(62 days)
The Medline UNITE® REFLEX™ Nitinol Staples are intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as : 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 (Nitinol). 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 8mm to 25mm x 27mm. The Medline UNITE® REFLEX™ Nitinol Staples are offered in three different bridge widths. The MNI features a 1.5mm bridge width, the MAX has a 4.0mm bridge width and the ULTRA has a 5.0mm bridge width. The MAX and ULTRA staples have a chamfer on the bridge that is not present on the MINI version of the staples. The system includes reusable instrumentation necessary to implant the staples, e.g. drill guides, drill bits, pins and an inserter.
The provided document describes the Medline UNITE® REFLEX™ Nitinol Staple System (K210482), a metallic bone fixation device, and its substantial equivalence determination by the FDA. The information focuses on non-clinical (bench) testing, as no animal or clinical testing was performed for this 510(k) submission.
Since the submission is for a traditional 510(k) for a metallic bone fixation device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to bench testing for mechanical and material properties, rather than AI/software performance as would be typical for an AI-powered medical device.
Therefore, the response will interpret the request within the context of the provided document, focusing on the mechanical and material performance testing rather than AI-specific criteria.
Here's a breakdown based on the provided text:
Preamble: This 510(k) submission is for a physical medical device (bone staples), not an AI/software device. Consequently, the "acceptance criteria" and "study proving the device meets the acceptance criteria" pertain to benchtop performance testing (mechanical and material properties) to demonstrate substantial equivalence to a predicate device, rather than AI model performance (e.g., sensitivity, specificity, AUC). Therefore, many of the requested points (e.g., number of experts for ground truth, MRMC study, training/test set sample sizes, data provenance for AI) are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
The document details performance testing conducted to show substantial equivalence. The specific numerical acceptance criteria and exact reported performance values are not explicitly stated in the summary, but rather implied by the statement that testing was "conducted to ensure that the proposed Medline UNITE® REFLEX™ Nitinol Staples are equivalent to the predicate FuseForce Implant System." For 510(k) submissions of this type, the acceptance criterion is typically that the subject device's performance is demonstrably equivalent or superior to the predicate device within a specified statistical margin, or meets established ASTM standards.
| Acceptance Criteria Category | Basis of Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|---|
| Elastic Static Bend Testing (per ASTM F564.A4) | Proposed device's bending stiffness is equivalent to the predicate FuseForce Implant System. | Testing was conducted to ensure equivalence. (Specific numerical results are not provided in this summary, but the conclusion is that they are equivalent). |
| Constant Amplitude Bending Fatigue Testing (per ASTM F564.A1) | Proposed device's bending fatigue performance is equivalent to the predicate FuseForce Implant System. | Testing was conducted to ensure equivalence. (Specific numerical results are not provided in this summary, but the conclusion is that they are equivalent). |
| Pull-Out Strength Testing (per ASTM F564.A2) | Proposed device's pull-out strength is equivalent to the predicate FuseForce Implant System. | Testing was conducted to ensure equivalence. (Specific numerical results are not provided in this summary, but the conclusion is that they are equivalent). |
| Corrosion Susceptibility Testing (per ASTM F2129) | All samples achieve electrostatic breakdown potential (Eb) equal to or greater than +400mV, as per FDA guidance (Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol) and Corrosion Testing of Medical Implants. | Testing was conducted to ensure the proposed device meets the outlined criteria. (Specific numerical results are not provided in this summary, but the conclusion implies this criterion was met). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the summary for each specific test (e.g., how many staples were bend tested, how many for corrosion). For bench testing, sample sizes are typically determined by statistical power requirements to demonstrate equivalence to the predicate or adherence to a standard, and can vary by test type.
- Data Provenance: The studies were non-clinical bench tests performed by Medline Industries, Inc. (location: Northfield, Illinois, USA). This is retrospective in the sense that the testing was performed to support the 510(k) submission for the device already designed and manufactured. There is no patient or image data involved.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a bench test for a physical device, not an AI/software device requiring "ground truth" established by human experts on clinical data. The "ground truth" for these tests is the quantitative measurement of mechanical and material properties against established ASTM standards and the performance of the predicate device.
4. Adjudication Method for the Test Set
- Not Applicable. As this is bench testing of physical properties, there is no human adjudication process involved. Measurements are objective and quantitative.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- Not Applicable. MRMC studies are used for assessing the performance of medical imaging interpretation systems, particularly AI-assisted reading, by comparing human readers with and without AI assistance across multiple cases. This submission is for a physical orthopedic implant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not Applicable. This point refers to AI algorithm performance. The Medline UNITE® REFLEX™ Nitinol Staple System is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Bench Test Results Against Predicate & Standards: The "ground truth" for this device's performance evaluation comes from:
- Quantitative measurements of mechanical and material properties (e.g., bending stiffness, fatigue life, pull-out strength, corrosion potential).
- Comparison of these measurements against the performance of the legally marketed predicate device (FuseForce Implant System).
- Adherence to specified ASTM international standards (ASTM F564, ASTM F2129).
8. The Sample Size for the Training Set
- Not Applicable. This question relates to AI/machine learning models. The device is a physical product, and no training set (in the ML sense) was used. The device design and manufacturing processes are based on established engineering principles and material science.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no "training set" for an AI model, this question is not relevant to this submission. The "ground truth" in physical device development is often internal R&D, design specifications, and the historical performance of similar devices and materials.
§ 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.