(301 days)
The welloStationX is a non-contact infrared forehead thermometer intended for use to measure the body temperature of individuals over 5 years of age and older. The welloStationX can be used by medical professionals or laypersons in any public or private indoor facility with environmental conditions maintained within 15°C to 28°C (59°F to 82.4°F), 20 -70% RH non-condensing.
The welloStationX uses an infrared sensor to measure human body temperature. It is offered as a desktop or kiosk model. The WSX consists of a display screen with an IR camera mounted to the top of the display screen. The display screen provides instructions to subjects being screened. Both the kiosk and desktop model operate in the same manner. The subject reads and follows the on-screen instructions to position themselves in the correct location approximately 10 inches from the WSX. In 3 seconds, the WSX provides output of the subject's core body temperature. Each temperature reading will be output with either a green background or a red background. Temperature displayed with a red background will also include a prompt to obtain a second temperature evaluation using an alternate method. The facility can select the action threshold or use the default threshold above which the reading will be displayed with a red background. Users can receive email alerts for any subject with a temperature reading displayed with a red background. For some features, an active internet connection is required.
Here's a breakdown of the acceptance criteria and study information for the welloStationX device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
Device: welloStationX (K180298)
Predicate Device: Caregiver Professional Clinical Thermometer (K131771)
| Feature / Performance Metric | Acceptance Criteria (Predicate or Standard based) | Reported Device Performance (welloStationX) | Comparison |
|---|---|---|---|
| Intended Use | Measuring body temp of individuals >5 years old, by medical professionals or laypersons in indoor facilities (10°C to 40°C, 5 years old, by medical professionals or laypersons in indoor facilities (15°C to 28°C, 20-70% RH non-condensing). | Substantially similar, slight difference in environmental conditions. | |
| Technology | Non-contacting IR sensor | Non-contacting IR sensor | Identical |
| Accuracy (Body Temp) | Predicate: | ±0.2°C (±0.4°F) across 95°F to 107.6°F (35°C to 42°C) | Better/More Consistent: welloStationX has constant accuracy across its entire body temperature range, unlike the predicate which has varying accuracy across different sub-ranges. |
| ±0.2°C (±0.4°F) for 96.8-102.2°F (36-39°C) | |||
| ±0.3°C (±0.54°F) for 94.0-96.7°F, 102.3-108.0°F | |||
| Displayed Temp Range | Predicate: Body: 94°F-108°F (34.4°C-42.2°C) | Body: 95°F-107.6°F (35°C-42°C) | Slightly different, but both cover typical fever/hypothermia ranges. |
| Reading Time | 1-2 seconds | 3 seconds | Similar, within acceptable range for quick measurements. |
| Interval between measurements | 20 seconds | 10 seconds | Faster |
| Startup/Acclimation Time | Patient Acclimation: 20 min, Thermometer Acclimation: 20 min | Startup: 30 seconds (includes self-test and calibration) | Significantly faster device acclimation for welloStationX. |
| Compliance Standards | ASTM E1965-98, IEC 60601-1-2 (among others) | ASTM E1965-98, IEC 60601-1-2 (among others) | Identical/Similar (both claim compliance) |
The primary acceptance criteria for clinical accuracy would be the ASTM E1965-98 standard for infrared thermometers and the ISO 80601-2-56 standard for clinical thermometers. The document states that the clinical accuracy validation was "equivalent to the oral thermometer and reported values for the predicate device," implying it met the accuracy requirements set by these standards and/or demonstrated comparable performance to the predicate and a validated oral thermometer.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 110 males and females.
- Data Provenance: Not explicitly stated, but the study was a "Clinical accuracy validation... conducted in 110 males and females aged 5 years of age and older." This phrasing suggests a prospective clinical study. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications: "a trained technician" was responsible for recording measurements. The ground truth was established by a Welch Allyn SureTemp oral thermometer, which is a legally marketed device itself. Therefore, the "experts" for ground truth are the technicians following the instructions for use of the oral thermometer, rather than medical experts interpreting data like in imaging studies.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the traditional sense. This was a direct comparison study of two temperature measurement devices against each other (welloStationX vs. Welch Allyn SureTemp).
- Each measurement (by welloStationX and the oral thermometer) was recorded by a single trained technician. There's no mention of multiple readers or an adjudication process for discrepancies in temperature readings; rather, the agreement between the devices was assessed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. This device is a measurement tool, not an interpretation tool where human readers would typically improve with AI assistance. The study focused on the accuracy of the device itself.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done. The "Clinical accuracy validation" directly assessed the welloStationX's ability to measure temperature when compared to a reference standard (Welch Allyn SureTemp oral thermometer). The stated accuracy for the welloStationX (±0.2°C (±0.4°F)) is a standalone performance metric. The entire 510(k) process for a thermometer focuses on the device's inherent accuracy.
7. Type of Ground Truth Used
- Ground Truth: A reference medical device (Welch Allyn SureTemp oral thermometer) and its measurements, which are themselves validated against established clinical standards for body temperature measurement. This can be considered a form of clinical reference standard. The study report compared the welloStationX measurements to those obtained from the oral thermometer.
8. Sample Size for the Training Set
- Not Applicable / Not Provided. This document does not suggest the welloStationX uses machine learning or AI that would require a separate "training set" in the context of typical AI device development. It's a sensor-based device with embedded software for calculation. The "software" mentioned refers to operational and control functions, not necessarily AI requiring a training data set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided (as no training set for AI was indicated).
§ 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.