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The Stableloc II External Fixation System is used to address Colles' fractures and distal radial osteotomies and is not intended for use in the spine.

The Stableloc II External Fixation System consists of an external fixation device and a selection of threaded guide pins. The external fixator is not intended for implantation, only as a tool in surgery. It holds in place the pins which provide fracture reduction and alignment. The Stableloc II External Fixation System is manufactured from Ultem, aluminum, stainless steel, and titanium while the guide pins are made from stainless steel per ASTM F 138. The external fixator is provided non-sterile. Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 106 as validated by data on file at Acumed. The guide pins are provided sterile. Sterility is achieved by a minimum of 2.5 megarads gamına radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility level is 10th. We make no claims as to the pyrogenicity of this product. Information regarding packaging and labeling has been provided.

This document is a 510(k) summary for a medical device (Stableloc II External Fixation System) submitted in 1997. It describes the device and claims substantial equivalence to a predicate device (EBI Medical System's Orthofix Dynamic Axial Fixation System).

Based on the provided text, there is no information available about acceptance criteria, a study proving device performance against such criteria, or any of the detailed study parameters you've requested.

Here's why and what we can extract:

• Type of Submission: This is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process typically relies on comparisons to known safe and effective devices, rather than de novo clinical performance studies or specific acceptance criteria for novel performance metrics.
• Focus of the Document: The summary focuses on:
  • Device description (components, materials, intended use).
  • Comparison to a predicate device (material, intended use, design, surgical techniques).
  • Sterilization methods.
  • Claims of substantial equivalence based on these similarities.

Therefore, I cannot provide the requested information from the given text.

Explanation for each point you asked for:

1. A table of acceptance criteria and the reported device performance: Not present. The document claims "safety and effectiveness is expected to be similar" to the predicate, but provides no quantitative performance data or specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not present. No "test set" in the sense of a clinical or specific performance study is mentioned. The comparison is based on device characteristics, not a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/present. No ground truth establishment for a test set is discussed.
4. Adjudication method for the test set: Not applicable/present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not applicable/present. This type of study is more common for diagnostic imaging AI systems, which did not exist in this context in 1997 for an external fixator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/present. This is not an AI/algorithm-driven device.
7. The type of ground truth used: Not applicable/present.
8. The sample size for the training set: Not applicable/present. There's no machine learning or AI involved.
9. How the ground truth for the training set was established: Not applicable/present.

In summary, the provided text describes a regulatory submission for a physical medical device from the late 1990s. The type of detailed performance studies and AI-related metrics you're asking for were not standard or relevant for this kind of device and submission at that time.

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