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The DigniCap® Scalp Cooling System is indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors.

The DigniCap® Scalp Cooling System consists of a computer controlled system that includes a refrigerated tank containing the liquid coolant that is maintained at -7 ± 2°C. The coolant circulates from the cooling unit to and through the channels of the cap and back to the cooling unit. The scalp temperature is monitored by three separate sensors. Deviations from the treatment temperature are automatically adjusted by the system (scalp temperature can be controlled with an accuracy of ± 2.0°C). The DigniCap® Scalp Cooling System components include the following:
Digni C3 – Is a refrigerator unit with an integral control system operated via a touch screen and is capable of controlling two separate DigniCap® Cooling caps independently of each other. Scalp cooling is performed in conjunction with a silicone inner cap (DigniCap®), an outer neoprene cap (DigniTherm), and the liquid coolant (DigniCool).
DigniCap® – A soft, tight-fitting silicone cap which has two separate cooling circuits, one for the front and one for the back of the head. Each cooling circuit is equipped with a temperature sensor, and the cap is also equipped with a third sensor for safety control. The cap is available in different sizes.
DigniCool - The liquid coolant monopropylene glycol.
DigniTherm - The outer neoprene cap that insulates and keeps the inner cap in place. This neoprene cover cap, called the DigniTherm, comes in different sizes and is colored coded to match the corresponding DigniCap® Cooling cap.
DigniStick- A component used to save data from a treatment or for troubleshooting. It can also be used to update software.
DigniCard - A key card which has to be inserted in order to start a treatment.

The provided document is a 510(k) summary for the DigniCap Scalp Cooling System. It focuses on the substantial equivalence to a predicate device and an expanded indication for use.

Based on the document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for K170871 does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., success rate thresholds) that the device must meet for this specific submission. Instead, it relies on demonstrating substantial equivalence to a previously cleared device (DEN150010) and provides a literature review of clinical studies from outside the U.S. to support the expanded indication for use.

The clinical studies vary in their definitions of success and methods of assessment. Here's a summary of the reported success rates and the conditions under which they were achieved, derived from "Table 1 Clinical Data with the DigniCap® Scalp Cooling System Outside of U.S.":

| Study (Year) | Chemotherapy Regimens (Examples) | Sample Size | Completed Cooling % | Reported Device Performance (% Success with

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