(78 days)
The Bionx Impact™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Bionx Impact™ Suture Anchor is contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, osteoporotic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3) Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6) Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials.
Impact™ Suture Anchor is a smooth, cylindrical/conical shape, bioabsorbable, pushin suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Colour of green suture is D&C Green No 6, white suture represents original colour of polyester suture. Diameter of the anchor is 3.5mm and length 10.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a drill bit. The Impact™ Suture Anchor is made of poly-L/D-lactide copolymer.
The provided text is a 510(k) summary for the Bionx Implants Inc. Impact™ Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices and describes the device, its intended use, and contraindications. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC/standalone).
Therefore, I cannot fulfill your request for that specific information based on the provided text.
The text does include:
- Device Name: Impact™ Suture Anchor
- Intended Use: To reattach soft tissue to bone in orthopedic surgical procedures, either arthroscopic or open. It stabilizes damaged soft tissue in conjunction with postoperative immobilization.
- Device Description: A bioabsorbable, screw-in (though later described as "push-in") suture anchor, preloaded with two non-absorbable #2 polyester sutures. Made from Self-Reinforced (96/4D) PLA Copolymer, 3.5mm diameter, 10.5mm length. Resorbs over several years, retains 90% strength for 20 weeks.
- Predicate Devices: Numerous Bionx Implants Inc., Arthrex Inc., Innovasive Devices, Inc., Instrument Makar, Inc., Linvatec Corporation, Mitek Surgical Products, Acufex Inc., and DePuy Inc. suture anchors.
- Material: Self-Reinforced (96/4D) PLA Copolymer, stated to be inert, non-collagenous, and non-pyrogenic. The poly-L/D-lactide material is the same as used in several previously cleared Bionx Implants Inc. devices.
Without the specific study information, I can only provide the structure of the requested table and indicate that the data is not available in the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (as per document) |
|---|---|---|
| Mechanical Strength | N/A (Not specified in document) | Retains 90% strength through 20 weeks |
| Biocompatibility | N/A (Not specified in document) | Copolymer is inert, non-collagenous, non-pyrogenic through absorption |
| Resorption Rate | N/A (Not specified in document) | Completely resorbs over a period of several years in vivo |
| Material Composition | N/A (Not specified in document) | Manufactured from Self-Reinforced (96/4D) PLA Copolymer |
| Suture Type | N/A (Not specified in document) | Preloaded with two non-absorbable, braided, polyester #2 sutures |
For the remaining points, the information is not available in the provided text:
- Sample size used for the test set and the data provenance: Not specified. The document does not describe specific performance testing with a test set of data/samples, but rather relies on substantial equivalence to predicate devices and material properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical medical implant, not an AI/software device involving human readers or AI assistance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a physical medical implant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no external "ground truth" for performance is described in the context of a study. The substantial equivalence argument relies on material characteristics and predicate device equivalence.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that uses training sets.
- How the ground truth for the training set was established: Not applicable.
§ 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.