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Procedure trays containing components intended for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes (i.e. Hysterosalpingography or Hysterosonography).

The H/S Procedure Tray, Elliptosphere Procedure Tray and Multi-Purpose Tray contain components that can be used for conducting either Hysterosalpinography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and falopian tubes using ultrasound sonography). All components are provided sterile for single use only.

The provided document describes a 510(k) premarket notification for "H/S Catheter Procedure Tray," "H/S Elliptosphere Procedure Tray," and "Multipurpose Procedure Tray." This submission is for medical devices, specifically procedure trays used for hysterosalpingography or hysterosonography.

Based on the content, this document does not contain the information required to answer your request. The request asks for details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, and MRMC studies, which are typically part of a comprehensive clinical validation report or performance study.

Here's why the provided text is insufficient:

• Type of Submission: This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on proving de novo performance against specific acceptance criteria through a new study.
• Focus on Equivalence: The "Technological Characteristics" section explicitly states: "The expanded tray has the same technological characteristics as the predicate device. The intended use, operating principle, incorporate the same product designs incorporate the same materials and are packaged and sterilized using the same materials and processes." This indicates that the claim for acceptance is based on similarity to an already approved device, rather than new, independent performance testing against defined metrics.
• Lack of Study Details: There is no mention of a specific study, clinical trial, or performance data beyond the assertion of equivalence. All points in your request (sample sizes, experts, adjudication, MRMC, standalone performance, ground truth types and establishment) are absent because they are not typically required for a 510(k) pathway that relies solely on substantial equivalence without new clinical performance claims.
• Device Type: Procedure trays are collections of components. The performance claims for such devices usually relate to sterility, material compatibility, and the ability of the components to facilitate the intended procedure, not complex diagnostic accuracy metrics that would require algorithms or AI. The FDA letter even highlights that the drug components (povidone-iodine) are regulated separately.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and performance studies based on the provided text. The document serves its purpose for a 510(k) by establishing substantial equivalence to a predicate device (Ackrad H/S Procedure Tray K881680) rather than presenting new performance data.

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