Search Results

The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.

The Infrared thermometer is a handheld device, 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 can also be transmitted to a non-device APP to record and display through Bluetooth.
There are two models AOJ-20A and AOJ-20Y. Both models share the same construction except differences on product enclosure,PCB layout and button designs.

The provided text describes a 510(k) premarket notification for an Infrared Thermometer (AOJ-20A; AOJ-20Y). It details the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

However, the document does not contain the level of detail typically found in a clinical study report or a more comprehensive validation plan. Specifically, it lacks:

• Explicit acceptance criteria in a tabular format with corresponding performance results.
• Specific sample sizes for test sets beyond general statements of testing being conducted.
• Data provenance (country, retrospective/prospective) for clinical data.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance details.
• Specific details on the type of ground truth (e.g., pathology, outcomes data) beyond "performance effectiveness."
• Training set sample size and ground truth establishment for training.

The document primarily focuses on non-clinical performance data to support the substantial equivalence claim, rather than a clinical study demonstrating acceptance criteria met in a real-world setting with human subjects. The tests mentioned are:

• Biocompatibility testing: Cytotoxicity, Skin Sensitization, Skin Irritation per ISO 10993-1.
• Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2.
• Bench Testing: Compliance with ISO 80601-2-56 for performance effectiveness.
• Software Verification and Validation Testing: Conducted as per FDA's "Content of Premarket Submissions for Device Software" guidance, with the device considered "Basic" documentation level.

Given these limitations in the provided text, I can only extract the general types of tests and the standards they comply with, rather than specific acceptance criteria values and the device's measured performance against them. The information on "study that proves the device meets the acceptance criteria" is limited to the types of non-clinical tests conducted.

Therefore, direct answers to many of your questions cannot be provided from the given document as it does not contain clinical study data or a detailed validation report with specific performance metrics against acceptance thresholds.

Based on the provided text, here is what can be inferred and what is explicitly stated:

1. A table of acceptance criteria and the reported device performance

The document references compliance with ISO 80601-2-56 for "performance effectiveness" in bench testing. This standard likely specifies accuracy and precision requirements for clinical thermometers. However, the specific numerical acceptance criteria (e.g., ±0.2°C) and the actual measured performance values of the device against these criteria are not provided in this summary.

Inferred/General:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified. The document states "Bench testing was conducted on the thermometer device, consisting of all the system." This suggests testing of the physical devices, but no numerical sample count (e.g., number of thermometers tested, number of measurements taken) is given.
• Data provenance: Not specified. The tests are non-clinical bench and lab tests, not clinical human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as the testing described is non-clinical/bench testing, not involving human expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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 medical device (thermometer), not an AI imaging or diagnostic algorithm used by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The document describes the performance of the device itself (sensor, electronics, software) in a standalone manner via bench testing, but not an "algorithm only" in the sense of a standalone AI model. The device's function is temperature measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For "performance effectiveness," the ground truth (or reference standard) would typically be calibrated reference thermometers or temperature sources compliant with the ISO standard used for test and measurement, not clinical outcomes or expert consensus.
• For biocompatibility, the ground truth is the chemical and biological assays.
• For electrical safety and EMC, the ground truth is the measurement against standard limits using appropriate test equipment.

8. The sample size for the training set

• Not applicable, as this is a traditional medical device (thermometer), not an AI/machine learning model requiring a training set for its core function. The "software verification and validation testing" refers to standard software engineering practices, not machine learning model training.

9. How the ground truth for the training set was established

• Not applicable for the same reasons as point 8.

Ask a specific question about this device