(39 days)
OSSIOfiber ® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization.
The OSSIOfiber® Compression Screws are cannulated bone screws made of degradable poly (Llactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.
The OSSIOfiber® Compression Screws are supplied sterile, for single patient use only. The screws are partially threaded and have a cannulated design. The additional devices included in this submission are: 14- 50 mm long, and 3.5 mm diameter.
The OSSIOfiber® Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5835/ISO 9714 compatible instrumentations.
This document describes the OSSIOfiber® Compression Screw, 3.5mm, a medical device used for bone fixation. The provided text is a 510(k) summary submitted to the FDA to gain clearance for marketing. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific performance acceptance criteria in a clinical setting.
Therefore, the requested information elements related to clinical study design, expert evaluation, and AI performance metrics are not applicable to this document, as it outlines a pre-market notification process for a physical medical device based on non-clinical (mechanical) testing and comparison to existing devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices, particularly the Tyber Medical Compression Screw (K133842) for mechanical performance. The "performance" here refers to mechanical properties, not clinical outcomes.
| Acceptance Criterion (Implied) | Reported Device Performance (OSSIOfiber® Compression Screw, 3.5mm) |
|---|---|
| Pull-out Strength (Initial) | At least equivalent to the metal predicate device (K133842) |
| Pull-out Strength (After in-vitro degradation) | At least equivalent to the metal predicate device (K133842) |
| Torsional Strength (Time Zero) | Supported by testing and rationale |
| Driving Torque (Time Zero) | Supported by testing and rationale |
| Biocompatibility | Established based on primary predicate (K193660) and reference device (K203465) |
| In-vitro Degradation Profile | Established based on primary predicate (K193660) and reference device (K203465) |
| Material Composition | Same as primary predicate device (K193660) |
| Manufacturing and Sterilization Methods | Same as primary predicate device (K193660) |
| Principles of Operation | Same as primary predicate device (K193660) |
| Intended Use & Indications for Use | Same as primary predicate device (K193660) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for AI, but rather references non-clinical (mechanical) testing.
- Sample Size: Not explicitly stated for each test (e.g., number of screws tested for pull-out). It states "Pull-out testing was performed..." and "Torsional testing and rationale were also provided...".
- Data Provenance: Non-clinical laboratory testing. No geographical or temporal provenance is mentioned, which is typical for such mechanical bench tests. This is not a human observational study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a physical medical device clearance based on non-clinical mechanical testing and comparison to predicate devices, not an AI or diagnostic imaging device requiring expert ground truth for image interpretation.
4. Adjudication Method
- Not Applicable. As above, no expert adjudication was involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is not an AI-assisted diagnostic device.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Mechanical Testing Results: Quantitative measurements of pull-out strength, torsional strength, and driving torque.
- Comparison to Predicate Devices: Demonstrating equivalence or superiority in these mechanical properties to already cleared devices.
- Validated Pre-clinical Studies: For biocompatibility and in-vitro degradation, referenced from the primary predicate and reference devices.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, there is no training set.
§ 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.