Search Results

The SBi Mini Rail External Fixation System is intended for fixation, compression, and distraction osteo-genesis of small bones, such as metacarpal and metatarsal. The system also includes the instruments with which to place the pins and assemble the construct. A tray is available for conveying and storing the system. The system is not intended for spinal use.

The SBi Mini Rail External Fixation System is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.

The SBi Mini Rail External Fixation System consists of pins of various diameters and lengths as well as the rails and accessories with which to connect and stabilize them. The system also includes instruments to implant the pins and connect the external components. A tray is included to store and transport the set. The devices are supplied non-sterile.

This document, K093550, is a 510(k) premarket notification for the "SBi Mini Rail External Fixation System". It primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining FDA clearance for marketing.

Therefore, the document does not contain the detailed clinical study information typically associated with establishing acceptance criteria and proving device performance through a study, especially for AI/algorithm-based devices.

The provided text describes a medical device (an external fixator) and its intended use, materials, and substantial equivalence to a prior device. It's a regulatory submission for product clearance, not a study report or a document detailing performance metrics.

Based on the provided text, I cannot extract the requested information regarding acceptance criteria and the study proving the device meets them because such information is not present in this type of FDA submission.

Here's a breakdown of why each specific point cannot be addressed from the given document:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for the device in the way you would expect for an AI algorithm study. It describes the physical device, its components, and its intended use, rather than quantifiable performance outcomes from a study.
2. Sample size used for the test set and the data provenance: No clinical or performance study data (test set, training set) is presented. The document states a modified device is equivalent to a cleared predicate (K964094), implying the basis for clearance is engineering and material equivalence, not clinical performance study data in the typical sense for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no test set or ground truth described for an AI/algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there is no test set or ground truth described for an AI/algorithm.
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 document describes a physical medical device (external fixator), not an AI diagnostic or aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as there is no ground truth described for an AI/algorithm.
8. The sample size for the training set: Not applicable, as there is no training set mentioned.
9. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.

In summary, the provided document is a regulatory submission for a physical medical device based on substantial equivalence, and it does not contain the information required to answer your questions regarding acceptance criteria and study data for an AI or imaging diagnostic tool.

Ask a specific question about this device