(62 days)
Indications for the ALLthread™ LactoSorb® Suture Anchor include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart repair, SLAP lesion repair, acromioclavicular separation repair, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral Stabilization, medial stabilization, Achilles tendon repair/reconstruction, Halluxvalgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, Biceps tendon reconstruction, ulnar or radial collateral ligament reconstruction.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, patellar ligament/tendon repair.
The ALLthread™ LactoSorb® Suture Anchor is made with an L-Lactide / Glycolice resorbable material, preloaded with #2 polyethylene surgical sutures. The design will enable the anchor to be inserted either without pre-drilling or through a pre-drilled hole.
The provided document is a 510(k) summary for the ALLthread™ LactoSorb® Suture Anchor. It details the device's characteristics and its substantial equivalence to a legally marketed predicate device. However, it explicitly states:
"Clinical Testing: None provided as a basis for substantial equivalence."
This means that a study proving the device meets specific acceptance criteria based on clinical performance was not performed for this submission. The substantial equivalence was determined through non-clinical laboratory testing.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from this document.
If this were a document that included such a study, the information would typically be presented as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| [Metric 1, e.g., Tensile Strength] | [e.g., > 100 N] | [e.g., 125 N] |
| [Metric 2, e.g., Fixation Strength] | [e.g., No pull-out after X cycles] | [e.g., Maintained fixation after Y cycles] |
| [Metric 3, e.g., Biocompatibility] | [e.g., Passes ISO 10993 cytotoxicity test] | [e.g., Passed ISO 10993-5] |
| ... | ... | ... |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: [Number of devices/tests]
- Data Provenance: [e.g., In vitro laboratory testing, Animal study in X species, etc. (Since clinical testing was not done, this would describe the non-clinical test set)].
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable for this type of submission. For clinical studies involving human interpretation or diagnosis, this would usually involve physicians, radiologists, or other specialists.
4. Adjudication Method for the Test Set:
- Not applicable for this type of submission. Adjudication is typically used in clinical trials involving human assessment to resolve discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done. These are highly specific to AI/software performance studies involving human readers.
6. Standalone (Algorithm Only) Performance:
- No, standalone performance was not assessed. This is also specific to AI/software.
7. Type of Ground Truth Used:
- For this submission, the "ground truth" for non-clinical testing would be the established scientific and engineering principles and standards used to evaluate the device's physical and mechanical properties, as well as its biocompatibility. For instance, tensile strength measurements have an objective "ground truth" based on physics.
8. Sample Size for the Training Set:
- Not applicable. This relates to machine learning models, which are not described in this submission.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This also relates to machine learning models.
In summary, based on the provided text, the ALLthread™ LactoSorb® Suture Anchor received its 510(k) clearance based on non-clinical laboratory testing demonstrating substantial equivalence to a predicate device, without the need for clinical testing or establishing specific clinical acceptance criteria.
§ 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.