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Agfa's Skintell is an Optical Coherence Tomography (OCT) system indicated for use in two-dimensional, cross-sectional, real-time imaging of external tissues of human body.

Agfa's Skintell is an optical coherence tomography imaging device (OCT) weighing approximately 105kg. It is used to create images of non-open wounded human skin and the corresponding close-to-surface tissue. Skintell offers users the following functions: volume and cross-sectional imaging, high resolution rendering of structures, geometrical length- measurements.

Here’s an analysis of the acceptance criteria and supporting study for the Agfa Skintell OCT system, based on the provided 510(k) summary:

The 510(k) summary for Agfa Skintell (K132800) is a substantial equivalence submission, meaning it aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device (Michelson Diagnostics VivoSight Topical OCT System, K093520). Therefore, the "acceptance criteria" are primarily defined by the performance of the predicate device and relevant product safety/quality standards. The "study" largely consists of verification and validation testing, including comparative evaluations with the predicate and histological analysis.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission relying heavily on a predicate device, the "acceptance criteria" are implicit in demonstrating performance that is equivalent or superior in key aspects, while adhering to relevant standards. The performance aspects are compared directly to the predicate.

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