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The Cytology Brush is used to collect cells from the bronchi and upper and lower gastrointestinal tracts.

The main component of the proposed device is Brush Head, Outer Sheath and Handle. The main operation is move the Finger Ring back and forth to achieve the movement of Brush Head, then the Brush Head can collect cells from the target site. The proposed device has seven (7) specifications, the main differences of these specifications are Diameter of Brush Head, Diameter of Outer Sheath and Working Length, Color of Finger Ring. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10° and placed in a sterility maintenance package to ensure a shelf life of 2 years.

This document, K172663, is a 510(k) Premarket Notification for a Cytology Brush. It compares the proposed device to a predicate device and demonstrates substantial equivalence.

It does not describe an AI/ML-based medical device. Therefore, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

Specifically, it lacks the following information that would typically be present for an AI/ML device:

• A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets used for evaluating AI performance.
• The number and qualifications of experts for ground truth establishment.
• Adjudication methods for AI training/test sets.
• MRMC studies or effect sizes of AI assistance on human readers.
• Standalone algorithm performance.
• Types of ground truth (e.g., pathology, outcomes data).
• Sample size and ground truth establishment for training sets.

The document discusses performance in terms of:

• Biological safety: Meeting ISO standards for biocompatibility and sterilization.
• Mechanical performance: Dimension testing, tensile strength testing.

These are standard for physical medical devices but not AI/ML performance.

Therefore, based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria as requested, because this document pertains to a physical medical device (cytology brush), not an AI/ML device.

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Indications for use are the endocervical collection of specimens used in Pap smear, chlamydia and HPV testing.

Cytology Brush

The provided documents are a 510(k) clearance letter and an Indications for Use statement for a Cytology Brush (K971849). These documents are relevant for regulatory approval but do not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

The 510(k) clearance process for this type of device (cytology brush) primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring extensive clinical trials with specific performance metrics like those for AI/ML-based medical devices.

Therefore, I cannot provide the requested information as none of the 9 points are addressed in the given text. The documents merely state that the device is a cytology brush intended for the endocervical collection of specimens for Pap smear, chlamydia, and HPV testing, and that it has been deemed substantially equivalent to a predicate device.

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