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The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.

The sam CS Long Duration Ultrasound Device consists of:

• Rechargeable Power Controller and Timer
• Ultrasound Generating Applicators
  Single use disposable accessories
• Ultrasonic Coupling Patch
  The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches.
  The sam CS Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) premarket notification summary for a medical device (sam CS Long Duration Ultrasound Device). It aims to demonstrate substantial equivalence to a predicate device (sam X1 Long Duration Ultrasound Device, K211513) to gain market clearance from the FDA.

Here's what can be extracted based on your request, highlighting the absence of specific details about acceptance criteria and a detailed study:

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

The document provides a "Substantial Equivalence Summary" (Table 1 on pages 5-6) which compares the subject device (sam CS) to the predicate device (sam X1) across various technical specifications. This table effectively serves as a comparison of performance characteristics, where "Identical" implies the sam CS meets the same reported performance as the sam X1. However, it does not explicitly state pre-defined acceptance criteria (e.g., "Device must achieve X% accuracy," or "Temperature rise must be between Y and Z degrees"). Instead, the acceptance is based on demonstrating equivalence to the predicate device.

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