(78 days)
The BioStinger™-V Bioabsorbable Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus.
Implantation of the device is accomplished through arthroscopy or arthrotomy.
The BioStinger™-V Bioabsorbable Meniscal Repair Device is a cannulated, sterile, single-use fixation device made of an absorbable homopolymer derived from poly(Llactic acid), similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The device is colored with D&C Violet #2.
The provided document describes the BioStinger™-V Bioabsorbable Meniscal Repair Device, and its submission for 510(k) clearance based on substantial equivalence to a predicate device. This type of regulatory submission does not typically include detailed performance studies with acceptance criteria comparing the new device against specific metrics in a clinical setting. Instead, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Therefore, the requested information regarding acceptance criteria, sample sizes, expert involvement, and detailed study methodologies for proving device performance is not present in the provided text.
Here's an explanation of why this information is absent in the context of this specific regulatory document:
- 510(k) Submission Focus: A 510(k) (Premarket Notification) is a regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. The primary goal is to demonstrate that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
- No "Study Proving Acceptance Criteria" for 510(k) Equivalence: Unlike a PMA (Premarket Approval) submission, which often requires extensive clinical trials to prove efficacy and safety against specific acceptance criteria, a 510(k) typically relies on comparisons to the predicate device, including material properties, design, function, and sometimes non-clinical testing (e.g., biocompatibility, mechanical testing). The document explicitly states, "The BioStinger™-V Bioabsorbable Meniscal Repair Device is substantially equivalent in design, function and intended use to the Linvatec BioStinger™ Bioabsorbable Meniscal Repair Device."
- Emphasis on Predicate Comparison: The "Chart of Similarities and Dissimilarities" clearly shows that the new device and the predicate have identical intended use, material (poly L-lactic acid), sterilization, and similar design characteristics. The key difference noted for the new device is the addition of a color additive (D&C Violet #2).
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details because the provided text for the BioStinger™-V Bioabsorbable Meniscal Repair Device 510(k) submission does not contain this information.
If this were a different type of submission (e.g., a PMA or a de novo application), or if the 510(k) included specific performance data to address a new technological characteristic, such information might be present. However, for this particular document, the demonstration of safety and effectiveness relies on substantial equivalence to the predicate device.
§ 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.