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Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.

Spine & Trauma Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.

The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image databased model of the anatomy.

The Spine & Trauma Navigation is an image quided surgery system for navigated treatments in the fields of spine and trauma surgery, whereas the user may use image data based on CT, MR, 3D fluoroscopic image reconstruction (cone beam CT) or 2D fluoroscopic images. It offers different patient image registration methods and instrument calibrations to allow surgical navigation by using optical tracking technology. To fulfil this purpose, it consists of software, Image Guided Surgery platforms and surgical instruments.

Modified Drill Guides and Drill Bits have been introduced as part of the Subject Device. The Drill Guide instruments are navigated instruments which support the surgeon in guiding drill bits and K-wires during spinal procedures. They consist of a guide tube, a trocar insert (both available in five different diameters), a body with two available handles, an array and a depth control (available in two different sizes for various drilling depths). The Drill Guide Tubes and Drill Guide Trocar Inserts have patient contact. All instruments are delivered unsterile and require end user sterilization.

The Drill Bits are used for drilling of bone. They are made of stainless steel and are delivered non-sterile. They require steam sterilization onsite before use. There are several variants in terms of diameter, length, and presence of a depth stop feature.

The provided text describes the regulatory clearance for the Brainlab AG Drill Guide, Drill Bit, and Spine & Trauma Navigation system. Here's a summary of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document doesn't explicitly state sample sizes for all test sets.

• Usability Testing: 15 representative users.
• Other Testing (Accuracy, Assembly Stability, Lifecyle assessment, Skiving, Handling and interface analysis, Mechanical failure testing, Biocompatibility, Reprocessing validation): Sample sizes are not specified in the provided text.
• Data Provenance: Not specified, but generally, these types of performance tests are conducted in a controlled laboratory environment. The document does not mention the country of origin of data or whether it was retrospective or prospective, as clinical data was not required.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• This information is not provided in the document. The performance tests described (e.g., accuracy, mechanical failure) are typically assessed against engineering specifications rather than expert consensus on medical images or diagnoses.
• For usability testing, the 15 "representative users" likely served as the evaluators, but their specific qualifications beyond being "representative" are not detailed.

4. Adjudication Method for the Test Set:

• An adjudication method (like 2+1, 3+1) is not applicable for the reported performance testing, as these are engineering and functional tests.
• For usability testing, the document states "The final design was proven safe and effective," implying an overall assessment rather than a specific multi-reader adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• No MRMC comparative effectiveness study was done. This device is a navigation system and surgical instruments, not an AI diagnostic or assistive tool that would typically be evaluated in an MRMC study comparing human reader performance with and without AI.
• The document explicitly states: "No clinical testing was required for the subject device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• The "Spine & Trauma Navigation" system is an image-guided surgery system that inherently involves a human surgeon in the loop. The performance tests (e.g., navigation accuracy) evaluate the system's ability to accurately guide instruments, which is a standalone function of the technology when used by a surgeon. It's not an "algorithm-only" performance in the sense of a fully automated diagnostic or interpretive AI.

7. The Type of Ground Truth Used:

• The ground truth for most of the performance tests (e.g., accuracy, mechanical failure, stability) is based on engineering specifications and metrology (precise measurements against known values).
• For biocompatibility and reprocessing, the ground truth is established by adherence to international standards (ISO 10993-1:2018, ISO 11737-1:2018, ANSI/AAMI ST98:2022, ISO 15883-5:2021-07).
• For usability, the ground truth is the satisfaction of predefined acceptance criteria by the representative users in a simulated scenario.

8. The Sample Size for the Training Set:

• This information is not applicable/not provided. The device is an image-guided surgery system and newly modified instruments, not a machine learning or AI model trained on data in the traditional sense that would have a "training set." The development of such physical devices and software systems involves rigorous engineering design, verification, and validation, but not typically a "training set" like that seen in deep learning applications.

9. How the Ground Truth for the Training Set Was Established:

• This information is not applicable, as there is no mention of a "training set" for an AI model.

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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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical surgical instrument.
7. 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.
8. The sample size for the training set: Not applicable, as this is not a machine learning or AI device that requires a training set.
9. 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.

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