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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.

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