Search Results

Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:

• the use of EXPEDIUM 4.5, EXPEDIUM 6.35, VIPER 2, VIPER SAI, EXPEDIUM VERSE, VIPER PRIME (without stylet control), SYMPHONY OCT and the TriALTIS Spine System is indicated,

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebra, can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.

The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™ 4.5, EXPEDIUM™ 5.5, EXPEDIUM™ 6.35, VIPER™ 2, VIPER™ SAI, VIPER PRIME™, EXPEDIUM VERSE™, SYMPHONY™ OCT and TriALTIS™ screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.

This document is a 510(k) premarket notification for the "TriALTIS Navigation Enabled Instruments". It's a regulatory submission to the FDA, not a study report detailing AI/algorithm performance. Therefore, most of the information requested in your prompt (acceptance criteria for AI, study details like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) is not present in this document.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It describes the physical device, its intended use, and confirms that its technological characteristics (design, materials, performance) are consistent with the predicates.

Here's a breakdown of what can and cannot be answered from the provided text:

Information NOT available in this document regarding AI/algorithm performance:

• 1. A table of acceptance criteria and the reported device performance (for an AI/algorithm): This document does not describe performance metrics or acceptance criteria for an AI or algorithm. It's for a physical medical instrument.
• 2. Sample size used for the test set and the data provenance: Not applicable, as there's no AI algorithm being tested in the traditional sense.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 device is a navigation instrument, not an AI diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

What the document does provide, related to its "performance" (as a physical device):

The document mentions "Performance Data" in Section I, but this refers to engineering analyses and compatibility testing for the physical instrument, not an AI algorithm.

• Acceptance Criteria Mentioned (for the physical instrument's performance):

  • Rigidity of Connections and Instrument During Use
  • Instrument Verification
  • Accuracy Verification

• Study described that proves the device meets these criteria:

  • Type of Study: "A dimensional comparison and engineering analysis demonstrates that the TriALTIS Navigation Enabled Instrument meet performance requirements..."
  • Compatibility Testing: "Compatibility testing was performed with Medtronic StealthStation System S8 using StealthStation Spine Software Version 1.2.0 (1.2.0-20) using automatic intraoperative 3D Scan on an OARM Imaging System according to set up and installation instructions outlined in Medtronic's StealthStation S8 Spine with O-arm and 3D Fluoro Imaging Pocket Guide."

• Sample Size: Not specified for the engineering analysis or compatibility testing in terms of "cases" or "patients." It's likely component-level testing or a few test runs with the integrated system.

• Data Provenance: Not explicitly stated (e.g., country of origin), but it would be laboratory/engineering test data.

• Ground Truth: For a physical instrument, ground truth would be established through engineering specifications, calibrated measurement tools, and functional success/failure in controlled test environments. This isn't the same as clinical diagnostic ground truth.

In essence, the prompt's questions are designed for a submission involving an AI/Machine Learning device, whereas this document pertains to a physical surgical navigation instrument.

Ask a specific question about this device

The Bolt Navigation System assists in the accurate placement of pedicle screws when used in conjunction with an intraoperative fluoroscope. It utilizes intraoperative fluoroscopic and pre- operative MRI or CT axial images to provide surgical planning and navigational telemetry relative to gravity, based on a fixed entry point ascertained by the user and validated by intraoperative fluoroscopic imaging. It is not intended to track patient position. The System is indicated for open and minimally invasive pedicle screw placement using a posterior approach in the thoracolumbar and sacral spine (T-9 to S1) where the patients' relevant rigid anatomical structures can be clearly identified on the imaging.

The BNS is comprised of the Bolt Navigation Unit (BNU) (an iPod touch® mobile digital device with the Bolt navigation software loaded on it), the Bolt single use case, and sterile drape. The BNS is intended to provide navigational guidance during spine surgery. The system uses preand perioperative imaging data, and input from the surgeon via the BNU touchscreen to construct the proper angular position of the instrumentation and implants relative to gravity, and communicates this information to the surgeon via the BNU screen attached to the instrument allowing the surgeon to look at both the surgical site and the navigation data at the same time, thus attenuating the risk of attention shift. The BNS provides guidance data by displaying the angular orientation of a surgical instrument (such as a pedicle probe or awl) relative to a surgeon selected entry point on the patient and gravity. Angular orientation of the instruments is linked to the imaging data via the BNS. The system is intended to be used for both image fusion and navigation for spine surgery applications where reference to relevant rigid structures can be identified relative to a perioperative image data of the anatomy and the gravity vector.

