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The SB Knife Jr2 is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47702, MD-47702L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current.

SB Knife Jr2 under application (Hereinafter "the Subject Device" is a single-patient use EtOsterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The Subject Device is designed to connect with Olympus and ERBE connectors and uses the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators.

The Subject Device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1-6 and IEC 60601 2-18 by ISO 17025 accredited laboratory.

The Subject Device consists of two models as follows:

MD-47702 Working Length: 1970 mm
MD-47702L Working Length: 2320 mm

The provided text is a 510(k) summary for the SB Knife Jr2, a medical device. It does not contain the information typically found in a study proving a device meets specific acceptance criteria based on performance.

Specifically, the text describes:

• The device and its intended use.
• A comparison to a predicate device (SB Knife®).
• Differences between the subject device and the predicate device, particularly regarding type, shape, structure, presence of a rotating operation portion, and materials.
• Non-clinical testing performed (transportation, shelf-life, packaging, sterilization, electromagnetic compatibility, electrical safety, biocompatibility).
• A statement that clinical testing was not performed.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from the provided text. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through technological comparison and non-clinical performance, rather than providing a detailed study of the device's performance against pre-defined acceptance criteria for a new clinical claim or feature that requires such a study.

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