(188 days)
The 2.9 ToggleLoc and JuggerLoc Soft Tissue 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
Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment - Knee Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
The JuggerLoc and 2.9 ToggleLoc Soft Tissue System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue to bone fixation. The system construct includes various components including; Juggerknot Soft Anchors or ToggleLoc Button with ZipLoop Technology with or without needles. These implants are single use devices and are provided sterile by exposure to Ethylene Oxide.
This document is a 510(k) premarket notification for the ToggleLoc 2.9 and JuggerLoc Soft Tissue System, seeking to demonstrate substantial equivalence to previously cleared predicate devices. The document explicitly states that no animal or clinical testing was required or performed to support substantial equivalence. Therefore, it does not contain information about acceptance criteria for device performance based on human or animal studies, nor does it describe a study showing the device meets such criteria.
The information provided only discusses non-clinical mechanical tests.
Here's a breakdown of the requested information based only on the provided text, primarily outlining what is NOT present in this type of submission:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. Specific quantitative acceptance criteria for mechanical testing (e.g., minimum tensile strength, maximum displacement under cyclic loading) are not provided. The document generally states that the device is "substantially equivalent to the predicate devices" based on mechanical testing. | Device Insertion Testing: Results demonstrate substantial equivalence to predicate devices. (No quantitative data provided.) |
| Cyclic and Static Tensile Testing: Results demonstrate substantial equivalence to predicate devices. (No quantitative data provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified for any of the non-clinical mechanical tests.
- Data Provenance: Not specified. This is non-clinical mechanical test data, likely performed in-house or by a contract lab; country of origin and retrospective/prospective don't apply in the same way they would for clinical data.
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 document describes non-clinical mechanical testing, not a study involving expert assessment or ground truth establishment in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This document describes non-clinical mechanical testing, not a study involving adjudication of clinical findings.
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
- No. The document explicitly states, "No animal or clinical testing was required to support substantial equivalence." This is not a study assessing AI or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not a study of an algorithm; it is a submission for a medical device (surgical implants).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. This document describes non-clinical mechanical testing. Ground truth in this context would refer to the actual physical properties of the materials and device constructs, measured by validated test methods, rather than clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
- Not applicable. There is no training set mentioned as this is not an AI/machine learning device or a clinical study that would involve such a set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set mentioned.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.