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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 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 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 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 IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools.

The Catalyft™ PL Expandable Interbody System navigated instruments consist of an Inserter (Outer), Inserter Inner Sleeve, Trials, a NAV Verification Tool, and Navigated Rotating Shavers that were cleared in K210425. These instruments are navigated instruments manufactured from stainless steel and are currently cleared for use in procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System (K050438. S.E. 06/02/2005; K201189. S.E. 05/29/2020). Per this 510(k) submission, Medtronic is seeking clearance of the subject devices to also be navigated with MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) with the devices remaining compatible with StealthStation™ System.

Please note that the Navigated Rotating Shavers were previously cleared for use on MAZOR X™ (K203005, S.E. 10/27/2020), and per this 510(k) submission, the Rotating Shavers can be used for disc prep and to trial for Catalyft™ PL on MAZOR XTM.

The Anteralign™ TL navigated instruments consist of an Inserter and Trials that were originally cleared in K212524. These instruments are navigated instruments manufactured from stainless steel and are currently cleared for use in procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System (K050438, S.E. 06/02/2005; K201189, S.E. 05/29/2020). Per this 510(k) submission, Medtronic is seeking clearance of the subject devices to also be navigated with MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) with the devices remaining compatible with StealthStation™ System.

The CD Horizon™ Solera™ Vovager™ Spinal System navigated instruments consists of new Drivers, which will be manufactured from stainless-steel. Medtronic is seeking clearance of the Drivers to be Navigated and Trajectory Guided via MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) and Powered via IPC™ POWEREASE™ System (K111520. S.E. 10/26/2011: K123270. S.E. 01/11/2013). To enable trajectory guidance compatibility, the Drivers have been designed to work with the MAZOR X™ Arm Guides. To enable power, the Drivers may also be attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011).

The provided document is a 510(k) summary for Medtronic surgical instruments, outlining their substantial equivalence to predicate devices. It focuses on the compatibility of these instruments with the MAZOR X™ system. However, the document does not contain the detailed acceptance criteria and performance data typically found in a clinical study report for proving a device meets acceptance criteria.

Specifically, it mentions "Performance Testing" and "Discussion of the Performance Testing" but then lists generic test descriptions rather than specific quantitative acceptance criteria or reported device performance metrics. There is no information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, based solely on the provided text, I cannot fill out the requested table or provide the detailed study information. The document serves as a high-level summary for regulatory submission, not a detailed performance study report.

Here's a breakdown of what can and cannot be extracted from the provided text according to your request:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document lists general "performance testing" but does not define quantitative acceptance criteria (e.g., "accuracy shall be within X mm") or specific numerical results.
• Sample sizes used for the test set and the data provenance: No information on the number of cases, images, or subjects used in the "performance testing," nor any details on whether it was retrospective or prospective, or data origin.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a ground truth established by experts for performance evaluation. The "ground truth" here is likely engineering validation against design specifications or a simulated environment, not clinical expert consensus.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no human adjudication 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: Not applicable. This device is surgical navigation instrumentation, not an AI / image analysis device that would assist human readers in diagnosis.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "performance testing" described is likely functional verification of the instruments and their compatibility with the navigation system, not a standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but inferred to be engineering specifications and simulated use assessments rather than clinical ground truth.
• The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

What can be inferred or extracted (though still lacking detail for your specific request):

• Device Type: Surgical Instruments for spinal surgery, intended to assist in precisely locating anatomical structures using navigation systems (MAZOR X™ Stealth™ Edition and StealthStation™ System).
• Nature of "Performance Testing": The document briefly lists categories of testing:
  • Navigation Accuracy Analysis
  • CAD Model Verification
  • Tools Package Functional Verification
  • NAV Simulated Use
  • Anatomical Simulated Use
• Purpose of Testing: "To ensure the functionality and compatibility of the identified Medtronic products when used with the Mazor X™ system."
• Conclusion: Based on the supporting information (which includes the performance testing), the subject instruments are deemed "substantially equivalent" to the predicate devices. This implies they met internal benchmarks/acceptance criteria, but the specific values are not provided.

