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The DataTherm® II Continuous Temperature Monitor is intended to continuously measure, display and monitor human body temperature updating every 4 seconds. Additionally, it stores up to 140 temperature/time/day data sets that may be stored at a user-selected frequency range from once per minute to once every 24 hours in one minute intervals. The current temperature and stored information may be viewed on the LCD screen that is integrated into the instrument or, from a PC computer screen after installation of the DataTherm software to a PC. The DataTherm II is intended to be used on patients of all ages.

The DataTherm® II Continuous Temperature Monitor is used to measure and monitor human body temperature and for storing temperature data at adjustable, preset time intervals.

The DataTherm II Continuous Temperature Monitor (model HD-2300) consists of four components.

• 1. A control / display assembly measuring 3.16'' X 2.37' X 0.71" with an LCD screen and 5 control keys (On/Off, Mode Selection, &(increase), (decrease) and keyboard Lock). The interior electronic components consist of a circuit board, a battery compartment housing 2 - AAA batteries, a buzzer and LED alert light.
• 2. A disposable flexible temperature probe having a plug-in connector at one end and thermistor sensor at the other.
• 3. A USB interface connector cable that permits the transfer of stored and real-time temperature/time/day information to a PC computer screen.
• 4. Proprietary software that permits an individual patient's current temperature to be viewed and temperature/time/date information to be displayed and archived, if desired.

The provided text describes the DataTherm® II Continuous Temperature Monitor and its regulatory submission (K070878). Unfortunately, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Specifically, the document states:

• "Discussion of Clinical Tests Performed: Not Applicable" (page 2, Section 8). This is a crucial point, as it indicates a clinical trial demonstrating the device's performance against specific acceptance criteria was not part of this 510(k) submission. Instead, the submission relies on substantial equivalence to a predicate device and non-clinical (bench) testing.

Therefore, for aspects related to clinical study design, sample sizes, expert involvement, and ground truth in human subject testing, the information is not present. I can, however, extract details regarding performance standards, which implicitly define some acceptance criteria, and what non-clinical testing was performed.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document references compliance with specific performance standards, which serve as the implicit acceptance criteria for the non-clinical performance of the device. However, specific numerical performance results (e.g., accuracy in degrees Celsius) of the DataTherm® II are NOT provided in the text. The document only states that the device "complies with" and "conforms to" these standards.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable/Not specified for clinical data, as no clinical tests were performed or presented. For non-clinical (bench) testing, the sample size is not disclosed.
• Data Provenance: The non-clinical "bench testing" was performed by the submitting company (RG Medical Diagnostics/Geratherm Medical AG). The origin country or retrospective/prospective nature of this unspecified bench testing data is not detailed beyond being "bench testing contained in this submission."

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

• Not applicable, as no clinical tests were performed with human subjects requiring expert ground truth establishment.

4. Adjudication method for the test set

• Not applicable, as no clinical tests were performed with human subjects requiring 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

• No MRMC or AI-related study was mentioned. The device is a continuous temperature monitor, not an AI diagnostic tool.

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

• While the device functions as a standalone electronic thermometer, the document does not describe "standalone performance" in the context of an algorithm's performance without human interaction in a diagnostic sense (which is common for AI/imaging devices). Its performance is assessed against the aforementioned standards for electronic thermometers.

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

• For compliance with standards like ASTM E1112-00, the ground truth would typically be a highly accurate reference thermometer or temperature measurement system in a controlled laboratory environment. The document does not explicitly state the specific ground truth used for these compliance tests, but it would not involve expert consensus, pathology, or outcomes data in this context.

8. The sample size for the training set

• Not applicable. The device is a physical electronic thermometer, not an AI/machine learning model that requires a training set.

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

• Not applicable. (See point 8)

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