(77 days)
The Stryker AxSOS™ Small Fragment Plating System is intended for internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies in the following:
In Adults:
- 4mm Waisted Compression Plate radius, ulna, distal tibia, fibula, distal humerus, clavicle
- 4mm Locking Insert
- 4mm Locking Screws
- 3.5mm Cortical Screws
- 3mm One Third Tubular Plate - fibula, metatarsals, metacarpals
- 4mm Reconstruction Plate - humerus, pelvis
In Pediatrics:
- 4mm Waisted Compression Plate radius, ulna, distal tibia, distal humerus, clavicle
- 4mm Locking Insert
- 4mm Locking Screws
- 3.5mm Cortical Screws
The Stryker AxSOS™ Basic Fragment Plating System is intended for internal fixation, stabilization and support of long bone fractures as well as bone fixation osteotomies in the following:
In Adults:
- 5mm Waisted Compression Plate - Broad -femur, tibia, humerus, pelvis
- 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus, pelvis
- 5mm Locking Insert
- 5mm Locking Screws
- 4.5mm Cortical Screws
- 5mm Reconstruction Plate - femur, tibia, humerus, pelvis
In Pediatrics:
- 5mm Waisted Compression Plate -- Broad -femur, tibia, humerus
- 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus
- 5mm Locking Insert
- 5mm Locking Screws
- 4.5mm Cortical Screws
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to add the pediatric indication to a specific subset of plates, screws and inserts of the previously cleared Stryker Plating System (K060514). The components from the previously cleared system, some of which carry the pediatric indication, will make-up the system to be marketed as the AxSOS™ Locking Plate System. The indications for use will clarify which components will include the pediatric indication.
The provided text describes a 510(k) submission for the AxSOS™ Locking Plate System. This is a traditional 510(k) to add a pediatric indication to a previously cleared system, making it a medical device submission, not a study of a device employing AI. Therefore, the information requested in your prompt (e.g., acceptance criteria, test set sample size, ground truth, MRMC study, AI improvement effect size, training set, etc.) is not applicable to this document. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for pediatric use, particularly in fatigue resistance for long-term pediatric use. | Non-clinical compression fatigue testing demonstrated that the AxSOS™ Locking Plate Systems are substantially equivalent to devices currently cleared for market with pediatric indications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This submission relies on non-clinical (laboratory) testing, not clinical data or a test set in the context of an AI/algorithm study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This is a mechanical device submission, not an AI/algorithm study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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. This is a medical device submission, not an AI/algorithm study. There is no AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" equivalent for this type of device submission is the established performance benchmarks and regulatory requirements for similar predicate devices, particularly regarding mechanical integrity and fatigue resistance.
8. The sample size for the training set:
- Not applicable. This is a medical device submission, not an AI/algorithm study.
9. How the ground truth for the training set was established:
- Not applicable. This is a medical device submission, not an AI/algorithm study.
Summary of the study/submission:
The submission focuses on demonstrating substantial equivalence of the AxSOS™ Locking Plate System to previously cleared predicate devices (K082807- Synthes 3.5 and 4.5mm Locking Compression Plate (LCP) System and K060514- Stryker Locked Plating System) to add a pediatric indication.
- Non-Clinical Testing:
- Study performed: An additional compression fatigue testing was conducted for the subject plates, screws, and inserts.
- Purpose: To evaluate the fatigue resistance in long-term pediatric use.
- Conclusion: The testing demonstrated that the AxSOS™ Locking Plate Systems are substantially equivalent to devices currently cleared for market with pediatric indications.
- Clinical Testing: Not required for this submission.
Therefore, the "study" described is a non-clinical laboratory test specifically for compression fatigue, aimed at showing the new pediatric indications for the AxSOS™ Locking Plate System are as safe and effective as existing legally marketed predicate devices for pediatric use.
§ 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.