(25 days)
The LARGE UNI-CLIP® STAPLE is indicated for fixation of bone fractures or for bone reconstruction.
Examples include:
- Arthrodesis in hand or foot surgery
- Fractures management in the foot or hand
- Mono or Bi-cortical osteotomies 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 size and number of staple(s) used should be adapted to the specific indication.
The LARGE UNI-CLIP® STAPLE is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs.
The surgeon can obtain a true compression, adjustable and controlled with many choice of size.
The LARGE UNI-CLIP® STAPLE is made from 316L Stainless Steel that conforms to ISO 5832-1 and ASTM F138 & F139 standards.
Here's a breakdown of the acceptance criteria and study information for the LARGE UNI-CLIP® STAPLE based on the provided 510(k) summary:
This device is not an AI/ML device, so many of the requested fields regarding AI/ML specific studies (like MRMC, standalone performance, training set details) are not applicable. The device is a bone fixation staple and the submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical properties similar to predicate device (UNI-CLIP® staples, K011716). | "Results have shown that the mechanical properties of the LARGE UNI-CLIP® staples are thus similar to the properties of the unmodified device, UNI-CLIP® staples, K011716." |
Note: The document does not explicitly state numerical acceptance criteria (e.g., minimum tensile strength, maximum deformation). Instead, it relies on a comparative assessment of mechanical properties to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Mechanical tests have been carried out," implying a set of samples were tested, but the exact number isn't provided.
- Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer (Newdeal SAS). The document does not indicate country of origin for the data or if it was retrospective/prospective in a clinical context. Given it's mechanical testing of a device, it is typically laboratory-generated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is derived from instrumentation and engineering standards, not expert clinical interpretation.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, not for objective mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human performance (e.g., radiologists reading images) with and without AI assistance, which is not applicable to a bone staple.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used was objective mechanical measurements (e.g., load-to-failure, stiffness, deformation) obtained through laboratory testing, compared against the predicate device.
8. The Sample Size for the Training Set
This is not applicable. There is no AI/ML algorithm involved, so no training set was used.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI/ML algorithm.
§ 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.