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The device measures the body temperature of a patient by means of a sensor (transducer) coupled with electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

The shaker digital thermometer, model ST8S Series, are the electronic thermometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. ST8S uses a hand shaking power generation mechanism to generate the electrical power required for short time temperature measurement operation. Whenever the generated power is low, the device as well as LCD display are switched off automatically. Regarding the performance of ST8S Series, it was designed and verified according to the US standard ASTM E 1112-00.

The provided text describes a 510(k) summary for a Shaker Digital Thermometer. However, it does not include the detailed information required to answer all the questions about acceptance criteria and a study proving device performance as typically expected for advanced AI/ML medical devices. The document focuses on regulatory equivalence to a predicate device based on standard compliance rather than clinical performance studies.

Here's a breakdown of what can and cannot be extracted from the provided text:

What can be extracted:

• Acceptance Criteria and Reported Device Performance: This device's "performance compliance" is directly tied to the voluntary standard ASTM E1112-00. The text states:

  • "Regarding the performance of ST8S Series, it was designed and verified according to the US standard ASTM E 1112-00."
  • "Compliance is ensure via the following voluntary standard testing reports: 1> ASTM E1112-00 for device performance compliance tested by manufacturer."

  The document doesn't provide specific numerical acceptance criteria (e.g., accuracy, precision values) from ASTM E1112-00, nor does it list the reported device performance results against those numerical criteria. It only states that the device "was designed and verified according to" and achieved "compliance" with the standard.

  To fully answer this, one would need to refer to the ASTM E1112-00 standard itself, which would define the acceptance criteria for clinical electronic thermometers (e.g., accuracy limits, response time, stability). Since the 510(k) states compliance, the reported performance is implicitly within the limits set by that standard.

What cannot be extracted (and why):

The following questions are typically relevant for AI/ML or more complex diagnostic devices involving clinical studies, which are not described in this 510(k) for a digital thermometer:

• Sample sized used for the test set and the data provenance: Not applicable/not provided. Performance was verified against a standard in a lab setting, not a clinical test set with patient data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. No expert ground truth was established for "test sets" in the context of this device.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
• 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 standalone digital thermometer, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of AI algorithms. The device functions as a standalone thermometer.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a thermometer, the "ground truth" for performance testing (as per ASTM E1112-00) would typically involve comparison to highly accurate reference thermometers under controlled environmental conditions, rather than expert consensus or pathology. The document doesn't specify the exact ground truth methodology used within the ASTM E1112-00 testing.
• The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

Summary Table of Available Information:

Conclusion regarding the study proving device meets acceptance criteria:

The study that proves the device meets its acceptance criteria is the performance compliance testing conducted by the manufacturer according to the US standard ASTM E1112-00. The 510(k) submission asserts that this testing demonstrated compliance, thereby proving the device meets the performance specifications defined within that standard. No further details about the study methodology, sample size, or specific results are provided in this regulatory summary, as is common for predicate-based 510(k) submissions which rely on compliance with recognized standards.

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