(84 days)
The Hansson Pin™ System is intended for the treatment of reducible intracapsular femoral neck fractures, i.e. subcapital and transcervical fractures, and has been designed to minimize surgical trauma to the patient and offer secure, stable fixation.
The Hansson Pin™ System is a femoral neck fracture fixation device. Each pin consists of two parts: an outer sleeve and an inner sliding tongue, and is provided pre-assembled. The outer sleeve features a proximal window, where the inner sliding tongue's hook protrudes when properly introduced. Two pins are inserted into parallel drill holes through the femoral neck and into the femoral head. Fixation of the pin in the femoral head is achieved when the inner sliding tongue is intraoperatively pushed up partially through the proximal window, and the end hook curls around into the subchondral bone. The pins measure 6.5mm in diamctcr, are available in lengths ranging from 80mm to 150mm, and are made of ASTM F-138 Stainless Steel 316 LVM.
This document, a 510(k) premarket notification summary for the Hansson Pin™ System, does NOT contain information about acceptance criteria or a study proving that the device meets those criteria.
Instead, the document focuses on:
- Device Identification: Naming the device, its common name, and classification.
- Predicate Device Identification: Stating that the Hansson Pin™ System is substantially equivalent to other legally marketed Class II femoral neck fracture fixation devices (Howmedica Knowles Hip Pins, Zimmer Knowles Hip Pins, and Howmedica Gouffon Hip Pin System).
- Device Description: Detailing the components, mechanism of action, dimensions, and material of the Hansson Pin™ System.
- Intended Use: Specifying the type of fractures the device is designed to treat.
- Statement of Technological Comparison: Highlighting similarities with predicate devices in materials, intended use, and surgical procedures, while noting a difference in the fixation method. It vaguely mentions that "testing performed substantiates the use of the subchondral bone end hook design for fixation of the pins," but does not provide any details about this testing, including acceptance criteria, study design, or results.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
- Adjudication method for the test set: Not applicable.
- 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, as this device is a physical medical device (femoral neck fracture fixation system), not an AI/software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This document describes a physical medical device, and the information provided is typical for a 510(k) summary focused on substantial equivalence to predicate devices, rather than detailed performance study results against specific acceptance criteria.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.