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Unimed Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips, Marquette, Mindray, Spacelabs, Siemens, Artema/S&W and other monitors compatible with YSI 400 series temperature probes.

These devices are indicated for used by qualified medical personnel only.

Unimed Skin Temperature Probe (T2252-AS, THP-AS, TMQ-AS, TSW-AS, TSM-15AS, TSL-AS, TMR-AS), and Unimed General Purpose Temperature Probe (T2252-AG, THP-AG, TMQ-AG, TSW-AG, TSM-15AG, TSL-AG, TMR-AG) are used during patient temperature measurement. These probes consist of a connector on the monitor end and a thermistor on the patient end. These probes are to be used with YSI 400 series compatible temperature measurement systems only.

Temperature probes measure temperature by a resistor that is sensitive to temperature changes.

The probe is connected to the monitor either directly by using the connector or by an extension cable. These probes have a skin or core contact with a patient.

The provided text is a 510(k) summary for a medical device (Unimed Temperature Probe) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, the following information about acceptance criteria and a study to prove meeting them cannot be fully extracted as such a study with explicit acceptance criteria and corresponding performance metrics for the new device is not primarily detailed. The document primarily relies on the predicate devices' established performance and the new device having the same technology and accuracy range.

However, I can extract information related to the device's characteristics and the types of testing performed to ensure safety and effectiveness, which indirectly support its equivalency.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for the Unimed Temperature Probes themselves, nor does it provide a table of performance data against such criteria. Instead, it claims substantial equivalence based on having the "same thermistor, accuracy in 25-45℃ range" as the predicate devices. The performance data section refers to general safety and effectiveness testing to demonstrate compliance with recognized standards.

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

The document does not specify a sample size for a test set in the context of a performance study to establish specific accuracy or other performance metrics for the Unimed probes. The "performance data" section refers to general compliance testing.

• Sample Size: Not specified for performance testing.
• Data Provenance: Not specified, but the manufacturer is based in China. The document does not indicate a clinical study with patient data, so "country of origin" of data is less relevant here. It refers to "bench and laboratory testing."

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

This is not applicable. The document does not describe a study involving expert review or ground truth establishment for a test set. This type of evaluation is common for diagnostic imaging or AI devices, not typically for temperature probes where performance is assessed through physical or electrical testing.

4. Adjudication Method for the Test Set

This is not applicable. There was no expert review or ground truth adjudication process described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. The device is a temperature probe, not an AI-assisted diagnostic tool. No MRMC study was conducted or described.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

The document describes standalone performance testing in the sense that the device's technical specifications are evaluated independently. However, it's important to clarify that this is not an "algorithm" in the context of AI, but rather the performance of the physical temperature measurement device. The "Performance data" section indicates:

• "Bench and laboratory testing to demonstrate safety and effectiveness per: IEC 60601-1, EN 12470-4, ISO 10993-5, ISO 10993-10."
• This refers to direct measurements and evaluations of the probe's conformity to electrical safety, performance (temperature measurement accuracy within a given range), and biocompatibility standards.

7. Type of Ground Truth Used

The "ground truth" for the performance claims of a temperature probe would be established by reference standard measurements (e.g., highly accurate reference thermometers/calibrators) in controlled laboratory environments. The document implies this through references to standards like EN 12470-4, which specifies performance requirements for clinical thermometers.

8. Sample Size for the Training Set

This is not applicable. The device is a physical temperature probe, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

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