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510(k) Data Aggregation
(196 days)
Overjet Caries Assist (OCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.
Overjet Caries Assist (OCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.
OCA is a software-only device which operates in three layers: a Network Layer, a Presentation Layer, and a Decision Layer. Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer.
The machine learning system with the Decision Layer processes bitewing and periapical radiographs and annotates suspected carious lesions. It is comprised of four modules:
- Image Preprocessor Module
- Tooth Number Assignment Module
- Caries Module
- Post Processing
This document describes the Overjet Caries Assist (OCA) device, a computer-assisted detection (CADe) software intended to aid dentists in the detection and segmentation of caries on bitewing and periapical radiographs.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria for sensitivity or specificity in a "table" format as initial goals. However, it does state a performance objective for the clinical reader improvement study: "Increase in dentist's sensitivity of greater than 15%". The other metrics are presented as reported performance from standalone and clinical evaluation studies.
| Metric | Acceptance Criteria (if stated) | Reported Device Performance | Comments |
|---|---|---|---|
| Standalone Performance | Bitewing Images (n=1,293) | ||
| Overall Sensitivity | Not explicitly stated | 76.6% (73.8%, 79.4%) | Based on surfaces (27,920) |
| Primary Caries Sensitivity | Not explicitly stated | 79.9% (77.1%, 82.7%) | |
| Secondary Caries Sensitivity | Not explicitly stated | 60.9% (53.5%, 68.2%) | |
| Enamel Caries Sensitivity | Not explicitly stated | 74.4% (70.4%, 78.3%) | |
| Dentin Caries Sensitivity | Not explicitly stated | 79.5% (75.8%, 83.2%) | |
| Overall Specificity | Not explicitly stated | 99.1% (98.9%, 99.2%) | |
| Primary Caries Dice Score | Not explicitly stated | 0.77 (0.76, 0.78) | Pixel-level metric for true positives |
| Secondary Caries Dice Score | Not explicitly stated | 0.73 (0.70, 0.75) | Pixel-level metric for true positives |
| Enamel Caries Dice Score | Not explicitly stated | 0.76 (0.75, 0.77) | Pixel-level metric for true positives |
| Dentin Caries Dice Score | Not explicitly stated | 0.77 (0.76, 0.79) | Pixel-level metric for true positives |
| Periapical Images (n=1,314) | |||
| Overall Sensitivity | Not explicitly stated | 79.4% (76.1%, 82.8%) | Based on surfaces (16,254) |
| Primary Caries Sensitivity | Not explicitly stated | 79.8% (76.0%, 83.7%) | |
| Secondary Caries Sensitivity | Not explicitly stated | 77.9% (71.4%, 84.5%) | |
| Enamel Caries Sensitivity | Not explicitly stated | 67.9% (60.7%, 75.1%) | |
| Dentin Caries Sensitivity | Not explicitly stated | 84.9% (81.3%, 88.4%) | |
| Overall Specificity | Not explicitly stated | 99.4% (99.2%, 99.5%) | |
| Primary Caries Dice Score | Not explicitly stated | 0.79 (0.78, 0.81) | Pixel-level metric for true positives |
| Secondary Caries Dice Score | Not explicitly stated | 0.79 (0.77, 0.82) | Pixel-level metric for true positives |
| Enamel Caries Dice Score | Not explicitly stated | 0.75 (0.73, 0.77) | Pixel-level metric for true positives |
| Dentin Caries Dice Score | Not explicitly stated | 0.81 (0.80, 0.82) | Pixel-level metric for true positives |
| Clinical Evaluation (Reader Improvement) | Bitewing Images (n=330) | ||
| Increase in reader sensitivity (overall) | > 15% | 78.5% (assisted) vs. 64.6% (unassisted) | Increase = 13.9%. This falls slightly below the stated >15% criterion, though the document concludes it demonstrates a "clear benefit". The text states "overall reader sensitivity improved from 64.6% (56.4%, 72.1%) to 78.5% (72.6%, 83.6%) unassisted vs assisted", if calculated as a direct percentage difference (78.5-64.6 = 13.9), it is slightly below 15%. If interpreted as (assisted/unassisted)-1 * 100 ((78.5/64.6)-1)*100 = 21.5%, then it meets the criterion. The framing in the document implies the latter. |
| Overall reader specificity (decrease) | Not explicitly stated (implied minimal decrease is acceptable) | 98.6% (assisted) vs. 99.0% (unassisted) | Decrease of 0.4% |
| Overall wAFROC AUC (increase) | Not explicitly stated | 0.785 (assisted) vs. 0.729 (unassisted) | Increase of 0.055, statistically significant (p<0.001) |
| Reader Dice Score (overall) | Not explicitly stated | 0.72 (assisted) vs. 0.66 (unassisted) | Average across caries types. Mean increased from 0.67 to 0.76 (Primary), 0.65 to 0.67 (Secondary), 0.65 to 0.74 (Enamel), 0.67 to 0.74 (Dentin). |
| Periapical Images (n=330) | |||
| Increase in reader sensitivity (overall) | > 15% | 79.0% (assisted) vs. 65.6% (unassisted) | Increase = 13.4%. Similar to bitewing, falls slightly below the stated >15% criterion as a direct percentage difference. If interpreted as ((79.0/65.6)-1)*100 = 20.4%, then it meets the criterion. |
| Overall reader specificity (decrease) | Not explicitly stated (implied minimal decrease is acceptable) | 97.6% (assisted) vs. 98.0% (unassisted) | Decrease of 0.4% |
| Overall wAFROC AUC (increase) | Not explicitly stated | 0.848 (assisted) vs. 0.799 (unassisted) | Increase of 0.050, statistically significant (p<0.001) |
| Reader Dice Score (overall) | Not explicitly stated | 0.77 (assisted) vs. 0.71 (unassisted) | Average across caries types. Mean increased from 0.73 to 0.80 (Primary), 0.69 to 0.74 (Secondary), 0.64 to 0.73 (Enamel), 0.76 to 0.81 (Dentin). |
2. Sample Size for Test Set and Data Provenance:
-
Standalone Testing:
- Sample Size: 1,293 Bitewing images (27,920 surfaces) and 1,314 Periapical images (16,254 surfaces).
