(90 days)
The Parcus 3.5mm 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
The Parcus 3.5mm 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.
The provided document is a 510(k) summary for the Parcus 3.5mm PEEK CF Push-In Suture Anchor. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on performance data. However, it does not describe an AI/ML-driven device or study. Therefore, the following information cannot be extracted from the provided text.
Acceptance Criteria and Study for an AI/ML Device:
Since the provided document pertains to a physical medical device (suture anchor) and not an AI/ML-driven device, the following categories are not applicable. The document describes a "Summary Performance Data" section which details a mechanical pull-out strength test for the suture anchor, not an AI model's performance.
-
Table of acceptance criteria and the reported device performance:
- The document states: "The Parcus 3.5mm PEEK CF Push-In Suture Anchors were placed in prepared holes and the pull out strength was measured. 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."
- It does not provide specific acceptance criteria values (e.g., minimum pull-out strength in Newtons) nor the precise numerical performance results of the Parcus anchor or the predicate devices. It only states that the results demonstrated "substantial equivalence."
-
Sample size used for the test set and the data provenance: Not applicable for an AI/ML device study. For the mechanical test, the sample size is not explicitly stated. The nature of the data is mechanical test results, not clinical or image data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/ML device requiring expert ground truth for classification or detection.
-
Adjudication method for the test set: Not applicable.
-
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.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/ML device. For the mechanical test, the "ground truth" would be the direct measurement of pull-out strength in a lab setting.
-
The sample size for the training set: Not applicable.
-
How the ground truth for the training set was established: Not applicable.
In summary, the provided text describes a 510(k) submission for a physical medical device (suture anchor) and does not contain information related to an AI/ML device or its performance study against specific acceptance criteria relevant to AI/ML.
§ 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.