(99 days)
The OS2®-V Varisation Staples are indicated for Akin type osteotomies.
The OS2®-V Varisation Staple is a metallic staple with two self- drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface.
Sizes: The OS2®-V Varisation Staple is available in various angles (90° and 26°) and interaxis (8mm and 10mm).
Material: The OS2®-V Varisation Staple is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138. It does not have any coating.
Single use: The OS2®-V Varisation Staple is designed for single use only.
Sterilization: The OS2®-V Varisation Staple is supplied sterile, using gamma irradiation.
Place of use: The OS2®-V Varisation Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
The provided text is a 510(k) Summary for a medical device called the "OS2®-V Varisation Staple." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested categories for AI/algorithm performance criteria (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this document, as it describes a physical orthopedic implant.
Here's an attempt to answer the relevant questions based on the provided text, while also noting where information is not present or applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the OS2®-V Varisation Staple are primarily based on demonstrating substantial equivalence to existing predicate devices (Integra / Newdeal SOLUSTAPLE (K991566) and Memometal Varisation staple (K070033)). This equivalence is established across several characteristics, summarized below. The "reported device performance" in this context refers to showing that the OS2®-V Varisation Staple matches or is comparable to the predicate devices in these aspects.
| Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (OS2®-V Varisation Staple) |
|---|---|
| Intended Use & Indications for Use | Indicated for Akin type osteotomies, which is identical to both predicate devices. |
| Design | Metallic staple with two self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire. This design is similar to both predicate devices. |
| Size Range | Available in 8mm and 10mm interaxis, 10mm leg length, 26° and 90° angulation options. This size range is equivalent to both predicate devices. |
| Material | Manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138. This is similar to the predicate devices which use stainless steel 316L, according to ISO 5832-1 and ASTM F138. The document states "similar raw material." |
| Mechanical Properties | Compliant with standard ISO 8827 “Implants for surgery – staples with parallel legs for orthopaedic use – general requirements”, similar to predicate devices. The document implies testing was done to ensure compliance with this standard, leading to the conclusion of similar mechanical properties. While specific test results are not detailed in this summary, the statement "The OS2®-V Varisation Staple has similar intended use and mechanical properties when compared to the Integra / Newdeal SOLUSTAPLE (K991566) and Memometal Varisation staple (K070033). Indeed, they are all compliant with standard ISO 8827" indicates that compliance with mechanical standards for bone staples serves as a key acceptance criterion. |
| Sterilization | Supplied sterile, using gamma irradiation. (Implied acceptability based on common practice for implants). |
| Single Use | Designed for single use only. (Implied acceptability based on common practice for implants). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it pertains to a physical implant, not an AI/algorithm. The submission focuses on substantial equivalence based on material, design, indications, and compliance with general mechanical standards for orthopedic staples. Clinical trial data or specific human subject test sets are not detailed in this 510(k) summary for this type of device.
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)
This information is not applicable/not provided for a physical medical implant device. Ground truth, expert consensus, and qualifications of medical readers are relevant for diagnostic AI algorithms, not for physical staples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided for a physical medical implant device. Adjudication methods are relevant for evaluating diagnostic performance, typically of AI tools or human readers.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable/not mentioned in this document. Such studies are conducted for diagnostic devices (often AI-assisted) to evaluate the impact on human reader performance, which is not the subject of this 510(k) for a surgical staple.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not mentioned because the device is a physical surgical staple, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided for a physical medical implant. The "ground truth" for this device revolves around its physical and mechanical properties, material biocompatibility, and its intended use aligning with established surgical procedures, rather than diagnostic accuracy. Its performance is evaluated against engineering standards (e.g., ISO 8827) and comparison to legally marketed predicate devices for similar applications.
8. The sample size for the training set
This information is not applicable/not provided as the device is a physical surgical staple, not an AI/algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided as the device is a physical surgical staple, not an AI/algorithm requiring a training set and corresponding ground truth.
§ 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.