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510(k) Data Aggregation
(87 days)
THE UNI-CLIP STAPLE
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.
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