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The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.0mm (cannulated), Ø3.50mm (cannulated and non-cannulated) and Ø4.00mm (cannulated and non-cannulated) and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided text is a 510(k) summary for the VECTOR™ Hammertoe Correction System. It describes the device, its indications for use, and its equivalence to predicate devices, primarily through engineering analysis. This document does not contain information about an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance in the context of AI/ML.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone (algorithm only) performance data
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document explicitly states: "No FDA performance standards have been established for the Vector Hammertoe Correction System. The following was performed to demonstrate safety per methods of the previous submission: Engineering Analysis comparison of mechanical performance characteristics." This indicates that the safety and effectiveness were demonstrated through mechanical performance characteristics engineering analysis and comparison to predicates, not through clinical or AI/ML performance studies with human readers or AI algorithms.

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The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The VECTOR Hammertoe Correction System is comprised of a sterile PEEK (polyetheretherketone) HA (hydroxyapatite) fixation device. The implants are offered in Ø3.50mm and Ø4.00mm and in 0° angle. The system has K-wires, drill, taps, implant inserters, and sizers manufactured from medical grade stainless steel.

The VECTOR Hammertoe Correction System is a medical device designed for the fixation of osteotomies and reconstruction of lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. The provided text describes the regulatory filing for this device, not a study evaluating its performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted directly from this document.

However, based on the "SUMMARY OF NON-CLINICAL TESTING" section, we can infer the types of tests performed to demonstrate safety and equivalence to predicate devices, which serve as the implicit acceptance criteria for this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify the sample size for individual tests (e.g., number of implants tested for torsion, pullout, etc.). It describes non-clinical laboratory testing. The data provenance is from laboratory testing conducted by the manufacturer, Nvision Biomedical Technologies, LLC. Since these are non-clinical (mechanical and biological) tests, "country of origin of the data" and "retrospective or prospective" are not directly applicable in the same way they would be for clinical studies with human subjects.

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 non-clinical study involving mechanical and biocompatibility testing, not human expert evaluation of clinical images or diagnoses. The "ground truth" here is established by the specifications of the ASTM standards and regulatory limits (e.g., endotoxin levels).

4. Adjudication method for the test set
Not applicable. There was no expert adjudication process as this was non-clinical laboratory testing.

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 the regulatory filing for a medical fixation device, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI-based device.

7. The type of ground truth used
The "ground truth" for the non-clinical tests is based on:

• Engineering specifications and recognized consensus standards: Specifically ASTM F543, which outlines standard test methods for metallic medical bone screws.
• Regulatory limits for biocompatibility: Recommended Bacterial Endotoxins limits (20 EU/device).
• Comparison to predicate devices: The "substantially equivalent" determination implies that the test results met or exceeded the performance characteristics of the predicate devices.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.

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