(53 days)
The Parcus V-LoX™ Titanium 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.
- Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
- Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Foot/Ankle Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
- Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow
- Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Hand/Wrist Ligament Reconstruction, TFCC.
Acetabular Labral Repair Hip
The Parcus V-LoX Titanium Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136). It comes preloaded with two #2 sutures either with or without attached needles, and is available in two different diameters, 5mm and 6.5mm.
The provided document describes the Parcus V-LoX™ Titanium Suture Anchor and its substantial equivalence to predicate devices, focusing on mechanical performance rather than algorithm-based device performance. Therefore, many of the requested criteria related to AI/algorithm performance (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies) are not applicable or cannot be extracted from this documentation.
However, I can provide information based on the mechanical testing described for this medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance | Study Conclusion |
|---|---|---|
| Pullout Strength | Measured and compared to predicate devices. | No significant differences compared to predicate devices. |
| Insertion Torque | Measured and compared to predicate devices. | No significant differences compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the mechanical testing (pullout strength and insertion torque). It mentions "side by side comparisons were done with the Smith & Nephew predicate device."
- Test Set Sample Size: Not specified.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing performed by Parcus Medical, LLC. It is a prospective study in the sense that the new device was manufactured and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a mechanical implant, and its performance is evaluated through physical measurements (pullout strength, insertion torque) against established engineering standards or predicate device performance, not against expert-established ground truth like in image analysis or diagnostic algorithms.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing does not involve subjective adjudication by experts. The results are objective measurements.
5. 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. This is a medical implant, not an AI-assisted diagnostic or imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done
Not applicable. This is a medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on:
- Measured physical properties: Direct measurements of pullout strength and insertion torque.
- Comparison to predicate devices: The established performance of existing, legally marketed suture anchors (e.g., Smith & Nephew Suture Anchor, Arthrex Corkscrew FT II Suture Anchor, ConMed Linvatec Bio Mini-Revo Suture Anchor) serves as the benchmark for "substantial equivalence."
- Published literature: The document states that "The published literature was reviewed," suggesting that general performance expectations for such devices were also considered.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for a mechanical medical device in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" or "ground truth" in the AI/algorithm sense for this type of device.
§ 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.