In summary, the provided document is a regulatory submission summary demonstrating substantial equivalence, not a detailed technical report of the performance studies with acceptance criteria and results for the device's navigation accuracy or other functionalities.

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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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Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, 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 Navigated Reusable Instruments are also compatible with the IPC™ POWEREASE™ System.

Medtronic Surgical Instruments for use with MAZOR X Stealth™ Edition

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 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 IPC™ 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 subject CD Horizon™ Spinal System drivers are non-sterile instruments that may be used during placement of various Medtronic screws during spinal surgery. The Medtronic instruments are made from materials commonly used in orthopedic and neurological procedures which meet available national or international standards specifications. The subject CD Horizon™ Spinal System drivers are compatible with POWEREASE, Medtronic NavLock trackers and Medtronic single-use sterile spheres to allow a Medtronic computer-assisted surgery system to track the instruments in the surgical field.

The provided text is a 510(k) Summary for the Medtronic CD Horizon™ Spinal System Instruments. This document is a regulatory submission for a medical device and describes its intended use, comparison to predicate devices, and testing performed to demonstrate substantial equivalence. It does not contain information about the performance of an AI/ML device in detail as it pertains to acceptance criteria and performance metrics typically expected for such technologies.

The device in question is "CD Horizon™ Spinal System Instruments", which are non-sterile instruments for use during spinal surgery with navigation systems (StealthStation, MAZOR X Stealth™ Edition) and power tools (IPC™ POWEREASE™ System, AO* style quick connect drilling motors). These are physical surgical instruments, not an AI/ML software device.

Therefore, many of the requested categories regarding AI/ML device performance, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set information are not applicable to this submission, as it is for physical surgical instruments.

However, I can extract the relevant information regarding the performance testing for these instruments as described in the document.

Acceptance Criteria and Device Performance for Medtronic CD Horizon™ Spinal System Instruments

The document describes the performance testing undertaken to ensure the functionality and compatibility of the instruments. While specific numerical acceptance criteria (e.g., accuracy thresholds) are not explicitly stated in this summary, the tests confirmed the instruments meet their functional requirements.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. This submission concerns physical instruments, not data-driven AI/ML models. Testing would have involved the instruments themselves, likely in a lab setting or simulated surgical environment. No specific sample sizes for data or data provenance (country, retrospective/prospective) are mentioned as it's not a data-based study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For physical instruments, "ground truth" typically refers to engineering specifications and functional performance. Clinical experts might be involved in defining "customer needs" for simulated use testing, but specific numbers and qualifications are not mentioned.

4. Adjudication method for the test set: Not applicable. This type of regulatory submission for physical instruments does not typically involve adjudication methods like those used for expert consensus in AI/ML model ground truth generation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This is not applicable to physical surgical instruments.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a set of physical surgical instruments, which are used by humans and with other integrated navigation systems. There is no "standalone algorithm" performance to assess for these instruments.

7. The type of ground truth used: For these physical instruments, the "ground truth" would be established through engineering specifications, design requirements, and possibly functional performance benchmarks against predicate devices or industry standards. The document states that testing was "completed to ensure the functionality and compatibility with the identified Medtronic products" and that the "test results show that the subject device and the predicate device are equivalent." This implies a comparison to established performance of predicate devices and adherence to design specifications.

8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established: Not applicable. This device is not an AI/ML model.

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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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Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation™ System, 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 Navigated Instruments are also compatible with the IPC™ POWEREASETM System.

The subject Navigated INFINITY™ drill bit is a sterile, single-use instrument that can be operated manually or under power. This instrument is intended to be used when implanting components of the INFINITY™ OCT System. The Navigated INFINITY™ Drill bit is also compatible with the StealthStation® and IPC® POWEREASE® Systems. Note: The subject devices are not intended to support occipital screw placement.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) premarket notification for "Navigated INFINITY™ Instruments," detailing its indications for use, comparison to a predicate device, and sterilization information.

