(145 days)
The MedShape Solutions, Inc., WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
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, Mid-foot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral 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
WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures
This document, K091202, is a Special 510(k) summary for the MedShape Solutions WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures. It asserts substantial equivalence to a previously cleared device (K083792) and other predicate devices, rather than detailing a new study with specific acceptance criteria and performance data for the 180X model itself.
Therefore, many of the requested categories for a new clinical study are not directly applicable or available in this submission. This 510(k) is primarily focused on demonstrating that the minor changes to the WedgeLoc™ suture anchor (the "180X" designation) do not raise new questions of safety and effectiveness, and thus do not require new acceptance criteria or a dedicated study for the device's performance against such criteria.
Here's the breakdown of what can be extracted from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance against such criteria are provided for the WedgeLoc™ 180X Suture Anchor in this document. The submission argues for substantial equivalence based on the predicate device's established performance and the minor nature of the changes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) does not describe a new clinical study with a test set.
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 510(k) does not describe a new clinical study with a test set and ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This 510(k) does not describe a new clinical study with a test set and adjudication.
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 device is a medical implant (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 device is a medical implant (suture anchor), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. This 510(k) does not describe a new study that required ground truth establishment. The basis for substantial equivalence relies on the established safety and effectiveness of the predicate device.
8. The sample size for the training set
Not applicable. This 510(k) does not describe a machine learning model or a training set.
9. How the ground truth for the training set was established
Not applicable. This 510(k) does not describe a machine learning model or a training set.
Summary of the document's content relevant to acceptance criteria and study:
The core of this Special 510(k) is the assertion that the WedgeLoc™ 180X Suture Anchor is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K083792) and the Arthrex PushLock™ Suture Anchor (K051219).
- Acceptance Criteria: The implied "acceptance criteria" for this Special 510(k) are that the minor differences between the new device and its predicates do not raise new questions concerning safety and effectiveness. This is a regulatory acceptance criterion for the submission itself, not a performance criterion for the device in a clinical study.
- Study That Proves the Device Meets Acceptance Criteria: The "study" isn't a new clinical trial but rather a comparative analysis of the technological characteristics of the WedgeLoc™ 180X Suture Anchor against its predicate devices. The document states:
- "The proposed WedgeLoc™ 180X Suture Anchor is is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K08379) and the Arthrex PushLock™ Suture Anchor (K051219) in which the basic features and intended uses are the same."
- "In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ Suture Anchors are equivalent."
- "Any differences between the WedgeLoc™ 180X Suture Anchor and the predicate WedgeLoc™ or Arthrex PushLock™ Suture Anchors are considered minor and do not raise questions concerning safety and effectiveness."
In essence, the "proof" is the argument of substantial equivalence based on a comparison of features, intended use, and technological characteristics, rather than new device-specific performance data. The device's performance is accepted as equivalent to the already cleared predicate devices.
§ 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.