(77 days)
Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments; implants, crowns, endodontic treatment (previous root canal treatment), fillings.
The device is intended to assist dental professionals in producing dental charts based on image analysis. The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth.
The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history.
Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals in detecting dental structures and producing dental charting data based on interpretation of 2D dental radiographs. The device is intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image analysis.
The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth. The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history.
The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets the acceptance criteria for "Overjet Charting Assist" (K241684).
The document explicitly states: "Since the device remains unchanged from the Overjet Charting Assist Device cleared under K233590, no additional performance testing was conducted, and the existing data from the previous testing remains applicable."
Therefore, to answer your request, we would need to refer to the K233590 submission. However, based only on the provided text for K241684, I can only extract limited relevant information:
Key Takeaways from the Provided Text (K241684 Submission):
- No New Performance Testing: This submission (K241684) for "Overjet Charting Assist" did not conduct new performance testing. It relies entirely on the testing from the previous clearance, K233590, because "the device remains unchanged."
- PCCP Details Acceptance Criteria for Future Modifications: The Predetermined Change Control Plan (PCCP) outlined for this device states that the "Performance Evaluation Activity" for future algorithm modifications (e.g., re-training the ML model with new data to reduce false positives/negatives) will be "Identical to the acceptance criteria and standalone study protocol for the pre-modified version of the device cleared in K233590. Primary endpoints will be the main acceptance criteria, other endpoints and additional analyses will be conducted and reviewed for any major drop in performance." This strongly suggests that the acceptance criteria for K241684 are those from K233590.
- PCCP Requirement: "If a specific modification fails performance evaluation, failure(s) will be documented, and the modification will not be implemented."
Since the detailed study information (sample size, ground truth, expert qualifications, etc.) for the initial clearance (K233590) is not present in this document (K241684), I cannot provide a complete answer to all your questions.
However, based on the principle of the K241684 submission relying on K233590's data, here's what can be inferred/extracted about the acceptance criteria and study design for the original device, as referenced by the PCCP:
Inferred Information from the Provided Text (Regarding the Study conducted for K233590, as referenced by K241684's PCCP)
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Performance Evaluation Activity: Identical to the acceptance criteria and standalone study protocol for the pre-modified version of the device cleared in K233590. Primary endpoints will be the main acceptance criteria, other endpoints and additional analyses will be conducted and reviewed for any major drop in performance."
This means the acceptance criteria and reported device performance exist in the K233590 submission, but are not detailed in this K241684 document.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify these details for the K233590 study.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not specify these details for the K233590 study.
4. Adjudication Method for the Test Set:
The document does not specify this detail for the K233590 study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not specify if an MRMC study was done for K233590, nor does it provide an effect size for human readers' improvement with AI assistance. The focus of the PCCP is on standalone performance evaluation for future modifications.
6. Standalone (Algorithm Only) Performance:
Yes, a standalone study was done. The PCCP explicitly states: "Performance Evaluation Activity: Identical to the acceptance criteria and standalone study protocol for the pre-modified version of the device cleared in K233590." This confirms that a standalone performance evaluation was conducted for the original clearance.
7. Type of Ground Truth Used:
The document does not specify the type of ground truth (e.g., expert consensus, pathology, outcomes data) used for the K233590 study.
8. Sample Size for the Training Set:
The document does not specify this detail for the K233590 study, nor for any future re-training mentioned in the PCCP (it only mentions "re-training the ML model with new data").
9. How the Ground Truth for the Training Set was Established:
The document does not specify this detail for the K233590 study, nor for any future re-training mentioned in the PCCP.
For a complete answer to your questions, the K233590 submission documents would need to be reviewed. The provided document (K241684) serves primarily as a notification for adding a Predetermined Change Control Plan to an already cleared device, stating that no new performance testing was conducted for this specific submission.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).