Specifically, the document states:

• No acceptance criteria or study details: The "Performance Data" section (VII) only mentions "Sterilization" and that "The addition of the sterile drill bit does not create a new 'worst case' and it was adopted in to the existing product family as detailed in the sterilization rationale provided in this submission since the design, material, manufacturing process, and manufacturing facilities of the sterile subject devices are equivalent to that of the referenced product family. The sterilization justification supports an SAL of 10-6. Based on the information provided in this submission, Medtronic believes that adequate evidence has been provided to show that we have fully validated the sterilization parameters." This indicates that the main "performance data" presented is a sterilization justification, not a study with acceptance criteria for device performance.
• Focus on substantial equivalence: The document's goal is to demonstrate substantial equivalence to previously cleared devices, primarily based on identical indications, intended use, technology, materials, dimensions, and design features, with the only technological difference being that the subject device is sterile and single-use, while the predicate was non-sterile and single-use. This type of submission often relies on a comparison to a predicate device rather than extensive new performance studies if the changes are minor and do not introduce new questions of safety or effectiveness.

Therefore, I cannot populate the requested table and information as the necessary details are not present in the provided text.

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Medtronic Navigated Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Instruments are specifically designed for use with the StealthStation™ System, 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 Navigated Instruments are also compatible with the IPC® POWEREASE® System.

The Navigated INFINITY™ Instruments are non-sterile, reusable and single use instruments that can be operated manually or under power. These instruments are intended to be used when implanting components of the INFINITY™ OCT System. The Navigated INFINITY™ Instruments are also compatible with the StealthStation® and IPC® POWEREASE® Systems.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Navigated INFINITY™ Instruments":

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report for new device approval. As such, the information provided for some of your requested points is limited or not applicable in the context of a 510(k).

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: The document does not specify the sample size (e.g., number of instruments tested, number of simulated cases) for any of the performance tests.
   • Data Provenance: Not specified. Given the nature of a 510(k) and the types of tests listed (simulated use, accuracy analysis, CAD evaluation, functional testing), it is highly probable that the data provenance is retrospective (using internal testing data) and likely in-house laboratory or engineering testing, rather than clinical data from a specific country of origin.

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

   • This information is not provided in the document. For the types of engineering and functional tests described (e.g., navigation accuracy, instrument functionality, CAD evaluation), "ground truth" would likely be established through engineering specifications, validated measurement systems, and perhaps expert observation from R&D engineers, rather than clinical experts like radiologists.

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

   • This information is not provided and is unlikely to be relevant for the non-clinical, performance-based tests described in the 510(k) summary. Adjudication methods like 2+1 are typically used for clinical endpoints, especially in image interpretation.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. The device (Navigated INFINITY™ Instruments) is a surgical navigation instrument, not an AI-powered diagnostic or assistive tool for "human readers." Therefore, this type of study and its associated effect size are not applicable.

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

   • The term "standalone" and "algorithm only" are typically used for AI/software devices. This device is a physical surgical instrument that works with existing navigation systems (StealthStation™ System, IPC® POWEREASE® System). The performance tests listed (e.g., Navigation Accuracy Analysis, Anatomical Simulated Use) assess the instrument's accuracy and functionality within the intended surgical navigation system, which inherently involves human interaction (the surgeon). Therefore, a "standalone algorithm only" performance is not applicable in the context of this device.

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

   • For the tests described:
     • Navigation Accuracy Analysis: Ground truth would likely be established through pre-defined engineering specifications and validated measurement systems (e.g., comparing navigated position to physically measured, known positions).
     • Functional/Simulated Use Tests: Ground truth would be defined by the device's design specifications and intended functionality (i.e., whether it performs as designed under various conditions).
     • CAD Model Evaluation: Ground truth would be the original CAD models themselves and the expectation of their accurate representation in the software.
     • No expert consensus, pathology, or outcomes data is explicitly mentioned or seems relevant for these specific engineering tests.

7. The sample size for the training set:

   • This question is not applicable. The "Navigated INFINITY™ Instruments" are physical surgical instruments, not a machine learning model that requires a training set. The underlying navigation systems (StealthStation™) might have calibration data or algorithms, but the instruments themselves do not have a "training set" in the sense of AI.

