(295 days)
InterActive/SwishPlus2 Implant System consists of two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework: Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization.
Compatibility: InterActive and SwishPlus2 implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform - 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform- 3.0mm diameter) and NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5-18mmLength) implants.
The InterActive/SwishPlus2 Implant System consists of InterActive implant, SwishPlus2 implant, abutments, healing components, and screws for use in one or two-stage placement and restorations.
The InterActive implants are two-stage implants that offer four body diameters (3.2, 3.7, 4.3 and 5.0mm) in six lengths (All 6 thru 16mm except for the 3.2 which is 8-16mm). The SwishPlus2 implant body diameters (3.3, 4.1, 4.8, and 5.7mm) in six lengths (All 6 thru 16mm except for the 3.3mm which is 8-16mm).
The InterActive dental implant is a tapered screw-type endosseous with an external thread configuration consisting of double-lead threads over the body of the implant and 2mm of quadruple lead mini-threads near the coronal portion of the implant. The implant body features an even taper from the apical along its body and a straight walled coronal aspect. The implants offer two interface diameters (3.0mm and 3.4mm) which are identical to the interface of the predicate devices, NobelActive implants, having a conical leading bevel and an internal hex engaging surface.
The SwishPlus2 dental implant is a screw-type endosseous with an external thread configuration consisting of single lead threads over the body of the implant and 2mm of micro-grooves near the coronal portion of the implant. The implant body features an even taper at the apical end and a straight wall coronal aspect. The SwishPlus2 (two-stage) implant offer two interface diameters (3.0mm and 3.4mm) which are identical to the interface diameters of the predicate devices, NobelActive implants, having a conical leading bevel and an internal hex engaging surface.
The InterActive/ SwishPlus2 implants are available with two surface coatings: SBM Blast and HA Coating.
Here's an analysis of the acceptance criteria and supporting studies for the InterActive/SwishPlus2 Implant System, based on the provided 510(k) summary:
The InterActive/SwishPlus2 Implant System is a dental implant system. The application does not describe an AI/ML device.
Therefore, most of the requested information (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not applicable to this submission. The 510(k) primarily focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a dental implant device and not an AI/ML system, "acceptance criteria" here refers to demonstrating substantial equivalence to predicate devices across various technological characteristics and meeting relevant mechanical safety standards. There isn't a direct "performance metric" in the way one would define it for an AI/ML model (e.g., accuracy, sensitivity, AUC). Instead, performance is demonstrated by meeting or exceeding the mechanical properties of the predicate devices.
| Feature / Acceptance Criteria Category | Reported Device Performance (as demonstrated by comparison or testing) |
|---|---|
| Indications for Use | Substantially equivalent to multiple predicate devices. Intended for use in partially and fully edentulous upper and lower jaws for single or multiple-unit restorations, fixed bridgework support, and immediate loading when primary stability is achieved. Narrow diameter implants are indicated for specific single or multiple tooth replacements and denture stabilization. |
| Material | InterActive and SwishPlus2 implants: Titanium 6Al-4V ELI (Substantially equivalent to predicate devices including CP Titanium Grade 4 and Titanium 6Al-4V). Various abutments: Titanium alloy or Gold Alloy 6019. Temporary abutments: PEEK or Titanium alloy. |
| General Design (Implants) | Threaded groove, root form endosteal implant (Substantially equivalent to predicate devices). InterActive: tapered screw-type with double-lead and mini-threads. SwishPlus2: screw-type with single lead and micro-grooves. Both have conical leading bevel and internal hex. |
| Placement Method | Two-stage surgery (Substantially equivalent to predicate devices, some of which also allow single-stage). |
| Surface Treatment | SBM (Soluble Blasted Media) with roughness between 1.5-2.3 μm or HA (Hydroxyapatite) coated surface (Substantially equivalent to predicate devices including TiUnite, SBM, HA, Integra-Ti, Integra-CP, SLA, SLActive). |
| Implant Body Diameters & Lengths | Varying diameters (3.2mm to 5.7mm) and lengths (6mm to 16mm) provided, comparable to ranges offered by predicate devices. |
| Interface Name & Diameters | 3.0 Platform, 3.4mm Platform (identical to NobelActive implants' NP and RP interfaces). |
| Engaging Feature (Implants) | Single 2.3 hex with M1.6 threads, Single 2.7mm hex with M2 threads (comparable to predicate devices). |
| Compatibility with Abutments | Prosthetically compatible with InterActive 3.0/3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP/RP abutments. |
| Mechanical Safety (Strength) | Devices have mechanical safety (strength) equivalent to predicate devices, able to withstand loads higher than functional masticatory loads as per FDA guidance and ISO 14801 in static compression bending, fatigue, implant driving torque, and abutment/screw torque to failure tests. |
| Sterilization Validation | Validated in accordance with ISO 17665 -1&2. |
2. Sample Sizes Used for the Test Set and Data Provenance
This is not an AI/ML device, so there is no "test set" in that context. The "testing" involved non-clinical performance and mechanical safety testing on the device prototypes/samples. The document does not specify the exact number of units tested for each mechanical test, but mentions "worst-case devices."
The data provenance is from non-clinical laboratory testing conducted by the manufacturer, Implant Direct Sybron Manufacturing LLC, located in Calabasas Hills, CA, USA. This is not retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as this is not an AI/ML device requiring expert-labeled ground truth from medical images or clinical data. The "ground truth" for mechanical testing is established by engineering standards and specifications (e.g., ISO 14801 for mechanical properties of dental implants).
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are typically evaluated against pre-defined engineering thresholds and standards, not through expert 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
Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The Type of Ground Truth Used
For the non-clinical performance testing (mechanical strength, fatigue, torque tests), the "ground truth" is derived from established international and FDA-recognized engineering standards and guidance documents, specifically:
- FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments"
- ISO 14801 (Dentistry - Implants - Dynamic loading test for endosseous dental implants)
- ISO 17665 -1&2 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices).
The device's performance is compared against the performance of similar predicate devices (physical products) that have already been cleared by the FDA.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device. There is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study to demonstrate the device meets acceptance criteria was a non-clinical performance testing program. This program involved:
- Mechanical Safety (Strength) Testing: Conducted on "worst-case devices" following FDA "Class II Special Control Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. This included:
- Static compression bending tests
- Fatigue tests
- Implant driving torque tests
- Abutment/screw torque to failure tests
The results showed that the components exhibited equivalent mechanical strength to the predicate devices and that the implant/abutment combinations could withstand loads higher than functional masticatory loads.
- Sterilization Validation: Carried out in accordance with ISO 17665 -1&2, meeting the requirements and complying with the standards.
- Substantial Equivalence Comparison: Detailed comparison of the InterActive/SwishPlus2 Implant System's technological characteristics (indications for use, general design, placement method, material, surface treatment, body dimensions, interface, engaging features, and abutment compatibility) against multiple legally marketed predicate devices (e.g., NobelActive 3.0, NobelActive Internal Connection Implants, Spectra-System Dental Implants, SwissPlant Dental Implant System, Bicon Implants, Straumann ITI Dental Implant System). The submission argues that the new device has the same intended use, same technological characteristics, implant/abutment interface, and similar materials and surface treatments as the predicates.
No clinical testing was performed; the decision was supported by clinical evaluation based on the established safety and effectiveness of the predicate devices and the documented substantial equivalence.
§ 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.