Here's an analysis of the acceptance criteria and study details for the Bolt Navigation System ("BNS"), based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set (Cadaveric Trajectory Accuracy Study): The document doesn't explicitly state the number of cadavers or individual screw placements used in the cadaveric study. However, the results are presented as overall accuracy, testing levels T9 to S1 (thoracolumbar and sacral spine).
   • Data Provenance: The cadaveric study is a non-clinical test, implying it was conducted in a controlled lab setting, likely in the country of the manufacturer or test facility. It is a prospective study in the sense that the data was generated specifically for this validation.

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

   • The document does not provide information on the number of experts or their qualifications used to establish ground truth for the cadaveric study.
   • For the cadaveric study, "Planned trajectory vs actual placement accuracy" was assessed, but the method for determining "actual placement" (e.g., post-insertion imaging, dissection measurement) and who evaluated it is not detailed.

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

   • The document does not specify an adjudication method for the cadaveric study.

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:

   • A formal MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was not explicitly detailed in the provided summary.
   • A "multi-surgeon clinical study" was conducted, but its results are only summarized as supplementary information to show the device performs as intended, not as a comparative effectiveness study against a non-AI control group with quantifiable improvement.

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

   • The "Clinical phantom accuracy results" represent a standalone performance assessment of the system against a known phantom, demonstrating the system's inherent accuracy in a controlled environment. The mean accuracy was 0.35 degrees.
   • The "Cadaveric accuracy results" also reflect the algorithm's performance in a more realistic surgical simulation, where surgical instruments guided by the BNS were evaluated for accuracy of placement against a planned trajectory. While a human surgeon uses the system, the
   • accuracy measurement itself quantifies the system's guidance.

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

   • Clinical Phantom Accuracy: The ground truth for the phantom study would be the known, precisely manufactured dimensions and orientations of the phantom, which the device is designed to measure.
   • Cadaveric Trajectory Accuracy Study: The ground truth for this study is described as "Planned trajectory vs actual placement accuracy." The "planned trajectory" would be established pre-procedure (likely by a surgeon using imaging), and the "actual placement" would be measured post-procedure using a precise method (e.g., high-resolution CT, C-arm imaging, or physical measurement) to determine the deviation from the plan. The specific method for determining "actual placement" (which serves as the "truth") is not detailed.

7. The sample size for the training set:

   • The document does not provide information on the sample size of any training set used for the BNS software. The BNS utilizes "pre- and perioperative imaging data" and "intraoperative fluoroscopic and pre-operative MRI or CT axial images," suggesting it may rely on existing imaging data for its functionality, but details about supervised machine learning training, if any, are absent.

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

   • Since the document does not specify a training set or the use of machine learning that would require a distinct training set with ground truth, this information is not available. The system appears to be more of a navigation system based on physical principles and image registration rather than a deep learning model requiring extensive annotated training data.

Ask a specific question about this device

Spineology Navigation Instruments are indicated for use during the preparation and placement of:

• Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ pedicle screws .
• Spineology's OptiMesh® Portal Assembly .

during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous orthopedic procedures.

These instruments are designed for use with the Medtronic StealthStation® Spine 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 the spine or pelvis, can be identified relative to images of the anatomy.

Spineology Navigation Instruments are non-sterile, reusable surgical instruments that are manufactured from stainless steel and operated manually.

Spineology Navigation Instruments for Pedicular Fixation include Awls, Bone Taps, Drills, and Screwdrivers. The navigable instruments are equipped with a dimensional feature that allows connection to Medtronic's NavLock Trackers. A Navigation Adapter is also available with dimensional features that allows the same instruments to Medtronic's SureTrak" II Universal Trackers. These instruments are compatible with Spineology's Fortress", Threshold" Threshold™ V2, and Palisade™ Pedicular Fixation Systems and Medtronic's StealthStation® S7 (v2.1.0) and S8 (v1.0.0) Spine System.

Spineology Navigation Instruments for Portal Placement include a Dilator, Portal, Tightener, Wrench, and a Portal Surrogate. The navigable instruments are equipped with dimensional features that allow connection to Medtronic's SureTrak II Universal Trackers. These instruments are compatible with Spineology's OptiMesh Expandable Interbody Fusion System for Access Portal Placement and Medtronic's StealthStation® S8 (v1.2.0) Spine System.

Spineology Navigation Instruments are intended to be used during the preparation and placement of spinal implants in optically navigated procedures.

