(108 days)
The XP1 Angled Abutment is intended for use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. The angled abutment is indicated in cases where angle correction is required.
The XP1 15° Angled Abutment is intended to be placed into a dental implant to support prosthetic restorations in partially or fully edentulous mandibles and maxillae. The angled abutment can be used for single or multiple-unit restorations and is intended for cement-retained crowns. The angled abutment is used to correct the prosthetic anqulation of implants that are placed off-axis to the occlusal load.
The distal end of the angled abutment has a hex and taper design that engages the mating internal hex and taper of the implant. In addition, the angled abutment has a screw channel with a screw thread at the distal end through which an abutment screw is used to screw the abutment into the implant.
The XP1 Angled Abutment and the abutment screws are machined from titanium allov (Ti-6AL-4V ELI) conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surqical Implant Applications.
The device is provided non-sterile to the user in medical grade packaging.
Here's an analysis of the provided information regarding the acceptance criteria and supporting study for the XP1 Angled Abutments, presented in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition: Machined from titanium alloy (Ti-6AL-4V ELI) conforming to ASTM F136. | The device is machined from titanium alloy (Ti-6AL-4V ELI) conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. |
| Design Principles: Substantially equivalent in design principles to predicate devices. | Keystone Dental, Inc. has demonstrated that the XP1 Angled Abutment is substantially equivalent in design principles to predicate devices. (Implicitly, the FDA's clearance confirms this was met.) |
| Intended Use: For use in conjunction with the XP1 Dental Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations, where angle correction is required. | The device's stated "Indications for Use" directly matches this criterion. (Implicitly, the FDA's clearance confirms this was met.) |
2. Sample size used for the test set and the data provenance
The provided document does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for proving the device meets acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study on the XP1 Angled Abutments themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document does not describe a performance study involving a test set that required expert-established ground truth. The primary method of demonstrating acceptance was substantial equivalence to previously cleared devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as the document does not describe a performance study involving a test set that would require an adjudication method.
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
This information is not applicable. The device is an angled dental abutment, a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe a study that required a "ground truth" in the typical sense for analytical or clinical performance evaluations. Instead, the "ground truth" for the device's acceptance was:
- Conformance to Industry Standards: The material composition (Ti-6AL-4V ELI conforming to ASTM F136) is a verifiable standard based on material science and engineering specifications.
- Substantial Equivalence: The primary "ground truth" for regulatory clearance was a comparison to predicate devices, meaning the regulatory body (FDA) determined the XP1 Angled Abutments were sufficiently similar in design principles, materials, and intended use as devices already legally marketed and deemed safe and effective.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device and does not involve AI or machine learning that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable. The device is a physical medical device and does not involve AI or machine learning that would require a "training set" or its associated ground truth establishment.
Summary of the "Study" for Acceptance:
The submission for the XP1 Angled Abutments (K090397) primarily relies on the concept of substantial equivalence to predicate devices. This means that instead of conducting new clinical trials or extensive performance studies on the new device, the manufacturer demonstrated that the XP1 Angled Abutments were:
- Identical or substantially equivalent in intended use.
- Identical or substantially equivalent in material composition (Ti-6AL-4V ELI conforming to ASTM F136).
- Identical or substantially equivalent in design principles.
The FDA reviewed this comparison and a description of the device's characteristics to determine that it was as safe and effective as the predicate devices already on the market. The letter from the FDA confirms this determination of substantial equivalence, which is the "study" or justification for its acceptance into the market. No specific performance study with a test set, ground truth, or expert involvement as typically understood for software or diagnostic devices is described.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)