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510(k) Data Aggregation
(270 days)
The TTP™ is a non-sterile temperature monitoring system intended to measure and monitor core body temperature of patients of all ages, by applying a sensor unit on the forehead.
The TTP™ system monitors the body core temperature through continuous measurements of the patient. The system is non-sterile and comprised of a disposable Sensor Unit, attached to the patient temple, and connected to a Monitor Connecting Unit which is connected to a power supply and to any YSI-400 input vital signs monitor, through which, the patient temperature is presented. The MCU is able to present the patient temperature as a standalone unit.
The provided text describes the Medisim Temple Touch Pro™ (TTP™) – Temperature monitoring system, a clinical electronic thermometer. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy | ± 0.2°C |
| Temperature Measurement Range | 25°C - 45°C (77°F - 113°F) |
| Bench Testing | Passed all bench tests successfully according to ASTM E-1112-00 |
| Clinical Study Goal | No statistically significant difference between TTP™ and invasive thermometers (compared to various reference measurements across diverse populations) |
| Software Validation | Fully functional |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study (Test Set): 181 subjects (95 males, 86 females) with a total of 4591 temperature samples.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It mentions the applicant is Medisim Ltd. based in Neve Ilan, Israel, so it's likely the study was conducted in Israel or a closely associated region. The study was conducted according to GCP standards, implying a prospective and controlled approach.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical study. It states that the TTP™ measurements were compared to "various reference measurements" from "other invasive thermometers," implying that these reference measurements served as the ground truth.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set. The clinical study aimed to show "no statistically significant difference" between the TTP™ and reference thermometers, suggesting a direct comparison without an independent adjudication process for each reading.
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
This is not applicable as the device is a temperature monitoring system and not an AI-assisted diagnostic tool that requires human reader interpretation. No MRMC study was mentioned or performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done through the clinical study. The device's accuracy and performance were assessed by comparing its measurements directly to established reference thermometers. The study did not involve human interpretation or assistance in the measurement process itself, beyond the initial application of the sensor.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the clinical study (test set) was based on measurements from "other invasive thermometers." These invasive thermometers are considered the gold standard for core body temperature measurement.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. The description focuses on validation and performance testing. For a device like a thermometer, the "training" (calibration, algorithm development) would likely occur during the device development phase, and the provided clinical study serves as a final validation (test set).
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned in the document, details on how its ground truth was established are not available. It's inferred that the device's measurement algorithms were developed and refined against established temperature measurement standards and reference methods during its engineering and design phases.
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