Search Results

The applicant device of Clinical Electronic Thermometers, Model MT901, Mode MT518 and Mode ECT-1 are the electronic thermometers by using a thermistor as the temperature sensor to measure the body temperature in oral, axillaries (underarm use), and rectal.

The applicant device of Clinical Electronic Thermometers, Model MT901, Model MT518, Model ECT-1 are the electronic thermometers by using a the temperature sensor. tor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC), JA31106, the CMOS digital clinical thermometer IC for measuring body temperature from 32.0℃~42.0℃(90°F ~ 109.0°F)

All variants follow same design, same application with same performance and safety. The only difference is appearance. Therefore, all variants have same specifications parameters, same PCB Design, and same components with exception of shell.

No antimicrobial or antithrombotic ingredient is applied on the applicant device.

No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device.

No specific drug or biologic is applied with the applicant device.

The provided 510(k) summary for the Clinical Electronic Thermometers (Models MT901, MT518, ECT-1) does not contain the detailed information necessary to complete the requested table and answer all questions regarding acceptance criteria and a definitive study proving the device meets those criteria.

This 510(k) submission is for a Class II device and relies on demonstrating substantial equivalence to a predicate device (Rapid Digital Thermometer, Model RDT-18-XY, K062016). The summary explicitly states: "The applicant device has same classification informations and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device."

Therefore, concrete acceptance criteria and a detailed study proving performance against those specific criteria for the new device are generally not provided in such a submission when substantial equivalence is asserted. Instead, the assumption is that if the new device is substantially equivalent to a legally marketed predicate, it shares the predicate's established performance and safety.

However, I can extract the relevant information and infer some details based on typical thermometer requirements and the general nature of 510(k) submissions for substantially equivalent devices.

1. Table of Acceptance Criteria and Reported Device Performance

As the submission relies on substantial equivalence and does not present a new specific performance study against defined acceptance criteria, I will infer typical performance expectations for clinical electronic thermometers and note that the device is stated to meet the "same performance effectiveness" as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. It's highly unlikely a new clinical test set was used if the claim is substantial equivalence based on design and specifications rather than a de novo performance study. It's more likely that bench testing was performed to confirm the specifications of the new device match the predicate.
• Data Provenance: Not specified. For substantial equivalence, the "data" primarily refers to the characteristics and specifications of the new device matching the predicate, and possibly engineering/bench testing data. Not a typical clinical study in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts/Qualifications: Not applicable for this type of 510(k) submission. Ground truth, in the sense of clinical expert consensus for diagnosis, is not relevant here as it's a device for direct physiological measurement, not an interpretative AI/diagnostic tool.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance.

• MRMC Study: No. This device is a standalone electronic thermometer, not an AI-assisted diagnostic tool requiring human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.

• Standalone Performance: Yes, in the sense that the device itself is standalone. Bench testing would have been implicit to verify that the thermometer accurately measures temperature within its specified range. However, no specific details of such "standalone" testing are provided in this 510(k) summary beyond asserting it has the "same performance effectiveness" as the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For a thermometer, the "ground truth" would be calibrated reference temperature standards used during manufacturing and quality control testing, and implicitly, during any verification testing to confirm the device's accuracy against its specifications.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable. See point 8.

Ask a specific question about this device