(129 days)
The BioDrive® Cannulated Screw System is indicated for the following:
- Fixation of fractures in long bones
- Fixation of small bones, including those in the foot, patella, ankle, wrist & elbow
- Arthrodesis of the foot, wrist and elbow
- Small and long bone osteotomies
- Fixation of pelvis and the illiosacral joint
The Biodrive® Cannulated Screw System consists of cannulated screws of various diameters and lengths with four threaded configurations. The system includes 3 different size washers, the use of which are optional, as well as guide wire and complete instruments. They are made from made Titanium alloy (Ti-6AL-4V) in conformance with ASTM F136 standard. The Titanium screws are also available acid etched (Osseotite™).
The provided document K082874 is a 510(k) summary for the BioDrive® Cannulated Screw System. Based on the content of this document, here's an analysis of the acceptance criteria and study information:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Mechanical Performance, Biocompatibility related to Materials, Intended Use) | Demonstrated through an "engineering rationale" |
Note: The document explicitly states "Clinical Testing: None provided as a basis for substantial equivalence." This implies that the acceptance criteria are not based on specific clinical performance metrics (e.g., success rates, complication rates) but rather on demonstrating substantial equivalence to predicate devices through non-clinical means.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No clinical test set was used for this 510(k) submission.
- Data Provenance: Not applicable. The submission relies on an "engineering rationale" and equivalence to existing devices rather than new clinical data from a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set was used, and thus no ground truth was established by experts for human performance evaluation.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no MRMC study, which typically involves human readers assessing cases with and without AI, was conducted or reported.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a medical implant (cannulated screw system), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not relevant. The substantial equivalence is based on the physical properties and intended use.
7. Type of Ground Truth Used
- Engineering Rationale and Predicate Device Performance: The "ground truth" for this submission is implicitly the established safety and effectiveness of the identified predicate devices, as well as the mechanical and material specifications (ASTM F136 standard for Titanium alloy) which form the basis of the engineering rationale. There is no biological or diagnostic "ground truth" in the traditional sense, as it's a structural medical device.
8. Sample Size for the Training Set
- Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for a physical medical device. The "ground truth" for its design and manufacturing is derived from established engineering principles, material standards (ASTM F136), and the performance history of similar predicate devices.
§ 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.