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The Vectrix External Fixator is indicated for use in which external fixation is necessary for the treatment of long- and shortbone trauma and reconstruction in adult and pediatic patients, including limb lengthening, pseudarthroses, infected fractures, distraction, arthrodesis, and severe open fractures.

The Vectrix External Fixator is a comprehensive and modular external fixator, the design of which is based on a ball collet pin clamp system and consists of:

• 6AL-4V titanium and/or 304SS stainless steel spline . rod (0.125, 0.25, and 0.375 inches in diameter)
• . 6AL-4V titanium and/or 316L stainless steel selftapping, threaded fixation pins (5.0 mm and 4.0 mm thread diameter pins with thread lengths from 25 mm to 75 mm, varying in 5 mm increments; and 3.5 mm thread diameter pins with thread lengths of 15 mm)
• Titanium pin clamps
• Titanium ball collets ●
• Titanium collet caps
• Titanium drive knob ●
• Titanium drive screw ●

Fixation pins are percutaneously inserted into the bone segments and secured with pin clamps to the external spline rod. The choice of thread diameter and length is made by the surgeon on a case-by-case basis. The ball and collet design allows extensive pin rotation and, thus, pin placement freedom.

The system can be assembled in three sizes, determined by the spline rod size. Furthermore, elements of the system may be combined in a wide range of configurations as needed to achieve the external fixation structure best suited for each patient. The drive screw and drive knob can also be added to the spline rod constructs of each size to mediate bone compression and distraction for limb reconstruction.

The provided document is a 510(k) summary for the Vectrix External Fixator. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain the detailed clinical study information typically found in an AI/ML device submission.

Based on the content provided, I can only extract information related to the performance data and acceptance criteria based on mechanical testing, not clinical performance.

Here's a breakdown of what I can determine from the text:

1. Table of Acceptance Criteria and Reported Device Performance (based on mechanical testing):

Missing Information: The document does not specify numerical acceptance criteria or direct performance metrics (e.g., specific load values or deformation limits) for the ASTM tests. It only states that all requirements were met and that the connection mechanisms were found equivalent to the predicate.

Regarding the study proving the device meets acceptance criteria:

• Study Type: Non-clinical interconnection testing per ASTM F1541-02, Standard Specification and Test Methods for External Skeletal Fixation Devices (A2.8.4 Pin/Clamp Eccentric Loading).
• Purpose: To confirm that the connection mechanisms of the Vectrix External Fixator are equivalent to those of the Torus External Fixation System (K925635).

The following information is not present in the provided text, as it pertains to AI/ML device evaluations which this document does not cover:

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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