(262 days)
The Anspach iMRI 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) environment rated at 1.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.
The iMRI Surgical Drill System is a Class II medical device which includes a pneumatic drill motor and foot control; a variety of nosepiece attachments; and various bone dissection tools (cutters). To make the drill system "MRI useable", ferrous metals comprising each system component have been replaced with materials known to have significantly lower or no discernable magnetic susceptibility. The iMRI Drill System foot control was tested with the Drill System within Zone IV. The iMRI motor does not require continuous oiling and therefore runs at slower speeds (60 - 65k RPM) than noniMRI Anspach motors (80 - 85k RPM). Nosepiece attachments (bearing tubes) support the cutter to minimize vibration , wobble and whipping. iMRI cutters are identical to other Anspach non-iMRI cutters with exception of materials and indications for use.
The provided text is a 510(k) summary for the Anspach iMRI Surgical Drill System. It describes the device, its indications for use, and its substantial equivalence to predicate devices, focusing on material changes to ensure MRI compatibility. However, the document does not contain specific acceptance criteria or details of a study with performance metrics in the format requested.
It primarily outlines:
- Device Description: A pneumatic drill system modified for use in an MRI environment by replacing ferrous metals with low or non-magnetic susceptibility materials.
- Indications for Use: Intra-operative (non-imaging) use within a 1.5 Tesla or less MRI environment for cutting, shaping, and removal of bone (skull and spine).
- Contraindications: Presence in Zone IV of an iMRI system during actual imaging due to potential image distortion.
- Performance Standards: Lists various ASTM, ISO, and AAMI standards related to materials, biological evaluation, sterilization, and risk management. It explicitly states, "Full conformance to these standards is not intended to be implied or declared, as implementation of various specific aspects of the standards are not yet fully established."
- Substantial Equivalence: Claims equivalence to other Anspach pneumatic drill systems (MicroMax, original 65K) with primary differences in materials, indications for use, and a modified locking mechanism to prevent interchangeability.
Based on the provided text, I cannot complete the requested tables and information because the document does not include:
- A table of acceptance criteria and reported device performance. The document lists standards applicable to materials and processes but does not detail specific performance metrics, pass/fail criteria, or how the device explicitly met those criteria through a study. The relevant ASTM standards mentioned (F2213-04 for magnetically induced torque and F2052-02 for magnetically induced displacement force) imply acceptance criteria related to MRI compatibility, but the actual performance results against these criteria are not reported.
- Details of a specific study proving device meets acceptance criteria. There is no mention of a formal clinical or technical study designed to generate performance data for the iMRI Surgical Drill System. The closest references are to standards that should be met (e.g., ASTM standards for MRI safety), but not to data demonstrating compliance.
- Sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or details of training sets. These types of details are typically found in studies evaluating performance (e.g., accuracy, sensitivity, specificity for diagnostic devices, or specific functional performance criteria for surgical devices) against a defined ground truth, which this document does not present. The document focuses on regulatory compliance through substantial equivalence, primarily based on material science and safety considerations for MRI compatibility, rather than a performance study as might be conducted for an AI/diagnostic device.
Therefore, many parts of your request cannot be answered from the given text. The 510(k) summary focuses on demonstrating substantial equivalence primarily through material changes and adherence to general safety standards, rather than providing a detailed performance study with quantitative results as a diagnostic or AI-driven device might.
§ 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).