(175 days)
PerioType X-Pert Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients. PerioType X-Pert Dental Implant Systems are indicated for delayed loading.
The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType. X-Pert dental implant fixture to aid in prosthetic rehabilitation.
PerioType X-Pert Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients. PerioType X-Pert Dental Implant Systems are indicated for delayed loading. The Dental Implant System has an internal octagonal connection between the implant and the abutment. The surface structure of the implant is PerioCoat-R which allows for osseointegration of the implants that is substantially equivalent to the TilUnite surface from Nobel Biocare. The Dental Implants and the abutments are made of Titanium Grade 4. The PerioType X-Pert features an implant-abutment interface with a tapered tight metal fit and an integrated platform switch. The abutments are coated with ZircoSeal™ - a hard coating layer of zirconium nitride. The implants are provided sterile, with sterility achieved by gamma radiation pursuant to ISO 11137.
The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType X-Pert dental implant fixture to aid in prosthetic rehabilitation.
The provided text describes a 510(k) premarket notification for the PerioType X-Pert dental implant system. This application focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo performance criteria typically seen in clinical trials for new medical devices.
Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical performance study with specific endpoints and ground truth determinations, as might be expected for an AI/ML device, does not directly apply here. Instead, the study's goal is to show that the new device is as safe and effective as existing legally marketed predicate devices.
The document highlights the PerioType X-Pert's characteristics and compares them to predicate devices, primarily the Nobel Biocare NOBELSPEEDY Implants (K050406) for the implant and Nobel Estehtik Abutments (K111581) and other Branemark System abutments for the abutments.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence submission, the "acceptance criteria" are not explicit performance metrics for the device itself against a clinical gold standard. Instead, the acceptance criteria are implicit in demonstrating that the new device is as safe and effective as the predicate devices. The "reported device performance" is primarily a comparison of materials, design, intended use, and mechanical testing results to assert this equivalence.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: Similar to predicate device. | PerioType X-Pert Implants have the same intended use as NOBELSPEEDY Implants (K050406): threaded, root-form dental implants for upper/lower jaw to support prosthetic devices to restore aesthetics/chewing function in edentulous patients. PerioType X-Pert Abutments are for prosthetic rehabilitation with PerioType X-Pert dental implant fixtures, similar to predicate abutments. |
| Technological Characteristics: Similar materials, design principles, sterility methods, and mechanical performance as predicate device. | Material: Both PerioType X-Pert implants and abutments (base material) are made of Titanium Grade 4, identical to the predicate implant and abutment. |
| Surface Coating (Implant): PerioCoat-R is demonstrated to be equivalent to the TilUnite surface of the predicate device based on morphological and chemical viewpoints by "Meyer&Horn-Salmondelkin Gbr" laboratory. | |
| Surface Coating (Abutment): Abutments are coated with ZircoSeal™ (zirconium nitride). This is a difference from the predicate device but is addressed by conducting testing based on the Guidance of Modified surfaces. | |
| Design (Implant): Threaded (self-tapping, tapered apical end), root-form, internal octagonal connection, micro groove with reduced thread pitch. Similar to predicate (Nobel Biocare NOBELSPEEDY Implant has an internal hexagon connection and tri channel design, but overall form and thread characteristics are stated as similar). | |
| Design (Abutment): Straight, angled, and ball abutments with various gingiva heights and diameters. Similar to predicate abutments. | |
| Sterility: Devices are sold gamma sterilized (implants) or not sterilized (abutments), similar to predicate practices. | |
| Biocompatibility: Products comply with ISO 7405, similar to predicate device. | |
| Mechanical Safety/Performance: Mechanical testing demonstrates comparable safety and effectiveness to predicate device. | "We conducted mechanical tests to support the substantial equivalence... Fatigue tests according to the FDA Guidance as appendix A22-A25. Conclusion: The test results shows that PerioType X Pert Implants are as Safe and effektiv as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
- Implants: The document mentions "direct comparative test between the device and the predicate device" for the surface coating and "mechanical tests" and "Endolab Fatigue test for endosseus dental implants in accordance with the ISO 14801" for performance.
- The sample size for these tests is not explicitly stated in the provided text (e.g., number of implant samples tested for fatigue). It only refers to appendices (A22-A25 for fatigue, A42 for surface coating).
- Data Provenance: The tests appear to be conducted by the manufacturer or their designated testing facilities (e.g., "Meyer&Horn-Salmondelkin Gbr" laboratory for surface, "Endolab" for fatigue). The nature of the tests (mechanical, chemical, morphological) implies a retrospective laboratory testing environment rather than a prospective clinical study involving human patients. The country of origin for the testing is not specified, though the manufacturer is in Switzerland.
- Abutments: Mention of tests "quested by the Guidance of Modified surfaces" and biocompatibility testing to ISO 7405. No specific sample sizes for these tests are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
For a 510(k) submission based on substantial equivalence and mechanical testing, the concept of "ground truth" established by experts in a clinical context (like radiologists for image analysis) is not directly applicable.
- For the surface coating comparison, the "Meyer&Horn-Salmondelkin Gbr" laboratory is mentioned as having judged "morphological and chemical view points." The specific number and qualifications of the experts within this laboratory are not detailed in the provided text.
- For mechanical testing (fatigue), the "Endolab" entity is mentioned. Again, the specific number and qualifications of experts overseeing or performing these tests are not provided.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies involving interpretation of data (e.g., medical images, pathology slides) by multiple human readers, which is not the type of study described here. The studies involve laboratory-based comparisons and mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance on various cases, which is irrelevant for a submission concerning dental implants where the primary goal is substantial equivalence through material properties and mechanical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone (algorithm-only) performance study was not done. This device is a physical dental implant system, not a software algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context is established through laboratory-based analytical and mechanical testing methodologies, comparing the new device's properties directly against those of the predicate device.
- Material Composition: Chemical analysis and material specifications (Titanium Grade 4).
- Surface Morphology/Chemistry: Morphological and chemical examinations performed by the "Meyer&Horn-Salmondelkin Gbr" laboratory.
- Biocompatibility: Conformance to ISO 7405 standards.
- Mechanical Performance: Fatigue testing according to ISO 14801.
8. The Sample Size for the Training Set:
Not applicable. As this is not an AI/ML device, there is no "training set" in the sense of data used to train an algorithm. The testing described focuses on evaluating the physical and mechanical properties of the device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
§ 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.