(164 days)
VitalSense® can be used in any setting where physiological body core and skin temperature are used to further the understanding of body function. The device can be used for simultaneous assessment of core body temperature, dermal surface temperature, or ambient temperatures that require logging of data over time with subsequent conversion, display, and analysis of the aforementioned parameters. VitalSense® may be used in any instance where quantifiable analysis of temperature data is desirable.
VitalSense® is a compact, ambulatory, physiological data logger. VitalSense® may be attached to the belt or worn in a shirt pocket. Up to ten telemetric sensors may be used with a single VitalSense® logger. The device senses and records physiological data and displays the data on its LCD screen. Recorded data may be transferred later to a PC for display and conversion for export to other programs.
Here's a breakdown of the acceptance criteria and study information for the VitalSense® device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Figure of Merit | Acceptance Criteria (Stated) | Reported Device Performance (VitalSense®) | Reported Predicate Performance (Mini-Logger® Series 2000) |
|---|---|---|---|
| Temperature Stability | Must not drift more than +/- 0.1 °C over 10-12 hours | +/- 0.01 °C | +/- 0.03 °C |
| Temperature Linearity/Accuracy | Within +/- 0.1 °C of a standard, NIST-traceable digital RTD thermometer (over 25-50 °C range) | +/- 0.05 °C | +/- 0.08 °C |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a "test set" in the context of clinical data or human subjects. The tests described are laboratory-based performance verification tests.
- Sample Size: For the stability test, the image description mentions "Two Temperature Probes" (Sensor 24 and Sensor 26). For linearity, the image description also refers to "Sensor_24" and "Sensor_26". The total number of devices or sensors tested across the entire evaluation is not specified beyond these two examples for illustration.
- Data Provenance: The data is generated from internal laboratory testing by Mini Mitter Co., Inc. (as indicated by "Mini Mitter Company has established criteria..." and "Mini Mitter has tested the accuracy..."). The country of origin is the USA, specifically Bend, Oregon, where the company is located. The study is prospective in nature, as it involves active testing of the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The ground truth for these performance tests is based on objective, quantifiable measurements against established standards and calibration, not expert consensus or interpretation of medical data. The "ground truth" for temperature linearity is a "standard, NIST-traceable digital RTD thermometer."
4. Adjudication Method for the Test Set:
Not applicable. There is no adjudication method used for these non-clinical performance tests, as the results are numerical comparisons against defined thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document describes engineering performance tests of the device itself (accuracy and stability of temperature measurement), not studies involving human readers or assessment of human interpretation with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the studies described are standalone performance evaluations of the device's ability to accurately and stably measure temperature. The device functions as a data logger, and the tests evaluate its fundamental measurement capabilities directly, without human intervention in the data acquisition or algorithmic processing during the test.
7. The Type of Ground Truth Used:
The ground truth used for these performance tests is based on:
- Reference Standards: For temperature linearity, a "standard, NIST-traceable digital RTD thermometer" served as the reference for ground truth.
- Defined Baseline/Stability: For temperature stability, the expectation of minimal drift over time (e.g., in a stable bath) serves as the ground truth.
8. The Sample Size for the Training Set:
Not applicable. This document describes the verification and validation of a finished device's performance, not the development or training of an algorithm using a dataset. The device is a physiological data logger, not an AI/ML algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm described.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.