(248 days)
Reusable Temperature Probes:
Reusable Temperature Probes are intended to be used for monitoring temperature for multi- patient use. The temperature probes are reusable and designed for use with monitor of GE-Marquette Model DASH3000. These devices are used by qualified medical professionals only.
Disposable Temperature Probes:
Disposable Temperature Probes are intended to be used for monitoring temperature for single patient use. The temperature probes are non-sterile and designed for use with monitors of GE- Marquette Model DASH3000. These devices are used by qualified medical professionals only.
The proposed devices are used for patient temperature measurement. The probes are reusable or disposable depending on the model. These probes consist of a connector on the monitor end and a thermistor on the patient end. The working principle is resistance based on the metal conductor increasing with temperature decrease, and the linear changes to the characteristics of the temperature measurement. The proposed devices are designed to be used in a healthcare facility and compatible with a monitor, GE-Marquette Model DASH3000.
The six models have two types of structure designs corresponding to reusable and disposable use which consists of different materials. The Negative Temperature Coefficient (NTC) of the six models are identical. Reusable models ST1304, ST2304, ST3304, ST4304 have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials. Disposable models ST5105A and ST6105A have a similar structure design with two different sensor shapes for different measure sites and consist of the same materials.
The provided text describes the regulatory clearance of a medical device (Reusable and Disposable Temperature Probes) and its substantial equivalence to a predicate device, rather than a study designed to prove the device meets acceptance criteria through detailed performance metrics and a comparison to a defined ground truth.
Therefore, many of the requested details about acceptance criteria, specific study design elements (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, effect sizes, standalone performance, training set details) are not present in the provided document.
However, I can extract the following information that is available:
1. A table of acceptance criteria and the reported device performance:
The document mentions compliance with standards which inherently include performance criteria. Specifically, the "Accuracy" is listed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy | ±0.1°C |
| Measurement Range | 25-45°C |
| Measurement Time | 60s |
| Biocompatibility | Complied with ISO 10993-1, ISO 10993-5, and ISO 10993-10 |
| Electrical Safety | Complied with IEC 60601-1 |
| Performance Standard | Complied with ISO 80601-2-56 |
| Electromagnetic Compatibility | Complied with IEC 60601-1-2 |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document states "Non-clinical testing has been conducted to verify that the subject devices meet all design specifications." The exact number of units or measurements in these tests is not provided.
- Data Provenance: The tests are non-clinical, conducted by the manufacturer, Shenzhen SINO-K Medical Technology Co., Ltd., which is based in Shenzhen, Guangdong, China. The testing confirms compliance with international standards (IEC, ISO, ASTM).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. The testing described is non-clinical performance testing against established international standards, not expert evaluation of medical images or diagnostic outputs.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. This document describes objective performance testing against engineering standards, not a diagnostic study requiring expert adjudication.
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 device is a temperature probe, not an AI-assisted diagnostic tool.
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's inherent performance (e.g., accuracy, measurement range) was demonstrated through non-clinical testing against standards (e.g., ISO 80601-2-56) without human interpretation of results beyond reading the device's output.
7. The type of ground truth used:
- Ground Truth Type: International standards (ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2), and established biocompatibility standards (ISO 10993 series). These specify acceptable ranges and methodologies for determining performance, forming the "ground truth" for compliance.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is a hardware temperature probe, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this 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.