(410 days)
The ELAN 4 Air Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
The ELAN 4 Air Motor System is a pneumatic motor system that can be used with any sterile, pressurized gas (usually nitrogen). The system consists of several components such as wall adaptors, foot pedals, and handpieces. The foot pedal has the ability to connect various handpieces with integrated motors that contain attachments such as burrs, saw blades, and drills. The system allows for high-speed dissection at up to 80.000 RPM while also allowing low speed cutting between 1.000 and 20.000 RPM. The speed and rotation direction of the handpieces can be controlled via the foot pedal.
The provided text is a 510(k) summary for the ELAN 4 Air Motor System, a pneumatic cranial drill motor. It does not describe a study involving an AI or algorithm-based device, human readers, or a test set with expert ground truth establishment. Instead, it describes a medical device (a surgical drill) and its performance validation through design verification and biocompatibility testing.
Therefore, I cannot answer your request as the information you've asked for (acceptance criteria for an AI/algorithm, sample size for AI test and training sets, expert consensus for ground truth, MRMC study, etc.) is not contained within the provided document.
The document focuses on demonstrating substantial equivalence to predicate devices (other surgical drills) based on:
- Indications for Use: The ELAN 4 Air Motor System is intended for high-speed cutting, sawing, and drilling of bone in various surgical fields.
- Technological Characteristics: Comparison of components, power source (pneumatic vs. electric), operating speeds, rotation, materials, and control mechanisms.
- Performance Data (Design Verification): Functional testing to ensure the device performs as intended and safely meets specifications over time. These tests are explicitly listed as "Pass: All requirements met."
- Biocompatibility: Confirmation that materials used are safe for patient contact.
To reiterate, the provided text does not describe the kind of study you are asking about, which typically pertains to diagnostic or assistive AI software rather than mechanical surgical instruments.
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).