601-1-2:2014. |
Clinical Electronic Thermometer Standards: Compliance with specific standards | Complies with ISO 80601-2-56:2017. |
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: Not explicitly stated for specific tests. The tests performed are primarily bench testing (e.g., testing multiple physical units of the thermometer for accuracy, biocompatibility, and electrical safety). It's typically a small number of physical samples (e.g., n=3 or n=5) from a production lot for regulatory testing, not a "data set" in the AI sense.
- Data Provenance: Not applicable in the sense of patient data. The tests are laboratory bench tests.
- Retrospective or Prospective: Not applicable as it's not a clinical study on patients. These were tests conducted on the physical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a digital thermometer, "ground truth" for temperature is established using calibrated reference thermometers and controlled environments (e.g., water baths). There are no human experts "adjudicating" temperature readings in the way a diagnostic image might be.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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
- No. This device is a standalone digital thermometer, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant or performed for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The performance data presented (accuracy, biocompatibility, safety) are inherent properties of the device itself, functioning independently of human interpretation in a diagnostic context. However, it's not an "algorithm" in the typical software sense, but the physical device's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for temperature accuracy is established against calibrated reference standards, typically highly accurate laboratory thermometers traceable to national/international standards.
- For biocompatibility, the ground truth is the absence of adverse biological reactions in established in-vitro and in-vivo tests according to ISO standards.
- For safety and EMC, the ground truth is compliance with the specified electrical and electromagnetic compatibility limits/requirements defined in the IEC standards.
8. The sample size for the training set
- Not Applicable. This is a physical digital thermometer, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
In summary: The provided document is for a general medical device (digital thermometer) and describes its compliance with established performance, safety, and biocompatibility standards through bench testing. It does not describe an AI/ML-driven device or a clinical study that would involve expert readers, complex ground truth establishment, or MRMC studies. The "study" proving acceptance criteria is a series of non-clinical, laboratory-based tests comparing the device's performance to recognized international standards and its predicate device.
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