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The Monotube® Carbon Tubes, previously cleared in a premarket 510(k) submission, are connecting elements for use with the Monotube® Clamps for the construction of external fixation frames.

The Monotube® Carbon Tubes, previously cleared in a premarket 510(k) submission, are connecting elements for use with the Monotube® Clamps for the construction of external fixation The tubes are available in 15mm, 20mm and 25mm diameters frames. and a variety of lengths to accommodate varying anatomical This present submission describes a change in situations. material and manufacturing method to these tubes.

The provided 510(k) summary for the Monotube® Carbon Tube External Fixation System (K963614) does not contain the detailed information requested to describe acceptance criteria and associated studies for device performance. This summary is from 1996 and pertains to a change in material and manufacturing method for an already cleared device.

Here's why the requested information cannot be extracted from the provided text:

• Focus of the document: The document primarily focuses on establishing substantial equivalence to a previously cleared device due to a change in material and manufacturing method. It mentions "Testing of the devices is presented in the submission," but only gives a high-level overview of the types of tests performed, not the specific acceptance criteria or detailed results.
• Nature of the device: This is a mechanical external fixation tube, which typically has acceptance criteria based on mechanical strength, fatigue, and biocompatibility, rather than diagnostic accuracy or human-AI interaction. Therefore, questions regarding "ground truth," "expert readers," "MRMC studies," or "standalone algorithm performance" are not applicable to this type of device.
• Age of the document: As a 1996 510(k) summary, the level of detail provided is typical for that era and generally less comprehensive than what might be expected for more complex devices or AI/ML-driven devices cleared today.

Based on the provided input, here's what can be stated, along with what cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document states "Testing of the devices is presented," but doesn't mention how many tubes or subassemblies were tested.
• Data Provenance: Not specified, but given the nature of the device and testing, it would be laboratory bench testing rather than clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a mechanical device. "Ground truth" in this context would refer to the actual material properties and structural integrity, which are measured using engineering tests, not human expert interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. This concept applies to human interpretation of diagnostic data, not mechanical device testing.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• Not Applicable. This device is a mechanical implant, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device does not involve an algorithm.

7. The type of ground truth used:

• Mechanical Measurement Results: For this device, "ground truth" would be established by physical measurements (e.g., force, displacement, material composition) using calibrated sensors and testing equipment, defining properties like yield strength, stiffness, and material characteristics.

8. The sample size for the training set:

• Not Applicable. This documentation describes a conventional mechanical device, not an AI/ML system that requires a "training set."

9. How the ground truth for the training set was established:

• Not Applicable.

In summary, the provided 510(k) summary is for a traditional mechanical device, and thus, many of the questions related to AI/ML or diagnostic performance are not applicable to its evaluation. The document itself provides only a high-level overview of the types of mechanical testing performed to demonstrate equivalence, without specific quantitative acceptance criteria or detailed results.

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