(275 days)
The Stryker SonicPin™ System is intended to maintain alignment and fixation of bone fractures, osteotomies, or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast, brace). The Stryker SonicPin™ is designed only to be inserted with the ultrasonic driver of the Stryker SonicPin™ System.
The Stryker SonicPin™ System consists of a bioresorbable implant pin made of a PLDLA copolymer and an ultrasonic unit (generator and sonotrode). Pins are implanted using ultrasonic energy generated by an ultrasonic unit, allowing the pin to adapt to the previously drilled hole. Its intended use is the correction of the Hallux Valgus deformation.
The provided text is a 510(k) summary for the Stryker SonicPin™ System. This document focuses on demonstrating substantial equivalence to predicate devices based on intended use, indications for use, technological characteristics, design, materials, and operational principles. It does not contain information about acceptance criteria or a study that evaluates device performance against specific metrics.
Therefore, I cannot provide the requested information, as the input document does not detail:
- Acceptance criteria and reported device performance: No specific performance metrics or acceptance criteria are listed.
- Sample size for test set and data provenance: No test studies or associated data are mentioned.
- Number of experts and their qualifications: No expert involvement in establishing ground truth is described.
- Adjudication method: Not applicable as no ground truth establishment is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone performance study: No standalone algorithm performance study is described.
- Type of ground truth used: Not applicable as no ground truth is established.
- Sample size for the training set: No training sets are mentioned.
- How ground truth for the training set was established: Not applicable as no ground truth for training is mentioned.
The document is a regulatory submission for substantial equivalence based on a comparison to existing devices, not a performance study evaluating the device against a set of 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.