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The PANALOK Loop Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES SHOULDER 1. Bankart repair 2. SLAP lesion repair 3. Rotator cuff repair 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus 5. Biceps tenodesis 6. Acromio-clavicular separation 7. Deltoid repair ELBOW 1. Biceps tendon reattachment 2. Tennis elbow repair ANKLE 1. Achilles tendon repair/reconstruction 2. Lateral stabilization 3. Medial stabilization at the medial talus site Foot: Hallux Valgus reconstruction 4. Midfoot reconstruction KNEE 1. Medial collateral ligament repair 2. Lateral collateral ligament repair 3. Joint capsule closure to anterior proximal tibia 4. Posterior oblique ligament or joint capsule to tibia repair 5. Extra capsular reconstruction/ITB tenodesis 6. Patellar ligament and tendon avulsion repairs ARTHROSCOPIC PROCEDURES SHOULDER 1. Bankart repair 2. SLAP lesion repair 3. Rotator cuff repair 4. Capsule shift repair (glenoid rim)

The PANALOK Loop Anchor System is a preloaded absorbable disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The absorbable poly lactic acid (PLA) anchor is the identical anchor as that of the BIOKNOTLESS Anchor in design, configuration and dimensions. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.

There is no information in the provided document about acceptance criteria, device performance metrics, or a study report detailing how such criteria were met. The document is a 510(k) summary and an FDA clearance letter for a medical device (Panalok Loop Anchor), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and results from a clinical study or specific validation testing.

The document states that "Biocompatibility studies have demonstrated the Panalok Loop Anchor to be non-toxic, non-irritating, and non-cytotoxic," but it does not provide acceptance criteria for these studies, the reported performance, sample sizes, ground truth establishment, or any details about the study design.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or adjudication methods based on the provided text.

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