(43 days)
The Medline UNITE® REFLEX® Nitinol Staples are intended to provide fixation for fractures of the bones of the hand and foot such as: First metatarsalcuneiform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.
The Medline UNITE® REFLEX® Nitinol Staples are manufactured from nickel titanium alloy (Nitimol). The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The system includes staples offered in a range of sizes from 8mm x 20mm x 20mm. The Medline UNITE® REFLEX® Nitinol Staples are offered in different bridge lengths and include 2-leg and 4-leg staples. The system also includes reusable instrumentation necessary to implant the staples, e.g. drill guides, drills, locating pins, staple inserter, and tamp.
The document describes the Medline UNITE® REFLEX® Nitinol Staple System and its substantial equivalence to a predicate device. The information is limited to non-clinical bench testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Bending Strength/Stiffness per ASTM F564 | Not explicitly stated, implied to be equivalent to predicate. | Subject staples perform equivalently to predicate staples in bending strength/stiffness. |
| Pullout Performance per ASTM F564 | Not explicitly stated, implied to be equivalent to predicate. | Subject staples perform equivalently to predicate staples in pullout performance. |
| Corrosion Susceptibility per ASTM F2129 and FDA Guidance | Electrostatic breakdown potential in excess of minimum acceptance criteria. | All samples achieved electrostatic breakdown potential in excess of the minimum acceptance criteria, demonstrating acceptable corrosion susceptibility. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the bench tests. The tests performed are non-clinical (bench tests). No information is provided regarding the country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for this device is established through engineering analysis and bench testing, not expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical bench test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a non-clinical bench test for a medical device (staple system), not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (staple system), not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Engineering analysis: Comparing the subject device's design and expected mechanical performance to the predicate device.
- Bench testing: Controlled laboratory tests (e.g., bending, pullout, corrosion) against established ASTM standards and FDA guidance.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is a physical medical device undergoing non-clinical testing, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
Study Proving Device Meets Acceptance Criteria
The study proving the device meets its acceptance criteria is a series of non-clinical bench performance tests and engineering analyses.
- Engineering Analysis: An initial engineering analysis was performed to determine that the subject Medline UNITE® REFLEX® Nitinol Staples do not represent a new worst-case in terms of bending and pullout performance when compared to the previously cleared predicate device (K210482). A further engineering analysis was conducted to identify the worst-case staple for corrosion susceptibility.
- Performance Testing (Bench):
- Bending Strength/Stiffness and Pullout Performance: Engineering analysis was used to compare these characteristics of the subject staple to the predicate staples (K210482) per ASTM F564. The results indicated substantial equivalence.
- Corrosion Susceptibility Testing: This was conducted per ASTM F2129 and the FDA guidance document "Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol." The testing ensured that the proposed staples met predefined acceptance criteria. All samples achieved an electrostatic breakdown potential exceeding the minimum acceptance criteria, demonstrating acceptable corrosion susceptibility.
Conclusion of the Study: Medline Industries, LP concluded that the subject Medline UNITE® REFLEX® Nitinol Staple System is as safe and effective for its intended use as the predicate device (K210482) based on these non-clinical tests and analyses. No animal or clinical testing was performed.
§ 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.