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The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavily for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use.

The Cook® Sonohysterography Biopsy Catheter is used to access the uterine cavity for sonohysterography and to obtain endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, biopsy of the endometrium using the same device. The device will be supplied sterile and is intended for one time use. The materials used in the construction of the Cook® Sonohysterography Biopsy Device are well known in the medical field. Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective. Literary articles prove the usefulness of this type of device to the clinician and patient population.

The provided text is a 510(k) summary for the Cook® Sonohysterography Biopsy Catheter, submitted in 2006. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because the document does not contain this information.

The document details:

• Device Description: The Cook® Sonohysterography Biopsy Catheter is designed for saline infusion sonohysterography and, if indicated, endometrial biopsy using the same device. It is supplied sterile for one-time use.
• Substantial Equivalence: The submission asserts that the device is substantially equivalent to existing predicate devices based on its indications for use, materials, physical construction, manufacturing process controls, quality assurance, packaging, and sterilization procedures.
• Predicate Devices: Several predicate devices are listed for both the sonohysterography function (e.g., Tampa Catheter, EZ-HSG Catheter, Cook Hysterocath™, Goldstein Sonohysterography Catheter) and the biopsy function (e.g., Probet, Uterine Explora Model I, Wallace Suresample, Pipelle de Cornier®, Aspiracath™).
• Testing Mentioned: The document briefly states, "Biocompatibility, Ethylene Oxide Residual, and Functional testing have shown that the materials and the device meet the test requirements and are safe and effective." However, it does not elaborate on these "test requirements," specific acceptance criteria, or the results of these tests in detail. It also mentions "Literary articles prove the usefulness of this type of device," implying reliance on existing scientific literature rather than a new, specific performance study for this device.

None of the requested specific information about acceptance criteria, a formal study demonstrating performance against these criteria, sample sizes, ground truth establishment, or expert involvement is present in the provided text. The 510(k) process for this type of device often relies on demonstrating similarity to already marketed devices, and detailed performance studies with explicit acceptance criteria might not be fully presented in the public summary.

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