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The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only.

The probe is offered in the following two configurations:

• Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities.

• Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.

Sterile Disposable Temperature Probes are used during patient temperature measurement. These probes consist of a phone plug connector on the adapter cable end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor by using an interconnect cable which is also included in the submission as an accessory. These probes have a skin or core contact with a patient.

These temperature probes are typically used with Mindray uMEC10, which was cleared under K171901.

Products are packed individually into a paper pouch in sterile condition.

The provided document is a 510(k) summary for a medical device (Sterile Disposable Temperature Probe). It does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device where performance metrics like accuracy, sensitivity, and specificity would be evaluated against a ground truth.

Instead, this document focuses on demonstrating substantial equivalence to an existing predicate device based on design specifications, intended use, and a series of non-clinical tests (biocompatibility, electrical safety, EMC, and compliance with general medical device standards like ISO 80601-2-56 for clinical thermometers).

Therefore, I cannot extract the information required to populate the table and answer the detailed questions about acceptance criteria for AI/ML performance, study design, sample size, expert adjudication, or MRMC studies. This type of information is not relevant to the 510(k) clearance process for this specific traditional medical device (a temperature probe).

The "Performance Data" section (Section 8) lists, for example, "Biocompatibility testing" and "Non-clinical data" showing compliance with various ISO and IEC standards. These are acceptance criteria in the sense of regulatory compliance for a temperature probe, but not performance metrics of an AI model.

Here's an attempt to structure what can be inferred from the document regarding acceptance criteria and performance, but it deviates significantly from the AI/ML context implied by the prompt's questions.

Based on the provided document, which describes a traditional medical device (Sterile Disposable Temperature Probe) and its 510(k) clearance, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" refers to demonstrating substantial equivalence to a predicate device and compliance with relevant medical device standards, rather than the performance evaluation of an AI-powered diagnostic tool.

Therefore, most of the requested information (related to AI/ML performance metrics, ground truth establishment, expert adjudication, and MRMC studies) is not applicable to this document. I will fill in what can be inferred relating to the device's regulatory acceptance.

Acceptance Criteria and Device Performance (Regulatory Compliance)

Study Details (as inferable from a 510(k) for a traditional device)

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in terms of number of devices tested for each standard, but it's implied that sufficient samples were tested to demonstrate compliance with the relevant standards. These are engineering/device performance tests, not clinical studies with patient data.
   • Data Provenance: The document states that "Non-clinical testing has been conducted to verify that the Sterile Disposable Temperature Probe meets all design specifications." The testing was likely conducted by the manufacturer or a contracted lab in line with international device standards. There is no mention of country of origin of patient data or whether it was retrospective/prospective, as this is not a study involving patient data collection for performance evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For a traditional medical device like a temperature probe, "ground truth" typically refers to precise measurement standards and calibrated equipment used in engineering and performance testing (e.g., standard temperature baths for accuracy verification). It does not involve expert readers establishing a medical diagnosis "ground truth" from images or other clinical data.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. This concept is relevant to human interpretation of data, often in AI/ML performance studies. For this device, standard engineering test methods and protocols are followed, where results are measured against defined specifications, not adjudicated by a panel of experts.

4. 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:

   • Not Applicable. This is a traditional temperature probe, not an AI-assisted diagnostic device. Therefore, no MRMC study would have been performed.

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

   • Not Applicable. There is no algorithm or AI component in this device. Its performance is inherent to its physical design and sensor.

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

   • Engineering Standards / Calibrated Reference Measurements. For example, temperature accuracy is verified against a calibrated reference thermometer in a precisely controlled temperature environment. Device safety (e.g., biocompatibility) is determined by specific laboratory assays according to predefined ISO standards.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device, so no training set is relevant.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set exists for this type of device.

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