(180 days)
The Infrared thermometers (JPD-FR400 and JPD-FR402) take human body temperature via the eardrum or forehead. They apply to all age groups except for babies under three months. Both devices apply to both professional use and home use.
The infrared thermometers (JPD-FR400, JPD-FR402) are handheld instruments which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The results can be displayed on LCD. And, the results measured by JPD-FR400 can be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application "Angel Doctor" installed on a mobile device using the iOS system or the Android system. The thermometers, which are powered by AAA 1.5Vx2 Alkaline batteries, can be used for all age groups except for babies under three months. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or F .
This document describes the premarket notification for a non-contact infrared thermometer (models JPD-FR400, JPD-FR402). The information provided pertains to the device's technical specifications and the testing conducted to demonstrate its substantial equivalence to previously marketed devices.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Key Takeaways:
- This submission is for a medical device (non-contact infrared thermometer), not an AI/ML diagnostic device. Therefore, many of the requested categories related to AI performance (e.g., ground truth establishment for training, MRMC studies, human-in-the-loop performance, expert consensus) are not applicable.
- The primary method for demonstrating acceptance and substantial equivalence is through compliance with recognized performance standards for clinical thermometers and non-clinical testing.
- A clinical performance test was conducted, which is crucial for proving the accuracy of a thermometer.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from recognized standards like ASTM E 1965-98. The document does not present a formal table of "acceptance criteria" vs. "reported performance" in the typical AI/ML sense (e.g., sensitivity, specificity thresholds). Instead, it states that the device's performance complied with the requirements of the standards.
However, we can infer some key performance criteria and the device's reported capabilities from the "Substantial Equivalence Comparison" table and "Non-clinical Performance Testing" section.
| Feature / Performance Metric | Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (JPD-FR400/402) |
|---|---|---|
| Accuracy | Predicate 1 (Ear): ±0.2°C (36-39°C), ±0.3°C (rest); Predicate 2 (Forehead): ±0.2°C | 1) ±0.2°C (±0.4°F) for 36.0°C-39.0°C/96.8°F-102.2°F |
- ±0.3°C (±0.5°F) from 32.0°C-35.9°C/89.6°F-96.7°F
- ±0.3°C (±0.5°F) for 39.1°C-42.2°C/102.3°F-108.0°F
(Comment in table: "For the forehead temperature mode: same as Predicate Device 2. For the ear canal temperature mode: same as Predicate Device 1.") |
| Measurement Range | Predicate 1 (Ear): 32-43°C; Predicate 2 (Forehead): 32.2-43.3°C | Forehead: 0.0°C-100.0°C; Ear: 0.0°C-100.0°C
(Note 02: "The subject devices' measuring range is larger than that of both predicate device 1 and predicate device 2. Due to the subject devices also apply to measuring the environmental temperature, so their measuring range is larger.") |
| Display Resolution | 0.1°C/0.1°F | 0.1°C/0.1°F |
| Measurement Mode | Predicate 1: Ear; Predicate 2: Forehead | Ear and Forehead measurement mode (Matches both predicates) |
| Auto Power-off | Yes | Yes |
| °C/°F Switchable | Yes | Yes |
| Working Ambient Temp. | Predicate 1: 10-40°C; Predicate 2: 10-40°C | 10°C-40°C |
| Electrical Safety | AAMI ANSI ES60601-1:2005/(R)2012+A1:2012; IEC 60601-1:1988+A1:1991+A2:1995 | Compliance stated. |
| EMC | IEC 60601-1-2: 2014 / 2007; ETSI EN 301 489-1; ETSI EN 301 489-17 | Compliance stated, including specific tests for Bluetooth functionality (JPD-FR400). |
| Home Healthcare Env. | IEC 60601-1-11:2015 / 2010 | Compliance stated. |
| Risk Management | ISO 14971:2007 | Compliance stated. |
| Biocompatibility | ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010 | Compliance stated. |
| Clinical Performance | ASTM E 1965-98 (Reapproved 2009) requirements | "The test report showed the clinical performance of proposed devices complied with the requirements of ASTM E 1965-98 (Reapproved 2009)." |
| Waterproof | Predicate 1/2: No | IP22 (Different from predicates, but indicates better performance/feature and passed IEC60601-1 and IEC60601-1-11 test.) |
| Bluetooth Function | Predicate 1/2: No | JPD-FR400: Yes (Passed FCC, EN301489-1, EN301489-17, EN 300328, wireless coexistence test.) JPD-FR402: No. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document explicitly states: "The clinical performance test is conducted according to ASTM E 1965-98 (Reapproved 2009)." This standard specifies the methodology for clinical accuracy testing of infrared thermometers. While the exact number of subjects or measurements is not explicitly stated in this summary document, adherence to ASTM E 1965-98 implies a sufficient sample size as mandated by that standard.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document is a 510(k) submission from Shenzhen Jumper Medical Equipment Co., Ltd. in China. Given the manufacturer's location, the testing was likely conducted in China.
- Retrospective or Prospective: Unspecified, but clinical performance testing for medical device approval is typically prospective to ensure controlled conditions and data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This category is not applicable in the context of this device. A non-contact infrared thermometer directly measures temperature. The "ground truth" for thermometer accuracy is established by comparing the device's readings against a highly accurate reference thermometer, typically in a controlled clinical setting or using a black body calibrator. It does not rely on subjective expert interpretation like radiological images.
4. Adjudication Method for the Test Set
- Not applicable. As above, the "truth" is a physical measurement, not a subjective interpretation requiring adjudication.
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
- Not applicable. This is a standalone medical device (thermometer), not an AI-based diagnostic tool that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in effect. The device's primary function is to provide an objective temperature reading, acting as a standalone measurement tool. The "clinical performance test" evaluates the device's accuracy in a clinical setting without human interpretation impacting the reading itself. The performance is assessed based on how closely its readings match reference measurements.
7. The Type of Ground Truth Used
- Reference Thermometer Readings / Clinical Patient Temperatures: The ground truth for a clinical thermometer's accuracy is established by comparing its readings to known, accurate body temperatures obtained via a reference method (e.g., rectal thermometer or an established highly accurate clinical thermometer) in subjects, or by using precisely controlled temperature sources (e.g., black body calibrators) for calibration and laboratory accuracy testing. The text states "The clinical performance test is conducted according to ASTM E 1965-98 (Reapproved 2009)," which details how this ground truth is established (e.g., using a reference thermometer to perform simultaneous or near-simultaneous measurements on subjects).
8. The Sample Size for the Training Set
- Not applicable / Unknown: This device is a traditional infrared thermometer. It is not an AI/ML device that undergoes "training" on a data set in the way a deep learning model would. Its "training" or calibration would involve engineering and manufacturing processes to ensure its sensor and algorithms accurately convert infrared radiation to temperature readings according to physical principles.
9. How the Ground Truth for the Training Set Was Established
- Not applicable: As discussed above, this is a traditional medical device, not an AI/ML model requiring a distinct "training set" with established ground truth in the AI sense. Its "ground truth" for manufacturing calibration would involve highly accurate laboratory temperature references.
§ 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.