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510(k) Data Aggregation
(80 days)
The OraCam is used to provide Intra oral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy allowing the dentist to examine patient's teeth in order for them to adequately plan in the treatment.
The OraCam is therefore similar in indicated use as Stomavision, Vipercam, Telicam, Digital Doc, S555 and S575, MiniCam and Smilie PC systems, in its intended use.
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Here's an analysis of the provided text regarding acceptance criteria and study details for the OraCam device:
The provided document is a 510(k) premarket notification letter from the FDA to Video Dental Concepts for their device, OraCam. This type of document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device rather than detailing specific performance studies with acceptance criteria in the way an AI/ML device would.
Therefore, much of the requested information (especially about specific performance metrics, sample sizes for testing/training datasets, expert qualifications, and adjudication methods for AI performance) is not present in this document. The device, an "Intra-Oral Camera," is a much older technology and likely did not undergo the rigorous AI/ML-specific validation studies typical today.
However, based on the document's content, here's what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of explicit, quantified acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy). The core "acceptance" here is the FDA's determination of substantial equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from Substantial Equivalence) |
|---|---|
| Safety: Device is safely used for intra-oral imaging. | The FDA has determined the device is substantially equivalent to legally marketed predicate devices, implying it meets established safety profiles for such devices. |
| Effectiveness/Functionality: Device provides intra-oral images as intended. | The device provides "Intra oral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy," similar to its predicate devices. |
| Indications for Use: Matches predicate devices. | The OraCam's indications for use are "similar in indicated use as Stomavision, Vipercam, Telicam, Digital Doc, S555 and S575, MiniCam and Smilie PC systems." |
| General Controls Compliance: Meets regulatory requirements. | The device is subject to general controls provisions of the Act (annual registration, listing, GMP, labeling, etc.). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. This document is not a clinical study report for performance metrics.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No. This device is an intra-oral camera, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This device is a camera and does not have an "algorithm" in the sense of an AI/ML model for standalone performance evaluation. Its performance is related to image capture quality, not AI-driven analysis.
7. The type of ground truth used
- Type of Ground Truth: Not applicable in the context of AI/ML performance. For a camera, "ground truth" would relate to the physical reality being captured accurately (e.g., image resolution, color accuracy, distortion), which is assessed through engineering and quality control, not typically a "ground truth" derived from expert consensus or pathology in a clinical study for FDA clearance in this manner.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document is for a camera, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
Summary of what the document does provide regarding device evaluation:
The document indicates that the OraCam is an "Intra-Oral Camera" (Regulation Number: 872.6640, Regulatory Class: I, Product Code: EIA).
Its Indications for Use are: "The OraCam is used to provide Intra oral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy allowing the dentist to examine patient's teeth in order for them to adequately plan in the treatment."
Crucially, the FDA determined that the device is substantially equivalent to legally marketed predicate devices, explicitly listing: "Stomavision, Vipercam, Telicam, Digital Doc, S555 and S575, MiniCam and Smilie PC systems." This substantial equivalence determination is the primary "proof" of meeting acceptance criteria for this Class I device. It implies that the OraCam's design, materials, performance, and indications for use are sufficiently similar to devices already on the market that have been deemed safe and effective.
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