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

   • This question is not applicable as there is no "training set" for these physical instruments.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC® POWEREASE™ System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

1. The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

2. MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE WITH THE IPC® POWEREASE® System
   The Medtronic Reusable drivers and taps that are compatible with Medtronic's IPC® POWEREASE® System are spine preparation instruments, which are manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The subject taps and drivers may be connected to the POWEREASE® Driver or used manually if desired. These instruments are also compatible with various Medtronic spinal implant systems.

This document is a 510(k) Pre-market Notification for the Medtronic Sofamor Danek CD HORIZON® Spinal System and the IPC® POWEREASE® System. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/algorithm-driven device.

Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable or not provided in this type of regulatory submission.

The document primarily addresses the safety and effectiveness of the device by comparing its technological characteristics and intended uses to previously cleared devices.

Here's an attempt to answer the questions based on the provided text, indicating when information is not applicable or not found.

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

This document does not present a table of specific acceptance criteria (e.g., performance metrics like sensitivity, specificity, accuracy) or quantitative device performance metrics in the context of an algorithm's classification or prediction capabilities. This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of indications for use, technological characteristics, and material safety.

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

Not applicable. This submission does not describe a clinical study with a test set of patient data to evaluate algorithmic performance. The "performance data" mentioned refers to material biocompatibility and mechanical testing (not detailed in this summary).

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)

Not applicable. No ground truth establishment for a test set is described.

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

Not applicable. No adjudication method for a test set is 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

Not applicable. This is not an AI/algorithm device that supports human readers; it is a spinal surgical system (implants and instruments).

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

Not applicable. This is not an AI/algorithm device.

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

Not applicable. No ground truth for an algorithmic performance evaluation is described. The "performance data" refers to biocompatibility testing, where the "ground truth" would be established by standard analytical and biological testing methods for materials.

8. The sample size for the training set

Not applicable. This document is not about an AI/algorithm requiring a training set.

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

Not applicable. No training set is involved.

Summary of Relevant Information from the Document:

While the direct questions about "acceptance criteria" for an algorithm's performance are not applicable, the document does contain information about how the substantial equivalence of the device was demonstrated, which is the regulatory "acceptance criterion" for a 510(k) submission.

• Device Description:

  • CD HORIZON® Spinal System: Consists of various shapes and sizes of rods, hooks, screws, CROSSLINK® plates, staples, and connecting components, which can be rigidly locked into various configurations.
  • MEDTRONIC REUSABLE INSTRUMENTS COMPATIBLE WITH THE IPC® POWEREASE® System: Spine preparation instruments (drivers and taps) manufactured from materials commonly used in orthopedic procedures. These can be connected to the POWEREASE® Driver or used manually.

• Predicate Devices (used for comparison to establish substantial equivalence):

  • CD HORIZON® Spinal System (K141605, S.E. 07/14/2014)
  • IPC® POWEREASE® System (K111520, S.E. 10/26/2011)

• Comparison of Technological Characteristics:

  • The subject Medtronic CD HORIZON® Reusable drivers and taps, compatible with the IPC® POWEREASE® System, have the same fundamental technology and stainless steel materials as the predicate devices.
  • Materials: Medical grade stainless steel (ASTM A564, ASTM F899, ASTM A693, Custom 465, Custom 455, 17-4 Stainless Steel).

• Performance Data (Type of data provided, not quantitative results):

  • Biocompatibility: The instruments are classified as external communicating devices with limited body contact (up to 24 hours), according to FDA's Draft Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing. (No specific test results are provided in this summary, but the materials meet standards).

• Conclusion: Based on risk analysis and supporting documentation, the subject CD HORIZON® Spinal System is substantially equivalent to the listed predicates.

In essence, this document demonstrates that the new device is as safe and effective as previously cleared devices by showing similar design, materials, and intended use, rather than demonstrating improved or specific quantitative performance against defined clinical acceptance criteria through a study with a test set of data.

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