(143 days)
SHOULDER: Acromio-clavicular; Bankart repair; Biceps tenodesis; Capsule shift/capsulolabral reconstruction; Deltoid repair; Rotator cuff repair; SLAP lesion repair. ANKLE: Achilles tendon repair/reconstruction; Lateral instability; Medial instability; Midfoot reconstructions. FOOT: Hallux valgus reconstruction. WRIST: Scapholunate ligament reconstruction. HAND: Ulnar or lateral collateral ligament reconstruction. ELBOW: Biceps tendon reattachment; Tennis elbow repair. KNEE: Extra capsular reconstruction, ITB tenodesis; Lateral ligament; Patellar ligament and tendon avulsion repairs; Posterior oblique ligament or joint capsule to tibia; Joint capsule closure to anterior proximal tibia; Medial collateral ligament. BNS: Fixation in pubic bone for bladder neck suspension using USP #2 Class I nonabsorbable synthetic suture (e.g. polypropylene). A minimum of 2 Anchors should be used in this procedure.
The only proposition of this 510(k) submission is to add a "MR-Conditional" statement and symbol to all applicable product package-insert and labels of GII™ Anchor devices. Technological characteristics including indications, product design, material, and packaging are the same as the predicate devices.
The provided text describes a 510(k) submission for the DePuy Mitek GII™ Anchor, focusing on adding an "MR-Conditional" statement and symbol to the product. This submission is for a modification to an already marketed device, not for a new medical device that performs a diagnostic or predictive function.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or adjudication methods typically associated with studies proving the performance of AI/analytic devices.
The "Nonclinical Testing" section mentions "MRI Testing using a scanner operating with a static magnetic field was performed on the DePuy Mitek metal implant devices." and "Results of 'Evaluation of Magnetic Field Interactions, Heating, and Artifacts' have demonstrated that the currently marketed DePuy Mitek GII™ Anchors are 'MR-conditional'." This refers to physical testing to ensure safety in an MRI environment, not a study evaluating an algorithm's performance.
§ 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.