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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:

1. 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.
2. Sample size used for the test set and data provenance: Not applicable as no clinical or specific non-clinical test set details are provided.
3. 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.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study was mentioned.
6. Standalone (algorithm-only) performance: Not applicable, as this is a physical medical device, not an algorithm.
7. Type of ground truth used: Not applicable, as no specific ground truth for performance evaluation is described.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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