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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 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 Dental Bone Cutting Instruments are nonpowered hand-held for trauma, reconstruction, or orthognathic procedures to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw.

Dental bone cutting instruments are taps and countersinks. Countersinks are used to create a countersink feature in bone to provide a contact surface for screw heads and to reduce the palpability of the screw head. Taps are used to create threads in a pre-drilled hole in order to accommodate a bone screw. The taps and countersinks are manufactured from Stainless Steel 440A in accordance with ASTM F899 Standard Specification for Stainless Steel for Surgical Instruments as well as ASTM A276 Specification for Stainless Steel Bars and Shapes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dental Bone Cutting Instruments:

This document is a 510(k) premarket notification for a medical device (Dental Bone Cutting Instruments). A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" and "device performance" in the context of this 510(k) submission is primarily focused on demonstrating substantial equivalence to a predicate device. The performance data provided is mechanical testing, indicating that the new device performs comparably to the predicate.

Study Details:

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

   • Test Set Sample Size: Not specified in the document. The testing performed was "Mechanical Testing" (Tolerance Analysis, Torque and Torsional Testing, Reliability Analysis) which likely involved specific device samples for these tests, but the exact number isn't mentioned.
   • Data Provenance: The testing was conducted by or for Synthes (USA) Products, LLC. The location of the testing laboratories or the origin of the materials used in the testing is not specified. It is an internal company study for regulatory submission.

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

   • This type of information is not applicable to this submission. The "ground truth" for mechanical testing is typically established through engineering specifications, material standards (e.g., ASTM F899, ASTM A276), and comparison to the predicate device's known performance, rather than expert consensus on interpretive data like images.

3. Adjudication Method for the Test Set:

   • Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies where multiple experts interpret data (e.g., medical images) to establish a consensus ground truth. This submission relies on objective mechanical engineering tests.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

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

   • Not applicable. This device is a manual bone cutting instrument, not an AI algorithm. Therefore, "standalone algorithm" performance is irrelevant.

6. The Type of Ground Truth Used:

   • For the mechanical testing, the "ground truth" would be the engineering specifications, material properties (e.g., as defined by ASTM standards), and the performance characteristics of the legally marketed primary predicate device (Synthes 90° Screwdriver K082649). The goal was to demonstrate that the subject device's mechanical performance was comparable within acceptable engineering tolerances.

7. Sample Size for the Training Set:

   • Not applicable. This device is a physical instrument, not a learning algorithm or AI. There is no concept of a "training set" in this context.

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

   • Not applicable for the reason stated above.

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