(18 days)
SPS Small Fragment Set The Stryker Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following: One third tubular plate: fibula, metatarsals, metacarpals Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation, Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
This Special 510(k) submission is a line extension to address modifications to the Stryker® Plating System (SPS), which includes the SPS Small Fragment Set, the SPS Basic Fragment Set, the SPS Pelvic Set and the Stryker Locked Plating Set. This line extension is to add additional styles of monoaxial plates based on the SPS Small Fragment Set and the SPS Basic Fragment Set.
This document describes a Special 510(k) submission for a line extension to the Stryker® Plating System. It focuses on the substantial equivalence of the new components to existing predicate devices, rather than a study proving device performance against acceptance criteria in the traditional sense of a clinical or analytical performance study for a novel device.
Therefore, many of the requested elements for a performance study (like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, and training set information) are not applicable in this context. The acceptance criteria here are about demonstrating that the modified device maintains the same safety and effectiveness as its already-cleared predicates.
Here's a breakdown based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance (Stated Equivalence) |
|---|---|
| Intended Use: The modifications to the device must not alter the intended use of the predicate systems. | "The modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below... The subject plates and subject accessories have the same indications as cleared their predicates." |
| Indications for Use: The new components must have the same indications for use as their predicates. | The document explicitly lists the indications for use for the SPS Small Fragment Set and SPS Basic Fragment Set, and states: "The subject plates and subject accessories have the same indications as cleared their predicates." This is further reiterated in the FDA's "Indications for Use" enclosure. |
| Substantial Equivalence (Design, Performance, Operational Principle): The new components must be substantially equivalent to their predicates in design, performance, and operational principle as internal fixation components to ensure safety and effectiveness. | "These additional monoaxial components are substantially equivalent to their predicate systems from the Stryker® Plating System in respect to design, intended use, performance and operational principle as internal fixation components." The FDA's 510(k) clearance itself is a determination that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies the FDA concurred with the applicant's assessment that the design, performance (presumably mechanical testing, biocompatibility, etc., as per similar predicate devices, though not detailed in this summary), and operational principles are equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study with a test set of data in the traditional sense of evaluating an algorithm's performance on a dataset. The "test" here refers to the comparisons made to predicate devices for substantial equivalence. The data provenance would be the design and manufacturing specifications of the new components compared against those of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth, in the context of device performance, usually refers to a definitive diagnosis or reference standard. Here, the "ground truth" for substantial equivalence is the FDA's regulatory framework and the established safety and effectiveness profiles of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There's no specific adjudication method described for a "test set" as this is a regulatory submission demonstrating substantial equivalence, not a performance trial. The FDA's review process itself serves as the "adjudication" for the substantial equivalence claim.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is performed to evaluate the diagnostic accuracy of a medical imaging device with and without AI assistance across multiple readers and cases. This document is for a bone plating system, not an imaging device, and its purpose is to demonstrate substantial equivalence, not comparative effectiveness of human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device (bone plating system), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for this submission is the established regulatory compliance and performance of the predicate devices. The new components are asserted to be equivalent to these cleared devices, meaning they meet the same safety and effectiveness standards already accepted by the FDA for the predicates.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.