(70 days)
IQL Bone Plates and Screws are used for adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
IQL Bone Plates and Screws are used for the same indications as stainless steel bone plates and screws that have been commercially available continually since the 1950s. These devices are to be implanted by insertion into bones for fixation of fractures, or the fixation of bones that have been surgically prepared (osteotomy) for correction of deformity, or arthrodesis. Bone screws are used to attach the plates to the bone and stabilize bone fragments until bone union has occurred. A wide variety of bone plates similar to those included in this submission have been in commercial distribution since prior to May 28, 1976.
The provided text describes a 510(k) premarket notification for IQL Stainless Steel Bone Plates and Screws. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/software device.
Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.
Here's an explanation based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable: This document does not present acceptance criteria for performance metrics in the way an AI or software device would. The approval is based on substantial equivalence to predicate devices, material standards, and intended use. The "performance" is inherently tied to meeting the material standards and having the same indications and technological characteristics as the predicates.
2. Sample sized used for the test set and the data provenance
- Not Applicable: There is no "test set" in the context of an FDA 510(k) for this type of hardware device. Performance is largely demonstrated through material standards (e.g., ASTM F-138 and ASTM F-139 for stainless steel) and equivalence to established predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: "Ground truth" in the sense of expert consensus on data is not relevant for this device. The 'truth' is based on the known performance and safety profile of the predicate devices and the material properties.
4. Adjudication method for the test set
- Not Applicable: No test set or adjudication method is described.
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 hardware medical device (bone plates and screws), not an AI or imaging device. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a hardware device; no algorithm is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: As mentioned, the concept of "ground truth" for data labeling is not applicable here. The "truth" for this submission is related to the established safety and effectiveness of the predicate devices and compliance with material standards.
8. The sample size for the training set
- Not Applicable: Not an AI/software device; no training set.
9. How the ground truth for the training set was established
- Not Applicable: Not an AI/software device; no training set.
Summary of Device and Approval Basis from the Document:
- Device Name: IQL Basic Fragment Plate Set, IQL Basic Fragment Screw Set, IQL Small Fragment Set, IQL Mini Fragment Set (collectively, IQL Stainless Steel Bone Plates and Screws).
- Classification Name: Plate, Fixation, Bone (21 CFR 888.3030); Screw, Fixation, Bone (21 CFR 888.3040).
- Device Classification: Class II.
- Product Code: HRS (plates), HWC (screws).
- Intended Use/Indications for Use: For adult or pediatric patients for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Specific bones include tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, middle hand and middle foot bones.
- Basis for Approval (Substantial Equivalence): The device is substantially equivalent to various stainless steel bone plates and screws sold by Biomet Inc. (OEC) prior to May 28, 1976. Similar devices were included in the Kirschner (Biomet) Small Fragment Fixation System cleared under K864924 in March 1987.
- Technology Summary: Utilizes standard technology, commonly known and used in commercially available metallic internal fixation devices prior to May 28, 1976.
- Material Standards: The stainless steel used conforms to ASTM F-138 and ASTM F-139.
This 510(k) essentially argues that because the IQL Bone Plates and Screws are made of materials meeting established standards and are technologically identical to and intended for the same uses as legally marketed devices from before 1976 and later cleared devices, they are equally safe and effective.
§ 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.