(267 days)
The GEISTER® K-Rex™ rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.
Geister Geister® K-Rex™ rongeurs are reusable stainless steel instruments that are coated with TiAIN that are sterilizable and packaged non-sterile.
The provided FDA 510(k) clearance letter for the Geister K-Rex Rongeurs does not contain information about the acceptance criteria or a study that proves the device meets those acceptance criteria in the context of an AI/software device. Instead, the document describes a traditional medical device (surgical rongeurs) and its clearance process.
Therefore, I cannot provide the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) as the provided text does not pertain to an AI/software device or a study involving such elements.
The documentation focuses on:
- Device Description: Manual, reusable stainless steel instruments coated with TiAIN, used for cutting or biting bone.
- Intended Use: Cutting or biting bone during surgery involving the skull or spinal column.
- Substantial Equivalence: Comparison to existing legally marketed rongeurs (predicate devices) based on intended use, technological characteristics (materials, bite size, length, jaw opening/angles, footplates, detachable, ejector), and performance.
- Non-Clinical Performance Data: Biocompatibility testing (ISO 10993), Reprocessing/Cleaning/Sterilization validation (ANSI/AAMI ST98:2022, ISO 17665, ISO 17664), and a "Cutting performance test" of 10,000 cycles compared to the predicate device to show similar performance.
- Clinical Performance Data: Stated that no clinical testing was required as the device is equivalent to predicate devices with proven safety and efficacy.
In summary, the provided document describes the clearance of a mechanical surgical instrument, not an AI/software-based medical device. Thus, the specific metrics and study methodologies typically associated with validating AI/software performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test sets) are not present in this 510(k) clearance letter.
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).