(209 days)
The ToogleLoc™ System devices, except the TogaleLoc XTender and TogaleLoc XL devices, 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 ZipTight™)
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, Iliotibial 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 XTender and ToggleLoc XL devices are used for fixation of tendons and ligaments in cases of unanticipated intraoperative complications such as cortical breaching during orthopedic reconstruction procedures, such as Anterior Cruciate (ACL) or Posterior Cruciate (PCL) Reconstruction. The ToggleLoc™ XTender is for use in conjunction with a titanium alloy ToggleLoc™ device, excluding the ToggleLoc™ XL devices.
This submission is for the ToggleLoc™ System in which a series of titanium and stainless steel ToggleLoc devices are being included. These items include the ToggleLoc™ XTender, ToggleLoc™ XL with ZipLoop™ Technology, ToggleLoc™ with ZipLoop™ Inline, expanded offering of components of the previously cleared ToggleLoc™ with ZipLoop™ System (K083070), and implants previously cleared in K083070 being included in this submission to add MRI language.
The ToggleLoc™ System is made up of various combinations of components, including: ToggleLoc™ buttons, ZipTight construct and buttons, Continuous Loops, and ZipLoop™ Technology.
The acceptance criteria and study proving the device meets them are summarized below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Load Testing | Not explicitly stated, implied to meet predicate devices. | "met or exceeded the established acceptance criteria" |
| Cyclic Load Testing | Not explicitly stated, implied to meet predicate devices. | "met or exceeded the established acceptance criteria" |
| MR Evaluation/Simulations | Not explicitly stated, implied to meet predicate devices. | "indicated that the devices are MR Conditional." |
2. Sample size used for the test set and data provenance:
- Sample Size: Not specified. The document states "The following tests were performed on the ToggleLoc™ System," implying testing on the new metallic ToggleLoc™ buttons and ZipLoop™ constructs.
- Data Provenance: Not specified; however, the testing is non-clinical performance data, likely conducted in a laboratory setting by the manufacturer, Biomet Manufacturing Corp.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
This information is not applicable as the study is a non-clinical (mechanical and MR) performance study, not a study involving human interpretation of data where expert ground truth would be required.
4. Adjudication method for the test set:
This information is not applicable for a non-clinical performance study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This is a non-clinical performance study for a device (soft tissue fixation system), not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a non-clinical performance study for a medical device (soft tissue fixation system), not an algorithm.
7. The type of ground truth used:
For the mechanical tests (Static and Cyclic Load Testing), the "ground truth" would be the established engineering specifications or performance characteristics of the predicate devices that the new devices aim to be substantially equivalent to.
For the MR Evaluation/Simulations, the "ground truth" would be the established industry standards and scientific principles for MR safety and compatibility.
8. The sample size for the training set:
This information is not applicable as this is a non-clinical performance study for a medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
Study Description:
The study conducted was a series of non-clinical performance tests designed to demonstrate the substantial equivalence of the new ToggleLoc™ System components (additional metallic ToggleLoc™ buttons and ZipLoop™ constructs) to legally marketed predicate devices (K083070 ToggleLoc™ System, K102982 EndoButton CL, K112990 TightRope RT).
The tests performed included:
- Static Load Testing: To evaluate the strength and structural integrity of the new line extensions under static conditions.
- Cyclic Load Testing: To assess the fatigue resistance and durability of the devices under repeated loading, simulating physiological conditions.
- MR Evaluation/Simulations: To determine the magnetic resonance (MR) compatibility of the devices, particularly to support the addition of MR compatibility language to the product labeling.
The document explicitly states that "All testing met or exceeded the established acceptance criteria," and "The results of mechanical testing indicated the devices performed mechanically equivalent to marketed devices and did not raise any new safety and efficacy issues. The results of the MR evaluation indicated that the devices are MR Conditional."
No clinical testing was necessary for the determination of substantial equivalence.
§ 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.