(107 days)
The Tyber Medical Staple System is indicated for:
- Fracture and osteotomy fixation, joint arthrodesis hand and foot.
- Fixation of proximal tibial metaphysis osteotomy.
- Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
- Fixation of small bone fragments (i.e., small fragments of bone which are not comminuted to the extend to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and in flat bone such as the pelvis and scapula.
The Tyber Medical Staple Fixation System consists of sterile, single use orthopedic implants and instruments. The single use bone fixation compression staples are intended to be permanently implanted. The staples are made out of Nickel Titanium (Nitino) available in two or four legged designs with multiple combinations of bridge width, leg lengths, and cross sections to accommodate various anatomies. The staple implant applies compression across the bone segments when the staple implant legs are released from an insertion system that applies opposing forces to the staple legs to keep them parallel during implantation. The staple is provided preloaded on a disposable inserter.
The sterile staple kit contains all the instruments necessary for a single-staple-implantation procedure. These instruments include an inserter with a preloaded staple implant, locating pin, a drill guide for creating appropriately spaced holes and drill bits to create appropriately sized holes in the bone for staple implantation. These components will be provided in a sterilized package to accommodate a range of anatomical sites and are discarded after the procedure is complete, removing the need for any facility reprocessing.
The provided document is a 510(k) Pre-market Notification for a medical device called the "Tyber Medical Staple Fixation System." This type of document focuses on establishing substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics against those criteria.
Therefore, the requested information regarding "acceptance criteria" and "device performance" in a table, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment is not available in this document.
However, based on the non-clinical tests summary, we can infer the types of tests performed to demonstrate performance and substantial equivalence.
Here's a breakdown of what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Inferred from tests performed): The document doesn't explicitly state numerical acceptance criteria. Instead, it states that test results "demonstrated good corrosion resistance," "demonstrated substantially equivalent results to predicates," and "showed equivalent bend stiffness to the predicate." This implies the acceptance criteria were likely based on meeting or exceeding the performance of the predicate devices or relevant ASTM standards.
- Reported Device Performance:
- Corrosion Resistance: "good corrosion resistance" (per ASTM F2129)
- Pull-out Strength: "substantially equivalent results to predicates" (per ASTM F564)
- Bend Stiffness (Static and Dynamic): "equivalent bend stiffness to the predicate" (per ASTM F564)
- MRI Compatibility: Results from MRI testing (magnetically induced displacement force, torque, image artifact, and radio frequency induced heating) are included in the Instructions for Use, indicating the device meets compatibility requirements. No specific numerical performance is provided in this summary.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not applicable. These are mechanical/material tests on the device itself, not clinical data involving human subjects or biological samples from a population.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. These tests involve laboratory measurements and engineering assessments, not expert interpretation of clinical ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. This pertains to clinical data interpretation, not mechanical testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a mechanical/material device, not an AI/imaging device requiring MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical/material device, not an AI algorithm.
7. The Type of Ground Truth Used:
- Not applicable. For mechanical/material tests, the "ground truth" is established by the standardized test methods (e.g., ASTM F2129, ASTM F564) and the scientific principles governing those measurements. The device's physical properties and performance under specific conditions are directly measured.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/machine learning model that requires a training set. The "training" for such a device involves design iterations, manufacturing process validation, and quality control.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As above, no training set or associated ground truth in the AI/ML context is relevant here.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.