(60 days)
The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are contoured to match the anatomy of the distal fibula and diaphyseal region. The plates feature a low-profile design and Combi holes (Dynamic Compression Plate holes combined with locking screw holes), which accept 3.5 mm cortex, 3.5 mm self-tapping cortex, 3.5 mm shaft, 3.5 mm locking screws, and 4.0 mm cancellous screws. The plates locking holes accept 2.4 mm, 2.7 mm locking screws along with 2.4 mm and 2.7 mm self-tapping cortex screws. The plates are available in stainless steel and titanium, as well as a variety of lengths.
This document is a 510(k) Summary for a medical device called "Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates - Modifications." It's for an orthopedic implant, not an AI/ML powered device. Therefore, the questions regarding acceptance criteria and studies for AI/ML performance are not applicable.
The document primarily focuses on demonstrating substantial equivalence to a predicate device. This means the manufacturer is asserting that their modified device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness.
Here's the information extracted from the provided text that is relevant to the type of device:
Device Information:
- Device Name: Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates - Modifications
- Classification: Class II, §888.3030 - Single/multiple component metallic bone fixation appliances and accessories
- Predicate Device: Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates, Synthes One Third Tubular LCP Plate
- Intended Use/Indications for Use: The Synthes 2.7 mm/3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
- Material: Available in stainless steel and titanium.
Substantial Equivalence:
The document states that "Information presented supports substantial equivalence" to the predicate devices. This is the primary "acceptance criterion" for a 510(k) submission of this type. The specifics of how this equivalence was demonstrated (e.g., mechanical testing, material comparisons, design comparisons) are not detailed in this summary document but would have been part of the full 510(k) submission.
Regarding the specific questions about acceptance criteria and studies for an AI/ML device:
As this is a mechanical orthopedic implant, the following questions are not applicable:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.