(77 days)
The Stryker Crossfire System is intended for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip. The Crossfire System provides abrasion, resection, debridement and removal of bone and soft tissue through its shaver blade; and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels, through its electrosurgical probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.
The Stryker Crossfire System consists of a console, footswitch, shaver handpiece and two possible disposable attachments (RF probe and shaver blade).
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This document is a 510(k) summary for the Stryker Crossfire System, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a study with acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the given text.
The document primarily states:
- Product Description: The Stryker Crossfire System consists of a console, footswitch, shaver handpiece, and two disposable attachments (RF probe and shaver blade).
- Indications for Use: Intended for orthopedic and arthroscopic procedures in various joints for abrasion, resection, debridement, bone and soft tissue removal (shaver blade), and ablation, coagulation, hemostasis of soft tissue and blood vessels (electrosurgical probe).
- Contraindications: Electrosurgical probe should not be used with nonconductive irrigants or in patients with pacemakers/electronic implants.
- Voluntary Safety and Performance Standards: The system conforms to numerous IEC, ISO, and EN standards.
- Predicate Devices: Stryker CORE (K032303), SERFAS Energy (K041810), and Total Performance Shaver (K973195) Systems.
- Substantial Equivalence: Claimed due to same intended use and no new questions of safety and effectiveness compared to predicate devices.
The FDA's letter confirms the substantial equivalence determination but does not detail specific performance studies.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.