(29 days)
The Smith & Nephew Bone Plate System is 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, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; hip arthrodesis, and provisional bone fixation.
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are for single use only.
The subject devices are line additions to the Smith & Nephew Bone Plate System. These line additions are comprised of 6.5mm and 8.0mm diameter Cannulated Screws, which are self-tapping and self-drilling screws with a cancellous thread that can be guided into position through use of a guide-wire. These devices are available partially or fully threaded. Partially threaded Cannulated Screws are available in overall lengths ranging from 30mm - 180mm and with thread lengths of 16mm, 40mm and 47mm. Fully threaded Cannulated Screws are available in overall lengths ranging from 30mm - 180mm. Three washer configurations will also be made available as accessory items. Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are manufactured from stainless steel and titanium materials.
This submission is for a traditional 510(k) for medical devices, specifically bone screws, not for an AI/ML powered device. Therefore, the detailed information requested about acceptance criteria, study methodologies for AI/ML performance, sample sizes, expert ground truth establishment, adjudication methods, and MRMC studies is not applicable.
The submission focuses on demonstrating "substantial equivalence" to predicate devices already on the market, based on similarities in indications for use, design features, operational principles, and material composition.
Here's a breakdown of the relevant information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like these bone screws, "acceptance criteria" are generally related to their mechanical properties and biological compatibility, ensuring they can withstand normal physiological loads and are safe for implantation. Performance is demonstrated through similarity to existing devices and, implicitly, through mechanical testing.
| Acceptance Criteria Category | Reported Device Performance (as implied by Substantial Equivalence) |
|---|---|
| Indications for Use | Identical to predicate devices (pelvic, small and long bone fracture fixation for adult and pediatric patients including specific bone fractures, hip arthrodesis, provisional bone fixation). |
| Design Features | 6.5mm and 8.0mm diameter Cannulated Screws, self-tapping, self-drilling, cancellous thread, guided by guide-wire, available partially or fully threaded (30-180mm lengths), various thread lengths (16mm, 40mm, 47mm), three washer configurations. These are similar to predicate devices. |
| Operational Principles | Identical to predicate devices. |
| Material Composition | Manufactured from stainless steel and titanium materials, similar to predicate devices. |
| Mechanical Strength/Integrity | "A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure." (Specific numerical acceptance criteria for mechanical tests are not detailed in this summary document but would be part of the full submission.) |
| Biological Compatibility | Implied equivalent to predicate devices, which are already accepted for implantation in human body. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for a 510(k) submission showing substantial equivalence for mechanical devices. The "test set" would refer to mechanical testing of the screws themselves, not a dataset of patient information. The document states "test data" was reviewed, implying mechanical/bench testing, not clinical trials or data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for mechanical device performance is established through engineering specifications, biomechanical principles, and standardized testing methods, not expert consensus on patient data.
4. Adjudication Method
Not applicable for this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is for AI/ML-powered diagnostic or assistive devices, not bone screws.
6. Standalone Performance Study
Not applicable. This concept pertains to AI/ML software.
7. Type of Ground Truth Used
For this device, the "ground truth" for demonstrating safety and effectiveness relies on:
- Engineering Specifications and Bench Testing: Mechanical properties (e.g., torsion, bending, pull-out strength, fatigue life) are tested against established engineering standards and compared to the performance of predicate devices.
- Material Standards: Conformance to industry standards for medical-grade stainless steel and titanium.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the safety and effectiveness profile of the already cleared predicate devices (K993106, K903810, K000080, and K051296).
8. Sample Size for the Training Set
Not applicable. There is no AI/ML training set for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/ML training set.
§ 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.