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510(k) Data Aggregation
(142 days)
CamX Triton HD Proxi Head
The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
The CamX Triton HD "Proxi" aids in the detection and diagnosis of proximal caries. It consists of a toothbrush-sized handpiece and a "Proxi" head. A USB cable connects the handpiece to a personal computer with PACS software such as DBSWIN to enable communication between a PC computer and the handpiece. After a camera cover (single patient disposable sheath, K132953) is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the teeth to be examined. The camera functions by transilluminating sound tooth enamel with infrared light. Areas that spread and reflect the light (e.g. caries lesions) show up clearly delimited bright areas. A digital camera converts the object situation into an electrical signal, sent it over USB to a computer, converted into an image (by imaging software) and presented on a monitor in monochrome colors to illustrate suspected areas of decay.
This document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a clinical study. Therefore, comprehensive information regarding acceptance criteria and a detailed study proving the device meets them, as typically found in a clinical trial report, is not present.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format with corresponding performance results. Instead, it relies on a comparison to the predicate device and validation of key performance attributes.
| Acceptance Criteria (Inferred from non-clinical testing) | Reported Device Performance |
|---|---|
| LED Illumination and output (similar to predicate) | Validation and verification test results showed that new device and the predicate device are equivalent. |
| Image Quality (similar to predicate) | Illumination and image quality of potential caries detection products are similar for both Duerr Dental AG's CamX Triton HD Proxi and KaVo's DIAGNOcam camera. |
| Compliance with Standards | Duerr Dental AG's CamX Triton HD Proxi complies with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (edition 3), IEC 60601-1-2:2014 (edition 4), and IEC 80601-2-60:2012 (first edition). |
| Sterilization Validation | Sterilization validation testing was successfully performed according to ANSI/AAMI/ISO 17665-1, Annex D and the validation approach outlined in ANSI/AAMI/ISO 14937, Annex D (Approach 3). |
| Biocompatibility (for patient-contacting components) | Patient contact Distance Spacer component was tested and complies with ISO 10993-10:2002 Standard and Amendment 1, and ISO 10993-5. (Other components isolated from patient contact). |
| Functional Principle (transillumination) | The main function is based on transillumination, same as the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "11. Clinical Data: Not required for a finding of substantial equivalence." This means a clinical test set of patient data, as would be used in a typical clinical study, was not required or performed for this submission. The performance assessment was based on non-clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Given that clinical data was not required, there is no mention of experts establishing ground truth for a clinical test set. The "ground truth" concept in a clinical context (e.g., confirmed caries presence) is not applicable here as no clinical study was performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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 device for detecting caries, not an AI-assisted diagnostic tool for human readers in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as "a diagnostic aid," implying human-in-the-loop use. The primary mode of operation described is a digital camera converting the object situation into an electrical signal, sent to a computer, converted into an image, and "presented on a monitor in monochrome colors to illustrate suspected areas of decay." This suggests the image is then interpreted by a dentist. A standalone algorithm performance was not reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing of "illumination and image quality," the ground truth implicitly would be objective measurements and comparisons against the predicate device's characteristics and output. For biocompatibility and sterilization, the ground truth is adherence to established international standards and successful completion of specified tests.
8. The sample size for the training set
Not applicable. This device does not appear to be an AI/machine learning product that would require a "training set" in the conventional sense. Its function is based on transillumination and image capture.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/machine learning model.
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