(43 days)
The Braun Thermoscan® IRT 4000 series and Braun Thermoscan@PRO 4000 series Clinical Infrared Ear Thermometers is indicated for the intermittent measurement and monitoring of thuman body temperature by consumers of all ages in a home use professional use environment respectively.
The probecover is used as a santary barnier between the mometer and the car canal.
The Braun Thermoscan® Pro/IRT 4000 series 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 with a built-in correction algorithm to compensate the influence of ambient temperature using a heated tip. The difference between the Pro 4000 series thermometer and the IRT 4000 series thermometer is that the Pro 4000 series sories themselver and any professional use in hospitals and healthcare or professional office settings, while the IRT 4000 series is meant for home use. There is no change to the thermometer or its manufacture as part of the modification described in this submission.
The probe cover (also called as lens filter) is a disposable plastic cover made of a biocompatible clarified polypropylene material (Pacur) that is dimensionally manufactured to set tolerances so that it can be fitted on the probe tip of the thermometer. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different people.
Here's a breakdown of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Probe Cover Transmissivity) | Reported Device Performance (95% Confidence Interval for Difference) |
|---|---|
| ±0.01 deg F (10% of 0.2 deg C tolerance) | Within ±0.01 deg F |
Note: The document states that the 95% confidence intervals for the difference between the two dataset populations (existing probe covers and new probe covers) were within the chosen acceptance criteria of ±0.01 deg F.
Biocompatibility Acceptance Criteria: "acceptance criteria in accordance with ISO 10993 were chosen and are outlined in the Biocompatibility test reports." The document states the new material passed these tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Transmissivity): 1800 data points were collected for the gold standard samples on the new transmissivity test machine setup. The number of samples manufactured at the new site using new material is implied to be similar for comparison.
- Data Provenance: The document does not explicitly state country of origin for the data (beyond manufacturing site locations). The study is prospective in nature, as it involves testing newly manufactured probe covers and comparing them to existing ones.
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 study focuses on the physical characteristic (transmissivity) of the probe cover and its biocompatibility, not direct performance of the thermometer in measuring human temperature against a ground truth established by medical experts for a clinical outcome.
4. Adjudication Method for the Test Set
- This information is not applicable as the study design focuses on statistical equivalency of transmissivity and biocompatibility testing, not on adjudicated clinical outcomes.
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, an MRMC comparative effectiveness study was not done. This submission is for modifications to a non-AI medical device (thermometer probe cover), and thus this type of study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is not an AI algorithm. The study evaluated the standalone performance of the probe cover in terms of transmissivity and biocompatibility.
7. The Type of Ground Truth Used
- Transmissivity: The "gold standard samples" (existing probe covers) were used as the reference "ground truth" for transmissivity. The performance was compared to these established samples.
- Biocompatibility: The acceptance criteria were established in accordance with ISO 10993.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of an AI algorithm. The manufacturing process for the new probe covers was validated, and then samples from this validated process were tested.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As mentioned, there is no training set for an AI algorithm in this context.
§ 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.