(87 days)
The "new" uni-clip® staple is indicated for fixation of bone fracture or for bone reconstraucion, including:
- Arthrodesis in hand or foot surgery .
- Mono or Bi-cortical osteotomies in the foot or hand ●
- Fracture management in the foot or hand ●
- Distal or proximal metatarsal or metacarpal osteotomies .
- Fixation of osteotomies for Hallux Valgus treatment such as . scarf, chevron, etc.
The UNI-CLIP® STAPLE is designed so that, by widening the "chamond", mosseon can obtain a true compression, adjustable and controlled, with many choices of size.
The provided text describes a 510(k) submission for the "UNI-CLIP® STAPLE," a bone fixation staple. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving specific performance criteria through a clinical study with detailed metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested details regarding acceptance criteria and study particulars cannot be found in this document.
Here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device). | The new UNI-CLIP® STAPLE is stated to have "the same intended of use and all are the same technologies." It is also made from stainless steel. |
| Mechanical Performance: Resistance to torsion in compliance with selected standard (implied criterion for predicate device). | Rupture torque of the "new" UNI-CLIP® STAPLE is the same as for the predicate device. Torque of divergence and strength of compression of the "new" UNI-CLIP® STAPLE is the same as for the predicate device. |
| Material: Biocompatibility (implied from predicate). | Made from stainless steel (same as predicate). |
2. Sample size used for the test set and the data provenance:
- This information is not provided. The study mentioned is about comparing mechanical properties to predicate devices, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set with ground truth established by experts is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set with expert adjudication is described.
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:
- This is not an AI/diagnostic device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a medical device (bone staple), not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical performance comparison, the "ground truth" or reference was the performance of the predicate device (UNI-CLIP® STAPLE (K991482)) based on its stated resistance to torsion, torque of divergence, and strength of compression. This is a technical/engineering "ground truth" rather than clinical.
8. The sample size for the training set:
- Not applicable as this is a bone staple, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.