(89 days)
The SYLFIRM X™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The SYLFIRM X™ includes a system main device, a probe equitable with a consumable tip, and a foot switch. The RF signal is generated from the main device which is then delivered to the probe and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the consumable tip. The consumable tip is placed in light contact with the epidermis while the probe is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SYLFIRM X™ creates heat within the target skin tissue via needle electrodes from the consumable tip.
The provided text describes the 510(k) summary for the SYLFIRM X™ device, which is an electrosurgical cutting and coagulation device and accessories. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-driven device for diagnostic or prognostic purposes, which is what your query implies with terms like "ground truth," "multi reader multi case," and "standalone performance."
Instead, the document focuses on demonstrating substantial equivalence to predicate devices for a radiofrequency heating device used in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The "performance data" section details various preclinical tests and validations required for this type of medical device, such as:
- Sterilization validation test: To verify sterility assurance level (10-6) for EO sterilization using the biological indicator (BI) overkill method, in accordance with ISO 11135-1, ISO 10993-1, ISO 10993-7, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO 11737-2, AAMI TIR 15, and ISO 13485:2016.
- Shelf-life validation test: Conducted using the accelerated aging method in accordance with ASTM F1980-07 (2011), ISO 11607-1, ISO 11607-2, ISO 11737-2, ASTM F1929, ASTM F 88, and USPNF.
- Biocompatibility test: For the patient-contacting consumable tip, in accordance with ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, and USP 39 .
- Software validation test: For software (firmware) of moderate level of concern.
- EMC & Electrical safety test: Per IEC 60601-1:2005, IEC 60601-1:2012; IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013; IEC 60601-2-2:2017, CISPR 11:2009/AMD1:2010, IEC 60601-1-2:2014.
- Preclinical (Animal) test: Three Yucatan Mini-pigs were used to evaluate safety and effectiveness as an RF heating device to treat dermal conditions and hemostasis. Animals were euthanized at different time points (3h, Day 4, Day 21). Microscopic findings included minimal to moderate, multifocal deep dermal collagen necrosis and minimal to mild multifocal deep dermal fibrosis.
None of the provided information aligns with the specific points you requested for an AI/algorithm-driven device (e.g., acceptance criteria for diagnostic accuracy, sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details). The SYLFIRM X™ is a physical medical device, not an AI software intended for diagnosis or prediction.
Therefore, I cannot provide the requested table and details based on the given document as it describes a different type of device validation.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.