(19 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 Fibular plate: fibula 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 plates based on the plates in the SPS Small Fragment Set and the SPS Basic Fragment Set.
The provided document is a 510(k) summary for the Stryker® Plating System. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving device performance against specific acceptance criteria through a clinical study in the way an AI/ML device submission would.
Therefore, many of the requested points related to acceptance criteria, specific studies, sample sizes, and ground truth establishment (which are common for AI/ML device evaluations) are not applicable or explicitly stated in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Design: The new components are similar in design to the predicate systems. | The additional styles of plates are based on the existing SPS Small Fragment Set and SPS Basic Fragment Set. |
| Intended Use: The new components do not alter the intended use of the predicate systems. | The indications for the subject plates and accessories are the same as their cleared predicates. |
| Performance: The new components perform similarly to the predicate systems. | The document asserts "substantial equivalence... in respect to design, intended use, performance and operational principle as internal fixation components." No specific performance metrics or studies proving this are detailed, as equivalence is often established through design comparison, materials, and (sometimes) mechanical bench testing for orthopedic implants, which are not included here. |
| Operational Principle: The new components function on the same operational principle as the predicate systems. | The document asserts "substantial equivalence... in respect to design, intended use, performance and operational principle as internal fixation components." |
Explanation: For a 510(k) submission, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate. The "reported device performance" is essentially the claim that the new device meets the equivalence standard in areas like design, intended use, performance, and operational principle. Specific quantitative performance metrics are usually not required for this type of submission unless a significant change that impacts safety or effectiveness is introduced, necessitating new testing.
2. Sample Size Used for the Test Set and the Data Provenance
- Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of analytical or clinical performance evaluations for an AI/ML device. The submission is for a physical medical device (bone plates and screws). The "sample size" here refers to the number of new plate styles being added to an existing system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable/Not provided. This is not relevant for a 510(k) for a bone plating system. Ground truth establishment with experts is a concept often applied to AI/ML clinical evaluations, not for demonstrating substantial equivalence of orthopedic implants.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. This concept is not applicable to this type of device submission.
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/Not provided. This is irrelevant as the device is a physical bone plating system, not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable/Not provided. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable/Not provided. The concept of "ground truth" as typically discussed in AI/ML device evaluations (e.g., pathology, outcomes data, expert consensus) does not apply directly here. For a bone plating system, the "truth" is established through design specifications, material properties, biocompatibility, and mechanical testing (though the details of such testing are not in this summary). Substantial equivalence is the primary "truth" being established in this document.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This device is not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. This device is not an AI/ML system that requires a "training set" or corresponding ground truth.
§ 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.