(118 days)
The intended use of the Satelec Implant Center is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
The Satelec Implant Center is a dental operative unit that supplies utilities to and serves as a base for dental tools and accessories for use by qualified dental practitioners.
The provided text is a 510(k) summary for a dental operative unit. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a medical AI/ML device submission would. This document is for a physical medical device.
Therefore, I cannot extract the requested information as it is not present in the provided text.
Here's why and what kind of information is present instead:
- Type of Device: The "Implant Center" is described as a "dental operative unit that supplies utilities to and serves as a base for dental tools and accessories." This is a hardware device, not an AI/ML algorithm.
- Approval Type: This is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device. This is a common pathway for physical medical devices and typically focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving specific performance metrics through a clinical study with detailed acceptance criteria.
- "Study" Information: The document states that the "Satelec Implant Center is substantially equivalent to the predicate device by Satelec, the Cocoon Hygienist (K040529)." This "substantial equivalence" is the core of the evaluation, not a performance study against acceptance criteria.
- Missing Details: There is no mention of sensitivity, specificity, AUC, or any other performance metrics typically associated with AI/ML diagnostic or assistive devices. Likewise, no human reader studies, ground truth establishment, sample sizes for test/training sets, or expert qualifications are discussed because they are not relevant to this type of device submission.
In summary, the provided document describes a traditional medical device (dental operative unit) and its 510(k) clearance process based on substantial equivalence, not an AI/ML device with performance studies against acceptance criteria.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.