(211 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The Neodent GM Helix LG implants can be placed bicortically in cases of reduced bone density. The Neodent GM Helix LG implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67 – ISO 5832-2). The GM Helix LG Implant is a long conical implant with external diameters of 3.75 and 4.0 mm and lengths of 20, 22.5 and 25 mm. It has trapezoidal threads, conical apex with spherical tip and helical chambers, cylindrical body and Grand Morse prosthetic interface. The GM Helix LG implants share the same design characteristics as the existing GM Helix but are longer than the previously cleared range of implants. Indicated to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
The provided text, a 510(k) summary for the Neodent Implant System, does not describe the acceptance criteria and study that proves the device meets clinical performance criteria in the way a traditional clinical study report would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through various performance tests.
Therefore, many of the requested elements for a clinical study analysis (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not explicitly stated in this type of regulatory submission. The goal of a 510(k) is to show that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance and a comparison of technological characteristics.
However, I can extract the relevant information regarding the performance data and how it supports the claim of substantial equivalence.
Acceptance Criteria and Device Performance (as inferred from the 510(k) summary)
The "acceptance criteria" in this context are not explicitly listed with numerical targets as they would be for a direct clinical performance claim. Instead, the acceptance criteria are implicitly met by demonstrating that the subject device performs equivalently to or satisfactorily when compared to the predicate device or established standards, based on the performed in vitro tests.
Here's a table summarizing the performance evaluations described:
1. Table of Acceptance Criteria (Inferred) and Reported Device Performance
| Test Type | Inferred Acceptance Criteria | Reported Device Performance and Support for Equivalence |
|---|---|---|
| Dynamic Fatigue Test (ISO 14801) | Determine fatigue strength for implant-prosthetic construct for multi-unit prosthesis, according to FDA Guidance. (Implied: performance comparable to predicate or acceptable for intended use.) | Performed to determine the fatigue strength for implant construct assembled with prosthetic abutment for multi-unit prosthesis, assembled with GM Helix LG Implants, according to FDA Guidance. (No specific numerical results are provided in this summary, but the completion of the test meeting guidance implies acceptable performance.) |
| Torsion Test | Evaluate the GM Helix LG Implant under static torsional loading. (Implied: Pass established thresholds for static torsional strength, demonstrating structural integrity.) | Performed to evaluate the GM Helix LG Implant under static torsional loading. (The submission states this supports the change in technology, implying acceptable performance.) |
| Insertion Test | Evaluate the insertion torque when inserted into sawbones (bone type II, III, IV). (Implied: Demonstrate controlled and effective insertion performance across various bone densities.) | Performed to evaluate the insertion torque of the GM Helix LG Implant when inserted into sawbones material representing bone type II, III, and IV. (Completion of test implies acceptable insertion characteristics.) |
| Pull-out Testing | Compare axial pull-out strength between the subject devices and predicate devices. (Implied: Demonstrate comparable or superior pull-out strength to the predicate device.) | Performed to compare the Axial Pull-out Strength between the subject devices and the predicate devices. (The submission states this supports the change in technology, implying comparable or acceptable performance to the predicate.) |
| Sterilization | Achieve a minimum Sterility Assurance Level (SAL) of 1 x 10⁻⁶ via gamma irradiation (25 kGy minimum dose) according to ISO 11137-2. | "Sterilization... has been performed according to the requirements established by ISO 11137-2. A minimum Sterility Assurance Level (SAL) of 1 x 10⁻⁶ has been validated." (Explicitly states criteria met.) |
| Biocompatibility (ISO 10993) | Assess biological safety, cytotoxicity, and chemical characterization in accordance with relevant ISO 10993 standards. (Implied: Demonstrate acceptable biocompatibility.) | Biological Safety Assessment guided by ISO 10993-1, Cytotoxicity guided by ISO 10993-5 and Chemical characterization guided by ISO 10993-18 were performed. Biocompatibility sample preparation was performed per ISO 10993-12. (Completion implies acceptable biocompatibility.) |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated for any of the performance tests. These are typically in vitro (laboratory) tests, not human subject studies.
- Data Provenance: The tests are in vitro engineering/materials tests performed in a laboratory setting, not derived from patient data (retrospective or prospective). The location of the test performance is not specified beyond being part of the submission from "JJGC Indústria e Comércio de Materiais Dentários SA" (dba Neodent) in Brazil.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. For in vitro performance testing of a dental implant, "ground truth" as it pertains to clinical outcomes or expert interpretation of patient data is not established. Performance is measured against engineering standards and internal specifications.
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where subjective assessments (e.g., image interpretation) require consensus among experts. This is not relevant for the in vitro mechanical and material tests described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is a type of clinical study involving multiple human readers assessing cases, often with and without AI assistance, to measure diagnostic performance. This submission does not describe such a study. The device is a physical dental implant, not a diagnostic AI system.
6. Standalone (Algorithm Only) Performance Study:
- No. A "standalone performance study" typically refers to the algorithmic performance of an AI diagnostic device without human interaction. This is not applicable to a dental implant device.
7. Type of Ground Truth Used:
- Engineering Standards and Specifications. The "ground truth" for the in vitro tests is based on established engineering standards (e.g., ISO 14801, ISO 11137-2, ISO 10993 series) and the internal specifications of the device, often benchmarked against the predicate device's performance characteristics. Pathology or outcomes data are not used for these in vitro tests.
8. Sample Size for the Training Set:
- Not Applicable. The device is a physical dental implant, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set, this question is not relevant.
In summary: The provided document is a 510(k) summary, which aims to demonstrate substantial equivalence of a new medical device to a legally marketed predicate. The "studies" described are primarily in vitro engineering and materials performance tests designed to show that the new device shares similar technological characteristics and performs equivalently to the predicate, ensuring it is as safe and effective. It is not a clinical study report with human subjects, associated ground truth establishment by experts, or AI performance metrics.
§ 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.