(81 days)
Both the Surgical Dynamics™ Bone Pin** and the Poly-Medics Lactosorb® Bone Pin (K953194) are intended for fixation of small bone fragments in non-load bones with appropriate immobilization.
The Surgical Dynamics™ Bone Pin** is a resorbable fixation pin intended for fixation of small bone fragments in non-load bones with appropriate immobilization. It will be available in a range of sizes and will be supplied without attached K-wires.
I apologize, but the provided text describes a medical device (Surgical Dynamics™ Bone Pin) and its intended use, materials, and predicate device. It is a 510(k) premarket notification summary from 1997.
This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific details requested in your prompt (e.g., MRMC studies, standalone performance, training set details).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input, as the necessary information is completely absent.
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United States Surgical Corporation 510(k) Premarket Notification Surgical Dynamics™ Bone Pin** MAR 2 5 1997 K9 +0036 510(k) SUMMARY OF INFORMATION: United States Surgical Corporation SUBMITTER: 150 Glover Avenue Norwalk, CT 06856 (203) 845-1000 CONTACT PERSON: Melissa Mazzoni December 31, 1996 DATE PREPARED: CLASSIFICATION NAME: Pin, Fixation, Smooth or threaded metallic bone fixation fastener COMMON NAME: Fixation Pin or Rod Trademark name not yet determined. PROPRIETARY NAME: The Surgical Dynamics™ Bone Pin** is a resorbable DEVICE DESCRIPTION: fixation pin intended for fixation of small bone fragments in non-load bones with appropriate immobilization. It will be available in a range of sizes and will be supplied without attached K-wires. Poly-Medics Lactosorb® Bone Pin (K953194) PREDICATE DEVICE: Both the Surgical Dynamics™ Bone Pin** and the Poly-INTENDED USE: Medics Lactosorb® Bone Pin (K953194) are intended for fixation of small bone fragments in non-load bones with appropriate immobilization. Both the Surgical Dynamics™ Bone Pin** and the Poly-MATERIALS: Medics Lactosorb® Bone Pin (K953194) are comprised of biosafe materials.
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§ 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.