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The InScope Precision Balloon Dilator - Wire Guided - with pre-loaded 0.035" guide wire - Is a sterile, single use, disposable dilator used in the alimentary tract (esophagus, pylorus and colon). In the sterile product packaging also a stopcock is provided to maintain pressure or vacuum by an inflation device. The balloon specific pressure / diameter relationship is represented on the labeling of each product.

The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract (i.e. esophagus, pylorus and colon).

The subject InScope Precision Balloon Dilator - Wire Guided described in this submission is virtually identical to its predicate device(s), which already have received 510(k) concurrence.

Compared to the previously cleared predicate device - InScope Precision Balloon Dilator - Fixed Wire, the subject InScope Precision Balloon Dilator - Wire Guided in this submission now resembles the Boston Scientific's CRE Wireguided Balloon Dilator, which already received FDA 510(k) concurrence.

The provided text is related to a 510(k) premarket notification for the "InScope™ Precision Balloon Dilator - Wire Guided." This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, the document does not contain information regarding specific acceptance criteria, a study proving the device meets these criteria, or any details about a standalone algorithm, human-in-the-loop performance, expert consensus, training set, or ground truth establishment.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the InScope™ Precision Balloon Dilator - Wire Guided is "virtually identical" and "substantially equivalent" to its predicate device(s) that have already received 510(k) concurrence.
• Performance Data: It states that performance has been "demonstrated via non-clinical bench type tests and analyses." However, it does not provide the results, acceptance criteria for these tests, or any details about a clinical study involving human patients or expert evaluations.
• FDA Clearance: The letter from the FDA confirms that based on the substantial equivalence argument, the device can be marketed.

Therefore, an answer based on your request and the provided text is not possible, as the necessary information for a detailed description of acceptance criteria, a supporting study, and related metrics (sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth) is absent.

The document is a regulatory submission for a medical device that establishes substantial equivalence to a predicate device, and thus, detailed performance metrics and studies are often not required in the same way they would be for a novel device or a device making new performance claims.

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