(70 days)
The Drill Guide Attachment of the Sodem High Speed System allows to make holes in adjustable depth and operate with drills and cutters in different applications and surgeries.
This attachment is intended for use in Neurology (spine and craniotomy), General Plastic surgery (median sternotomy) and Orthopedic (revision implant surgery, extremity: hand, foot ... ) applications.
The Drill Guide Attachment PN 3105 DG is used with different elements of the Sodem High Speed System (Pneumatic).
The Sodem High Speed System is a modular pneumatically powered high speed instrument system consisting of a hand piece, adapters and accessories/attachments (spindles, burs ... ) and especially Drill Guide Attachment used to make holes in the bone with an adjustable depth.
The Sodem High Speed System (Pneumatic) is a complete system including:
- a High Speed motor, .
- . a foot pedal,
- dedicated hoses to connect the motor and the foot pedal, -
- adapters (angled adapter)
- Drill Guide Attachment PN 3105 DG (other attachments/spindles already submitted exist as angled attachments, straight attachments standard and tapered, craniotomes)
- drills, burs and cutters -
The Sodem High Speed System (Pneumatic) for use in Neurology applications is the same product as the Sodem High Speed System (Pneumatic) already submitted for Neurology, Orthopedic and General plastic surgery (K954717, K954080, K955174) and currently submitted for ENT and Dental surgery. The difference is the addition of a new attachment PN 3105 DG : Drill Guide Attachment.
The provided text is a 510(k) premarket notification for a medical device, the "Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic)." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study demonstrating the device meets specific acceptance criteria through a clinical trial or performance study with detailed metrics.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and comparative effectiveness studies is not present in this document. The 510(k) process relies on demonstrating that the new device is as safe and effective as a predicate device, primarily through comparison of intended use, technological characteristics, and materials.
Here's a breakdown of why each specific point cannot be addressed from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria for the Drill Guide Attachment in the way a clinical trial would. Its performance is implicitly deemed acceptable if it is substantially equivalent to the predicate device.
- Sample sized used for the test set and the data provenance: No test set or associated data provenance (country of origin, retrospective/prospective) is mentioned, as this is not a clinical study report.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no "test set" and thus no ground truth established by experts within this document. The FDA reviews the submission for substantial equivalence.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no test set or adjudication process described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a surgical drill attachment, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or included.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical surgical instrument.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No "ground truth" as typically defined in diagnostic studies is used here. The basis for acceptance is substantial equivalence to a predicate device in terms of intended use, materials, and technological characteristics.
- The sample size for the training set: Not applicable, as this is not a machine learning or AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable, as there is no training set mentioned or required for this type of device submission.
In summary, the provided document demonstrates substantial equivalence, not performance against specific acceptance criteria through empirical study results. The "study" in this context is the FDA's review of the comparison between the new device and predicate devices.
§ 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).