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Medtronic Surgical Instruments are intended to be used during the preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the MAZOR X Stealth™ Edition, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ POWEREASE™ System. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

DO NOT IMPLANT THE INSTRUMENTS

The CD HORIZON™ Spinal System surgical instruments are non-sterile, single or re-usable instruments that may be used during the preparation and placement of various Medtronic spinal implants during spinal surgery. The subject instruments are made of a variety of materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. Single-use Medtronic Surgical instruments should never be reused under any circumstances.

The CD HORIZON™ instruments are specifically designed for use in spinal procedures with MAZOR X Stealth™ Edition. The instruments can be navigated or non-navigated manual instruments that may or may not be guided through the MAZOR X Arm Guide. Some instruments (e.g. drills, drivers, taps etc.) are also compatible with Medtronic's IPC™ POWEREASE™ System when connected to the POWEREASE™ Driver, these CD HORIZON™ instruments may or may not be guided through the MAZOR X Arm Guide. Medtronic surgical drills shall only be used through the MAZOR X arm guides, cannulas, and drill guides. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allow MAZOR X Stealth™ Edition to track the Medtronic instruments in the surgical field.

The document provided describes the CD HORIZON Spinal System Instruments for use with MAZOR X Stealth™ Edition. This is a medical device subject to FDA approval, specifically a 510(k) premarket notification. The document states that the device is substantially equivalent to a predicate device.

The provided text does not contain the detailed information requested regarding specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, expert qualifications, or adjudication methods. The information pertains to the regulatory approval process and a general summary of performance testing.

Therefore, many parts of your request cannot be answered from the provided document. I can, however, extract the information that is present.

1. A table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or reported device performance metrics in the format of sensitivity, specificity, or accuracy, which are typical for AI/diagnostic devices. Instead, it lists general performance tests conducted.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the described tests, nor does it detail the provenance of any data (e.g., country of origin, retrospective/prospective nature). The tests are described as "simulated use" and "analysis" rather than clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention using experts to establish ground truth for a test set. The nature of the device (surgical instruments for navigation) suggests performance testing would involve engineering and functional verification rather than expert clinical assessment of diagnostic output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not mention any adjudication method, as it doesn't describe expert-based ground truth establishment or a review process for a test set in the context of diagnostic performance.

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

The document does not indicate that an MRMC comparative effectiveness study was done. This device is a set of surgical instruments used with a navigation system (MAZOR X Stealth™ Edition), not typically an AI-powered diagnostic device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This request is not applicable to the device described. The device consists of surgical instruments that are part of a system intended for human use during surgery. It is not an algorithm that can perform standalone diagnostics or analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" in the diagnostic sense (e.g., pathology for a diagnosis) is not directly applicable here. The "ground truth" for the performance tests would likely be engineering specifications, physical measurements, and expected functional behavior of the instruments and system. For instance, "Navigation Accuracy Analysis" would involve comparing the navigated position to an objectively measured physical position, which is a form of engineering ground truth.

8. The sample size for the training set

The document does not mention a training set specific to an AI algorithm. This device is a set of physical surgical instruments, not a machine learning model that requires training data.

9. How the ground truth for the training set was established

Not applicable, as no training set for an AI algorithm is mentioned or relevant to this device description.

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The Mazor X is indicated for precise positioning of surgical implants during general spinal and brain surgery. It may be used in either open or minimally invasive or percutaneous procedures.

Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.

The Mazor X hosts guidance for spine and brain procedures and intra-operative 3D image processing capabilities. It enables the surgeon to precisely position surgical instruments and/or implants (in spinal surgery). The planning of the surgical procedure and virtual placement of surgical instruments and/or implants (e.g., a screw) can be achieved through pre-operation planning based on the patient's CT scan or intraoperative planning based on Mazor X 3D Scan image or on a 3D image uploaded from an external 3D image acquiring system. The Mazor X enables accurate deployment of surgical accessories in the precise anatomical location according to predefined planning. With the imaging capabilities of the system, the user can also visualize the implants on the patients CT. The Mazor X is a device modification of the original Mazor X System cleared in 510(k) K163221.

The provided text describes a 510(k) premarket notification for the "Mazor X" device. This submission is for a modification of an existing device (Mazor X System, K163221), and therefore, the performance testing focuses on demonstrating that the modifications do not adversely affect the device's safety, effectiveness, and performance compared to the predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Limited Information on Acceptance Criteria and Studies:

It's important to note that this 510(k) summary focuses on demonstrating substantial equivalence of a modified device to a predicate device. As such, it does not detail a comprehensive study establishing novel acceptance criteria or a full clinical study with specific performance metrics (like sensitivity, specificity, accuracy) that would be typical for a new device's initial clearance or a comparative effectiveness study. The "acceptance criteria" here are primarily about demonstrating that the modified device performs as well as the predicate and meets its design requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a modification submission, the "acceptance criteria" are implicitly tied to maintaining the performance and safety established by the predicate device and meeting design requirements for the modifications. Specific quantitative performance metrics are not provided in this document in a tabular format.

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

The document does not explicitly state sample sizes for tests. The descriptions focus on "validation testing" and "retesting" of specific modules and algorithms. It does not mention clinical studies with human patient data or specific "test sets" in the context of typical AI/machine learning evaluation (e.g., a set of patient images for diagnostic accuracy).

• Sample Size: Not specified.
• Data Provenance: Not specified. The tests are described as software validation testing and functionality testing for the modified Align module. This implies testing with internal data or synthetic data relevant to the software functionalities, rather than patient data from specific countries or retrospective/prospective studies.

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

Given the nature of the tests described (software and functionality validation), there's no indication that a "ground truth" was established by medical experts for a diagnostic or interventional task, which would typically involve human reviewers. The tests are against design requirements and algorithmic performance.

• Number of Experts: Not mentioned.
• Qualifications: Not mentioned.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the described tests are technical validations against specifications and functionality rather than human-interpreted diagnostic outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. The document focuses on demonstrating that the modified device is as safe and effective as the predicate device, not on comparing human performance with and without AI assistance.

• Effect Size of Human Readers Improve: Not applicable; no MRMC study reported.

6. Standalone (Algorithm Only) Performance Study

The performance tests mentioned are for the integrated "Mazor X system" and its "software version" and "Align module." While these are tests of the algorithm's functionality, the document describes the system as enabling surgeons to position instruments and implants, and its imaging capabilities provide processing and conversion of fluoroscopic projections. This suggests the algorithm's performance is tested within the context of its intended function as part of a surgical guidance system, rather than as a standalone diagnostic tool. The "algorithm only" performance is embedded within the "Software validation testing" and "retraining" of the Align module.

7. Type of Ground Truth Used

The "ground truth" for the reported tests appears to be based on:

• Design requirements/specifications: For the software validation.
• Established functionality of the original Mazor X Align module: For retesting the modified Align module.
• Algorithmically derived correct states: For parameters like lateral positioning validation and vertebral end-plates recognition.

It is not based on expert consensus, pathology, or outcomes data as these are not clinical studies.

8. Sample Size for the Training Set

No information about a training set is provided. This 510(k) pertains to a device modification and validation, not the initial development or training of a machine learning model from scratch where a distinct "training set" would typically be detailed. The "software optimization" and "enhanced functionalities" likely involved development and testing, but the specific "training set" for any underlying machine learning components is not discussed.

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

Not applicable, as no training set is described in this document.

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