(246 days)
NDX Custom Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
NDX Custom Abutments are fabricated for a specific prosthetic case and implant interface using a Computer Assisted Design /Computer Assisted Manufacturing (CAD/CAM) scanning and milling process. Milling of NDX Custom Abutments includes anti-rotation features compatible with specific implant systems. Each abutment is made from titanium alloy. It is created according to the specific design parameters designated by the clinician. All components and parameters of the system remain identical to those cleared for the TDS Abutment System predicates. Abutments are available in diameters of 3.5, 4.1, 4.3, 5.0, 5.1, and 6.0 mm, and can be fabricated straight or with an angle up to 30°.
The provided text describes the 510(k) summary for NDX Custom Abutments, a dental device. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Strength and Compatibility (for intended use) | Mechanical testing was conducted on worst-case constructs of NDX titanium abutments according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). |
| Fatigue Strength (for intended use) | Results showed adequate strength for their intended use based on ISO 14801. |
| Fit and Compatibility with Implant Systems | Extensive compatibility testing was performed. Multiple parameters of the NDX abutments and corresponding implants with designated screws were evaluated to determine appropriate fit. |
| Manufacturing Process Performance | All component designs and parameters of the system remain identical to those previously cleared for the TDS CAD/CAM Abutment System. Non-clinical testing data included engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801, and sterilization validation according to ISO 17665. |
| Substantial Equivalence to Predicate Devices | The data in this submission demonstrates substantial equivalence to the predicate devices (TDS Abutment for Friadent Xive - K103339, TDS Titanium Abutment for Nobel Biocare Bränemark - K091392, TDS Abutment for Nobel Biocare Replace - K091026, and TDS Abutment - K081460). NDX Custom Abutments have the same intended use, operating principle, design, materials, packaging, and sterilization processes as the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the mechanical and compatibility testing. It mentions "worst-case constructs" for mechanical testing and "multiple parameters" for compatibility testing. The data provenance is not specified, but it can be inferred that the testing was conducted by or for National Dentex Corporation to support their 510(k) submission in the USA. The study design (retrospective or prospective) is not explicitly mentioned but non-clinical testing is typically done prospectively as part of device development and validation.
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)
This device is an implantable medical device (dental abutment), not an AI/diagnostic software. The concept of "ground truth" established by experts in the context of diagnostic performance (like a radiologist reading an image) does not directly apply here. The "truth" for this type of device is established through engineering principles, material science, and mechanical testing against recognized standards (like ISO 14801). Therefore, no number of experts for "ground truth" in the diagnostic sense is applicable or mentioned. The expertise involved would be in engineering and materials science for conducting and interpreting the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic performance studies where multiple human readers assess cases and discrepancies need to be resolved. This is a non-clinical submission for a physical device. Therefore, no adjudication method of this type is applicable or mentioned. The determination of "passing" or "failing" acceptance criteria is based on objective measurements and comparison to predefined standards (e.g., ISO 14801).
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, an MRMC comparative effectiveness study was not done. This device is a physical dental abutment, not an AI or diagnostic software intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical dental abutment, not an algorithm. What was done was standalone mechanical and dimensional testing of the abutment itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is established through:
- International Standards: Specifically, ISO 14801 for dynamic fatigue testing. Compliance with this standard sets the "truth" for mechanical performance.
- Engineering and Dimensional Specifications: The precise dimensions, material properties, and fit parameters are defined by engineering drawings and measurements.
- Predicate Device Equivalence: A significant part of the "truth" for substantial equivalence is demonstrating that the NDX Custom Abutments match the established characteristics (intended use, operating principle, design, materials, packaging, sterilization) of the legally marketed predicate devices.
8. The sample size for the training set
This question is not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this type of device.
§ 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.)