(85 days)
INTEGRA® Total Foot System is indicated for skeletally mature patients for the following:
- Stabilization and fixation of fresh fractures
- Intra and extra articular fractures, joint depression, and multi-fragmentary fractures
- Revision procedures, joint fusion, and reconstruction of small bones of the feet.
The INTEGRA "Total Foot System consists of a variety of bone plates and screws intended to be used in fixating fractures, osteotomies, and fusions in the adult foot. The various plate designs are divided into forefoot, midfoot, and rearfoot applications. Plate designs include MPJ fusion, Opening Wedge, Calcaneus, Dwyer, Interpositioning, Lapidus, Reconstruction, 2-10 Hole Tarsalis, fibula, and fibula tubular plates. Screws include both locking and non-locking designs. All plates and screws are manufactured from ASTM F136 Ti-6Al-4V ELI alloy.
The provided text describes a 510(k) premarket notification for the "INTEGRA® Total Foot System," a medical device consisting of bone plates and screws. This type of submission is for demonstrating "substantial equivalence" to existing legally marketed devices, rather than proving efficacy through clinical studies with acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies.
The study described is a design verification and substantial equivalence comparison to predicate devices, not a study to prove performance against specific acceptance criteria.
Here's why the requested information is not available in this document:
- Acceptance Criteria and Reported Device Performance: The document states, "All new or redesigned components to this system were examined, and results of the verification activities demonstrated that the tests were acceptable and the components substantially equivalent to the predicate devices identified." It does not provide specific quantitative acceptance criteria (e.g., in terms of accuracy, sensitivity, specificity, or objective metrics) or actual performance data for the device. The "performance" being evaluated here is primarily mechanical and material equivalence to predicates.
- Sample Size for Test Set and Data Provenance: Not applicable. There is no "test set" in the context of clinical performance or algorithm evaluation. The "tests" mentioned are verification activities on the physical components.
- Number of Experts and Qualifications: Not applicable. There is no mention of experts establishing ground truth for a test set.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study relates to the diagnostic performance of humans with and without AI assistance, which is irrelevant for a bone fixation system.
- Standalone Performance: Not applicable. This term refers to the performance of an algorithm without human intervention, which is not relevant for a physical medical device like a bone fixation system.
- Type of Ground Truth Used: Not applicable in the context of diagnostic performance. The "ground truth" for this device would be established engineering standards and material properties, compared against the predicate devices.
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
- How Ground Truth for Training Set Was Established: Not applicable.
In summary, the provided K123000 document details a 510(k) submission for a bone fixation system. The "study" referenced is a technical verification of components and a demonstration of substantial equivalence to existing predicate devices based on design, materials, and intended use. It does not involve the types of performance studies or acceptance criteria that would be relevant for a diagnostic or AI-driven device, as implied by the questions.
§ 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.