This document (K213876) is a 510(k) premarket notification for Spineology Navigation Instruments. While it describes non-clinical testing performed to establish substantial equivalence to a predicate device, it does not detail a clinical study with an AI component or the specific acceptance criteria and performance data for an AI-powered device.

The document discusses "Spineology Navigation Instruments" which are physical surgical tools used for navigation during spinal surgery. The testing described (mating, registration, accuracy) relates to the mechanical and optical tracking performance of these instruments when used with Medtronic's StealthStation system, not the performance of an AI algorithm.

Therefore, I cannot extract the information required to answer your prompt because the provided input does not describe an AI/ML-based medical device.

**To answer your prompt, I would need a document describing the clearance/approval of an AI/ML device, ideally one that includes: **

• Specific performance metrics (e.g., sensitivity, specificity, AUC) for the AI model.
• Details about the datasets used (training and test sets, including provenance and size).
• Information on ground truth establishment (expert review, pathology, etc.).
• If applicable, details of MRMC studies or human-in-the-loop performance.

Without such information, any attempt to answer would be speculative and not based on the provided document.

Ask a specific question about this device

Navigation Enabled Instruments are reusable instruments intended to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are intended; and with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:
• the use of EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® SAI, EXPEDIUM VERSE®. VIPER PRIME® (without stylet control) or SYMPHONYTM OCT system is indicated,
· the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with Synthes Small Battery Drive II System and the Medtronic IPC® POWEREASE System.
The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM® 4.5, EXPEDIUM® 5.5, EXPEDIUM® 6.35, VIPER® 2, VIPER® SAI, VIPER PRIME®, EXPEDIUM VERSE®, and SYMPHONYTM OCT screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the Medtronic StealthStation navigation system and associated tracking arrays.

The provided FDA 510(k) summary for the "Navigation Enabled Instruments" (K200791) describes the device, its intended use, and a performance study. However, it does not contain the detailed acceptance criteria or the specific results in a format that would allow for a direct numerical comparison as requested in your prompt.

Specifically, the document states that "Simulated Use testing was performed" and lists what this testing aimed to demonstrate, but it does not provide:

• A table of quantitative acceptance criteria (e.g., specific accuracy thresholds)
• The reported device performance against those criteria (e.g., measured accuracy values)
• Sample sizes for test sets (it mentions "clinically relevant anatomical specimen / model" but not the number)
• Data provenance (country of origin, retrospective/prospective)
• Number/qualifications of experts for ground truth
• Adjudication method
• MRMC study information
• Standalone performance data
• Type of ground truth used (beyond "anatomical specimen / model")
• Sample size for training set
• How ground truth for the training set was established

Key information that can be extracted from the provided text, related to the performance study, is as follows:

1. Acceptance Criteria and Reported Device Performance:

The document describes the objectives of the simulated use evaluation, which implicitly define the areas for which performance must be acceptable. However, it does not state specific numerical acceptance criteria or the reported device performance against them.

• Navigation Enabled Instruments can be rigidly connected to the NavLock tracker (rigidity). |
  | Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic. | The Simulated Use Evaluation allows to show that:
• Navigation Enabled Instruments can be adequately verified on the StealthStation Medtronic (instrument verification). |
  | Navigation Enabled Instruments can be accurately navigated, and screws accurately placed. | The Simulated Use Evaluation allows to show that:
• Navigation Enabled Instruments can be accurately navigated, and screws accurately placed (accuracy verification). |

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

• Sample Size: The document mentions "a clinically relevant anatomical specimen / model." It does not specify the number of specimens/models used or the number of trials/measurements performed.
• Data Provenance: The study was a "Simulated Use testing," implying it was conducted in a controlled environment, likely at the manufacturer's facility. No information on country of origin of data, or whether it's retrospective or prospective is provided, though based on "simulated use," it's prospective testing.

3. 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. The ground truth would likely be established by the physical properties of the "anatomical specimen / model" and the known dimensions/placement attempts, but expert involvement for ground truth definition is not mentioned.

4. Adjudication method for the test set:

• This information is not provided in the document. Given it's a simulated use test on a model, formal adjudication as seen in clinical trials with human data is unlikely to be described here.

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:

• No MRMC comparative effectiveness study is mentioned. The device is a navigation system for surgical instruments, not an AI-assisted diagnostic or interpretive tool that would typically involve "human readers" in this context. The evaluation focuses on the instrument's performance, not human reader improvement.

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

• The device inherently involves human-in-the-loop, as they are "Navigation Enabled Instruments" intended to "assist the surgeon." Therefore, a "standalone algorithm only" performance study is not applicable or described for this type of device. The simulated use testing inherently includes the human (or simulated human interaction) with the system.

