(14 days)
The Synthes Universal Locking Trochanter Stabilization Plate for DHS® or LCP® DHHS is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS®) or the LCP® Dynamic Helical Hip System (DHHS) sideplates with four or more holes.
The Synthes ULTSP for DHS® and LCP DHHS fits over the sideplate of the Synthes DHS and LCP® DHHS. The ULTSP screw holes line up with the most proximal screw holes of the DHS and LCP DHHS sideplate and accept 4.5 mm cortex screws used for femoral shaft fixation. Slots accommodate both the DHS lag screw or the LCP DHHS Helix Blade and a parallel anti-rotational screw. The screw slot for the anti-rotational screw accepts a 6.5 mm cancellous bone screw or 6.5 mm, 7.0 mm or 7.3 mm cannulated screw. The proximal extension of the plate resides along the lateral side of the greater trochanter. The proximal locking holes of the ULTSP accept 3.5 mm locking screws and/or k-wires, cables, or sutures up to 2.0 mm in diameter.
This document is a 510(k) summary for the Synthes Universal Locking Trochanter Stabilization Plate (ULTSP). It focuses on establishing substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data for the ULTSP itself.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided text. The document does not describe a performance study in the way typically expected for software or AI medical devices.
The information provided confirms:
- Device Name: Synthes Universal Locking Trochanter Stabilization Plate (ULTSP)
- Intended Use: To treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric, and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS®) or the LCP® Dynamic Helical Hip System (DHHS) side plates with four or more holes.
- Classification: Class II, §888.3030 - Single/multiple component metallic bone fixation appliances and accessories.
- Predicate Devices: Synthes Trochanter Stabilization Plate (TSP) for DHS.
No information is available regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How 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.