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510(k) Data Aggregation
(214 days)
PreXolid CAD/CAM abutments
PreXolid CAD/CAM Abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in the prosthetic rehabilitation.
The subject patient-specific abutment, PreXolid CAD/CAM Abutment used in fabricating fully patient-specific abutments made of Ti-6A1-4V ELI, conforming to ASTM Standard F136. Each patient-specific abutment is individually prescribed by the clinician.
The subject devices are available in diameters ranging from 5.0mm. The subject device is provided with an abutment screw.
PreXolid CAD/CAM Abutments are compatible with XPEED AnyRidge Internal Implant System (K12231).
The allowable ranges of design parameters after CAD/CAM patient-matching are as follows:
Minimum wall thickness(mm): 0.45
Maximum angulation(°): 25
Minimum gingival collar height(mm): 2.00
Maximum gingival collar height(mm): 5.00
Minimum gingival collar(ø): 4.00
Maximum gingival collar(ø): 9.50 , 11.50
Minimum post height (mm): 4.00
Maximum post height (mm): 6.00
The subject abutments are provided non-sterile and are intended to be sterilized by the clinician.
Materials:
Pre-milled abutments and screws are fabricated from Ti-6A1-4V ELI, conforming to ASTM Standard F136.
The provided text includes information about the PreXolid CAD/CAM Abutments, but it does not contain acceptance criteria or study results for a device that is typically evaluated using acceptance criteria such as sensitivity, specificity, or AUC. This document is a 510(k) premarket notification for a dental abutment, focusing on establishing substantial equivalence to a predicate device.
The "acceptance criteria" presented are primarily standards that the device adheres to, and the "study" involves non-clinical testing to demonstrate compliance with these standards and substantial equivalence, rather than a clinical performance study with defined performance metrics like those for diagnostic or AI/ML devices.
Here's an breakdown of the information that is available based on the typical categories you requested, and where the requested information is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not present. The document focuses on compliance with engineering and biocompatibility standards, and a comparison table of technical characteristics with a predicate device.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| ISO 14801:2016 (Fatigue Tests) | Results successfully met the criteria outlined in the standards, affirming the device's suitability for use. |
| ISO 10993-1:2009 (Biocompatibility Testing) | Performed according to the standard and FDA guidance. |
| ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1 (End User Sterilization Validation Test Report) | Validated according to the standards and FDA guidance. |
| FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" (Fatigue Testing) | Testing involved examining finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation) through fatigue testing. |
| FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (Sterilization Validation) | Validated according to the guidance. |
| Dimensional analysis and reverse engineering of the implant-to-abutment connection platform | Confirmed implant to abutment compatibility and established substantial equivalency of the proposed device with predicate devices. |
| Magnetic Resonance (MR) Environment Safety (based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment") | Non-clinical worst-case MRI review performed using scientific rationale and published literature to evaluate magnetically induced displacement force and torque. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions "worst-case scenario" samples for fatigue testing (smallest diameter with maximum angulation) and reverse engineering. However, specific numbers of units tested are not provided.
- Data Provenance: The tests are described as non-clinical, conducted in accordance with ISO standards and FDA guidance. No information on country of origin for data or if it was retrospective/prospective is applicable or provided, as these are material and mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the "ground truth" for this type of device (dental abutment) is established by engineering and material property standards, not by expert interpretation of images or clinical data.
4. Adjudication method for the test set
This is not applicable as the "test set" involves physical and material tests, not subjective interpretations requiring adjudication.
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 is not applicable. This device is a dental abutment, not an AI/ML-driven diagnostic or image analysis tool. No human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical dental abutment, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is based on established engineering standards, material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI), and the compliance of mechanical properties (fatigue strength, dimensional accuracy) with these standards. Substantial equivalence is also a key "ground truth" to the predicate device K220562.
8. The sample size for the training set
This is not applicable. The device is a physical product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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