- Data Provenance: Not explicitly stated regarding country of origin. The images were from "the following sensor manufacturers: Carestream, Dexis, e2v, Gendex, Hamamatsu, Jazz Imaging, ScanX, Schick, Soredex Digora." The context of US licensed dentists for ground truth suggests the data is likely from the US or a similar dental practice environment. The document specifies "Digital files of bitewing and periapical radiographs whose longer edge is greater than 500 pixel resolution."
- Retrospective/Prospective: Not explicitly stated, but the description of collecting and annotating existing images suggests it was a retrospective study.
-
Clinical Evaluation (Reader Improvement Study):
- Sample Size: 330 bitewing images (94 containing caries / 236 without caries) and 330 periapical images (94 containing caries / 236 without caries).
- Data Provenance: Not explicitly stated regarding country of origin, but the "US licensed dentists" implies the study was conducted within the US.
- Retrospective/Prospective: Not explicitly stated, but similar to the standalone testing, the use of a predefined image set for readers suggests retrospective.
3. Number of Experts and Qualifications for Ground Truth:
- Standalone Testing: Ground truth established by consensus of three US licensed dentists. Non-consensus labels were adjudicated by an oral radiologist. No specific years of experience are listed, but "US licensed dentists" and "oral radiologist" imply professional qualifications relevant to dental imaging interpretation.
- Clinical Evaluation (Reader Improvement Study): Ground truth established by consensus of three US licensed dentists. Non-consensus labels were adjudicated by an oral radiologist. (Same as standalone testing).
4. Adjudication Method for the Test Set:
- Standalone Testing & Clinical Evaluation: The method described is consensus of three experts, with a fourth expert (oral radiologist) adjudicating non-consensus cases. This can be described as a "3+1 adjudication" method, where the "1" is specifically for tie-breaking or resolving disagreements among the initial three.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Yes, a MRMC study was done. This is detailed under "Clinical Evaluation - Reader Improvement."
- Effect Size / Reader Improvement:
- Bitewing Images:
- Overall reader sensitivity improved from 64.6% (unassisted) to 78.5% (assisted). This is an absolute increase of 13.9 percentage points.
- Weighted AFROC AUC increased from 0.729 (unassisted) to 0.785 (assisted), an increase of 0.055. This increase was statistically significant (p < 0.001).
- Mean Dice scores increased from 0.67 (unassisted) to 0.76 (assisted) for primary caries. Similar increases were observed for other caries types.
- Periapical Images:
- Overall reader sensitivity improved from 65.6% (unassisted) to 79.0% (assisted). This is an absolute increase of 13.4 percentage points.
- Weighted AFROC AUC increased from 0.799 (unassisted) to 0.848 (assisted), an increase of 0.050. This increase was statistically significant (p < 0.001).
- Mean Dice scores increased from 0.73 (unassisted) to 0.80 (assisted) for primary caries. Similar increases were observed for other caries types.
- Bitewing Images:
The document concludes that the increase in wAFROC numbers clearly demonstrates improvement in caries detection by dentists when aided by Overjet Caries Assist, aligned with increases in sensitivity and minimal decrease in specificity.
6. Standalone (Algorithm Only) Performance Study:
- Yes, a standalone performance study was done. This is detailed under "Standalone Testing." The results for the algorithm's sensitivity, specificity, and Dice scores are provided for both bitewing and periapical images.
7. Type of Ground Truth Used:
- Expert Consensus. For both standalone and clinical evaluation studies, the ground truth was "established by consensus of labels of three US licensed dentists, and non-consensus labels were adjudicated by an oral radiologist."
8. Sample Size for the Training Set:
- The document does not explicitly state the sample size for the training set. It describes the "Machine Learning model" and its components but does not provide details about the data used for training.
9. How the Ground Truth for the Training Set Was Established:
- The document does not explicitly state how the ground truth for the training set was established. It only details the ground truth establishment for the test sets used in standalone and clinical performance evaluations.
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