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The Max-It device is intended to provide or maintain an erection in men with impotence or premature ejaculation.

The Max-It device is intended to provide or maintain an erection in men with impotence or premature ejaculation. This is achieved as a result of blood vessel constriction which allows blood to flow into the penis but not to freely flow out (the valvular effect). The external pressure applied by the Max-It device restricts the free flow of blood out of the penis, but not into the penis. It is equivalent to the venous flow controller in that it constricts the blood flow at the dorsal vein on top of the penis. It differs from the venous flow controller in that not only does it constrict blood flow at the dorsal vein on top of the penis, the Max-It device also constricts the three cavernous cylinders. These cylinders originate in the anus and transverses the perineum area to the pubis area which forms the base of the penis and extends into and forms the shaft of the penis. Pressure applied to this perineum area and dorsal vein and artery on the dorsal base of the penile shaft at the pubis, will provide the valvular control, which is the formula to natural erection.

This 510(k) submission (K983438) for the "Max-It" device does not contain a study that establishes acceptance criteria or reports device performance in a clinical setting.

The provided document is primarily a notification of intent to market the device and the FDA's letter of clearance based on substantial equivalence to a predicate device. It does not include clinical trial data or performance metrics.

Therefore, I cannot fulfill most of your request for information about acceptance criteria and study details. However, I can infer some aspects from the available information:

1. A table of acceptance criteria and the reported device performance:

• Cannot provide. The document does not define specific performance metrics or acceptance criteria for the Max-It device. Its clearance is based on substantial equivalence to a predicate device, not on proving new performance.

2. Sample size used for the test set and the data provenance:

• Not applicable. No test set or clinical study data is presented in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No test set or clinical study data is presented in this document.

4. Adjudication method for the test set:

• Not applicable. No test set or clinical study data is presented in this document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a physical medical device (venous flow controller for erectile dysfunction), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable. No study data is presented. The basis for clearance is "substantial equivalence" to a predicate device. This typically involves demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device, often without requiring new clinical performance data if the devices are sufficiently similar.

8. The sample size for the training set:

• Not applicable. This document does not describe the development or training of an algorithm or any clinical trials with training sets.

9. How the ground truth for the training set was established:

• Not applicable. No training set is mentioned as this is a physical device, not an algorithm.

Summary based on the provided text:

The information provided in K983438 is a 510(k) premarket notification. The FDA's clearance is based on the device being substantially equivalent to a legally marketed predicate device (a "venous flow controller") for the indications for use: "The Max-It device is intended to provide or maintain an erection in men with impotence or premature ejaculation."

The document does not report any new clinical studies, performance data, acceptance criteria, or ground truth establishment for the Max-It device itself. The equivalence is primarily based on the functional mechanism (blood vessel constriction to maintain an erection) and intended use, as compared to the predicate.

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