(438 days)
The Braun ThermoScan Thermometer, Model IR-6000 is intended for the intermittent measurement and monitoring of human body temperature in the home. It is intended for use on people of all ages.
The Braun ThermoScan Thermometer, Model IR-6000 is a hand held instrument that measures temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the Tympanic membrane and adjacent surfaces
Here's a breakdown of the acceptance criteria and study information for the Braun ThermoScan Thermometer, Model IR-6000, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM Standard E1112) | Reported Device Performance (Laboratory Error) |
|---|---|
| Patient Temperature Range: | |
| 98.0 to 102.0°F (37.0 to 39.0°C) | ±0.2°F (±0.1°C) |
| 96.4 to <98.0°F (35.8 to <37.0°C) | ±0.3°F (±0.2°C) |
| >102.0 to 106.0°F (>39.0 to 41.0°C) | ±0.3°F (±0.2°C) |
| <96.4°F (35.8°C) or >106.0°F (41.0°C) | ±0.5°F (±0.3°C) |
| Meets laboratory accuracy requirements specified in ASTM Standard E1112 for infrared thermometers. | Passed |
Note: The document states "Accuracy is determined under laboratory conditions in calibrate mode with a typical lens filter installed."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for the accuracy testing. However, for the clinical comparison study and repeatability testing, four age groups were used: 0-3 years, 4-10 years, 11-65 years, and >65 years. The number of participants within each group is not provided.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective clinical and laboratory tests conducted to support the device's efficacy.
3. Number of Experts and Qualifications for Ground Truth for Test Set:
- Not Applicable / Not Specified: The ground truth for the accuracy testing appears to be based on laboratory conditions and established standards (ASTM Standard E1112-86), rather than expert consensus on individual readings. For the clinical comparison, the predicate devices (IR-2000 and IR-4000) serve as the comparison point, implying their established accuracy as a form of ground truth for comparison. No specific "experts" for ground truth establishment are mentioned in this context.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Specified: Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where multiple readers provide interpretations. For temperature measurement, which is objective, such methods are not relevant. The accuracy is determined by comparing device readings to a known standard or predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. This type of study is more common for diagnostic imaging devices where human readers interpret medical images. The ThermoScan is a measurement device, and its performance is evaluated based on accuracy against a reference, not on human interpretive improvement.
- Comparison Study: A "comparison study" was performed, demonstrating that the IR-6000 measured ear temperature equivalently to the IR-2000 and IR-4000 in all age groups. This is a comparison against predicate devices, not an MRMC study with human readers assessing AI vs. no AI.
- Effect size of human readers improving with AI vs without AI assistance: Not applicable, as no MRMC study with AI assistance was conducted.
6. Standalone (Algorithm Only) Performance:
- Yes, standalone performance was done. The "Accuracy characteristics" table and the statement "Accuracy is determined under laboratory conditions in calibrate mode" describe the standalone performance of the device's measurement capabilities. The device is intended for direct measurement, so its primary functionality is its standalone operation.
7. Type of Ground Truth Used:
- Laboratory Standard / Predicate Device Comparison:
- For the accuracy characteristics, the ground truth is based on meeting the requirements of ASTM Standard E1112-86. This implies comparison against a highly accurate reference thermometer or controlled temperature environments.
- For the clinical comparison study, the ground truth for comparison was the measurements obtained from the predicate devices, the ThermoScan Instant Thermometer, Models IR-2000 and IR-4000.
8. Sample Size for the Training Set:
- Not applicable / Not specified. Infrared thermometers like the Braun ThermoScan IR-6000 are not typically "trained" in the machine learning sense. Their accuracy is based on the physics of infrared detection and calibration, not on learning from a dataset. Therefore, there is no "training set" in this context. The manufacturing process involves calibration against known temperature sources.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no "training set" for this type of device, the concept of establishing ground truth for it does not apply. The device's inherent accuracy is validated through the methods described above (ASTM standards and comparison to predicate devices).
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X 954523
THERMOSCANINC.
