(285 days)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Revolution Compact with a 6 mm length is intended for delayed loading only.
The subject device includes six product lines (Revolution Compact, Micro-Mini Revolution, Strong SW HE, TryOn, Strong SW HI). Five of the product lines have an external hex implant/abutment connection (HE) and one has an internal hex implant/abutment connection (HI). Each product line includes implants with an acid-etched surface and abutments in multiple designs (healing, provisional, cemented, UCLA, overdenture, conical and mini).
Revolution implants (Revolution Compact, Micro-Mini Revolution) are cylindrical implants with apical cutting flutes and are placed with the Revolution Assembler mount. Strong SW HI are cvlindrical implants with apical cutting flutes and micro-threads on the collar. Strong SW HE has and external connection and Strong SW HI has an internal connection. TryOn implants with apical cutting flutes and a machined collar. Subject Device components are made of commercially pure titanium, titanium alloy or cobalt-chromium alloy. All subject device abutments have 0° angulation.
This document is a 510(k) summary for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technological characteristics, rather than presenting a performance study with acceptance criteria in the typical sense for a medical device with an AI/ML component.
Therefore, many of the requested details about acceptance criteria, study design, and AI performance metrics are not available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present acceptance criteria for a performance study in the way a clinical trial or AI validation study would. Instead, it demonstrates "substantial equivalence" of the S.I.N. Dental Implant System to existing predicate devices based on:
- Indications for Use: The subject device's indications align with those of multiple predicate devices.
- Technological Characteristics: Comparison of design (prosthesis attachment, restoration, implant/abutment interface, dimensions) and material composition (implant, surface, abutment, abutment screw) to predicate devices.
- Non-clinical Testing Data: This includes validation of sterilization, biocompatibility, endotoxin testing, and shelf-life testing. These are regulatory compliance criteria, not performance metrics related to diagnostic or predictive accuracy.
Reported Device Performance (in terms of substantial equivalence):
| Feature/Test | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Performance (Stated Equivalence/Compliance) |
|---|---|---|
| Indications for Use | Similar to predicate devices: placement in maxillary/mandibular arch for single/multi-unit restorations, immediate/delayed loading. | "Substantially equivalent in indications and design principles to the predicate devices." "Small differences... do not change the intended use." |
| Design Characteristics (e.g., diameters, lengths, connections) | Within common ranges and similar to predicate devices. | "Encompass the same range of physical dimensions." |
| Materials | Same or similar materials as predicate devices (e.g., CPTi Gr 4, Ti-6Al-4V, CoCr). | "Made of the same or similar materials." |
| Sterilization | SAL of 10^-6 according to ISO 11137-1, ISO 11137-2 (radiation); SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 (steam). | Validated to SAL of 10^-6 for both radiation and steam sterilization. |
| Biocompatibility | Acceptable biocompatibility according to ISO 10993-1. | Acceptable biocompatibility demonstrated by reference to K051859 and testing per ISO 10993-5 (cytotoxicity). |
| Endotoxin Testing | In accordance with FDA Guidance documents. | Limulus amebocyte lysate (LAL) endotoxin testing performed. |
| Shelf-Life Testing | Seal leaks according to ASTM F88/F88M, seal integrity according to ASTM F1929, accelerated age testing according to ASTM F1980. | Shelf-life testing including seal leak, seal integrity, and accelerated aging reported. |
| Surface Area Analysis | Substantially equivalent to a predicate. | Surface area analysis showed substantial equivalence to a predicate. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not applicable. This document does not describe a performance study involving a "test set" of patient data for evaluating diagnostic or predictive accuracy. The testing mentioned is for non-clinical aspects (sterilization, biocompatibility, etc.), which would involve material samples or batches.
- Data Provenance: Not applicable in the context of patient data. The "data" refers to non-clinical testing results.
3. Number of Experts for Ground Truth and Their Qualifications
- Not applicable. This document pertains to the substantial equivalence of a physical dental implant system and does not involve AI/ML or a ground truth established by experts for diagnostic performance.
4. Adjudication Method
- Not applicable. There is no "adjudication method" described as it relates to expert consensus for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This document explicitly states: "No clinical data were included in this submission." An MRMC study would fall under clinical effectiveness.
6. Standalone (Algorithm Only) Performance Study
- No. The device is a physical dental implant system, not a software algorithm.
7. Type of Ground Truth Used
- Not applicable. Not relevant for this type of device submission. The "truth" here relates to the physical and material properties meeting regulatory standards and being substantially equivalent to legally marketed devices, verified through laboratory testing and predicate comparisons.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" as this device is not an AI/ML product.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "ground truth for a training set" as this device is not an AI/ML product.
§ 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.