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The EasyLock XXS Plates are indicated for fixation of fractures in phalangeal and metacarpal bones.

The XXS Plates utilize the same integrated locking system for screws as the Xtremities Plates cleared in K050681. The titanium plates have PEEK-Optima® inserts which enables the screws to be locked at the desired angle by means of a "self-tapping" effect. The XXS Plats are thinner and smaller diameter screws (1.7mm) have been designed for use in small bones including the metacarpals and phalanges.

The provided text is a 510(k) summary for the TRIMED EASYLOCK OSTEOSYSTEM XXS PLATES. It details the device description, indications for use, and a comparison to predicate devices to establish substantial equivalence. However, this document does not contain information about acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

The document is a premarket notification for a medical device (bone fixation plates and screws). For this type of device, substantial equivalence is typically established by demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device. This often involves comparing design features, dimensions, material composition, and sometimes mechanical testing data. However, detailed study results with acceptance criteria, sample sizes, and ground truth information as requested for AI/software device evaluation are not typically part of a 510(k) for a physical orthopedic implant.

Therefore, for the questions asked, the answer is that the information is not present in the provided document. Devices like the TRIMED EASYLOCK OSTEOSYSTEM XXS PLATES typically rely on mechanical testing (e.g., fatigue, static strength) and biocompatibility testing for safety and effectiveness, rather than clinical studies with human readers or AI algorithms described in the prompt's questions.

Here's a breakdown of why each point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence to predicate devices, not specific performance metrics against pre-defined acceptance criteria for a new study.
2. Sample size used for the test set and the data provenance: Not present. No specific test set or study data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. This type of information is relevant for studies involving human interpretation (e.g., imaging devices) rather than a physical implant.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multicase (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 relevant and not present. This is a physical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant and not present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
8. The sample size for the training set: Not present. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not present.

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