(27 days)
The Aesculap Implant Systems® activL® Next Generation Instrumentation are indicated for the successful implantation of the Aesculap activL® device. These instruments are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of the activL® device.
The activl ® Next Generation Instrumentation would allow successful implantation of the Aesculap activL® device. These are manual surgical instruments which aid in selecting, placing, and revising the activL® device. These activL® instruments device comprises of trial, trial holders, single and double chisels, implant inserter, depth stop, depth stop driver, and impaction caps.
This document is a 510(k) Premarket Notification from the FDA regarding the activL® Next Generation Instrumentation. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on metrics like sensitivity, specificity, or AUC for an AI/CADe device.
Therefore, the requested information regarding acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found or inferred from the provided text. The document pertains to manual surgical instrumentation, not an AI or diagnostic device that would typically undergo such rigorous performance evaluation.
The "Performance Testing Summary" section (Page 4, {4}) briefly mentions:
- Simulated use/Functional testing
- Transit testing
- Sterilization/Cleaning validation
These are standard engineering and manufacturing performance tests for reusable surgical instruments, not clinical performance studies with human subjects or AI algorithm evaluations. The conclusion explicitly states the device is substantially equivalent based on "indication, design, materials, function, and performance" relative to predicate devices, and that performance testing demonstrated it "do not introduce any new question of safety or effectiveness."
§ 888.4515 Orthopedic manual surgical instrumentation for use with total disc replacement devices.
(a)
Identification. Orthopedic manual surgical instrumentation for use with total disc replacement devices are non-powered hand-held devices designed specifically for use with a total disc replacement device and interface with the associated implant for the purpose of insertion, removal, placement, or repositioning, or to cut, rasp, or create a defect specific to the features of the associated implant. This type of device includes instruments specific to the geometry of the implant.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant.
(2) The patient contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated.
(4) Labeling must include:
(i) Identification of implant(s) and instruments which have been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.