(76 days)
The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
This submission is a line extension to the Stryker® Plating System to add alternate styles of plates and screws including locking plates, bone screws and locking screws for use in the foot and ankle.
The provided text is a 510(k) summary for the Stryker® Foot Plating System, which is a metallic bone fixation device. This type of device, being a physical implant, does not typically involve the kinds of "acceptance criteria" or "studies" that would include performance metrics like sensitivity, specificity, or reader studies, as requested by the prompt for AI/diagnostic devices.
Instead, the "acceptance criteria" and "study" for such a device are primarily focused on substantial equivalence to legally marketed predicate devices, and the physical and mechanical properties of the materials and design. The FDA's review for this type of device evaluates:
- Intended Use: Is it similar to predicate devices?
- Design: Are the plates and screws designed similarly?
- Materials: Are the materials (e.g., metals) known to be safe and effective for this application?
- Operational Principles: Does it function similarly for internal fixation?
The document confirms that this device is a "line extension" and is "substantially equivalent" to predicate devices like the Profyle® System, Stryker® Plating System, DARCO Locking Bone Plate System, and Synthes LCP Locking Calcaneal Plates and Modular Foot System.
Therefore, many of the requested fields are not applicable to this type of medical device submission. I will provide the information based on what is available and indicate when a field is not applicable or relevant to this specific device type.
Acceptance Criteria and Device Performance for Stryker® Foot Plating System
1. A table of acceptance criteria and the reported device performance
For a metallic bone fixation device, formal "acceptance criteria" in terms of clinical performance metrics (like those used for diagnostic algorithms) are not typically defined in a 510(k) summary. Instead, acceptance is based on demonstrating substantial equivalence to predicate devices regarding:
| Acceptance Criterion (Demonstrating Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Intended Use | The Stryker® Foot Plating System is intended for use in internal fixation, reconstruction or arthrodeses of small bones including the fore, mid- and hind foot and ankle, for procedures like replantation, lag screw techniques, joint fusions, corrective osteotomies, and treatment of fractures. This is found to be substantially equivalent to other plating systems regarding intended use. |
| Design | The device is a line extension to add alternate styles of plates and screws (including locking plates, bone screws, and locking screws) for use in the foot and ankle. It is found to be substantially equivalent to other plating systems regarding design. |
| Materials | The device uses metallic bone fixation materials. It is found to be substantially equivalent to other plating systems regarding materials. |
| Operational Principles | The device functions as internal fixation components. It is found to be substantially equivalent to other plating systems regarding operational principles. |
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 product is a physical implant (bone plate/screw system), not a diagnostic device or algorithm requiring a "test set" for performance evaluation in the context of imaging or clinical data. Substantial equivalence for such devices relies on physical, mechanical, and material testing, and comparison to predicates, rather than human data sets of the kind implied by the prompt.
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: As above, a "test set" with "ground truth" derived from human experts is not relevant for demonstrating substantial equivalence of a physical orthopedic implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No test set or expert adjudication in this context.
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 physical implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (or rather, different type of "ground truth"): For this device, the "ground truth" for demonstrating safety and effectiveness comes from established engineering principles, material science standards (e.g., biocompatibility confirmation), mechanical testing (e.g., fatigue, static strength), and the clinical history of the predicate devices. There is no biological "ground truth" in terms of a disease state as would be relevant for a diagnostic device.
8. The sample size for the training set
- Not Applicable: This product is a physical implant, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable: No training set.
§ 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.