(71 days)
The INION ANCHRON™ BIODEGRADABLE ANCHOR SYSTEM is indicated for use in soft tissue to bone fixation in conjunction with appropriate post-operative immobilization as follows: A. Open procedures: 1. Shoulder:• Bankart repair - · SLAP lesion repair - · Rotator cuff repair - · Capsule shift/capsulo-labral reconstruction at the anterior glenoid rim site - · Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus - Biceps tenodesis - · Acromio-clavicular separation - · Biceps tendon reattachment 2. Elbow: - · Achilles tendon repair/reconstruction 3. Ankle: - · Lateral stabilization - · Medial stabilization at the medial talus site - Medial collateral ligament repair 4. Knee: - · Lateral collateral ligament repair - · Joint capsule closure to anterior proximal tibia - · Posterior oblique ligament or joint capsule to tibia repair - · Extra capsular reconstruction / ITB tenodesis - · Patellar ligament and tendon avulsion repairs - B. Arthroscopic procedures: - 1. Shoulder: Bankart repair - · SLAP lesion repair - · Rotator cuff repair - · Capsule shift repair (glenoid rim)
Inion ANCHRON™ Biodegradable Anchor System is intended to allow secure fixation of soft tissue to bone in conjunction with appropriate immobilization. The system consists of degradable suture anchor made of co-polymers PLDLA, non-degradable polyester sutures with stainless steel needles, and a single-use suture anchor inserter. The suture anchors are dyed green. Based on in vitro testing: the suture anchors retain most of their strength up to 16 weeks and gradually loose their strength thereafter; and bioresorption takes place within three years. Inion ANCHRON™ Biodegradable Suture Anchor is provided in size 3.0 mm x 8.5 mm. Inion ANCHRON™ Biodegradable Anchor system is provided sterile to the user and is nonpyrogenic. The shelf life of the device is 3 years.
The provided text describes a 510(k) summary for a medical device called the Inion ANCHRON™ Biodegradable Anchor System. It does not include information about acceptance criteria or a study proving the device meets specific performance criteria.
The 510(k) submission process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria in the format requested. The document states:
"Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion ANCHRON™ Biodegradable Anchor System are substantially equivalent with the predicate device Mitek 3.5 mm Panalok Wedge Absorbable Suture Anchor System (K970896)."
And further:
"Inion ANCHRON™ Biodegradable Anchor System is substantially equivalent to predicate Class II devices used for soft tissue to bone fixation with appropriate postoperative immobilization because the differences between Inion ANCHRON™ Biodegradable Anchor System and the predicate devices do not raise new questions of safety and effectiveness."
This means the device's "performance" is primarily demonstrated by its similarity to an already approved device. The document mentions in vitro testing for strength retention and bioresorption but does not provide specific details about the acceptance criteria for this testing, the study design, or the results in a quantifiable manner.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This is not present in the provided text.
- Sample sized used for the test set and the data provenance: Not detailed for any specific performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no mention of such a test set.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as this is a device for physical fixation, not an AI diagnostic tool.
- Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable for the type of device and submission.
- The sample size for the training set: Not applicable, as there's no "training set" in the context of this device.
- How the ground truth for the training set was established: Not applicable.
The document only provides the following information related to its "performance" based on in vitro testing:
- Strength Retention: The suture anchors retain most of their strength up to 16 weeks and gradually lose their strength thereafter.
- Bioresorption: Bioresorption takes place within three years.
However, these are descriptive statements of observed characteristics, not acceptance criteria against which specific performance metrics are measured and reported in a table.
§ 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.