(286 days)
Orthopedic Fixation Pin is indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants.
The Orthopedic Fixation Pin is straight, partially threaded; and has trocar point on one end. The device is available in various diameters and lengths to accommodate the specific indication. The pins are made from stainless steel in accordance with ASTM F138-13.
The provided text is a 510(k) premarket notification for an Orthopedic Fixation Pin. It focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, primarily through non-clinical performance data (bench testing and biocompatibility).
Crucially, this document does not describe a study that uses an AI/ML device, nor does it contain acceptance criteria or performance data for such a device. The "Orthopedic Fixation Pin" is a physical medical device, not a software or AI-driven diagnostic or assistive tool.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided input does not pertain to an AI/ML device.
Here's why the information you're asking for is absent in the document:
- Device Type: The "Orthopedic Fixation Pin" is a physical implant used for bone fixation. It is not an AI/ML algorithm or system.
- Performance Data: The performance data presented (static pullout, static torsion, tensile testing, biocompatibility) are standard engineering and materials tests for physical medical implants, not metrics like sensitivity, specificity, AUC, or reader performance improvement typically used for AI/ML devices.
- Clinical Studies: The document explicitly states, "No data from human clinical studies have been included to support the substantial equivalence of the proposed device, Orthopedic Fixation Pin, as clinical studies are not required for this medical device." This confirms that no clinical performance data, let alone data relevant to AI/ML device evaluation (like MRMC studies or human-in-the-loop performance), was generated or submitted.
- Ground Truth: The concept of "ground truth" as it applies to AI/ML (e.g., expert consensus on image interpretation, pathology reports) is not relevant to a physical pin. The "ground truth" for the pin is its adherence to material specifications and mechanical properties.
If you have a document describing an AI/ML medical device, please provide that, and I would be able to answer your questions.
§ 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.