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Second Opinion® CC is a computer aided detection ("CADe") software to aid dentists in the detection of caries by drawing bounding polygons to highlight the suspected region of interest.

It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 19 years of age or older as a second reader.

Second Opinion CC (Caries Contouring) is a radiological, automated, computer-assisted detection (CADe) software intended to aid in the detection of caries on bitewing and periapical radiographs using polygonal contours. The device is not intended as a replacement for a complete dentist's review or their clinical judgment which considers other relevant information from the image, patient history, or actual in vivo clinical assessment.

Second Opinion CC consists of three parts:

• · Application Programing Interface ("API")
• · Machine Learning Modules ("ML Modules")
• · Client User Interface ("Client")

The processing sequence for an image is as follows:

• Images are sent for processing via the API 1.
• 2. The API routes images to the ML modules
• 3. The ML modules produce detection output
• 4. The UI renders the detection output

The API serves as a conduit for passing imagery and metadata between the user interface and the machine learning modules. The API sends imagery to the machine learning modules for processing and subsequently receives metadata generated by the machine learning modules which is passed to the interface for rendering.

Second Opinion CC uses machine learning to detect caries. Images received by the ML modules are processed yielding detections which are represented as metadata. The final output is made accessible to the API for the purpose of sending to the UI for visualization. Detected carious lesions are displayed as polygonal overlays atop the original radiograph which indicate to the practitioner which teeth contain which detected carious lesions that may require clinical review. The clinician can toggle over the image to highlight a potential condition for viewing. In addition, the clinician has the ability to edit the detections as they see fit to align with their diagnosis.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for Pearl Inc.'s "Second Opinion CC" device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the non-inferiority study design. The primary performance metric was the Weighted Alternative Free-Response Receiver Operating Characteristic (wAFROC) Figure of Merit (FOM). The acceptance criterion for the Dice coefficient was explicitly stated.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 500 images
• Data Provenance: The dataset is characterized by a diverse distribution, including:
  • Geographical Regions (within the US): Northwest (15.2%), Southwest (17.8%), South (24.6%), East (22.6%), Midwest (19.6%), and 1 unknown origin.
  • Gender Distribution: Females (19.0%), Males (25.0%), Other genders (7.6%), and Unknown gender (48.4%).
  • Age: 12-18 (1.8%), 18-75 (46.6%), 75+ (2.6%), and Unknown age (49.0%).
  • Imaging Devices: Various models from Carestream-Trophy, DEXIS, and KaVo Dental Technologies, along with unknown devices.
  • Image Types: 249 periapical radiographs (49.8%) and 251 bitewing radiographs (50.2%).
• Retrospective/Prospective: The document does not explicitly state whether the data was collected retrospectively or prospectively. However, the diverse and "characterized" distribution of various demographic and technical factors, along with the specific mention of "a diverse distribution of radiographs," often suggests a retrospective collection from existing databases for a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Four expert readers.
• Qualifications of Experts: The document refers to them as "expert readers" with no further specific details on their qualifications (e.g., years of experience, board certification, specialty).

4. Adjudication Method for the Test Set

• Adjudication Method: Consensus approach based on agreement among at least three out of four expert readers (3+1 or 4/4 consensus).
  • "The ground truth (GT) was established using the consensus approach based on agreement among at least three out of four expert readers."

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for the subject device (Second Opinion CC) in this submission.
  • The document explicitly states: "Pearl demonstrated the benefits of the device through a non-inferiority standalone clinical study."
  • It also clarifies: "Second Opinion CC was clinically tested as a standalone device in comparison to the predicate device, Second Opinion, using a non-inferiority study."
  • It mentions that the original clearance (K210365) for the predicate device (Second Opinion) was "based on standalone and MRMC studies," but this current submission for Second Opinion CC did not include one.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Study: Yes.
  • "Clinical evaluation of Second Opinion CC was performed to validate the efficacy of the system in detecting potential caries lesions using polygons instead of bounding boxes on intraoral radiographs."
  • "Second Opinion CC was clinically tested as a standalone device in comparison to the predicate device, Second Opinion, using a non-inferiority study."
  • The results for each image were analyzed for "Non-Lesion Localization (NL)" and "Lesion Localization (LL)" directly by the algorithm's output.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus.
  • "The ground truth (GT) was established using the consensus approach based on agreement among at least three out of four expert readers."
  • Each GT expert independently marked areas using the smallest possible polygonal contour to encompass the entire region identified.

8. The Sample Size for the Training Set

• The document does not provide the sample size for the training set. It only describes the test set.

9. How the Ground Truth for the Training Set was Established

• The document does not describe how the ground truth for the training set was established. It only details the ground truth establishment for the test set.

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