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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 titanium mesh in bony defects of oral maxillofacial anatomy.

The ARCHITEX™ Space Maintenance System is a comprehensive, all-inclusive system which contains a variety of implants designed to temporarily reconstruct bony deficiencies common to the oral cavity that are not intrinsic to the stability of the bony structure. Bony deficiencies may be naturally occurring osseous defects, surgically created osseous defects, or osseous defects created from traumatic injury to the bone. The system contains a porous titanium mesh, titanium alloy mesh fixation screws (1.2 mm major thread diameter in 4mm, 6 mm, 10 mm, 12 mm, 14 mm, 14 mm lengths and-1.4 mm major thread diameter in 3 mm, 5 mm, and 7 mm lengths), titanium alloy tenting screws (1.2 mm and 1.4 mm major thread diameters in 8 mm, 10 mm, 12 mm, and 14 mm lengths), and titanium alloy socket preservation screws (3/4 head geometry with 1,2 mm and 1.4 mm major thread diameters in 18 mm and 20 mm lengths; 4/5 and 5/6 head geometries with 1.2 mm major thread diameter in 14 mm, 16 mm, 18 mm , 20 mm lengths and 1.4 mm major thread diameter in 18 mm and 20 mm lengths). When used as indicated, this system provides a semi-protected space to stabilize, support, and protect bone graft (autograft, autograft extenders, allograft, and bone void fillers) by minimizing soft-tissue collapse into the graft recipient site. 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 per ASTM F67-06 (2006) and Ti-6Al-4V ELI Alloy per ASTM F136-08el (2008). Additionally, the instruments components are manufactured from stainless steel per ASTM F899-09. The purpose of this 510(k) application is to seek marketing clearance for additional implant sizes to the family of Socket Preservation Screws to extend the product line for the ARCHITEX™ Space Maintenance System. Also included in the application is the dimensional modification to the diameter of the mesh fixation screws (Hex Self Drilling Screws) from the previously cleared implants in K100779. The device description in the IFU was also amended, which removed the implant sizes, the list of class I exempt placement instruments that can be used, the screw caddy and sterilization tray.

This document is a 510(k) summary for the ARCHITEX™ Space Maintenance System, which is a medical device for orthopedic use. It describes the device, its intended use, and its substantial equivalence to predicate devices. The submission focuses on expanding the size offerings for existing components and making a dimensional modification to some screws.

Here's an analysis of the provided information concerning acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a quantitative table with specific thresholds. Instead, it states that "all acceptance criteria were met" in the conclusions. The criteria are implied to be related to the performance of predicate devices, as the goal is to demonstrate "substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for the non-clinical tests (Static Removal Torque, Static Axial Pullout). It only mentions that "Subject Devices and Predicate Devices" were tested.

The data provenance is not mentioned. These are bench performance tests, so it's not applicable in the same way as human study data (e.g., retrospective/prospective from a specific country).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The ground truth for this type of device (implants, screws) is established through standardized engineering bench tests (e.g., ASTM F543-02) rather than expert consensus on medical images or clinical outcomes. No experts were mentioned as being involved in establishing "ground truth" for the test set in the traditional sense.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This section is not applicable. As these are bench tests and not human evaluations of data, there is no adjudication method involved.

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

This section is not applicable. This is a submission for a physical medical implant (screws for dental/oral maxillofacial surgery), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating substantial equivalence for this device is based on bench performance test results measured against industry standards (ASTM F543-02) and comparison to the established performance of legally marketed predicate devices. The acceptance criteria are essentially defined by the performance of the predicate devices in these specific mechanical tests.

8. The sample size for the training set

This section is not applicable. This device does not involve a "training set" as it's not a machine learning or AI-driven product.

9. How the ground truth for the training set was established

This section is not applicable. As there is no training set mentioned or relevant for this device.

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