(220 days)
The Parachute Corkscrew Suture Anchor is intended for fixation of tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction
The Parachute Corkscrew Suture Anchor is a 2 component product consisting of a titanium alloy anchor with a PLA disc attached by a #4 non-absorbable braided polyester suture. Once the tissue is in the desired position, the Parachute Corkscrew is inserted through the tissue and into bone. The insertion is discontinued when the soft tissue/bone apposition has been achieved. The distance between the disk and anchor ensures that the head of the anchor is not protruding from the surface of the bone.
The anchor is made of Titanium 6AI-4V alloy (ASTM F136-96), the biocompatibility of which has been well documented. In regards to the material for the disc, Poly (L-lactide), it is currently being used in the Arthrex Bio-Interference Screw, which has received clearance for both bone and soft tissue fixation.
The provided text describes a 510(k) submission for the Arthrex Parachute Corkscrew Suture Anchor. This is a pre-market notification for a medical device seeking clearance based on substantial equivalence to predicate devices, not a study performing clinical or AI performance evaluation. Therefore, most of the requested information regarding acceptance criteria and a study to prove the device meets them, especially in the context of AI, is not available in the given document.
The document primarily focuses on establishing substantial equivalence to predicate devices by comparing their intended use, materials, and mechanical properties.
Here's a breakdown of the available information and why other points cannot be addressed:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the format typically seen for a new study involving AI or a novel performance claim. Instead, it uses a comparative table to demonstrate that the new device's failure strength is equivalent or superior to predicate devices, which serves as a de facto performance criteria for demonstrating substantial equivalence.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Arthrex Parachute Corkscrew) |
|---|---|
| Intended Use: Soft tissue to bone fixation | Intended Use: Soft tissue to bone fixation |
| Material: Biocompatible, demonstrated safe | Anchor: Titanium Alloy (ASTM F136-96) - well documented biocompatibility |
| Disc: Poly (L-lactide) - currently used in cleared Arthrex Bio-Interference Screw | |
| Failure Strength (compared to predicate devices): Greater than or equivalent to predicate devices' suture tensile strength | Failure Strength: 40.98 lbs (using #2 suture, exceeding knot tensile strength of #2 suture for predicates) |
| No different questions regarding safety and effectiveness from predicate devices | Addressed by demonstrating equivalent/superior failure strength and using documented biocompatible materials. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "Testing performed using a 20 lb. density foam block to simulate poor quality bone." It does not specify the number of tests performed (sample size) or any other details about the "test set" in the context of clinical data. It refers to mechanical testing.
- Data Provenance: Not applicable in the context of clinical data for this 510(k). The "testing" appears to be mechanical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a review of a mechanical device, not an AI or diagnostic device that requires expert adjudication of "ground truth" from images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication of "ground truth" is described.
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 device (suture anchor), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context refers to the mechanical properties (specifically failure strength) of the device. This was established through bench testing (tensile strength measurement). The "ground truth" for the predicate devices' suture tensile strength likely came from their own testing or published specifications.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" presented here is a comparison to predicate devices to demonstrate substantial equivalence, as required for a 510(k) submission.
- Methodology: The manufacturer compared the new device (Arthrex Parachute Corkscrew Suture Anchor) against two predicate devices (Arthrex FASTak and Linvatec Bio-Anchor). The comparison focused on:
- Intended Use: All devices shared the same intended use (soft tissue to bone fixation).
- Materials: Materials were analyzed for biocompatibility and prior clearance (Titanium 6AI-4V alloy, Poly (L-lactide)).
- Mechanical Performance (Failure Strength): The new device underwent mechanical testing using a 20 lb. density foam block to simulate poor quality bone. Its failure strength (40.98 lbs.) was compared against the failure strengths of the predicate devices.
- Key Finding: The manufacturer argued that the "critical value for the FASTak and Bio-Anchor is the tensile strength of the suture." Since the failure strength of the Parachute Corkscrew (40.98 lbs.) was greater than the knot tensile strength of size #2 suture (the maximum recommended for predicates), the device was deemed "no less safe and effective than the predicate devices" and raised no "different questions regarding safety and effectiveness."
This document is a regulatory submission for a physical medical device, not a performance study of a diagnostic algorithm or AI system.
§ 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.