(271 days)
The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) ages 2 to 21. It is indicated for correction of the following conditions:
- Diaphyseal fracture of the femur, tibia and humerus ●
- . Fractures of the femoral neck
- Subtrochanteric, intertrochanteric and combination fractures ●
- . Correction of deformities (OI, Coxa vara, Coxa valga)
- . Nonunions and malunions
The GAP Endo-Exo Medullary System consists of an intramedullary cannulated nail linked to various types of plates via lag and/or mechanical screws creating a combined Endomedullary/ Exomedullary osteosythesis device. The nail is available is diameters ranging from 4.8 to 12.0mm in 0.8mm increments. Lengths available range from 160 to 320mm. 2.5, 3 and 4mm cortical screws are used to secure the nail to the bone.
The provided text is a 510(k) summary for the Pega Medical Inc.'s GAP Endo-Exo Medullary System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through clinical studies in the way an AI diagnostic device would.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device (especially an AI-driven one) meets those criteria. Specifically:
- It does not present a table of acceptance criteria or reported device performance for an AI device.
- It does not mention sample sizes for test sets, data provenance, or details about ground truth establishment by experts.
- It doesn't discuss adjudication methods, multi-reader multi-case studies, or standalone algorithm performance.
- There's no mention of training sets or their ground truth establishment.
Instead, this document details a biomedical device's substantial equivalence to a predicate device based on design, materials, manufacturing, and in-vitro biomechanical testing for a design modification. It explicitly states:
- "No Animal or Clinical testing was performed."
- "No clinical testing is provided as a basis for substantial equivalence."
The "Non-clinical Performance Data" section describes bench testing:
- Study: Bench testing in static and fatigue loading with an offset axial compression test set-up.
- Purpose: To evaluate the modified design of the distal holes of the 4.8 mm GAP Nail.
- Finding: The new design increases mechanical resistance and fatigue life compared to the predicate Ø4.8mm GAP Nail design.
This information is relevant to the mechanical properties of an implant, not the diagnostic performance of a device, especially an AI one.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.