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The ExsoMed ITN Cannulated Screw System is intended for fixation of intra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The ExsoMed ITN Cannulated Screw System is a stainless-steel bone screw system designed for bone fixation. The headless design of the screw allows for the screw to be countersunk below the surface of the bone. The screws are offered in one thread diameter (4.0mm distal / 4.5mm proximal) and lengths between 35 and 75mm. The screws are designed for permanent implantation. Screw implantation is facilitated by the use of three accessory devices provided in a separate procedure kit: • A K-wire to be used as a guide • A cannulated reamer to be used over the K-wire to create the desired pilot hole • A depth gauge to determine the appropriate screw length prepare the medullary cavity • A cannulated hexalobe driver

The provided text is a 510(k) Summary for the ExsoMed ITN Cannulated Screw System, which is a medical device for bone fixation. It does not contain information about an AI/ML-based medical device. Therefore, I cannot address most of the questions regarding acceptance criteria, study design, ground truth, or expert involvement as they pertain to AI/ML models.

However, I can extract the information that is present regarding the non-clinical performance testing for this physical medical device.

Here's a breakdown of what the document does provide:

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

The document states that "Bench testing studies were conducted to demonstrate the equivalence of the new and predicate devices." It lists the tests conducted and then broadly states, "The results from these evaluations demonstrated that the subject screws performed comparably to the predicate device."

It does not provide a specific table with acceptance criteria thresholds (e.g., minimum torque required) and precise numerical results for the ExsoMed ITN Cannulated Screw System. It only mentions that the results were "comparable" to the predicate.

Regarding the remaining points, the document pertains to a physical medical device (cannulated screw system) and not an AI/ML diagnostic or predictive tool. Therefore, the following AI/ML-centric questions cannot be answered from the provided text:

2. Sample sizes used for the test set and the data provenance: Not applicable to this physical device's non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical screw's mechanical properties is derived from physical measurements and established ASTM standards, not expert medical opinion on images.
4. Adjudication method: Not applicable.
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 for a physical device, not an AI assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" for performance is based on established engineering standards (ASTM) and physical measurements.
8. The sample size for the training set: Not applicable. This device is not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

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