(227 days)
The Wristore Fixator is intended to provide external fixation of the upper extremity. External fixation devices allow for three plane (axial, AP & medio/lateral) control over fractures and bone segments.
The materials utilized for the construction of the external elements of the Wristore Fixator are medical grade polyetherimide resin. This material is the identical material utilized to construct the Articulating Distal Radius Fixator (K984498). The materials utilized in the instruments and pin guides are instrument grade stainless steel. The pins and K-wires used to fix the fractured bones are produced from implant grade stainless steel (316L). The Wristore Fixator utilizes legally marketed commercially available fixation pins and/or K-wires. Once the provided K-wires and pins have been properly placed, the poly-resin external frame is tightened and the fracture(s) stabilized. Typical orthopaedic instrumentation is provided to place, tighten and adjust the fixator.
The provided document describes a 510(k) premarket notification for the "Wristore Fixator," an external fixator for upper extremity fractures. The focus of the document is on demonstrating substantial equivalence to legally marketed predicate devices, rather than on a clinical study proving specific performance criteria. Therefore, most of the requested information cannot be extracted directly from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document focuses on comparing design, materials, and intended use with predicate devices to establish substantial equivalence, not on pre-defined performance acceptance criteria and their fulfillment through a study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided. As no clinical study is detailed, there is no mention of a test set, sample size, or data provenance.
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 information is not provided. There is no mention of a test set requiring ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. There is no test set or adjudication method described.
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:
This information is not provided. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided. The device is a physical external fixator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. There is no clinical study described that would require a ground truth.
8. The sample size for the training set:
This information is not provided. There is no mention of a training set as this is not a machine learning device.
9. How the ground truth for the training set was established:
This information is not provided. There is no mention of a training set.
Summary of what is provided regarding the device:
- Device Name: Wristore Fixator
- Intended Use: External fixation of the upper extremity for Colles, mid, and proximal fractures. Allows for three-plane control (axial, AP & medio/lateral) over fractures and bone segments.
- Classification: Class II
- Substantially Equivalent Devices:
- Materials: Polyetherimide resin (external elements), stainless steel (instruments, pin guides, pins, K-wires).
- Sterilization: Supplied NON-STERILE; validated steam sterilization cycle: Gravity, 250° F (121° C) for 30 minutes.
The document primarily serves to demonstrate that the Wristore Fixator is substantially equivalent to existing devices based on its design, materials, and intended use, rather than presenting data from a performance study against specific acceptance criteria.
§ 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.