(86 days)
The OS2®-C Compression Staples are indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery.
The number and size of the OS2®-C Compression Staples must be adapted to the indication.
The OS2®-C Compression Staple is an osteosynthesis staple, enabling a constant and reproducible compression.
The OS2®-C Compression Staple is available in multiple lengths and interaxis. It is delivered sterile, ready to use, pre-assembled on its inserter.
The implant is manufactured from PEEK-OPTIMA®, polymer from Invibio®, and is designed for single use only.
Sizes:
The OS2®-C Compression Staple is available in various interaxis from 11mm to 15mm.
Material:
The OS2®-C Compression Staple is manufactured from PEEK according to standard ASTM F2026.
It does not have any coating.
Single use:
The OS2®-C Compression Staple is designed for single use only.
Sterilization:
The OS2®-C Compression Staple is supplied sterile, using gamma irradiation.
Place of use:
The OS2®-C Compression Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
The provided text primarily concerns the 510(k) premarket notification for the OS2®-C Compression Staple, a medical device. This document details the regulatory approval process and comparison to predicate devices, rather than describing an AI/ML powered medical device. As such, the information typically requested for AI/ML powered devices, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not present.
The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, a requirement for 510(k) clearance.
Here's an analysis based on the information that is provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of "acceptance criteria" in the context of an AI/ML algorithm's performance metrics (like accuracy, F1-score, etc.). Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices through various comparisons and mechanical testing. The reported "device performance" is therefore related to its mechanical properties and biocompatibility, not diagnostic or predictive accuracy.
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance |
|---|---|
| Similar Intended Use: OS2®-C Compression Staples indicated for fixation of arthrodesis, osteotomies, and fractures in hand or foot surgery. | The OS2®-C Compression Staples have the same indications for use as the predicate devices: "fixation of arthrodesis, osteotomies and fractures in hand or foot surgery." |
| Similar Technological Characteristics: Same intended use and design basis as predicates. | Design: Partially similar design to predicate devices (Integra / Newdeal UNI-CLIP, Memometal Easyclip, Biotech International / EOS Eleos Memory Staple). Differences in design are stated not to affect Safety and Effectiveness. |
| Material: Manufactured from PEEK-OPTIMA® (polymer from Invibio®) according to ASTM F2026, which is the same raw material as the Smith and Nephe Bioraptor 2.3 PK suture anchor (predicate). | |
| Equivalent Size Range: Similar range size to Biotech International Eleos Memory Staple, Integra / Newdeal UNI-CLIP, and Memometal Easyclip. | |
| Similar Principles of Operation: Operate similarly to predicate devices. | The document states "principles of operation are substantially equivalent to those of predicate devices." (No further operational details provided beyond being a compression staple for bone fixation). |
| Acceptable Performance Data (Mechanical): Mechanical properties comparable to predicate devices. | Performance assessment was made through mechanical comparison with predicate devices according to ASTM F564-06. The OS2®-C Compression Staple has similar mechanical properties when compared to the Biotech International Eleos Memory Staple (K112794). Results of testing performed indicated that the implants performed as expected for each test. |
| Biocompatibility: Safe for long-term implantation. | The implant is manufactured from PEEK-OPTIMA®, a polymer compliant with ASTM F2026. This material is widely accepted for biocompatibility in long-term implantation. (No specific biocompatibility study described in this summary, but implied by material choice and substantial equivalence). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of AI/ML testing. For mechanical testing, the sample size would refer to the number of staples tested according to ASTM F564-06. This number is not provided in the summary.
- Data Provenance: Not applicable in the context of AI/ML testing. The mechanical testing would have been conducted in a laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the device is not an AI/ML algorithm requiring expert-established ground truth for diagnostic or predictive performance. The ground truth for mechanical testing is based on engineering standards and measurements.
4. Adjudication method for the test set:
- Not applicable for the type of device and testing 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:
- Not applicable as the OS2®-C Compression Staple is a physical medical device, not an AI/ML system to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as the OS2®-C Compression Staple is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For the mechanical testing, the "ground truth" would be the specifications and performance characteristics defined by the applicable ASTM standard (ASTM F564-06) for metallic bone fixation devices.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable for the same reason as above.
In summary: The provided document is a 510(k) clearance letter for a physical medical device. It focuses on demonstrating substantial equivalence through comparison of intended use, technological characteristics (design, material, size), principles of operation, and mechanical performance with legally marketed predicate devices. The required information for AI/ML-powered device submissions, as outlined in your prompt, is not relevant to this document or device type.
§ 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.