(62 days)
The ToggleLoc™ System Devices are intended for soft tissue to bone fixation for the following indications:
Shoulder: Bankart lesion repairs Acromio-clavicular repair, Capsular shift/capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis
Foot and Ankle: Medial/lateral repair and reconstruction, Mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis fixation (Syndesmosis disruptions) and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures (only for ToggleLoc™ with Tophat)
Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee: ACL/PCL repair / reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx. Volar plate reconstruction
Hip: Acetabular labral repair
The ToggleLoc™ System contains toggle buttons and a Tophat suture button preloaded with sutures and/or fiber constructs. The suture button has multiple eyelets for attachment of fiber constructs and/or sutures. The fiber constructs and/or sutures are preloaded for the convenience of the surgeon for soft tissue attachment.
This 510(k) summary for the ToggleLoc™ System describes a medical device seeking clearance based on substantial equivalence to previously marketed devices. It does not contain information about a study proving device performance against specific acceptance criteria.
The submission states that:
- Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
- Clinical Testing: "None provided as a basis for substantial equivalence."
Therefore, I cannot populate the requested table and information as a study proving device meets acceptance criteria, an acceptance criteria table with reported performance, sample sizes, expert qualifications, or ground truth details were not provided in this document.
In summary:
- Table of acceptance criteria and reported device performance: Not provided. The submission states non-clinical testing was performed, but no specific acceptance criteria or performance metrics are detailed.
- Sample size used for the test set and data provenance: Not applicable as no clinical or specific non-clinical test set details are provided.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as no ground truth establishment for a test set is described.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was mentioned.
- Standalone (algorithm-only) performance: Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not applicable, as no specific ground truth for performance evaluation is described.
- Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.