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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.

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Overiet 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 Overiet Charting Assist detects these finding (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 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.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document explicitly states, "All conducted tests produced results that exceeded predefined acceptance criteria," but does not explicitly list numerical thresholds for each criterion. The reported performance metrics are presented as the results that met or exceeded these unstated criteria.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: 634 images (259 Bitewing, 239 Periapical, 136 Panoramic).
   • Data Provenance: From various clinics across the U.S. (44 distinct clinics). The data includes male and female patients of primary and permanent dentition. The study explicitly states it uses data from all U.S. regions (Southeast, Southwest, Northeast, West). The data collection method (retrospective or prospective) is not explicitly stated, but the mention of "obtained from male and female patients" and "collected from 44 distinct clinics" suggests retrospective collection of existing images.

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

   • Number of Experts: Not explicitly stated as a numerical count for each image, but the ground truth was established by "trained dentists."
   • Qualifications of Experts: Described as "trained dentists." No specific years of experience or board certifications are provided.

3. Adjudication method for the test set:

   • The ground truth was established by "majority pixel voting" among trained dentists. This implies a consensus-based adjudication method where multiple experts reviewed the images, and their agreement (or majority vote) determined the ground truth. The exact number of experts involved in each "vote" is not specified (e.g., 2+1, 3+1).

4. 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:

   • A formal MRMC comparative effectiveness study demonstrating human reader improvement with AI assistance (vs. without AI) was not explicitly detailed.
   • The study primarily focused on the standalone performance of the device and its ability to reduce manual charting operations. The metric "Mean % Reduction per image in Manual Charting Operations with (95% Cl) when using the OChA device is 80.5% (79.0%, 81.9%)" quantifies the efficiency gain, which is an indirect measure of how much human effort is reduced, rather than a direct measure of improved diagnostic accuracy by human readers with vs without AI assistance.

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

   • Yes, a standalone performance evaluation was conducted. The document explicitly states: "Standalone performance of the Overjet Charting Assist device was evaluated..." and "Tooth Level Standalone Analysis for subgroups of past restorative structures...", "Tooth Level Standalone Analysis for subgroups of dental tooth anatomy...", etc.

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

   • The ground truth used was expert consensus based on "robust consensus reference standard established by trained dentists via majority pixel voting."

7. The sample size for the training set:

   • The training set sample size is not explicitly mentioned in the provided text. The document describes the test set and its performance evaluation but does not detail the training data or its size.

8. How the ground truth for the training set was established:

   • Since the training set details are not provided, the method for establishing its ground truth is also not stated in this document.

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