(71 days)
The Digital Thermometer Model V901US is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is intended for the adult and pediatric population.
The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature, or standard mode (actual determination of temperature).
The Digital Thermometer Model V901US is a hand- held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive ( Instant ) mode ( 10-seconds in oral, rectal mode and under the arm mode-predicative temperature, or standard mode (actual determination of temperature).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text.
The provided document is a 510(k) summary for a Digital Clinical Thermometer Model V901US. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a novel device's efficacy through extensive clinical trials. Therefore, the "study" described herein is primarily a series of verification and validation (V&V) activities focused on changes from the predicate device, rather than a clinical study in the traditional sense involving human subjects for performance evaluation.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification | Acceptance Criteria | Reported Device Performance (Results of Verification) |
|---|---|---|
| Battery change from CR1225(3V) to LR41(1.5V) | The Unit should go into the factory mode and operating mode and function as expected. | PASS. Traceable to V901US Design Verification Tests 1 thru 28. |
| Backlight change from three color to no backlight | Verify by observation that unit does not have backlight. | PASS. Traceable to V901US Design Verification Test 11. |
| Indication icon for 42.9°C changed from "H" to "Hi" | Verify by observation that the "Hi" indicator comes up for temperature above 42.9°C or 109.9°F. | PASS. Traceable to V901US Design Verification Test 12. |
| Measurement time changed from 8 seconds to 10 seconds | The average measurement time shall be less than 10 seconds. | PASS. Traceable to V901US Design Verification Test 1. |
| Number of beeps after measurement changed from 5 to 10 | Verify by observation that the number of beeps after a measurement is complete is 10. | Pass. Traceable to V901US Design Verification Tests 2 and 26. |
| Fever alert point changed from 38.3°C/100.9°F to 37.8°C/100.0°F | Verify by observation that the number of beeps for fever is activated. | PASS. Traceable to V901US Design Verification Test 26. |
| Power down time changed from 90s to 10min | Verify that Auto power turns the unit off in 10 ± 1 minutes when no action is taken. | Pass. Traceable to V901US Design Verification Test 3. |
| Addition of password-triggered Factory mode (replaces un-triggered mode) | 1. Verify that the unit goes into the factory mode. |
- The product should have the following accuracy in water-bath mode:
• ±0.2 °F 98.0°F-102.0°F
• ±0.3°F 96.4°F-97.9°F, 102.1°F-106.0°F
• ±0.5 °F 106°F | PASS. Traceable to V901US Design Verification Tests 1 thru 28. |
Study Details (Verification & Validation Activities)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of devices) used for each specific test. However, the tests are described as "Verification
Activity," implying laboratory testing of device units. For the accuracy testing (part of the Factory Mode validation), it refers to "the product," which could imply a representative sample. - Data Provenance: The tests were conducted by Amperor Electronics (SZ) Co., Ltd. in Shenzhen, Guangdong, P.R. China, where the device is manufactured. The tests are in-vitro simulations (water-bath), not human clinical data. The studies are prospective as they are conducted as part of the design verification for the new device model.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the document. The ground truth for these engineering verification tests is established by calibrated laboratory equipment (e.g., precise temperature references, timers, power measurement devices), not by clinical experts.
4. Adjudication Method for the Test Set
- This is not applicable as the tests are objective engineering measurements and observations (e.g., checking if a beep sounds, if an icon displays correctly, or if a temperature is within a specified range). There is no "adjudication" in the sense of reconciling differing expert opinions.
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, this was not done. This device is a simple clinical thermometer, not an AI-powered diagnostic tool. MRMC studies are used for evaluating AI performance in image-based diagnostics with human interpretation, which is not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not explicitly applicable in the AI sense. The "algorithm" here is the device's
firmware for temperature measurement, display, and alerts. All cited tests (e.g., accuracy in water-bath, timing, display of icons, beeping) are effectively "standalone" tests of the device's automated functions without human interpretation of a complex output. The "human-in-the-loop" would be the user reading the temperature, but the tests verify the accuracy of the reading produced by the device itself.
7. The Type of Ground Truth Used
- The ground truth for these verification tests is physical measurement against calibrated standards. For example, for temperature accuracy, the ground truth is the precisely controlled temperature of a water-bath (simulated environment). For timing, it's a calibrated timer. For display, it's direct observation of the device's screen.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/Machine Learning product that requires a "training set." The firmware of the thermometer is developed using traditional software engineering methods, not by training on data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no ground truth needed for it. The functionality of the device is based on physical principles of temperature measurement and programmed logic, not learned patterns from data.
Summary of the "Study" Context:
This document describes a regulatory submission for a minor modification of an existing medical device (clinical thermometer). The "study" here refers to the design verification and validation activities performed to ensure that the changes introduced (e.g., battery type, display icons, measurement time, power-down time) do not negatively impact the device's safety or effectiveness and that the new functionalities meet their specified requirements. It is an engineering validation process, not a clinical trial or AI model validation. The "acceptance criteria" are the predefined performance thresholds for these engineering tests.
§ 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.