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The TriMed Humeral Supracondylar Fixation system is intended for supracondylar fractures of the distal humerus that occur in the adolescent, adult and elderly population. This system is contraindicated for use in infants and small children because of size discrepancy.

Fractures of the distal humerus that require fixation and lend themselves to open surgical treatment are appropriate indications for use with these devices. This includes simple supracondylar fractures of the distal humerus, isolated medial or lateral column fractures of the distal humerus, T-condylar fractures of the distal humerus, and comminuted intra-articular fractures of the distal humerus are all appropriate indications for fixation with the TriMed Humeral Supracondylar Fixation System.

Selection of specific implants is determined by the physician based on the pattern of fracture. Screw fixation, lateral plating, medial plating, and intramedullary nail plate fixation can be used either alone or in combination depending on the nature of the injury.

The following fracture configurations may be applicable for treatment using the TriMed Humeral Supracondylar Plates and TriMed Humeral Supracondylar Nail Plates:

1. Fractures of the humerus amenable to nail plate, plate and/or screw fixation where the size, shape, and location of the fractured bone are appropriate for the specific implant(s) being used.
2. The TriMed Humeral Supracondylar Fixation System intramedullary nail plates and associated screws are intended for use in fixation of fractures of the distal humerus.

The TriMed Humeral Supracondylar Fixation System is a set of implants which are to be used as an aid to the treatment of certain types of fractures that lend themselves to the principle of nail plate, plate and/or screw fixation. Devices include Medial Humeral Supracondylar Plates, Posterolateral Supracondylar Plates, Medial Humeral Supracondylar Nail Plates, bone screws, and pins. Like every type of orthopaedic implants, it cannot be assumed to be uniformly effective without risk. Use of these implants is not a substitute for normal tissue healing. These implants are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.

The TriMed Humeral Supracondylar Fixation System consists of implants designed for fixation of certain fractures. Variation in implant size, diameter, and shape are intended to allow the implants to accommodate variations in patient size and sites of application. These devices are manufactured from 316LS medical grade implant quality stainless steel. TriMed Humeral Supracondylar Plates and TriMed Supracondylar Nail Plates should only be used with the appropriate size TriMed Bone Screws and TriMed Supracondylar Nail Plate Interlocking Screws. As with interlocking nail plate and screw fixation in general, the surgeon should take measures to avoid excessive force on implant until bone healing has taken place. This includes protection of the fracture when appropriate, and instructions to the patient to avoid excess loading of the extremity until sufficient healing has taken place.

The document describes the TriMed Humeral Supracondylar Fixation System, a set of implants used for treating certain types of humerus fractures.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   For bench testing, the document mentions "any sample tested" and "three of the plates of the TriMed HSFS." While a specific numerical sample size for each material point is not explicitly stated (e.g., how many Medial Humeral Supracondylar Plates were tested for transverse static failure load), it implies that multiple samples of different plate types were tested.

   The data provenance is from bench testing conducted by TriMed, Inc. and reviewed by their QA/RA Manager. The sterilization validation was performed by North American Science Associates, Inc. (NAMSA) in their Northwood Ohio testing laboratory. This is laboratory-based data, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   Not applicable. The "ground truth" for this device's performance is based on engineering bench testing results comparing physical strength and mechanical properties against predicate devices and established standards (ASTM-F138/ASTM-F139 for biocompatibility). It does not involve human expert interpretation of medical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. This is not a clinical study involving human judgment. The results are based on objective physical measurements and computer analysis.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This is a medical device (surgical implant) and the testing described is mechanical bench testing, not a study evaluating human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a physical implant, not an algorithm or AI product. The "standalone" testing refers to the device itself (implants and plates) under mechanical stress, without human intervention in the test process, but it's not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for the device's performance is established through physical property measurements (transverse static failure load, transverse bend moment) and computational analysis of cross-sectional strength, compared against predicate devices and conforming to material standards (316LS medical grade implant quality stainless steel per ASTM-F138/ASTM-F139). Biocompatibility is based on the material's history of use and a Certificate of Biocompatibility (Attachment J). Sterilization validation was done according to established protocols.

8. The sample size for the training set:
   Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the typical sense.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set.

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