(267 days)
The TOMOFIX™ Medial High Tibia Plates are indicated for open- and closed-wedge osteotomies, fixation of fractures, and malalignment caused by injury or disease of the medial proximal tibia for the treatment of: Unicompartmental medial or lateral gonarthrosis with malalignment of the proximal tibia Idiopathic or posttraumatic varus or valgus deformity of the proximal tibia
The subject Titanium TomoFix™ Medial High Tibia Plate Anatomical is anatomically precontoured to fit the medial side of the proximal tibia (also referred to as high tibia) and is provided in a 'left' and 'right' version to accommodate the anatomy of the tibia in the left and right knee, respectively. The plate features seven round, threaded locking holes to provide a locked, fixed-angle construct and one combination locking / dynamic compression hole to allow temporary compression during the surgery. The subject plate is designed to accept existing, previously cleared 5.0 mm Locking Screws, 4.5 mm Cortex Screws and 5.0 mm Spacers
I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a device meets those criteria, as typically found in a medical device submission beyond a 510(k) summary. The document appears to be a 510(k) clearance letter and summary for a bone plate, focusing on substantial equivalence to a predicate device.
The 510(k) Summary for the "Titanium TomoFix™ Medial High Tibia Plate Anatomical" primarily addresses the substantial equivalence documentation, which involves comparing a new device to a legally marketed predicate device rather than establishing performance against specific acceptance criteria for a novel or de novo device.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not present quantitative performance metrics against predefined acceptance criteria for clinical or algorithmic performance. It discusses mechanical testing for equivalence.
- Sample size used for the test set and the data provenance: Not applicable to this type of submission, which relies on mechanical testing for equivalence, not a clinical test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not established in this document.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for a physical orthopedic implant, not an AI/imaging device requiring reader studies.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" here is mechanical equivalence demonstrated through testing against the predicate.
- The sample size for the training set: Not applicable to a physical implant.
- How the ground truth for the training set was established: Not applicable.
What the document does state regarding performance and equivalence:
- Acceptance Criteria & Performance (Implied for Equivalence): The document states that "Mechanical testing demonstrates substantial equivalence of the subject device to the predicate device." And "The subject device was tested under static and dynamic loading conditions to demonstrate mechanical equivalence compared to the predicate device." While specific numerical acceptance criteria (e.g., "must withstand X N of force") and reported performance values are not tabulated, the implicit acceptance criterion is that its mechanical performance is demonstrably equivalent to the predicate.
- The product is a "Titanium TomoFix™ Medial High Tibia Plate Anatomical," a bone plate used for osteotomies and fracture fixation. This is a physical orthopedic implant, not an AI/software device.
- The study referenced is mechanical testing (static and dynamic loading conditions) to demonstrate equivalence to the predicate device, not a study involving human readers or clinical data interpretation.
- Predicate Device: Titanium TomoFix™ Medial High Tibia Plate (cleared via K023941).
- Reference Device: TomoFix™ Medial High Tibia Plate, Small (cleared via K100676).
Therefore, this document does not contain the information requested, as it pertains to a different type of device submission (a 510(k) for substantial equivalence of a physical implant) than what your query implies (likely a software or AI/ML medical device).
§ 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.