Search Results

Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Fixation of proximal tibial metaphysis osteotomy. Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

The Elite™ Nitinol Fixation System, like primary predicate Speed Titan™ K133780, is a Nitinol implant for bone fixation and is designed to be delivered to the operating room in an "open" (legs parallel) and constrained state. The Elite™ Nitinol Fixation System was designed for surgeons who desire additional fixation points for increased rotational stability. The implant does not require any external heating. The implant is fully active at room and body temperature so that the legs compress after release from instrument (additional legs in Straight design compress in tandem). The primary differences between the Elite™ Nitinol Fixation System and the cleared Speed Titan™ K133780 are the configurations featured. The Speed Titan™ K133780 is a staple with two legs, while the Elite™ Nitinol Fixation System introduces three configurations: a Straight (with two and four legs), a Y-shape (three and four legs) and an H-shape (four legs).

The provided text is a 510(k) summary for the Elite™ Nitinol Fixation System, which is a bone staple. Medical device submissions like this primarily focus on showing substantial equivalence to a predicate device rather than comprehensive clinical studies proving specific performance metrics against acceptance criteria like those seen for AI/ML devices. Therefore, a direct answer for all your requested points, especially related to AI/ML device testing (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies), cannot be fully provided based solely on this document.

However, I can extract the information that is present and indicate where information is not available in the given text.

Here's the breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a specified threshold (e.g., Sensitivity > X%, Specificity > Y%). Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "reported device performance" is framed as meeting or exceeding the performance of the predicate in these tests.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the implied "acceptance criteria" (i.e., substantial equivalence) is a non-clinical performance testing study. The document states: "Performance testing includes: Corrosion (ASTM F2129-08), Elastic Static Bending (ASTM F564-10, A4) Pull-out Fixation Strength (ASTM F564-10, A2) and MR Compatibility (ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182) results of which demonstrate substantial equivalence or better."

Information Not Available (or Not Applicable for this type of device according to the document):

2. Sample sized used for the test set and the data provenance: Not applicable/provided in this document format. This is a physical bone staple, not an AI/ML device. The "test set" would refer to the samples used in the physical performance tests (e.g., number of staples tested for pull-out strength). This detail is not specified in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept is for AI/ML diagnostic devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for AI/ML diagnostic devices.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical bone staple, not an AI/ML diagnostic device meant to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical bone staple.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/Provided. For non-clinical performance testing of a physical device, the "ground truth" is typically defined by the ASTM standard test methods themselves and the physical measurements obtained.
8. The sample size for the training set: Not applicable. This is a physical staple, not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established: Not applicable. This is a physical staple.

Summary of what the document focuses on:

The Elite™ Nitinol Fixation System is cleared based on substantial equivalence to existing predicate devices (Speed Titan™ K133780, Speed Triad™ K133844, OSSplate™ K993714). The rationale for substantial equivalence is based on:

• Identical Indications for Use.
• Same technological characteristics: both are made of nitinol, follow the same manufacturing procedures, and function similarly.
• Non-clinical performance testing: demonstrating that the new device performs "substantially equivalent or better" than the predicate in terms of corrosion resistance, elastic static bending, pull-out fixation strength, and MR compatibility, according to specific ASTM standards.
• No new questions of safety or effectiveness are raised by the design changes (changes in geometry, number of legs, width, and implant shapes).
• No clinical evidence was deemed necessary ("N/A" for "Substantial Equivalence Clinical Evidence").

Ask a specific question about this device