(167 days)
The Parcus V-LoX™ PEEK CF Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair Foot/Ankle Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair. Elbow Tennis Elbow Repair, Biceps Tendon Reattachment. Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Hand/Wrist Ligament Reconstruction, TFCC.
The Parcus V-LoX™ PEEK CF Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The device is made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). It comes preloaded with two #2 sutures either with or without attached needles, and is available in two different diameters, 5.5mm and 6.5mm.
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Device Name: Parcus V-LoX™ PEEK CF Suture Anchor
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Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pull out strength | Substantially equivalent to Parcus V-LoX Titanium Suture Anchors |
| Insertion torque | Substantially equivalent to Parcus V-LoX Titanium Suture Anchors |
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Sample Size Used for the Test Set and Data Provenance: Not explicitly stated. The document mentions "Test results were compared to the results for the Parcus V-LoX Titanium Suture Anchors," implying a comparative test, but specific sample sizes are not provided. The data provenance (country of origin, retrospective/prospective) is not mentioned.
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Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. The study involved mechanical testing, not a clinical assessment requiring expert ground truth for interpretation.
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Adjudication Method: Not applicable, as no expert adjudication of clinical outcomes was performed.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC comparative effectiveness study was done. The study focused on mechanical performance.
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Standalone Performance: Yes, a standalone performance study was done in terms of mechanical properties (pull-out strength and insertion torque) of the device itself.
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Type of Ground Truth Used: The "ground truth" for the mechanical testing was the objective measurement of pull-out strength and insertion torque. The comparison was made against the performance of a legally marketed predicate device (Parcus V-LoX Titanium Suture Anchors).
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Sample Size for the Training Set: Not applicable. This was a mechanical performance study, not an AI or machine learning study requiring a training set.
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How Ground Truth for the Training Set Was Established: Not applicable, as there was no training set.
§ 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.