(566 days)
The IC-WHCD100 (Inspire) is intended to be used as an aid in the detection and diagnosis of dental caries.
The IC-WHCD100 is a toothbrush-sized handpiece used for diagnosis of caries. A USB cable is used to connect the handpiece to a personal computer with a dental imaging software. After a camera cover is placed over the end, the handpiece is positioned over the tooth to be examined. The camera takes images by illuminating the tooth surface with a white LED light for regular tooth image. With fluoresced light, the device can show bacteria on the surface of tooth. With infrared light, the device can show tooth cavity by highlighting enamel. The user can view the images on 510k cleared dental imaging software such as Apteryx vision (K983111), Romexis (K171385), Sidexis (K132773), etc.
The provided text details the FDA 510(k) summary for the IC-WHCD100 (Inspire) device, which is an intraoral camera intended as an aid in the detection and diagnosis of dental caries. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices and provides limited information regarding specific acceptance criteria and detailed study results. Critical information needed to fully answer the request, such as a precise table of acceptance criteria and reported device performance with numerical metrics (e.g., sensitivity, specificity for caries detection), detailed sample size for the test set, number and qualifications of experts for ground truth, adjudication methods, details of comparative effectiveness studies (MRMC), or a comprehensive standalone performance study report are not explicitly present in the provided text.
Based on the available information, here's what can be extracted and what remains unknown:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "Performance Test for imaging (Image Sharpness, Image Size, Image Resolution, tooth Caries Detection)" as a non-clinical test. However, it does not provide a specific table of acceptance criteria or the reported device performance metrics (e.g., sensitivity, specificity, accuracy) for caries detection. It only broadly states that "the performance test results of the subject device supports that the transillumination mode works well despite this difference." and "the performance test result supports that the subject device is substantially equivalent to the predicate devices."
Unfortunately, a specific table with numerical acceptance criteria and corresponding performance data for caries detection is not found in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document states "performance test results of the subject device supports that the transillumination mode works well despite this difference." and refers to "Performance Tests (Non-clinical)". However, the specific sample size used for the test set (number of teeth, lesions, or patients) and the data provenance (e.g., country of origin of the data, retrospective or prospective nature of data collection) are not disclosed in this 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided text does not specify the number of experts used to establish ground truth or their qualifications. It only refers to "Performance Tests" related to caries detection, implying some form of ground truth was used, but details are absent.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth for the test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
The provided text does not mention or describe a Multi Reader Multi Case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus is on the device's performance relative to predicate devices, not human-AI collaboration.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The document broadly states "Performance Test for imaging... tooth Caries Detection)". While the device has a caries detection aid capability, the summary does not explicitly detail a standalone algorithm-only performance study with specific metrics (e.g., sensitivity, specificity of the algorithm itself). The device is described as an "aid in the detection and diagnosis," implying human involvement.
7. The Type of Ground Truth Used
The document refers to "tooth Caries Detection" as one of the performance tests. However, the specific type of ground truth used (e.g., expert consensus, pathology/histology, clinical outcomes data, or a combination) is not explicitly stated.
8. The Sample Size for the Training Set
The 510(k) summary does not provide any information regarding a training set sample size. This type of document typically focuses on performance testing for regulatory clearance rather than details of model development. Given that the device is an "intraoral camera with Caries Detection Aid" using specific light sources (405nm and 940nm) to highlight bacteria and cavities, it's possible its "detection aid" might be based on optical properties rather than a complex AI model requiring extensive training data in the traditional sense, but this is speculative given the lack of detail.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, there is no information on how its ground truth was established.
§ 872.1745 Laser fluorescence caries detection device.
(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.