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The Intrauterine Venogram Needle Set is intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion.

The Intrauterine Venogram Needle Set contains two components: a catheter sheath and a needle. The single-lumen access catheter has a butb tip, turn connector cap and lock assembly manufactured from nylon. The injection needle is manufactured from stainless steel with a polycarbonate hub. The Information in Venogram Needle set is supplied sterile in lengths from 15 cm to 30 cm and is packaged in a sealed peel-open container.

The provided text is a 510(k) summary for the "Intrauterine Venogram Needle Set" and a letter from the FDA determining substantial equivalence. It describes the device, its intended use, and its similarity to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) process for this type of medical device (a needle set) typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical performance studies with specific acceptance criteria in the same way that a diagnostic algorithm or a complex interventional device might.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the document.
• Sample sized used for the test set and the data provenance: Not applicable/not present.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
• Adjudication method: Not applicable/not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/not present.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not present.
• The type of ground truth used: Not applicable/not present.
• The sample size for the training set: Not applicable/not present.
• How the ground truth for the training set was established: Not applicable/not present.

The document states that the device "will be manufactured according to specified process controls and a Quality Assurance Program" and "will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN." This indicates that the regulatory pathway relies more on manufacturing controls and similarity to existing devices than on a specific performance study with defined acceptance criteria as you've described for a diagnostic or AI-based device.

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