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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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The external fixation system is a device intended to be used in treatment of bone conditions including limb lengthening, osteotomies, the arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.

The external fixation system includes various size components to accommodate various anatomies and injuries. The clamps enable the frame to be coupled to bone by securing the rods and Schanz Screws for the intended use. Components designed for this system are the medium clamp to accept the 8.0mm carbon fiber rod (100mm to 500mm length) and Schanz Screws (4.0mm diameter x 125mm length and 5.0mm diameter x 150mm to 200mm lengths), and the large clamp to accept the 11.0mm carbon fiber rod (100mm to 500mm length) and Schanz Screws (4.0mm diameter x 125mm length, 5.0mm diameter x 150mm length to 200mm lengths, and 6.0mm diameter x 225mm to 300mm lengths).

The provided 510(k) summary does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices.

Therefore, the following information cannot be extracted from the provided text:

• Table of acceptance criteria and reported device performance: No performance criteria or results are mentioned.
• Sample size used for the test set and data provenance: No test set is described.
• Number of experts used to establish ground truth and their qualifications: Not applicable as no ground truth establishment is described.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
• Standalone performance study: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: No training set is described.
• How the ground truth for the training set was established: Not applicable.

The document states that substantial equivalence is based on the device having the "same intended use, materials, and same technological characteristics as the predicate devices." It explicitly mentions:

"The external fixation system is substantially equivalent to the Technological Characteristics predicate devices with respect to the design, function, and Comparison: material."

And concludes:

"There are no significant differences between the external fixation system and the other devices as listed in the Substantially Equivalent Devices. The external fixation system and the predicate devices have similar design attributes, material, and intended use thus is considered substantially equivalent."

This type of 510(k) submission relies on demonstrating similarity to already legally marketed devices rather than presenting new performance data against specific acceptance criteria.

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The TriMed X-Fix System is a unilateral external fixation device. It is intended to be used in the treatment of bone conditions including limb lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality.

The X-Fix System is a unilateral external fixation device. It includes various size components to accommodate various anatomies and injuries. The pin clamps enable the frame to be coupled to bone by securing the pins for the intended use.

The X-Fix System is made of aluminum, black carbon composite and F-138 surgical grade stainless steel.

This document describes the X-Fix System, a medical device, and its regulatory clearance. It does not contain information about acceptance criteria or a study proving its performance in the context of device performance metrics typically associated with AI/ML, clinical trials with statistical endpoints, or extensive testing against specific performance targets.

Instead, this document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The "summary of safety and effectiveness" for this type of submission is primarily concerned with establishing that the new device is as safe and effective as a device already on the market, rather than proving performance against predefined quantitative metrics in a detailed study.

Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not Applicable / Not Provided. This document does not describe specific acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) for the X-Fix System itself, nor does it provide a report of such device performance. The "acceptance" here refers to regulatory acceptance by the FDA based on substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided. No "test set" in the context of performance evaluation (like in an AI/ML study or a clinical trial) is mentioned. The submission is based on a comparison to a predicate device, not on new performance data from a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable / Not Provided. No "ground truth" establishment by experts for a test set is discussed.

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

• Not Applicable / Not Provided. No test set or adjudication method is described.

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 / Not Provided. This is a hardware medical device (external fixator). MRMC studies are typically relevant for diagnostic AI/ML devices where human readers interpret results. This type of study would not apply to the X-Fix System.

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

• Not Applicable / Not Provided. The X-Fix System is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable / Not Provided. There is no mention of ground truth in the context of performance testing for this device.

8. The sample size for the training set

• Not Applicable / Not Provided. No training set is mentioned as this is not an AI/ML device.

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

• Not Applicable / Not Provided. No training set or ground truth establishment is mentioned.

Summary of what the document does provide regarding "acceptance" and "proof":

The document serves as a "Summary of Safety and Effectiveness" for a 510(k) submission to the FDA. The "proof" the device met "acceptance criteria" here is that the FDA determined it was substantially equivalent to a legally marketed predicate device.

• Acceptance Criteria (Implicitly by FDA): The primary "acceptance criteria" for a 510(k) submission is demonstrating that the new device is as safe and effective as a predicate device already on the market, and does not raise new questions of safety or effectiveness. This is achieved by comparing indications for use, technological characteristics (design, materials), and performance (if applicable, through non-clinical or clinical data) to the predicate.
• Study Proving Acceptance (Implicit): The "study" here is the comparison made by the submitter (TriMed, Inc.) and reviewed by the FDA.
  • Device Compared To: Avanta Orthopaedics External Fixator (K974911/K981716).
  • Basis of Equivalence: "The X-Fix is equivalent in dimensions, design and materials." (Section III. Substantial Equivalence).
  • FDA Determination: The FDA reviewed the submission and found the device "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

In essence, the document serves as regulatory clearance, not a performance study report in the typical sense of testing against specific quantitative performance metrics.

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