(83 days)
The Welch Allyn Reveal Intraoral Camera System is indicated for use during dental examinations and procedures when a video image is desired.
The purpose of the Welch Allyn Reveal Intraoral Camera System is to provide video images of the mouth and oral structures. Video images aid in patient education and insurance documentation. The intended use of the Welch Allyn Reveal Intraoral Camera System is to provide video images during dental examinations and procedures. The Welch Allyn Reveal Intraoral Camera System is effective in its intended use.
The provided 510(k) summary for the Welch Allyn Reveal Intraoral Camera System does not contain detailed acceptance criteria or a study proving its performance in the manner typically expected for AI/ML-based medical devices. This is because the device appears to be an intraoral camera system from 1998, a time before the widespread use of AI/ML in medical imaging, and its regulatory submission focuses on its ability to provide video images and its safety/effectiveness for that purpose.
Therefore, many of the requested elements pertaining to AI/ML device evaluation (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details, etc.) are not applicable to this document.
However, I can extract the available information and structure it to the best of my ability based on the prompt's request.
Description of Acceptance Criteria and Device Performance Study (Based on Provided 510(k) Summary for K981937)
The Welch Allyn Reveal Intraoral Camera System is a Class I medical device intended to provide video images of the mouth and oral structures during dental examinations and procedures. The 510(k) submission, dated May 27, 1998, focuses on demonstrating substantial equivalence to a predicate device (UltraCam Intraoral Camera System, K933671) and compliance with relevant safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Inferred from Submission) | Reported Device Performance (Summary Statements) |
|---|---|
| Safety: | |
| - Compliance with Electrical Safety Standards | - Complies with IEC 601-1, EN 60601-1-2, and UL 2601. |
| - Provides safety to patient and user | - Designed to provide safety to the patient as well as the user. |
| Effectiveness/Intended Use: | |
| - Provides video images of mouth and oral structures | - "The purpose...is to provide video images of the mouth and oral structures." |
| - Aids in patient education and insurance documentation | - "Video images aid in patient education and insurance documentation." |
| - Effective in its intended use (providing video images during dental examinations and procedures) | - "The Welch Allyn Reveal Intraoral Camera System is effective in its intended use." |
- "The Welch Allyn Reveal Intraoral Camera System is effective for its intended use of providing video images during dental examinations and procedures." |
| Substantial Equivalence: | |
| - Technological Characteristics comparable to predicate device | - See Attachment "A" for a comparison of features and specifications with the predicate device (UltraCam Intraoral Camera System, K933671). |
Study Information (Limitations: As this is a 1998 device and not AI/ML, much of this is N/A)
This 510(k) summary does not describe a clinical study with a detailed test set, ground truth establishment, or performance metrics typically associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC). The "study" appears to be an internal assessment of compliance with performance claims and safety standards, and a comparison to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- N/A. The document does not describe a specific clinical "test set" with a defined sample size for performance evaluation in the context of diagnostic accuracy or AI/ML output. Assessment of effectiveness is based on the device's ability to produce video images and its technological characteristics compared to a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- N/A. Ground truth in the context of diagnostic accuracy or AI output is not applicable here, as the device's primary function is imaging, not automated interpretation.
4. Adjudication Method for the Test Set
- N/A. Not applicable, as there is no described test set requiring expert adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not mentioned. This type of study is typically used to assess human reader performance, often with and without AI assistance, which is not relevant for this intraoral camera.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This device does not have an "algorithm only" component for diagnostic output; its function is to capture video images.
7. The Type of Ground Truth Used
- N/A (for AI/ML context). For the purpose of regulatory clearance, the "ground truth" for this device's effectiveness would be its ability to physically capture and display video images, which is inherently verifiable through technical specifications and direct observation, rather than external expert consensus, pathology, or outcomes data for a diagnostic prediction.
8. The Sample Size for the Training Set
- N/A. The concept of a "training set" for an AI/ML algorithm is not applicable to this device.
9. How the Ground Truth for the Training Set was Established
- N/A. Not applicable, as there is no AI/ML component requiring a training set.
Conclusion on Device Evaluation:
The Welch Allyn Reveal Intraoral Camera System's regulatory submission, typical for devices of its era and classification, relied on demonstrating its technological characteristics, adherence to safety standards, and substantial equivalence to a legally marketed predicate device. The "effectiveness" was established by its ability to perform its core function (provide video images) as stated in its intended use, rather than through complex clinical trials assessing diagnostic accuracy or AI performance.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.