(166 days)
Prosthetic accessories are used in conjunction with ITI dental implants in the prosthetic restoration of the implant. These prosthetic accessories include abutments, copings and cylinders, and transfer system components. Abutments are placed into the dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures. Prefabricated copings and cylinders provide a machined or cast inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration. Transfer system components are used in the process of transferring the situation in the oral cavity to a precise dental model. Protection caps are used to protect the outer configuration of the abutment and to maintain and condition the soft tissues during the prosthetic phase.
The prosthetic accessories to the All-in-One implants include abutments, copings, cylinders, temporary posts, transfer copings, and miscellaneous accessories. These components are composed of titanium, titanium alloy, gold alloy, and plastic (burn-out).
The provided document is a 510(k) summary for prosthetic accessories for dental implants. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data. Therefore, most of the information requested in your prompt is not available in the given text.
Here's a breakdown of what can and cannot be answered based on the provided input:
1. A table of acceptance criteria and the reported device performance
- Not available. The document does not describe specific acceptance criteria (e.g., in terms of accuracy, precision, or durability) or reported device performance metrics because it's a submission for substantial equivalence, not a performance study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not available. No test set or associated data provenance is mentioned as this is not a clinical or performance study that measures specific device outputs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not available. No ground truth establishment activity is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. No adjudication method is described.
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
- No. No MRMC study or AI assistance is mentioned. This device is a set of physical prosthetic accessories, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware; there is no algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not available. No ground truth is established for this type of submission. The basis for marketing approval here is "substantial equivalence" to predicate devices, meaning the device is similar enough in intended use, materials, and design to devices already legally marketed.
8. The sample size for the training set
- Not applicable/Not available. No training set is mentioned as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
- Not applicable/Not available. No training set or ground truth for it is mentioned.
Summary of available information:
The document is a 510(k) premarket notification for "synOcta Prosthetics®" (prosthetic accessories to dental implants).
- Intended Use: To be used in conjunction with ITI dental implants for the prosthetic restoration of the implant, supporting crowns, bridges, or overdentures in edentulous or partially edentulous patients. Components include abutments, copings, cylinders, temporary posts, transfer copings, and miscellaneous accessories, made of titanium, titanium alloy, gold alloy, and plastic.
- Basis for Substantial Equivalence: The modified ITI prosthetic accessories are claimed to be "substantially equivalent in intended use, material and design to prosthetic accessories marketed by ITI (Straumann), Nobel Biocare, Implant Innovations, and Friatec." This means the product is shown to be as safe and effective as a legally marketed predicate device, rather than undergoing a new, extensive performance study with acceptance criteria.
The FDA's letter confirms that the device is substantially equivalent for the indications for use stated and allows the applicant to market the device subject to general controls.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.