(90 days)
Bone plates and screws from the Smith and Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include, fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.
The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.
The subject of this Traditional 510(k) premarket notification is to expand the indications of the already existing, cleared Smith & Nephew Cannulated Screws and Washers by adding osteotomies and arthrodesis. The subject devices are part of the Smith and Nephew Bone Plate System cleared under 510(k) number K993106 and K060736 with the same original indications but the subject 4.0mm, 5.5mm, 6.5mm, 7.0mm and 8.0mm cannulated screws and associated washers have additional indications independent of the Bone Plate System.
The screws vary in diameter, length and thread length; have fluted screw tips for self-tapping and self-drilling and have a hexagonal screw heads. The screws may be used with bone washers to extend the surface area of the head if needed. These screws are cannulated to allow the screws to be accurately positioned with the use of a guidewire instrument. The device offering consist of diameters of 4.0mm, 5.5mm, 7.0mm and 8.0mm in titlanium allov and stainless steel.
This is a 510(k) premarket notification for a medical device (Smith & Nephew Cannulated Screws and Washers), not an AI/ML medical device. Therefore, much of the requested information regarding acceptance criteria and study design for AI/ML performance is not applicable to this document.
However, I can extract information related to the device's functional performance and how its safety and effectiveness were demonstrated through bench testing and comparison to predicate devices.
Here's a summary of the information relevant to the device's acceptance criteria and the study that demonstrates it meets those criteria, rephrased to align with the spirit of your request where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric/Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance: Three-point bend fatigue | "Capable of withstanding expected in vivo loading without failure" (relative to predicates) | 4.0mm Screws (Ti and SS): Performed "equal or better" than the S&N 3.0mm SS screw (predicate). |
| 5.5mm Screws (Ti and SS): Performed "equal or better" than the Synthes titanium 4.5mm screw (predicate). | ||
| Mechanical Performance: Static torsional | "Capable of withstanding expected in vivo loading without failure" (relative to predicates) | 4.0mm Screws (Ti and SS): Performed "equal or better" than the S&N 3.0mm SS screw (predicate). |
| 5.5mm Screws (Ti and SS): Performed "equal or better" than the Synthes titanium 4.5mm screw (predicate). | ||
| Mechanical Performance: Axial pullout bend test | "Capable of withstanding expected in vivo loading without failure" (relative to predicates) | 4.0mm Screws (Ti and SS): Performed "equal or better" than the S&N 3.0mm SS screw (predicate). |
| 5.5mm Screws (Ti and SS): Performed "equal or better" than the Synthes titanium 4.5mm screw (predicate). | ||
| Biocompatibility/Material Safety (Chemical Composition): | Mechanical properties of Ti 6 Aluminum-7 Niobium should be similar to Ti 6 Aluminum-4 Vanadium (if substituting) | Bench testing showed the subject screws (possibly using Ti 6 Aluminum-7 Niobium, if this was the material in question as compared to the predicate's Ti 6 Aluminum-4 Vanadium) performed "equal or better" than the predicate screw made with the original material. The manufacturer of the raw material stated the mechanical properties are "almost identical" and it's a "common alloy used in orthopedic implants." This demonstrates the difference does not affect safety and effectiveness. |
| Substantial Equivalence: Indications for Use | Similar to predicate devices. | The subject device shares "very similar indications for use and intended use" with predicate devices. The expanded indications (osteotomies and arthrodesis) are consistent with existing predicate devices. |
| Substantial Equivalence: Design features | Similar to predicate devices. | "Similar in dimensions (screw diameter, screw length)," cannulated, varying thread lengths, offered with accessory bone screw washers. (Minor differences in screw head dimensions and thread length were deemed not to affect safety/effectiveness). |
| Substantial Equivalence: Operational principles | Similar to predicate devices. | Implied similarity is based on the devices being "cannulated screws and washers" for bone fixation. |
| Substantial Equivalence: Material composition | Similar to predicate devices. | Both offered in Stainless Steel (SS) and Titanium (Ti) Alloy. (Minor difference in specific Ti alloy composition for one predicate was addressed). |
Study Details:
Since this is a submission for a traditional medical device (cannulated screws and washers), the "study" demonstrating performance is primarily bench testing and comparison to predicate devices to establish substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical sample size in terms of "cases" or "patients" as would be for an AI/ML study. Instead, the "test set" consists of physical samples of the Smith & Nephew Cannulated Screws (4.0mm and 5.5mm in both Ti and SS) used for mechanical bench testing.
- Data Provenance: The mechanical testing was conducted by Smith & Nephew, Inc. at their facilities, using their manufactured devices and predicate devices. No patient or human data is involved in this type of testing for substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. For a traditional mechanical device, the "ground truth" for performance is established through objective physical measurements and engineering standards in bench testing. There are no "experts" establishing ground truth in the context of interpreting medical images or diagnoses. The interpretation of test results would be done by qualified engineers.
4. Adjudication Method for the Test Set
- Not Applicable. Mechanical bench testing results are quantitative and objective. There is no subjective interpretation requiring adjudication among multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI/ML device, so an MRMC study is not relevant or performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Bench Test Results / Engineering Standards: The "ground truth" for showing the device meets its performance criteria is based on direct measurements of mechanical properties (fatigue, torsion, pullout strength) against established engineering standards and comparisons to the performance of legally marketed predicate devices. The goal is to demonstrate that the new device performs "equal or better" than existing similar devices, suggesting it is safe and effective for its intended use.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.