(79 days)
This device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral, armpit and rectal in the neonatal pediatric and audit population used in the clinical and home testing.
The device Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 which is based on the 510(k) 042202 model DT-312 is designed to measure the human body temperature in the mouth or rectum. This device is used under the condition(s) or disease(s) to be screened, monitored, treated, or diagnosed: Fever, Hypothermia. The device is intended use at the following conditions: Age: newborn to geriatric, Weight: > 2.5 kg. The device operating conditions is between 10°C to 40°C (50°F to 104°F). The Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device.
The provided text describes a 510(k) summary for a clinical electronic thermometer and does not include information about AI/ML device performance, acceptance criteria, or studies to prove acceptance criteria for such a device. This document is for a traditional medical device, not an AI/ML powered one.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully provided. The document states compliance with ASTM E1112-00 for performance specifications but does not detail specific acceptance criteria values or reported performance metrics against those criteria. It only states the device complies with the standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention a specific test set sample size or data provenance for any studies. It refers to "bench testing" but provides no details.
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)
- Cannot be provided. This is not relevant for a clinical electronic thermometer as there is no "ground truth" established by experts in the context of AI/ML.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. Not applicable for this type of device.
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
- Cannot be provided. This is not applicable to a non-AI clinical electronic thermometer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. Not applicable to a non-AI clinical electronic thermometer.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be provided. Not applicable for this type of device in the context of AI/ML. For a thermometer, "ground truth" would relate to a highly accurate reference thermometer, but the document does not detail this.
8. The sample size for the training set
- Cannot be provided. This is not relevant for a clinical electronic thermometer as there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Cannot be provided. Not relevant for this type of device.
Summary based on the provided text for a non-AI device:
The Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 is a clinical electronic thermometer designed to measure human body temperature orally, rectally, and in the armpit.
Acceptance Criteria and Device Performance:
| Acceptance Criteria Category | Specific Criteria (as implied/referenced) | Reported Device Performance |
|---|---|---|
| Performance Standard | Compliance with ASTM E1112-00 | Device demonstrated compliance. |
| Safety Standard | Compliance with IEC60601-1 | Device demonstrated compliance. |
| EMC Standard | Compliance with IEC60601-1-2 | Device demonstrated compliance. |
| Intended Use | Measuring body temperature in various sites (oral, armpit, rectal) for neonatal, pediatric, and adult populations in clinical and home settings. | Device is intended for this use and is substantially equivalent to predicate device. |
| Operating Conditions | Operating temperature between 10°C to 40°C (50°F to 104°F) | Not explicitly reported as meeting this, but implied by substantial equivalence |
Study Details:
- Study Type: Non-clinical tests were performed to demonstrate substantial equivalence to a predicate device (TEMPTELLER, Model DT-312, K042202). These tests included "bench testing."
- Sample Size: Not specified for any testing.
- Data Provenance: Not specified for any testing.
- Ground Truth/Expert Involvement/Adjudication/MRMC/Standalone: These concepts are not applicable to the type of device and testing described in the document. The device's performance is gauged against recognized industry standards (ASTM E1112-00, IEC60601-1, IEC60601-1-2) rather than through AI/ML performance metrics against expert-labeled ground truth datasets.
- Training Set: Not applicable.
§ 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.