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Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist 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 medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a 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 Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPCT™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the label and the instrument.

The CD HORIZON™ Spinal System surgical instruments are non-sterile or 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 intended to be used when preparing and placing Medtronic screws during spinal surgery. To enable optical navigation compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the proximal ends of the instrument shafts have been designed with a bushing that provides a connection site where the NavLock™ trackers (K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E. 06/18/2020) can be attached. To enable trajectory guidance compatibility of the surgical instruments with the Mazor X Stealth™ Edition, the instrument dimensions have been designed to work with the Mazor X arm guides. The subject RG FAS Drivers may also be operated under power when attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011).

The subject instruments are reusable and will be provided non-sterile.

The provided text is a 510(k) summary for a medical device (Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition) and does not describe acceptance criteria for an AI/ML device or a study proving that an AI/ML device meets such criteria.

The document discusses:

• Device Name: CD Horizon™ Spinal System / Medtronic Surgical Instruments for use with Mazor X Stealth™ Edition
• Regulatory Information: 510(k) clearance, product codes, classification, predicate devices.
• Intended Use: Surgical instruments for preparing and placing Medtronic implants during spinal surgery, assisting in precisely locating anatomical structures, compatible with MAZOR X Stealth™ Edition.
• Technological Characteristics: Comparison with predicate devices, stating similar intended use, indications, material, fundamental technology, and sterilization method.
• Performance Data: This section briefly mentions verification/validation activities, but these are for the surgical instruments themselves and their compatibility with the navigation system, not for an AI/ML algorithm's performance. The activities listed are:
  • Design Validation and Anatomical Simulated Use
  • Navigation Simulated Use
  • Navigation Accuracy Analysis

Given this, I cannot provide the requested information about acceptance criteria and the study that proves an AI/ML device meets them because the provided text does not describe an AI/ML device or its evaluation. It focuses on traditional surgical instruments.

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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.

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 intended to be used when preparing and placing Medtronic screws during spinal surgery. To enable optical navigation compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the proximal ends of the instrument shafts have been designed with a bushing that provides a connect ion site where the NavLock™ trackers (K171267, S.E. 07/03/2017; K182104, 11/02/2018; K201327, S.E. 06/18/2020) can be attached. To enable trajectory guidance compatibility of the surgical instruments with the MAZOR X Stealth™ Edition System, the instrument dimensions have been designed to work with the MAZOR X arm guides. The subject taps and drivers may also be operated under power when attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011). The instruments will be provided non-sterile and are reusable.

The provided document is a 510(k) summary for the Medtronic CD Horizon Spinal System. It does not include information about a study proving the device meets specific acceptance criteria in the way a clinical study would for an AI/algorithm-driven medical device.

This document describes a new version of surgical instruments, designed to be compatible with existing navigation and robotic systems (MAZOR X Stealth™ Edition, IPC™ POWEREASE™ System, and NavLock™ trackers). The "performance data" section refers to engineering verification testing rather than a clinical study evaluating diagnostic or therapeutic accuracy against human performance. The device itself is a set of surgical instruments, not an AI algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, sample size, expert ground truth, MRMC study, standalone performance, etc.) from this document because it is not relevant to the type of device and study requested in the prompt.

The "Performance Data" table provided in the document refers to engineering and functional testing of the instruments, such as:

• Navigation Accuracy Analysis: Confirmed navigated instrument accuracy.
• Anatomical Simulated Use: Confirmed instrument functionality under expected use conditions.
• Navigation Simulated Use: Confirmed navigation system functionality under expected use conditions.
• CAD Model Evaluation: Verified that the CAD models are accurately reflected in the application software.
• Navigation Software Module Instrument Functional Testing: Verified that the instrument attributes are correctly implemented in the navigation software module.

These are design verification and validation activities for a physical instrument, not a study evaluating the performance of an AI algorithm or a diagnostic tool against human ground truth.

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The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with Medtronic systems utilizing STEALTH™ Technology. The NavLock™ Trackers should only be used with Medtronic instruments on Medtronic systems utilizing STEALTH™ Technology.

The NavLock™ Trackers are compatible with StealthStation™ Systems and Mazor X STEALTH™ Edition and are used in conjunction with various navigated spine instrumentation for optical navigation. To enable navigation compatibility, the proximal ends of the instruments are designed to fit into the NavLock™ Trackers for optical navigation. The NavLock™ Trackers have posts to affix reflective spheres, which are visible to the StealthStation camera as a means of tracking the position of the attached surgical instrument.

The provided text describes a 510(k) premarket notification for Medtronic Navigation's NavLock Trackers. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel study to determine acceptance criteria and device performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable or not provided in the given document.

However, based on the information available, here's a reconstructed answer:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated in the provided text for the current submission (K201327). The document indicates "worst-case test configurations" were used in previous clearances (K182104 and K171267).
• Data Provenance: The document does not specify the country of origin. The previous studies were "system-level accuracy testing." It's retrospective in the sense that the current submission relies on previous clearances and states "There have been no significant design changes to the NavLock™ Trackers since clearance in K182104. Therefore, performance testing is not needed to demonstrate substantial equivalence in the current submission."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. The performance testing was for device accuracy (positional and trajectory error), which typically relies on metrological measurements rather than expert human interpretation to establish ground truth.

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

• Not applicable/Not provided. Adjudication is typically relevant for studies involving human interpretation or subjective assessments, which is not the case for this device's accuracy testing.

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:

• Not applicable. This is a medical device (trackers for navigation systems), not an AI diagnostic algorithm that assists human readers.

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

• The performance testing cited (positional and trajectory error) represents the "standalone" accuracy of the navigation system when using the trackers. The device itself (NavLock Trackers) is a component of a navigation system, and its performance contributes to the overall system's accuracy. The stated accuracies (≤2.0 mm positional error and ≤2.0° trajectory error) can be considered the standalone performance based on the system's measurements.

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

• For the accuracy testing, the ground truth would have been established by precise measurement systems (e.g., optical metrology systems) used to determine the true position and trajectory, against which the device's measurements were compared. The text mentions "system level accuracy testing."

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set. Its performance is based on its physical design and optical tracking principles.

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

• Not applicable, as there is no training set for this device.

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