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These devices are intended to be used over a guidewire to dilate or calibrate blood vessels.

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I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria. The document describes a 510(k) submission for a medical device (Gelbfish Flex Vascular Dilator) and its substantial equivalence to a predicate device.

The provided text focuses on:

• Device Identification: Proprietary and generic names, classification, product code, and intended use.
• Predicate Device: Identification of the predicate device.
• Comparison to Predicate Device: Highlights two differences: the shaft material (polyurethane vs. stainless steel) and the bonding method for the tip (medical grade adhesive vs. laser welding).
• Conclusion: States that the modified device is substantially equivalent to the predicate device and has no additional safety issues, based on physical properties, performance characteristics, and intended use.
• FDA Communication: The FDA's letter granting substantial equivalence based on the submitted information.

There is no information in the provided text regarding:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically detailed in the full 510(k) submission, specifically in sections related to performance testing and clinical data, which are not included in this summary. The current text primarily addresses the regulatory path for a modified device claiming substantial equivalence to an existing one.

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The VascuMetrix Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels.

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This document discusses a Special 510(k) submission for the VascuMetrix Dilators, which are vessel dilators for percutaneous catheterization. The submission focuses on modifications to an existing device, the Gelbfish Vascular Dilators (K0012256).

Here's an analysis of the provided information, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria or quantitative performance metrics for the VascuMetrix Dilators. Instead, the submission relies on a comparison to a predicate device and a statement of "substantial equivalence."

Acceptance Criteria (Inferred from comparison to predicate):

Note: The phrase "substantially equivalent" in regulatory contexts implies that the new device is as safe and effective as the predicate device, and does not raise new questions of safety and effectiveness.

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

The document does not mention any specific test set, clinical data, or sample sizes used to demonstrate the performance of the modified device. The submission appears to be based on a comparison of device specifications and intended use against a legally marketed predicate device. This is typical for a Special 510(k) for minor device modifications, where new clinical data might not be required if the changes do not significantly affect safety or effectiveness.

Therefore, there is no information on data provenance (country of origin, retrospective/prospective) as no specific study data is presented.

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

This information is not applicable and not provided. Since no test set or clinical study is described, there's no mention of experts establishing a ground truth. The "ground truth" in this context is the performance and safety profile of the predicate device, to which the modified device is compared.

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

This information is not applicable and not provided for the reasons stated above (no test set 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

This information is not applicable and not provided. The device in question is a physical medical device (vascular dilators), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

This information is not applicable and not provided. As explained above, the device is a physical medical device, not an algorithm.

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

For this type of device submission (physical medical device with minor modifications relying on substantial equivalence), the "ground truth" is fundamentally the established safety and effectiveness profile of the predicate device as previously cleared by the FDA, along with engineering and manufacturing specifications. The FDA's determination of substantial equivalence (as stated in the letter) means they found adequate evidence (likely through bench testing, material comparisons, and engineering analysis, although not detailed here) that the modified device's performance aligns with the predicate's.

8. The sample size for the training set

This information is not applicable and not provided. Training sets are relevant for machine learning or AI models, which is not the case for this device.

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

This information is not applicable and not provided for the same reason as point 8.

In summary, the provided document describes a regulatory submission for a physical medical device based on substantial equivalence to a predicate device, focusing on changes in dimensions and markings. It does not detail specific acceptance criteria in a quantitative sense for novel testing, nor does it present any clinical study data, expert reviews, or AI-related performance metrics.

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The VascuMetrix Gelbfish™ Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels.

The VascuMetrix Gelbfish™ Vascular Dilators consist of a small diameter stainless steel tube with a smooth stainless steel tip welded to one end. The lumen of the tube sicer tube with a slide over an 0.035" guidewire. The tips are available in ten sizes and can be used to dilate or calibrate the lumen of a blood vessel.
The dilator can be inserted into a blood vessel either through a surgical cutdown or I he unator can of inserted int for use only by physicians using sterile technique. It is shipped sterile and intended as a single use device.

The provided text is a 510(k) submission for the Gelbfish™ Vascular Dilator, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a de novo clinical trial with explicit acceptance criteria and performance metrics typically associated with AI/ML devices. Therefore, a direct answer to all points of the request in the context of an AI/ML study is not applicable.

However, I can extract the relevant information from the document that pertains to the device's acceptance as substantially equivalent.

Acceptance Criteria and Device Performance (in the context of substantial equivalence):

The "acceptance criteria" here are not performance metrics in the AI sense, but rather a demonstration that the new device is as safe and effective as a legally marketed predicate device.

Study Details (in the context of substantial equivalence):

Given this is a 510(k) for a physical medical device, not an AI/ML product, many of the requested points ("sample sized used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set") are not applicable or documented in the provided text. The "study" here is a series of physical and material tests comparing the new device to a predicate.

• Sample size used for the test set and the data provenance: The document mentions "Physical testing has demonstrated..." and "results of the really strong..." for material characteristics like physical chemistry, wall thickness, etc. It does not specify the sample size for these physical tests or the provenance of the materials used in the tests, beyond stating the new device and predicate are constructed of "identical material."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device submission. The "ground truth" is established by comparing the physical and material properties to the predicate device.
• Adjudication method: Not applicable. Assessment is based on direct physical and material property comparison, not expert adjudication of outputs.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is not an AI/ML device.
• The type of ground truth used: For the physical device, the "ground truth" for comparison is the established physical properties and performance characteristics of the legally marketed predicate device (Peripheral Vascular Dilator, K974617). The comparison is based on direct measurement of manufacturing specifications and performance, not expert consensus or pathology in the clinical sense.
• The sample size for the training set: Not applicable. There is no concept of a "training set" for this physical device.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a 510(k) submission for a traditional medical device, the Gelbfish™ Vascular Dilator. The "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to a predicate device through comparison of physical properties, material composition, and intended use, rather than clinical performance metrics in the context of an AI/ML system.

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