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510(k) Data Aggregation
(159 days)
Infared Thermometer
The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the forehead for clinical or home use.
The thermometers are powered by AAA 1.5V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF. The measurement distance of the subject device is no more than 3cm.
The Infrared thermometer included DT-8836T, DT-8836P. These two models are identical on hardware and software except the physical dimensions and appearance.
The Infrared Thermometer (Model DT-8836T, DT-8836P) has undergone testing to demonstrate its performance against established acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Standard | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Accuracy | ±0.2°C (0.4°F) within 36.0°C ~39.0°C (96.8°F ~102.2°F), ±0.3°C (0.5°F) other range (per ASTM E1965-98 and ISO 80601-2-56) | ±0.2°C (0.4°F) within 35.0°C ~ 42.0°C (95.0°F ~ 107.6°F), ±0.3°C (0.5°F) other range (demonstrated compliance with IEC 80601-2-56 and ASTM E 1965-98 Reapproved 2009) |
| Measurement Range | 32.0°C ~42.9°C (89.6 to 109.22°F) | 32.0°C ~42.5°C (89.6 to 108.5°F) (demonstrated compliance with IEC 80601-2-56) |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10 | Passed Cytotoxicity, Sensitization, and Irritation tests based on ISO 10993-1 guidance |
| Electrical Safety | Compliance with IEC 60601-1 (General requirements for basic safety and essential performance) | Demonstrated compliance with IEC 60601-1 |
| EMC | Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Demonstrated compliance with IEC 60601-1-2 |
| Home Healthcare Environment | Compliance with IEC 60601-1-11 (Requirements for medical electrical equipment and systems used in home healthcare) | Demonstrated compliance with IEC 60601-1-11 |
| Software Validation | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005 | Software validation and verification conducted according to FDA guidance |
| Clinical Performance | Compliance with ASTM E 1965-98 (Reapproved 2009) for clinical accuracy | Clinical study demonstrated compliance with ASTM E 1965-98 (Reapproved 2009) |
2. Sample Size Used for the Test Set and Data Provenance
The clinical study was a randomization, simple blind homologous control, pairing design of clinical investigation.
- Sample Size: Minimum of 150 subjects.
- 1/3 Infants (newborn to one year)
- 1/3 Children (greater than one to five years)
- 1/3 Adults (greater than five years old)
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. It also does not specify if the data was retrospective or prospective, but the description of a "clinical investigation" strongly suggests a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. It refers to the "clinical performance of the subject device [having] complied with the requirement of standard ASTM E 1965-98 (Reapproved 2009)," which dictates methods for determining accuracy against a reference thermometer, but does not detail the roles of experts in this process.
4. Adjudication Method for the Test Set
The document describes the clinical study as a "randomization, simple blind homologous control, pairing design of clinical investigation." It does not provide details on an adjudication method involving multiple readers. The accuracy is assessed by comparing the device's readings to a reference thermometer as per ASTM E 1965-98.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is an infrared thermometer, and its performance is evaluated against a reference standard for temperature measurement, not through human reader interpretation of images or data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance
Yes, a standalone performance evaluation was conducted. The non-clinical data and the clinical data sections describe tests performed on the device itself against established standards:
- Non-clinical data: Testing to IEC 60601-1, IEC 60601-1-2, ISO 80601-2-56, and IEC 60601-1-11, and software validation. These are tests of the device's technical specifications and performance without human interpretation in the loop.
- Clinical data: Evaluation against ASTM E 1965-98 for accuracy. This standard defines how a clinical thermometer's readings are compared to a reference standard thermometer (e.g., a rectal thermometer for core body temperature), essentially assessing the device's standalone accuracy in a clinical setting.
7. Type of Ground Truth Used
The ground truth for the clinical performance evaluation was established by a reference standard thermometer (as per ASTM E 1965-98 requirements) which defines the true body temperature against which the infrared thermometer's readings are compared. This is a form of outcomes data or reference standard comparison.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" for the device. The device is an Infrared Thermometer, which typically relies on pre-calibrated sensors and algorithms based on physical principles, rather than machine learning models that require extensive training data. Therefore, the concept of a training set as used in AI/ML is not directly applicable here. The development and calibration of the device would involve engineering and physical testing, not a "training set" in the common sense of data-driven models.
9. How Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" in the context of AI/ML is not applicable to this device as described. The "ground truth" for the device's inherent accuracy and performance characteristics would have been established through laboratory calibration against highly accurate reference thermometers and physical standards during its design and manufacturing process, in accordance with standards like ISO 80601-2-56 and ASTM E 1965-98 for the initial development and calibration.
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(89 days)
BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER
The Braun ThermoScan® PRO 3000 Infrared Thermometer is intended for the intermittent measurement and monitoring of human body temperature, by medical professionals. It is intended for use on people of all ages.
The Braun ThermoScan® PRO 3000 Infrared Thermometer 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.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Braun ThermoScan® PRO 3000 Infrared Thermometer.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (ASTM Laboratory Accuracy Requirements for IR Thermometers in the range 36°C-39°C) | Reported Device Performance (Accuracy characteristics) |
|---|---|
| ±0.2°C (±0.4°F) | For patient temperature range 96.8°F to 102.2°F (36°C to 39°C): ±0.4°F (±0.2°C) |
| Outside this range: ±0.5°F (±0.3°C) |
The device also states it "meets the requirements established in ASTM Standard E 1965-98, 'Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature'."
2. Sample size used for the test set and the data provenance
- Sample Size: "Approximately 39% of the patients participating in the study were considered febrile." While a specific total number of patients is not provided, the study indicates it covered four age groups: 0-3 yrs, 4-10 yrs, 11-65 yrs, and >65 yrs.
- Data Provenance: Not explicitly stated, but based on the submitter's address (San Diego, CA) and assuming a clinical trial setting, it is likely prospective data collected in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study compared the PRO-3000 to a predicate device (ThermoScan® IR-2000) rather than establishing ground truth against a specific expert reference.
4. Adjudication method for the test set
This information is not provided in the document. The study was a "comparison study" and "clinical repeatability testing."
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
A MRMC comparative effectiveness study was not performed. The device is a standalone thermometer, not an AI-assisted diagnostic tool. The study was a comparison of the new device against a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance was done for the device's accuracy characteristics, as it is a medical device that provides a direct measurement. The "Accuracy characteristics" table directly reports the device's accuracy against defined temperature ranges. The "Five Environment Accuracy Test" is also a standalone test.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the accuracy assessment seems to be a comparison against the predicate device (ThermoScan® IR-2000) and adherence to ASTM laboratory accuracy requirements. The clinical study specifically states: "The comparison study demonstrated that the Braun ThermoScan® PRO-3000 Instant Thermometer measured ear temperature equivalently to the ThermoScan® IR-2000(PRO-1) in all age groups." For laboratory accuracy, it refers to "ASTM laboratory accuracy requirements."
8. The sample size for the training set
This device does not utilize a "training set" in the context of machine learning or AI. It is a measurement device, and its performance is based on inherent design and calibration, not learned parameters.
9. How the ground truth for the training set was established
Not applicable as there is no training set for this type of device.
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