(227 days)
The components of the EOS Small Bone Fixation System are indicated for use in osteosynthesis, osteotomy, and arthrodesis of the following areas of the bodv:
Large Cannulated Compression Screws – bones in the foot
Cannulated Compression Screws – small bones in the hand and foot
AND/OR
Snap-Off Screws - small bones in the foot
Bone Plates - first metatarso-phalangeal joint
Staples & Pins - small bones in the hand and foot
The TriMed EOS Small Bone Fixation System components are designed to provide internal fixation of various bones. The Cannulated Compression Screws are available in 7.3mm, 3.0mm, and 2.5mm diameters while the Snap-Off Screws are available in a 2.0mm thick Bone Plates utilize 2.7mm Bone Screws to secure the plate to the bone, and both items are available in various lengths. All screws and plates are available in implant grade Ti6AL4V Titanium. Staples and Pins are available in diameters ranging from 1.0mm to 2.5mm and are available in implant grade Ti6AL4V Titanium. 316L Stainless Steel, or Nitinol (N(T),
The provided document is a 510(k) summary for the TriMed EOS Small Bone Fixation System. It describes the device, its indications for use, and claims substantial equivalence to predicate devices. However, this document does not contain the type of information requested regarding acceptance criteria and a study proving a device meets those criteria.
Specifically, the document lacks details such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details about training sets.
- The number and qualifications of experts for ground truth establishment.
- Information on adjudication methods or multi-reader multi-case studies.
- Results from standalone performance studies.
- The type of ground truth used.
Instead, the document highlights:
- Indications for Use: The system is indicated for osteosynthesis, osteotomy, and arthrodesis in specific small bones of the hand and foot.
- Device Description: It comprises various screws, bone plates, staples, and pins made of Ti6AL4V Titanium, 316L Stainless Steel, or Nitinol.
- Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through substantial equivalence to previously cleared predicate devices (Omnitech Large Compression Screws, Omnitech Compression Screws, SPIN Snap-Off Screws, Hallu Plates, EasyLock Osteosystem Plates, Uni-Clip Staple, Memory Staple, Varisation Staples).
- Supporting Evidence for Substantial Equivalence: An engineering analysis, mechanical tests, functional implant and instrumentation tests, corrosion testing, and biocompatibility tests were performed to support this claim.
To answer your prompt, I would need a document that presents the results of a specific performance study (e.g., a clinical trial or a validation study) with defined acceptance criteria for a medical device's performance, along with the detailed methodology for that study. The current document is a regulatory submission focused on demonstrating substantial equivalence rather than reporting on a specific performance study with acceptance criteria.
§ 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.