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The Dyonics Varicose Vein Ablation Blade (proprietary name TBD) is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

The design of the blades offers required precision for varicose vein ablation by controlling the location and extent of tissue resection. Target tissue is drawn into the cutting window of the blade under suction while the rotating inner blade shears off the tissue. The location and extent of tissue removal is completely controlled by surgeon placement and rotary activation of the blade.

The provided document is a 510(k) summary for the Dyonics Varicose Vein Ablation Blade. It claims substantial equivalence to a predicate device based on "clinical experience submitted with this Premarket Notification Submission." However, it does not contain any information about specific acceptance criteria or a detailed study proving the device meets particular performance metrics.

Therefore, I cannot provide the requested table or detailed study information. The provided text primarily focuses on:

• Substantial Equivalence: Stating the device is substantially equivalent to the Medicon Ambulatory Phlebectomy Hook in intended use and procedural outcomes.
• Device Description: Explaining how the blade works.
• Intended Use: Defining its indication for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.
• FDA Correspondence: The FDA's 510(k) clearance letter.

Based on the provided text, the following aspects of your request cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented in the document.
2. Sample size used for the test set and the data provenance: No information about a test set or its data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of experts or ground truth establishment for a test set.
4. Adjudication method for the test set: No information is available.
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 device is a surgical tool, not an AI-assisted diagnostic or imaging system, so an MRMC study is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a surgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth for device performance is detailed. The "clinical experience" is mentioned as support for substantial equivalence, but not described in detail.
8. The sample size for the training set: No information about a training set.
9. How the ground truth for the training set was established: No information about a training set or its ground truth.

In summary, the provided 510(k) summary outlines the regulatory submission for a surgical device based on substantial equivalence, not a detailed performance study with acceptance criteria as one might expect for a diagnostic or imaging algorithm.

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