(269 days)
The ARCHITEX™ Space Maintenance System is indicated for use as temporary implants to stabilize and support autograft, autograft extenders, allograft, and bone void fillers and/or fractured bone segments with or without bone plates or ritanium mesh in bony defects of oral maxillofacial anatomy.
ARCHITEX™ Space Maintenance System is intended for use in oral-maxillofacial surgical reconstruction and dental regeneration procedures; the implants contained in the System are for maintaining space during bone grating procedures and/or to support soft tissue until bone formation.
The ARCHITEX™ Space Maintenance System consists of a variety of shapes and sizes of screws (Socket Preservation, Tenting, and Mesh Fixation Screws) and titanium mesh implants components as well as placement instruments components. These instruments supplied are general class I instruments added as a convenience for doctors to use to place the provided implants.
The ARCHITEX™ Space Maintenance System includes a selection of Socket Preservation screws which are designed to aid in extraction socket grafting while simultaneously supporting the original gingival margins and papilla.
The ARCHITEX™ Space Maintenance System components are fabricated from medical grade stainless steel and medical grade titanium or titanium alloy. Medical grade titanium and titanium alloy may be used together. The subject implants components will be manufactured from medical grade titanium allov described by such standards as ASTM F 136-08el or ISO 5832-3, and/or from medical grade unalloyed titanium described by such standard as ASTM F67-06. The placement instruments components will be manufactured from medical grade stainless steel as described in ASTM F8PP-09. The ARCHITEX™ Space Maintenance System is sold non-sterile.
The purpose of this 510(k) application is to seek marketing clearance for the ARCHITEX™ Space Maintenance System to be used as a root-form endosseous dental implants system.
The ARCHITEX™ Space Maintenance System (ARCHITEX™) a device used for dental implants used for oral-maxillofacial surgical reconstruction and dental regeneration procedures was evaluated for substantial equivalence to its predicate devices in accordance with the FDA 510(k) premarket notification process.
1. Table of Acceptance Criteria & Reported Device Performance
| Device Component | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Titanium Mesh | Geometrically, materially, and mechanically equivalent to TiMesh® (K062348) | Equivalent to TiMesh® (K062348) in static cantilever bending strength. |
| Titanium Mesh Screws | Geometrically, materially, and mechanically equivalent to TiMesh® (K062348) | Equivalent to TiMesh® (K062348) geometrically, materially, and mechanically. |
| Tenting Screws | Geometrically, materially, and mechanically equivalent to ACE Tru-FIX™ (K080074). Bone pull-out strength and screw subsidence equivalent to predicate. | Equivalent to ACE Tru-FIX™ (K080074) in static axial pullout and subsidence strength. |
| Socket Preservation Screws | Bone interfacing portion geometrically, materially, and mechanically equivalent to ACE Tru-FIX™ (K080074). Bone pull-out strength and screw subsidence equivalent to predicate. | Equivalent to ACE Tru-FIX™ (K080074) in static axial pullout and subsidence strength (bone interfacing portion). |
| Head portion of Socket Preservation Screws | Geometrically, materially, and mechanically equivalent to Straumann Dental Implant System (K071585) abutments. | Equivalent to Straumann Dental Implant System (K071585) abutments (head portion). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set. However, the non-clinical tests involved "Subject Devices and Predicate Devices" to compare their performance. The data provenance is not specified, but these are primarily bench performance tests conducted on the physical devices rather than patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The study involved non-clinical bench testing and material/dimensional analysis, not clinical ground truth established by experts.
4. Adjudication Method
This information is not applicable, as the study did not involve expert adjudication of clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the physical and mechanical properties of the device and its predicates.
6. Standalone (Algorithm Only) Performance
No, a standalone (algorithm only) performance study was not done. This device is a physical implant system, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission was established through:
- Dimensional and Material Analysis: Comparing the physical specifications and materials of the ARCHITEX™ components against the predicate devices.
- Bench Performance Testing: Conducting standardized and non-standardized mechanical tests (Static Axial Pullout, Static Subsidence, Static Cantilever Bending, Static "Removal Torque" and "Torque to Failure") on both the subject and predicate devices. The results of these tests served as the empirical "ground truth" for equivalence claims.
8. Sample Size for the Training Set
This is not applicable, as there was no "training set" in the context of an algorithm. The study compared the device components directly to predicate device components through bench testing.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there was no "training set" for an algorithm. The "ground truth" for the non-clinical evaluation was established through direct comparison of material properties, dimensions, and mechanical performance between the ARCHITEX™ System components and the legally marketed predicate devices, using established ASTM standards where available, and conducting comparative testing where industry standards were absent.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.