(136 days)
The Arthrosurface Bone Screws (2.0-3.0 mm solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist.
The Arthrosurface Bone Screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, shoulder, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.
The Arthrosurface Bone Screws have diameters ranging from 2.0 mm to 4.0 mm and lengths ranging from 8 mm to 50 mm. The screws are either partially or fully threaded, solid or cannulated, self-tapping or self-drilling and are manufactured from implant grade stainless steel or titanium alloy. Depending on their size, these bone screws are intended to be used for different indications for use.
Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the Arthrosurface Bone Screws:
It's important to note that this document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to existing devices, rather than proving a new device meets specific, novel acceptance criteria through a clinical trial. Therefore, the "study" described is primarily non-clinical testing to show equivalence in performance and safety.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for bone screws, the "acceptance criteria" are generally derived from recognized industry standards for mechanical performance and safety, and the "reported device performance" are the results demonstrating compliance with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Arthrosurface Bone Screws) |
|---|---|
| ASTM F543: Torque to failure requirements | Demonstrated compliance with ASTM F543 |
| ASTM F543: Insertion/removal torque requirements | Demonstrated compliance with ASTM F543 |
| ASTM F543: Axial pullout force requirements | Demonstrated compliance with ASTM F543 |
| USP , , AAMI ST72:2002/R2010: Bacterial Endotoxins Test (limit 0.5 EU/mL or 20 EU/Device) | Kinetic Chromogenic LAL Test Result: Meets the standard limit |
| Substantial Equivalence: Similar indications for use | Confirmed to have similar indications to predicates |
| Substantial Equivalence: Similar device designs | Confirmed to have similar designs to predicates |
| Substantial Equivalence: Same operating principle | Confirmed to use the same operating principle as predicates |
| Substantial Equivalence: Same manufacturing materials (Stainless Steel, Titanium) | Confirmed to use the same materials as predicates |
| Substantial Equivalence: Same packaging/sterilization methods | Confirmed to use the same packaging/sterilization methods as predicates |
Note: The document states "demonstrated that the Arthrosurface Bone Screws are substantially equivalent to the predicate devices" and "The safety and effectiveness... is adequately supported by the substantial equivalence and performance testing information," implying that the device met the established criteria within these standards.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of screws or tests performed for each non-clinical test (torque, pullout, LAL). It typically refers to "the Arthrosurface Bone Screws" as a general product line being tested.
- Data Provenance: The data is generated from non-clinical laboratory testing conducted by the manufacturer, Arthrosurface, Inc. The location of the testing is not specified beyond the company's address in Franklin, Massachusetts. This is prospective testing conducted specifically for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable in the context of this 510(k) submission for bone screws.
- Ground truth is typically established through expert consensus or clinical outcomes for diagnostic or AI-driven devices. For implantable mechanical devices like bone screws, "ground truth" is determined by objective physical and chemical testing against established engineering and biocompatibility standards (e.g., ASTM, USP). There are no human experts "establishing ground truth" in the way one would for image interpretation.
4. Adjudication Method for the Test Set
This section is not applicable. As described above, the "test set" involves physical and chemical property measurements against predefined international standards, not subjective assessments requiring adjudication among human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done.
- MRMC studies are typically used for diagnostic devices (e.g., imaging AI) to compare the performance of human readers with and without AI assistance. This device is a mechanical bone fixation fastener, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this concept is not applicable.
- This question pertains to AI/software as a medical device (SaMD). The Arthrosurface Bone Screw is a physical implantable device. There is no "algorithm" or standalone software performance to evaluate in this context.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance testing is based on:
- Established engineering standards: Specifically, ASTM F543 for mechanical properties (torque to failure, insertion/removal torque, axial pullout force).
- Biocompatibility and sterility standards: United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies.
8. The Sample Size for the Training Set
This section is not applicable.
- There is no "training set" in the context of a 510(k) submission for a mechanical bone screw. Training sets are used for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.