Search Results
Found 1 results
510(k) Data Aggregation
(145 days)
PARCUS DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR
The Parcus Draw Tight 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.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.
The Parcus Draw Tight Anchors are designed for use in attachment of soft tissue to bone. The devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and Polyetheretherketone (PEEK), The construct of the Draw Tight Anchors is such that when inserted into bone and deployed via the included suture, a suture ball is created in the prepared socket that provides the necessary fixation. The Draw Tight Anchors are designed to accommodate both sliding and fixed sutures to be used for soft tissue fixation and are provided sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Parcus Draw Tight Anchors:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for the Parcus Draw Tight Anchors. Instead, it uses comparative language to claim substantial equivalence to predicate devices. The "reported device performance" is summarized qualitatively.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance (Pull-out Strength): Sufficient pull-out strength in bone to ensure fixation and efficacy. (Implicit: Comparable to predicate devices) | "The Parcus Draw Tight Anchors were placed in prepared holes and the pull out strength was measured... Test results were compared to the results for the predicate devices and the Draw Tight Anchors demonstrated substantial equivalence in all aspects." |
| Mechanical Performance (Cyclic Loading): Ability to withstand cyclic loading conditions without failure or significant degradation. (Implicit: Comparable to predicate devices) | "In addition to straight load to failure, the proposed device was also tested under cyclic loading conditions. Test results were compared to the results for the predicate devices and the Draw Tight Anchors demonstrated substantial equivalence in all aspects." |
| Safety and Efficacy: No new safety or efficacy concerns raised by the device, even in challenging conditions. (Implicit: Comparable to predicate devices) | "However, even in the worst case scenario the Draw Tight Anchors perform as intended and do not raise any concerns regarding the safety or efficacy of the device... Any differences between the Draw Tight Anchors and the predicate devices are considered minor and do not raise any safety and/or efficacy concerns." |
| Indications for Use: The device can be used for the specified orthopedic soft tissue to bone attachment procedures. (Implicit: Identical or comparable to predicate devices) | "all of the indications for the proposed device are either identical or comparable to that of the predicate." |
| Material Equivalence: Device materials are the same or similar to predicate devices. | "they are manufactured from the same or similar materials" |
| Method of Fixation Equivalence: The method of fixation is similar to at least one predicate device. | "While the method of fixation for the Draw Tight Anchor differs from that of the Parcus predicate devices, fixation due to a suture ball rather than a solid anchor body, it is very similar to that of the Biomet predicate device." |
| Suture Specifications Equivalence: Specifications for the suture portion are within those of the predicate. | "When compared to the Biomet predicate device, the specifications for the suture portion of the proposed device are included within that of the predicate." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (number of anchors tested) for the performance testing. It generically refers to "the data" and "test results."
- Data Provenance: The document does not state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a medical device (suture anchor), it's highly likely to be prospective bench testing performed under controlled laboratory conditions, rather than a clinical study involving human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the type of device and study described. The "ground truth" for a mechanical device like a suture anchor is typically based on objective physical measurements (e.g., force required for pull-out, cycles to failure) in a laboratory setting, not on expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods are typically used in clinical trials or studies where human interpretation or subjective assessment of outcomes is involved. For bench testing of a mechanical device, the results are derived from instrumentation and physics-based 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
This question is not applicable. The device is a mechanical suture anchor, not an AI-powered diagnostic or assistive tool for human readers/clinicians. Therefore, an MRMC study or AI-related metrics are irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a mechanical suture anchor, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this study was objective physical measurements related to the mechanical performance of the suture anchors. This includes:
- Pull-out strength (force to failure)
- Resistance to cyclic loading
These measurements are then compared to established performance benchmarks (predicate devices).
8. The Sample Size for the Training Set
This question is not applicable. This is a study of a mechanical device, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. There is no training set for this type of device and study.
Ask a specific question about this device
Page 1 of 1