7. The type of ground truth used:

• "Clinically relevant anatomical specimen / model." This typically refers to cadaveric specimens or realistic physical models that mimic human anatomy. The ground truth for accuracy would be based on the known anatomical landmarks or pre-defined target locations within these models.

8. The sample size for the training set:

• This information is not provided. This device is largely mechanical and optical (for navigation) rather than a machine learning/AI device that typically requires a discrete "training set" in the conventional sense. Its "training" would be through engineering design, calibration, and predicate device experience.

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

• This information is not provided, and as noted above, a formal "training set" and its ground truth establishment, as understood in AI/ML contexts, is not explicitly documented for this type of medical device in this summary.

Ask a specific question about this device

The NavLock™ Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the MAZOR X Stealth™ Edition system. The NavLock™ Trackers should only be used with Medtronic instruments on the MAZOR X Stealth™ Edition system.

The Robotic Reference Frame is an accessory to the MAZOR X Stealth Edition system and is intended to enable navigation during spinal fusion and interbody procedures that utilize the MAZOR X Stealth Edition system.

The NavLock trackers are compatible with the MAZOR X Stealth™ Edition system. The NavLock Trackers 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 subject NavLock Trackers have posts to affix reflective spheres, which are visible to the MAZOR X Navigation camera as a means of tracking the position of the attached surgical instrument.

The Robotic Reference Frame is an accessory to the MAZOR X Stealth™ Edition system. The Robotic Reference Frame has posts to affix reflective spheres, which are visible to the MAZOR X Navigation camera for tracking location during navigated procedures.

Unfortunately, the provided text does not contain the specific details required to answer all parts of your request. It's a 510(k) summary for a medical device (NavLock Trackers and Robotic Reference Frame) which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a detailed study report with all the acceptance criteria, sample sizes, and ground truth establishment methods for a performance study of an AI/algorithm-based device.

Here's an breakdown of what can and cannot be extracted from the text:

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

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

• Sample size for the test set: Not provided. The document states "Testing conducted" and refers to "the subject devices" satisfying requirements, but gives no indication of the number of devices, patients, or data points used in the Navigational Accuracy Analysis or Accelerated Life Functionality tests.
• Data provenance: Not provided. The document does not mention the origin of any data, whether prospective or retrospective, or country of origin.

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 / Not provided. These tests appear to be primarily engineering performance tests (navigational accuracy, durability) for hardware components, not a study evaluating an AI/algorithm's diagnostic or predictive performance against human experts. Therefore, there's no mention of experts establishing a "ground truth" for a test set in this context.

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

• Not applicable / Not provided. Similar to point 3, this type of adjudication is typically for clinical or diagnostic studies involving human interpretation or consensus, which is not described here.

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:

• No. The document does not describe an MRMC study. The devices (NavLock Trackers and Robotic Reference Frame) are accessories for a navigation system (MAZOR X Stealth™ Edition system) and are for hardware tracking, not AI-driven image analysis or decision support that would typically involve human readers.

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

• Not explicitly applicable in the AI sense. The devices themselves are hardware (trackers) that enable optical navigation. While the system (MAZOR X Stealth™ Edition) might involve algorithms, this document is about the physical accessories. The performance tests described (navigational accuracy, functionality) are "standalone" in the sense that they test the device's intrinsic mechanical/optical performance.

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

• For the "Navigational Accuracy Analysis," the ground truth would likely be established through precise metrology equipment or other highly accurate measurement systems, rather than expert consensus or pathology, as it's a measure of physical tracking accuracy. However, the specific method is not detailed.
• For "Accelerated Life Functionality," the ground truth is simply continued functionality and integrity of the device under stress, measured against engineering specifications.

8. The sample size for the training set:

• Not applicable / Not provided. Since this document describes hardware accessories for a navigation system and not an AI or algorithm-based device that undergoes machine learning training, there is no "training set."

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

• Not applicable / Not provided. (See point 8).

In summary:

This 510(k) summary provides a high-level overview of performance testing for medical device accessories. It confirms that the devices met "necessary navigational accuracy requirements" and maintained "functionality throughout its intended useful life" after reprocessing. However, it lacks the granular detail (specific numerical acceptance criteria, exact performance metrics, sample sizes, detailed ground truth methods, and expert involvement) that would be present in a comprehensive study report, especially one for an AI or algorithm-driven device. The focus here is on demonstrating equivalence to an existing predicate device rather than presenting a detailed clinical or AI algorithm validation study.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device