510(K) SUMMARY
DEC 1 0 1996
| DEC 10 1996 | |
|---|---|
| Submitter's Name: | Thermoscan Inc. |
| Address: | 10421 Pacific Center CourtSan Diego, CA 92121 |
| Phone: | (619) 550-2100 |
| Contact: | Frances E. Harrison |
| Date of Summary: | December 9, 1996 |
| Name of Device: | Braun ThermoScan Thermometer, Model IR-6000 |
| Predicate Device: | ThermoScan Instant Thermometer, Model IR-2000ThermoScan Instant Thermometer, Model IR-4000 |
| Device Description: | The Braun ThermoScan Thermometer, Model IR-6000is a hand held instrument that measures temperature throughthe opening of the auditory canal. Operation is based onmeasuring the natural thermal radiation emitted from theTympanic membrane and adjacent surfaces |
| Intended Use: | The Braun ThermoScan Thermometer, Model IR-6000is intended for the intermittent measurement and monitoringof human body temperature in the home. It is intended foruse on people of all ages. |
| TechnologicalCharacteristics: | The Braun ThermoScan Thermometers, ModelIR-6000, IR-2000 and IR-4000 have the same general designand incorporate similar technologies, materials andcomponents.The primary function of the Braun ThermoScanThermometer, Model IR-6000 is the same as ThermoScanInstant Thermometer, Models IR-2000 and IR-4000 for themeasurement of body temperature and raise no newquestions of safety and effectiveness. ThermoScan Inc.concludes that the Braun ThermoScan Thermometer,Model IR-6000 is substantially equivalent to theThermoScan IR-2000 and ThermoScan IR-4000. |
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Page 2 510(k) Summarv Braun ThermoScan Thermometer, Model IR-6000
PRODUCT SPECIFICATIONS:
| Model Number | HM3, HM3P | |
|---|---|---|
| Technical Characteristics | ||
| Displayed temperature range | 93.2-108°F (34-42.2°C) | |
| Operating ambient temperature range | 61-104°F (16.1-40°C) | |
| Display resolution | 0.1°F or C | |
| Temperature scales (user selectable) | °F or °C | |
| Operating relative humidity (max) | 80% | |
| Long term storage ranges | ||
| Temperature | -4 to 122°F (-20 to 50°C) | |
| Humidity (max) | 95% noncondensing | |
| Display modes | EAR (The displayed EAR temperature is theactual measured ear canal temperature plusa mathematical adjustment to approximatethe familiar oral range. However, this is notnecessarily the same as an oral temperaturemeasured at the same time.) | |
| Weight (without batteries) | 3.5 oz (100g) | |
| Memory recall | One previous temperature | |
| Accuracy characteristics* | ||
| Applicable patient ages | All ages | |
| Laboratory error (max) | ||
| Patient temperature range | Error °F | Error °C |
| 98.0 to 102.0°F (37.0 to 39.0°C) | ±0.2 | ±0.1 |
| 96.4 to<98.0°F (35.8 to<37.0°C) | ±0.3 | ±0.2 |
| >102.0 to 106.0°F (>39.0 to 41.0°C) | ||
| <96.4°F (35.8°C or>106.0°F (41.0°C) | ±0.5 | ±0.3 |
*Accuracy is determined under laboratory conditions in calibrate mode with a typical lens filter installed. See ASTM Standard "Electronic Thermometer for Intermittent Determination of Patient Temperature" E1112-86, available from ASTM, 100 Barr Harbor Dr., West Conshoken, PA 19428-2959. Tel (610) 832-9285. Consult company for calibrate mode.
The Braun ThermoScan Thermometer has been proven to be safe. It meets the laboratory accuracy requirement specified in ASTM Standard E1112 as it pertains to infrared thermometers.
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Page 3 510(k) Summary Braun ThermoScan Thermometer, Model IR-6000
Summary of Testing:
Non-Clinical Results
| Accuracy Test | Passed |
|---|---|
| Consistency Test | ි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි හිටි හිමි කිරීම පිහිටි හිමි කිරීම පිහිටි හිමි හිමි කිරීම පිහිටි මෙම ප්රධාන බවට |
| Operating Life Test | ි පිහුළු පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහ |
| Lens Filter Detect Switch Operating Life Test | Passed |
| Cleaning Test | Passed |
| Acoustic Noise @st | Passed |
| TestAltitude | Passed |
| Electrical Short Heat Measurement Test | Passeg |
Product performance specifications, features and software were validated.
Clinical Results
A companison study and clinical repeatablify testing was performed on the following four age groups; 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs. The companson study demonstrated that the Braun ThermoScan Thermometer, Model IR-8000 measured ear temperature equivalently to both the IR-2000 and IR-4000 in all age groups. The clinical repeatability for each age group met ASTM standards.
§ 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.