(29 days)
The SternalPlate System is indicated for use in stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy, sternal fracture(s), and sternal reconstructive surgical procedures to promote bony fusion.
This Special 510(k) is submitted to evaluate the modifications to the Predicate Device plates resulting in the Subject Device plates. There have been no changes to the previously cleared plates and screws cleared in K183172, this submission is only for the addition of the four new Subject Device plates. The four Subject Device plates include T-Plates and Transverse Plates. Both Subject Device variants, the T-Plates and Transverse Plates, are geometrically derived from the following Predicate Device plates: the Ladder Plate Narrow (Reff/ 4740006) and the Straight 24-hole Plate (Ref# 4740012). The Subject Device plates therefore have the same features, the same tolerances, and are made from the same material as the Predicate Device plates. Furthermore, the Subject Device plates are manufactured with the same manufacturing process as the Predicate Device plates.
The provided FDA 510(k) summary (K243491) for the Stryker SternalPlate Expansion device focuses on the mechanical performance of the device and its biocompatibility. The document does not contain information related to software, AI, or human-in-the-loop performance. Therefore, many of the requested criteria cannot be extracted from this document.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the "Subject Device plates met all acceptance criteria as compared to the Additional Predicate Devices." However, the specific quantitative acceptance criteria (e.g., minimum stiffness, maximum deflection) and the detailed reported performance values are not explicitly stated in the provided 510(k) summary. The summary only mentions "appropriate strength and stiffness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "Performance Bench Testing" but does not specify the sample size for the mechanical tests. The tests compare the Subject Device to "Additional Predicate Devices," implying a comparative mechanical study rather than a clinical data-driven study. Data provenance (country of origin, retrospective/prospective) is not applicable as it's a bench test, not clinical data.
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)
This question is not applicable as the document describes mechanical bench testing of an orthopedic implant, not a diagnostic device requiring expert interpretation of images or data to establish a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the document describes mechanical bench testing. Adjudication methods are typically relevant for clinical studies or studies involving human readers/interpreters.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This document is for a physical orthopedic implant, not an AI-powered diagnostic tool. Therefore, the effect size of human readers with/without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical orthopedic implant, not a standalone algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance bench testing, the "ground truth" would be the engineering specifications and established mechanical testing standards against which the device's strength and stiffness are evaluated. The document states "The Subject Device plates met all acceptance criteria as compared to the Additional Predicate Devices," implying a comparison against established performance benchmarks of legally marketed devices.
8. The sample size for the training set
This question is not applicable as the device is a physical orthopedic implant. There is no concept of a "training set" in the context of mechanical bench testing for this type of device.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
§ 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.