(160 days)
The LTJ Screws (3.75mm solid and 4.5mm cannulated) are intended to be used in skeletally mature patient as stand-alone bone screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Optional washers are available for the 3.75 solid screws.
The LTJ Screws are partially threaded solid headless 3.75 mm screws and partially threaded cannulated headed 4.5 mm screws provided in various length ranging from 26 mm to 50 mm. They are provided in Stainless Steel Alloy compliant with ASTM F138. The headless implants can be associated to an LTJ diameter 8 mm Washer provided in Stainless Steel Alloy compliant with ASTM F138. It is essential to handle and insert implants with LTJ instruments specifically designed for this purpose.
This document is a 510(k) summary for a medical device called "LTJ Screws and Washer." It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
Based on the provided text, there is no acceptance criteria or study data related to device performance in terms of clinical outcomes or diagnostic accuracy involving human readers or AI systems. The performance data section refers exclusively to mechanical testing of the screws and not to any AI or human-assisted diagnostic performance.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device (a bone fixation fastener) and a different type of evaluation (mechanical properties rather than diagnostic accuracy).
Here's what can be extracted based on the primary focus of the request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Mechanical Testing (Torque Strength) | Measured according to ASTM F543 | Demonstrated adequacy for intended use. |
| Mechanical Testing (Insertion/Removal Torque) | Measured according to ASTM F543 | Demonstrated adequacy for intended use. |
| Mechanical Testing (Pullout Strength) | Measured according to ASTM F543 | Demonstrated adequacy for intended use. |
2. - 7. (Information regarding AI/human reader studies, ground truth, sample sizes for test/training sets, adjudication, etc.):
This information is not applicable to the provided document. The document describes a metallic bone fixation fastener (LTJ Screws and Washer), which is a physical implant, not a diagnostic AI device or a device requiring human reader interpretation for its primary function. The "performance data" mentioned refers to mechanical testing of the physical screws to ensure they meet engineering standards for their intended use in bone fixation, not to the performance of any AI algorithm or human diagnostician.
8. Sample size for the training set: Not applicable and not mentioned.
9. How the ground truth for the training set was established: Not applicable and not mentioned.
§ 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.