(112 days)
The Valkyrie Thoracic Fixation System is indicated for use in the stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.
The Valkyrie Thoracic Fixation System consists of a variety of screws and plates intended for use in the stabilization and fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.
To accommodate varying patient anatomy and surgeon preference, the Valkyrie Thoracic Fixation System includes screws in diameters from 2.5mm to 3.5mm diameters and lengths from 7-20mm. The system also includes various styles of plates. The Valkyrie Thoracic Fixation System plates are made from PEEK per ASTM F2026, and the screws are made from Ti-6Al-4V per ASTM F136.
The provided text is a 510(k) summary for the Valkyrie Thoracic Fixation System, which is a medical device for stabilizing chest wall fractures. It is not a software-as-a-medical-device (SaMD) or AI product. Therefore, the questions regarding acceptance criteria and studies typical for AI/SaMD are not applicable to this document.
The document discusses the mechanical and material aspects of the device and its substantial equivalence to a predicate device, not the performance of an algorithm.
However, I can extract the acceptance criteria and related information for the device's physical attributes as described in the summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| MR Conditional Labeling | Magnetically induced displacement force | Not explicitly stated, but implies compliance with ASTM F2052. | "All testing has met the documented acceptance criteria." |
| Magnetically induced torque | Not explicitly stated, but implies compliance with ASTM F2213. | "All testing has met the documented acceptance criteria." | |
| MR Image artifact | Not explicitly stated, but implies compliance with ASTM F2119. | "All testing has met the documented acceptance criteria." | |
| Radio frequency induced heating | Not explicitly stated, but implies compliance with ASTM F2182. | "All testing has met the documented acceptance criteria." | |
| Additional Screw Sizes | Screw torsional strength testing | Not explicitly stated, but implies compliance with ASTM F543. | "All testing has met the documented acceptance criteria." |
| Screw axial pullout strength testing | Not explicitly stated, but implies compliance with ASTM F543. | "All testing has met the documented acceptance criteria." | |
| Screw driving torque testing | Not explicitly stated, but implies compliance with ASTM F543. | "All testing has met the documented acceptance criteria." | |
| General | Material composition, manufacturing process, sterilization, and packaging | Substantially equivalent to predicate device (K202889). | Substantially Equivalent to the predicate device (K202889) in these aspects. |
Regarding the other points, as this is a physical medical device and not an AI/SaMD, the following information is not present or applicable in the provided text:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components of the device, and the testing is laboratory-based mechanical and MR compatibility testing, not data-driven performance evaluation.
- 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. "Ground truth" in this context would refer to established engineering standards (ASTM standards in this case), not expert interpretation of data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is not a concept used for mechanical and material testing of a physical device.
- 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 for an AI-assisted diagnostic tool, which this device is not.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical tests, the "ground truth" is defined by the requirements of the ASTM standards (F2052, F2213, F2119, F2182, F543). The ultimate "ground truth" for regulatory approval is demonstrating substantial equivalence to a legally marketed predicate device.
- The sample size for the training set: Not applicable. There is no training set for a physical device.
- 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.