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510(k) Data Aggregation
(177 days)
ITI One Part octa implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.
ITI one-part octa implants are for use in edentulous jaws in conjunction with barborne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately.
ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.
The All-in-O re implants are screw type dental implants made from CP titanium. Grade 4. They are available in various insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.
The provided document is a 510(k) summary for a dental implant system (ITI Dental Implant System®) seeking substantial equivalence to existing devices. It does not contain information on the acceptance criteria, study details, or performance of an AI/ML powered device. The document is primarily focused on the device description, intended use, and a comparison to predicate devices, which are all traditional medical devices and not AI-based.
Therefore, I cannot extract the requested information from the given text as it pertains to AI/ML device performance.
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(143 days)
ITT dental implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in edentulous or partially edentulous patients.
The All-in-One implants are screw and cylinder type dental implants made from CP titanium, Grade 4. They are available in various diameters and insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.
The provided text describes a 510(k) summary for the ITI Dental Implant System, which is a medical device submission to the FDA. This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on:
- Applicant and device identification.
- Declaration of substantial equivalence to previously cleared devices (K894593, K894595, K971578, K954512, K960288, K954347, K960417).
- Description of the device (materials, design, surfaces).
- Intended use (supporting crowns, bridges, or overdentures in edentulous or partially edentulous patients).
- FDA's response letter acknowledging the 510(k) submission and permitting market entry based on substantial equivalence.
Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
For a 510(k) submission, the "proof" often comes from demonstrating that the device is substantially equivalent to a predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. While performance testing is usually conducted to support the substantial equivalence claim, the specifics of such tests (acceptance criteria, results, expert reviews, sample sizes) are not detailed here.
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