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The ToggleLoc System devices, except the ToggleLoc XL device, are intended for soft tissue to bone fixation for the following indications:
Shoulder Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair 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/ZipTight Fixation Devices)
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
The ToggleLoc XL device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction, as well as fixation in cases of unanticipated intraoperative complications, such as cortical breaching.

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This section focuses on the regulatory information for the ToggleLoc System, specifically its 510(k) premarket notification. The provided text, however, does not contain any information regarding acceptance criteria, study details, or performance data in the context of device approval. It primarily establishes the legal basis for marketing the ToggleLoc System as substantially equivalent to previously approved devices.

Therefore, I cannot fulfill your request for the acceptance criteria and study details based on the provided input. The document explicitly states:

• "Summary of Performance Data (Nonclinical and/or Clinical) ... Clinical data was not required to establish substantial equivalence between the subject ToggleLoc System and the predicate devices."
• "Non-clinical evaluation demonstrated that the performance of the proposed devices is substantially equivalent to the predicate device in terms of safety and efficacy."

This indicates that the approval was based on demonstrating substantial equivalence through non-clinical evaluation and comparisons of intended use, indications, materials, design features, and sterilization methods to predicate devices, rather than a specific study with defined acceptance criteria and performance outcomes.

If this were a document about a de novo device or a device requiring clinical trials, such information would typically be present.

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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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