(33 days)
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is intented for the intermittent measurement and monitoring of human body temperature by consumers in the home.
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is a hand held instrument that measures human body temperature through the opening of the auditory canal. It is a single mode ear thermometer that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces. The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is meant for intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use environment.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Braun ThermoScan® 3 High Speed Compact Ear Thermometer
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Accuracy (ASTM E1965 & ISO 80601-2-56): | Measurement Accuracy: |
| - ±0.2°C/0.4°F for 35.5°C | - Achieved ±0.2°C/0.4°F for 35.5°C |
| - ±0.3°C/0.5°F for 34.0°C | - Achieved ±0.3°C/0.5°F for 34.0°C |
| - ±0.3°C/0.5°F for 42.1°C | - Achieved ±0.3°C/0.5°F for 42.1°C |
| Functional testing of software error handling (ASTM E1965 and ISO 80601-2-56) | Completed, implying it met requirements. |
| Functional testing of all functions after accelerated aging (ASTM F 1980-07 and ASTM D3045) | Completed, implying it met requirements. |
| Labeling verification (ASTM E1965, ISO 80601-2-56, and IEC 60601-1) | Completed, implying it met requirements. |
| Laboratory accuracy test (ISO 80601-2-56 Clause 201.101.2 and ASTM E1965 Clause 5.3.1) | Passed requirements. |
| Clinical accuracy validation test (ASTM E1965 Clause 5.5) | Passed requirements. |
| ME equipment identification, marking and documents (ISO 80601-2-56 Clause 201.7) | Passed requirements. |
| Accuracy of controls and instruments and protection against hazardous outputs (ISO 80601-2-56 Clause 201.12) | Passed requirements. |
| Displayed Temperature Range (ASTM E1965 Clause 5.2) | Passed requirements (reportedly 34.0°C |
| Maximum Permissible Laboratory Error (ASTM E1965 Clause 5.3) | Passed requirements. |
| Special Requirements (ASTM E1965 Clause 5.5) | Passed requirements. |
| Ambient Conditions (ASTM E1965 Clause 5.6) | Passed requirements. |
| Low Power Supply Operation (ASTM E1965 Clause 5.7) | Passed requirements. |
| Display and Human Interface (ASTM E1965 Clause 5.8) | Passed requirements. |
| Construction (ASTM E1965 Clause 5.9) | Passed requirements. |
| Labeling and Marking (ASTM E1965 Clause 5.10) | Passed requirements. |
| Test Method (ASTM E1965 Clause 6) | Passed requirements. |
| Documentation (ASTM E1965 Clause 7) | Passed requirements. |
| Biocompatibility (ISO-10993-1, 10993-5, 10993-10 and FDA Bluebook Memo G95-1) | Completed, implying it met requirements. |
| Usability (IEC 62366 and FDA Guidance Document on Human Factors) | Completed, implying it met requirements. |
| Electrical Safety (IEC 60601-1:2005) | Completed, implying it met requirements. |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2: 2007) | Completed, implying it met requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for the clinical accuracy validation test (ASTM E1965 Clause 5.5) or other non-clinical tests. It only states that the tests were completed and passed the requirements of the respective standards.
Given that this is a 510(k) submission for substantial equivalence, clinical data often relies on existing predicate device performance or standards-based testing rather than extensive new clinical trials with large patient cohorts. The "clinical accuracy validation test" passed requirements per ASTM E1965 Clause 5.5, which likely specifies the minimum number of subjects and measurements for clinical accuracy determination of ear thermometers.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, tests like those conforming to ASTM E1965 and ISO 80601-2-56 usually involve prospective testing to generate the required performance data.
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. For a thermometer, the "ground truth" for temperature measurements is typically established using highly accurate reference thermometers and controlled laboratory conditions, not through expert human assessment in the same way as, for example, image interpretation. The ASTM and ISO standards would dictate the methodology for establishing this reference.
4. Adjudication Method for the Test Set
This is not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., medical image reading) where an expert consensus is needed. For thermometer accuracy, the "truth" is objectively measured against a reference standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human performance improves with or without AI assistance, which is irrelevant for a standalone electronic thermometer.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The device itself is a standalone algorithm (or rather, an electronic device) that provides temperature readings. The "non-clinical testing" and "clinical accuracy validation test" outlined directly evaluate the performance of this device in its intended standalone function, without human-in-the-loop comparison. It performs the measurement and displays the result directly.
7. The Type of Ground Truth Used
The ground truth used for assessing the device's accuracy is based on objective measurements from reference standards/equipment in laboratory and clinical settings as defined by:
- Laboratory accuracy test: Passed requirements per ISO 80601-2-56 Clause 201.101.2 and ASTM E1965 Clause 5.3.1. This involves comparing the device's readings against highly precise reference temperature sensors under controlled conditions.
- Clinical accuracy validation test: Passed requirements per ASTM E1965 Clause 5.5. This involves comparing the device's readings against established core body temperature reference methods in actual human subjects.
8. The Sample Size for the Training Set
This document describes a medical device (thermometer), not an AI/ML algorithm that requires a "training set" in the conventional sense. The device operates based on fixed physical principles and pre-programmed algorithms. Therefore, the concept of a "training set" for an AI model is not applicable.
9. How the Ground Truth for the Training Set Was Established
As established in point 8, there is no "training set" for this device. The physical and software parameters of the thermometer are designed and verified against established engineering and medical standards, not "trained" on data.
§ 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.