(43 days)
The subject devices are sterile, single use devices. They are intended for use during cemented or cementless primary or revision hip arthroplasty and trochanteric osteotomy. The Stainless Steel alloy Grip and Grip Plates are intended for use with 2.0mm Stainless Steel beaded and nonbeaded Cables only. Wrought CoCr alloy Grip and Grip Plates are intended for use with 2.0mm CoCr beaded and non-beaded Cables only. Optional Stainless Steel and Titanium screws are also available for use with the Stainless Steel and Wrought CoCr Grip Plates, respectively.
- The Dall-Miles® System is indicated for reattachment of the trochanter in any hip . procedure using the trochanteric osteotomy (total or partial) approach.
- The Dall-Miles® Trochanteric Grips and Grip Plates are indicated for use in the . fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
- The Dall-Miles® Trochanteric Grip Plate is additionally indicated for use in the . fixation of the greater trochanter due to extended trochanteric osteotomies.
The Dall-Miles® product line will now be available with Trochanteric Grip Plates and Trochanteric Grips that facilitate reattachment and fixation of the Greater Trochanter. The Trochanteric Grips will be offered in small, medium, and large sizes. The Trochanteric Grip Plates will be offered in medium sizes ranging from 100-200mm and large sizes ranging from 110-210mm in length. Both the Trochanteric Grips and Grip Plates are compatible with the existing components of the Dall-Miles® System and will be available in Stainless Steel or CoCr alloy materials and packaging options with or without Cables.
The provided text is a 510(k) summary for the Dall-Miles® System, which is a bone fixation accessory. This type of document is a premarket notification to the FDA for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data for acceptance criteria.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided document. The document primarily focuses on:
- Device Description: What the Dall-Miles® System is and its components (Trochanteric Grip Plates, Trochanteric Grips).
- Intended Use and Indications for Use: How the device is meant to be used and for what specific conditions.
- Substantial Equivalence: A claim that the device is similar enough to previously cleared devices (predicate devices) that it does not require a new Preamarket Approval (PMA) application. The predicate devices mentioned are the Modified BMP™ Trochanteric Plates (K993510) and the Dall-Miles® Trochanter Cable Super Grip (K962162).
- FDA Clearance Letter: Confirmation from the FDA that the device has been cleared for marketing based on the substantial equivalence claim.
In summary, this document does not contain the information required to populate the tables and answer the questions about acceptance criteria and study data because it pertains to a 510(k) submission for a traditional medical device (bone fixation accessories), not an AI/ML-driven diagnostic device that would typically involve the detailed performance metrics and study designs you've inquired about.
§ 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.