(79 days)
The MRI Safe Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) system rated at 0.5 Tesla or less, for the surgical cutting, shaping and removal of bone, including bones of the skull and spine.
The MRI Safe Surgical Drill System is a class II medical device that includes a pneumatic drill motor, foot control, a variety of nosepiece attachments; and bone dissection tools. To make the motor and foot control, a variety of non-looping materials comprising each system component have been replaced with materials known to have significantly lower or no magnetic susceptibility. However, when imaging is being performed the drill system must be moved to at least Zone 4. The MRI Safe Drill System foot control is not intended to be placed within the sterile field nor within MRI magnetic field (Zones 1-3). The MRI Safe motor does not require continuous cooling within MRI magnetic field. The MRI Safe motor operates at a slightly slower speed (60-65k RPM) than non-MRI safe motors (80-85k RPM). Nosepiece and cutters are a direct attachment and support the cutter to minimize run-out, wobble and whipping. They are non-sterile for reusable applications. Cutters are surgically invasive, direct contact (with patient) devices and are provided sterile for single use applications. Cutters carry additional warnings to advise user that "dulling" may occur faster than non-MRI safe cutters if overused or reused.
The provided text describes a medical device, the Anspach MRI Safe Surgical Drill System, and its acceptance for market. However, it does not include detailed acceptance criteria and a study report with performance metrics, sample sizes, ground truth establishment, or multi-reader studies.
The document is a 510(k) summary (K040186) for premarket notification to the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a dedicated clinical study with the rigor described in the request.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes for test/training sets, ground truth establishment expertise, adjudication methods, MRMC studies, or standalone algorithm performance, as this information is not present in the provided text.
The text primarily outlines:
- Device Description: A pneumatic surgical drill system designed for use in an MRI environment by replacing magnetic components with non-magnetic ones.
- Intended Use/Indications for Use: Intra-operative (non-imaging) surgical cutting, shaping, and removal of bone (skull and spine) within a 0.5 Tesla or less MRI system. It explicitly states the system must be moved to at least Zone 4 when imaging is performed.
- Risks/Hazards: Addresses known risks like magnetic field interference, heat generation, noise, image distortion, projectile concerns, and unintended use of non-MRI safe components.
- Substantial Equivalence: Claims substantial equivalence to other Anspach Claim Systems (MicroMax and original 65K), noting material changes and a modified locking mechanism.
The FDA's decision letter (K040186) confirms that the device was found substantially equivalent to predicate devices, allowing it to be marketed. This decision is based on the information provided in the 510(k) summary, which argues for substantial equivalence primarily through design modifications and addressing potential risks, not through a performance study against predefined acceptance criteria as might be seen for AI/ML devices or novel therapies.
§ 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).