(141 days)
The Spectra Dental Implant System consists of one-piece implants for single-stage or twostage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.
The ScrewDirect 3.0mm implant is indicated for:
- An artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
- Multiple tooth replacements or denture stabilization.
The Screw Redirect implant is intended for support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of the partially edentulous maxillary jaw. It is indicated for immediate functional loading when four or more implants are splinted together in the endentulous upper or lower jaw.
The Screw Indirect implant is indicated for the support and retention of bar overdentures or as a terminal or intermediary attachment for screw-retained fixed bridgework. It is indicated for immediate functional loading when four or more implants are splinted together in the edentulous upper or lower jaw. This implant model is not indicated for use with abutments, only with a 2mm extender.
Spectra-System is substantially equivalent to the predicate devices; has comparable technological characteristics, identical intended use and are similar in terms of material, size, and basic design features. The overall implant product designs of the Spectra System are similar to the predicate devices.
The provided text is a 510(k) summary for the Spectra-System dental implants. This type of submission focuses on demonstrating substantial equivalence to previously cleared devices rather than proving safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics for a novel medical device is not applicable or cannot be extracted from this document.
However, I can provide information based on the comparison analysis presented to demonstrate substantial equivalence to predicate devices.
Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, the device's performance is demonstrated by its comparable technological characteristics to predicate devices. The "reported device performance" is essentially the alignment of the Spectra-System's features with those of the predicate devices.
The acceptance criteria here are implicitly:
- Identical Intended Use: The Spectra-System must have the same intended use as the predicate devices.
- Similar Technological Characteristics: The Spectra-System must be similar in terms of material, size, and basic design features to the predicate devices.
Here's a summary of the comparison analysis that serves as the "reported device performance" in this context:
| Acceptance Criteria (Implicit) | Reported Device Performance (Spectra-System, based on comparison) |
|---|---|
| 1. Identical Intended Use | The Spectra-System's intended use (e.g., surgical implantation in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary attachment for fixed or removable bridgework, or as a freestanding single tooth replacement, with immediate load indications) is explicitly stated as identical to the predicate devices. The ScrewDirect 3.0mm implant is for single tooth replacement of mandibular central/lateral and maxillary lateral incisors, and multiple tooth replacements or denture stabilization. The Screw Redirect implant is for fixed single tooth/partial denture restorations in premolar, cuspid, and incisor regions of partially edentulous maxillary jaw, with immediate functional loading when four or more are splinted. The Screw Indirect implant is for support/retention of bar overdentures or screw-retained fixed bridgework, with immediate functional loading when four or more are splinted. |
| 2. Similar Technological Characteristics (Material, Size, Basic Design) | The submission explicitly states: "Spectra-System is substantially equivalent to the predicate devices; has comparable technological characteristics, identical intended use and are similar in terms of material, size, and basic design features." Specific comparisons across various implant types (ScrewPlant, Legacy, RePlant, Screw Direct, Screw Indirect, ScrewPlus) against multiple predicate devices (Tapered Screw-Vent, Astra-Tech Implants Dental System, Advent and SwissPlus, Nobel Biocare Replace One-Piece Implant, Lifecore PrimaSolo One-Piece Implant System) show high similarity across: |
- General Design: All are threaded, root form implants.
- Placement Method: Predominantly two or single-stage surgery, aligning with predicates.
- Material: Primarily Titanium alloy, identical or comparable to CP4 Titanium or commercially pure titanium of predicates.
- Implant Body Type: Threaded body, often with micro-threads at the collar section, similar to predicates (some predicates have smooth collars or grooves).
- Body Diameter: Ranges (e.g., 3.0mm to 6.0mm) are comparable to or overlap with predicate devices.
- Lengths: Ranges (e.g., 8mm to 19mm) are comparable to or overlap with predicate devices.
- Platform Diameter: Ranges are generally comparable.
- Implant Surface: Roughened (HA blasted) or plasma HA coated, comparable to predicate devices which use HA coated, roughened, or micro-roughened surfaces.
- Packaging: Inner sleeve/vial system with components (carrier, cover screw, extender, coping), consistent with predicate packaging (double vial, carrier-based).
- Sterilization: Gamma irradiation, consistent with predicate devices. |
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) based on substantial equivalence to predicate devices, not on a clinical "test set" with patient data. No clinical studies are presented in this summary document with sample sizes or data provenance.
2. 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)
Not applicable. There was no clinical "test set" requiring ground truth establishment by experts.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical "test set" requiring adjudication.
4. 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
Not applicable. This document pertains to dental implants, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted or presented.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to dental implants, not a standalone algorithm.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the regulatory clearance status and established technological characteristics of the predicate devices, against which the new device is compared.
7. The sample size for the training set
Not applicable. There was no "training set" as this is not a machine learning or AI device submission.
8. How the ground truth for the training set was established
Not applicable.
§ 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.