(91 days)
The Hawk Intraoral Camera and Accessories are indicated for use to provide a view of mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.
Hawk Intraoral Camera composed of light (25g), small (185 x10mm) hand piece along with docking station. The hand piece consists of a focusing mechanism to assist the doctor in taking video of the patient's mouth. The hand piece connects to docking station via cable. The docking station attaches directly to monitor, TV, or computer via standard composite connection. It uses high definition imaging (480 lines) to capture images at 78 degrees field of view. Hawk Intraoral Camera includes also footswitch.
The provided 510(k) summary for the "Hawk Intraoral Camera and Accessories" does not describe any acceptance criteria or a study proving the device meets them. This type of submission, especially for a Class I device seeking substantial equivalence, generally relies on demonstrating equivalence to a predicate device through non-clinical testing of safety and performance against recognized standards, rather than clinical efficacy studies with specific performance metrics.
Here's why the requested information cannot be extracted from this document:
- No Acceptance Criteria: The document does not define specific metrics (e.g., sensitivity, specificity, accuracy, image resolution thresholds, field of view clarity) that the device must achieve to be considered effective.
- No Performance Study: There is no study described that measures the device's performance against predefined acceptance criteria. The document explicitly states: "Clinical testing was not conducted."
- Reliance on Substantial Equivalence: The approval is based on demonstrating substantial equivalence to a predicate device (Veracan Intraoral camera and accessories, K021083) in terms of intended use, operation, safety, and function, supported by non-clinical testing against electrical and medical device safety standards (EN 60601-1, EN 60601-2, EN 61000-3-2 and EN 61000-3-3).
Since the specific information requested about acceptance criteria and a performance study is not present in the provided text, the table and other details cannot be filled as requested. The available information primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Explanation of Missing Elements:
- Table of acceptance criteria and reported device performance: Not present. The submission focuses on meeting safety standards and equivalence to a predicate, not specific performance metrics.
- Sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, how ground truth for training was established: All these elements are relevant to performance studies, especially those involving AI or diagnostic devices, which were not conducted for this camera. The device is a viewing tool, not a diagnostic one requiring such detailed performance evaluation.
Summary of available relevant information:
- Intended Use: To provide a view of the mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.
- Predicate Device: Veracan Intraoral camera and accessories (K021083).
- Non-Clinical Testing Standards: EN 60601-1, EN 60601-2, EN 61000-3-2, and EN 61000-3-3. These are safety and electromagnetic compatibility standards, not performance criteria for diagnostic accuracy or image quality exceeding basic functionality.
- Clinical Testing: Not conducted.
- Conclusion: Substantially equivalent to the predicate and safe and effective for its intended use based on non-clinical testing against standards.
§ 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.