(100 days)
The Parcus PEEK CF Push-In 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.
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.
Hip Acetabular Labral Repair (3.0mm only)
The Parcus PEEK CF Push-In Suture Anchors are tapered fasteners with barbs for use in attachment of soft tissue to bone. The devices are made from Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). The Push-In Suture Anchors are provided sterile in 3.0mm and 4.5mm diameters.
The document describes a 510(k) premarket notification for the "Parcus PEEK CF Push-In Suture Anchors" by Parcus Medical, LLC. The study provided is a performance comparison to predicate devices, focusing on demonstrating substantial equivalence rather than a detailed clinical trial with human subjects/readers.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Pull-out strength comparable to predicate devices | "Test results were compared to the results for the Parcus V-LoX PEEK CF Suture Anchors as well as the Smith & Nephew BioRaptor 2.9 and demonstrated substantial equivalence." |
| Safety and Efficacy for intended use | Implied by "substantial equivalence" to predicate devices, which are already legally marketed and presumed safe and effective. |
| Mechanical characteristics suitable for soft tissue to bone attachment | Demonstrated through "pull out strength" measurements, indirectly showing the device's ability to secure tissue. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Test results" in plural, implying multiple tests, but does not provide specific numbers of anchors or tests conducted.
- Data Provenance: The study was a non-clinical in vitro or benchtop test comparing mechanical properties. It is not patient or human data. Therefore, country of origin or retrospective/prospective does not apply in the typical sense. It's an engineering performance test.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This type of study (comparative mechanical performance of a medical device) does not involve experts establishing "ground truth" in the way a diagnostic imaging study would.
- The "ground truth" here is the measured mechanical pull-out strength of the device itself and its comparison to established predicate devices. The "experts" involved would likely be engineers or lab technicians conducting the tests according to established protocols. Their specific qualifications are not mentioned.
4. Adjudication Method for the Test Set
- Not applicable. This was a mechanical performance test, not a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was not a clinical or diagnostic study involving human readers or cases. It was a benchtop comparison of the mechanical properties of a suture anchor.
- Therefore, an effect size of human readers improving with AI vs. without AI assistance is not relevant or provided.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a physical medical implant, not an AI algorithm. Therefore, a standalone performance study in the context of AI is not relevant.
7. Type of Ground Truth Used
- Measured Mechanical Properties: The "ground truth" was the measured pull-out strength of the suture anchors, obtained through direct physical testing. This is a form of objective physical measurement.
8. Sample Size for the Training Set
- Not applicable. This device is hardware, not an AI model. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing would be based on engineering principles and material science, potentially informed by prior device performance data, but not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI algorithm, this question is not relevant. The performance of the predicate devices would have been established through their own testing and market history, and the design of the new device would be based on engineering specifications and material properties.
§ 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.