(121 days)
The CastleLoc Pectus Bar System is indicated for the treatment of Pectus Excavatum and other anterior chest deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.
The CastleLoc Pectus Bar System is a thoracic support product that repairs the thoracic wall, using minimally invasive surgical techniques to elevate the ribs and sternum to correct a type of chest wall deformity called pectus excavatum. Recommended implantation time is 2~3 years but may vary based on surgeon preference and patient.
This system includes various sizes of straight and curved CastleLoc Pectus Bars. The apropriate bar is selected based on suitability for the patient body size. The CastleLoc Pectus Bar, and Castleloc Pectus Stabilizer, Nut and Castleloc Pectus Claw Fixator for fixing the Castleloc Pectus Bar are made of Ti-6Al-4V (ASTM F136).
The provided text describes a 510(k) premarket notification for the "CastleLoc Pectus Bar System." This document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than an AI/ML medical device's performance evaluation against specific acceptance criteria.
Therefore, the information required to answer your prompt, which pertains to acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and specific study types (like MRMC or standalone performance for AI), is not present in the provided text.
The document discusses:
- Trade/Device Name: CastleLoc Pectus Bar System
- Regulation Number/Name: 21 CFR 888.3030, Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
- Regulatory Class: Class II
- Indications for Use: Treatment of Pectus Excavatum and other anterior chest deformities in pediatric and adult populations.
- Predicate Devices: Park's Pectus System (K191057) (primary), Pectus Blu Support Bar System (K241709), KLS Martin Pure Pectus System (K221938).
- Technological Comparison: States that the subject device is substantially equivalent to predicate devices in materials, design, indications for use, intended use, and operational principles.
- Non-Clinical Tests: Mentions static and dynamic 4-point bending test and vertical test according to ASTM F382-17 standards.
- Acceptance Criteria (for mechanical tests only): The mechanical performance test results were "shown to be similar or higher than the predicate device, Park's Pectus System (K191057), and meets the specified acceptance criteria." However, the specific numerical values of these acceptance criteria and the reported device performance are not detailed in the text.
- Conclusion: The tests verified mechanical performance and supported substantial equivalence in mechanical performance compared to the predicate device.
In summary, this document is a regulatory approval letter for a medical device (a pectus bar system), not a study report for an AI/ML medical device. It does not contain the detailed performance metrics, ground truth information, or study methodologies that your prompt requests for AI devices.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.