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"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 to S1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

"POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification.

Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time.

The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking.

*CT image DICOM file reconstructed from the 3D C-arm or the same function equipment.

The provided document is a 510(k) Premarket Notification from the FDA, asserting substantial equivalence of the "POINT" Kinguide Agile Hybrid Navigation System to previously cleared devices. It outlines the device's indications for use, a comparison to predicate devices, and lists various performance tests and compliance with standards.

However, the document does not contain the specific acceptance criteria for system performance beyond general accuracy expectations, nor does it detail the methodology or results of a study that directly proves the device meets these criteria. It refers to verification and validation results and reports overall accuracy figures, but the granular details expected for a comprehensive study description are absent.

Therefore, much of the requested information cannot be directly extracted from the provided text.

Here is an attempt to address your request based on the available information from the document, with clear indications where the information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document states a system accuracy requirement and reports the performance. While it doesn't explicitly frame these as "acceptance criteria" for a specific study, these are the performance targets the device demonstrated.

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

• Sample Size for Test Set: Not specified. The document mentions "verification and validation results" and "Non-clinical Performance (Accuracy)" and "Cadaveric Validation Report," but it does not provide the sample size (e.g., number of cases, number of anatomical structures, number of screws tested) for these studies.
• Data Provenance (e.g., country of origin, retrospective or prospective): Not specified. The document does not provide details on the origin of the data or the study design (retrospective or prospective). The company's address is in New Taipei City, Taiwan, suggesting the studies might have been conducted there, but this is not explicitly stated.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document does not mention the use of experts for establishing ground truth in the context of these performance tests. The performance assessments appear to be based on physical measurements and system capabilities rather than human expert assessment of images.

4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none)

• Adjudication Method: Not applicable/Not specified. The tests described (positional and trajectory accuracy) are objective engineering and performance measurements, not typically requiring human adjudication in the way medical image interpretation might. The document does not mention any form of adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

• MRMC Study: No, a MRMC comparative effectiveness study was not done or described. This device is a surgical navigation system, not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting images. Its "performance" relates to its ability to accurately track and guide surgical instruments.
• Effect Size of Human Reader Improvement: Not applicable. As no MRMC study was done, this information is not provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Standalone Performance: Yes, implicitly. The reported "System Accuracy Requirement" and "Non-clinical Performance (Accuracy)" (mean accuracy of $\leq$ 2.0 mm for location error and $\leq$ 2.0° for trajectory angle error) appear to be measurements of the device's inherent accuracy, likely in a controlled, non-human-in-the-loop setting (e.g., phantom studies, cadaveric studies without surgical intervention by humans as the primary variable). The "Cadaveric Validation Report" and "Compatibility and Measuring Accuracy Verification Report" suggest standalone performance testing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: The ground truth for positional and trajectory accuracy would primarily be established through physical measurements against known standards or reference points (e.g., using a precisely calibrated phantom or a CMM - coordinate measuring machine). The "Cadaveric Validation Report" implies real anatomical structures were used, where the "ground truth" for screw placement or trajectory would be derived from post-procedure imaging (e.g., CT scans) analyzed against planned trajectories and positions. It does not mention expert consensus readings or pathology.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. The document describes a navigation system, not a machine learning or AI model that requires a "training set" in the conventional sense of image data for model learning. The navigation algorithm uses transformation matrices, which are mathematical calculations based on tracking data, not a learned model from a large dataset.

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

• How Ground Truth for Training Set Was Established: Not applicable. As explained above, there is no "training set" for a machine learning model, and thus no ground truth establishment for such a set. The accuracy of the system's underlying mathematical algorithms and optical tracking mechanism is verified through engineering tests.

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The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the CT images of the anatomy.

The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the virtual screen is indicated for displaying the virtual in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location from plan.

The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.

The OnPoint Augmented Reality Spine System is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. Infrared tracking technology is used to track the patient's anatomy as well as surgical instrumentation. The tracking information is registered with image information of the patient's anatomy in a common coordinate system. To guide the surgeon through the pedicle screw placement process, the system will display a visual representation of the following elements in an augmented reality optical head mounted display in addition to being displayed on a workstation monitor:

• . Target position and orientation of toolpath
• . Current position and orientation of instrument
• . Cross sectional images
• . 3D model of the patient's spine

Depending on surgeon preference, different combinations of these elements can be displayed. Optional planning steps allow the surqeon to define the target position and orientation as well as length and diameter of the pedicle screws.

The OnPoint Augmented Reality Spine System consists of the following components:

• Tracking camera, workstation, and cart ●
• . Headsets with supplemental battery
• . Software
• Tracked instruments and adapters ●

The provided text, a 510(k) summary for the OnPoint Augmented Reality Spine System, describes various performance tests conducted to demonstrate the device's substantial equivalence to a predicate device. However, it does not provide specific acceptance criteria or detailed results for all mentioned tests in a comparative format.

The document primarily focuses on explaining the types of tests performed rather than presenting the quantitative acceptance criteria and the actual performance data against those criteria. It states that "Verification/validation testing... has been successfully completed and demonstrates that the device is safe for its intended use and is substantially equivalent to the predicate device," but does not explicitly list the numerical results that support this claim for each criterion.

Based on the provided text, I can infer and extract some information related to your request, but many details, particularly the quantitative performance data against specific acceptance criteria, are not present.

Here's a breakdown of what can be extracted and what is missing, structured according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, only one specific numerical acceptance criterion is explicitly stated for the "System Accuracy Requirement":

Note: The document states that the system's accuracy was validated in a cadaver study, and that "positional and trajectory errors were calculated," but it does not then report the calculated values against these 2.0mm and 2° criteria. It only states that the device "functions as intended" and "demonstrates that the device is safe for its intended use and is substantially equivalent to the predicate device."

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

• Cadaver Study (Accuracy Validation): The document mentions "a cadaver study" (singular) for accuracy validation. It does not specify the number of cadavers used, the number of screw placements, or the number of anatomical regions targeted.
• Registration Testing: "multiple 3D CT scanners" were used, but the number of scanners or the number of tests performed is not specified.
• OnPoint AR Image Quality Testing: No sample size is mentioned.
• Human Factors Usability Testing: No specific sample size (number of users or use cases) is mentioned, other than "intended users."
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given it is a 510(k) submission to the FDA, the studies would typically be conducted to support a premarket notification for a U.S. device. Cadaver studies are inherently prospective for the data collection.

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

• The document states that "Clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing the post-op scans." This implies expert review. However, it does not specify the number of experts involved in this evaluation or their qualifications (e.g., "Radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

• The document mentions "viewing the post-op scans" for clinical accuracy (Gertzbein-Robbins score). This suggests a review process, but it does not specify any adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies among expert reviews, if multiple experts were used.

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 describe an MRMC comparative effectiveness study in the context of human readers improving with AI assistance. The device is a "Spine Navigation System" with "Augmented Reality," intended to aid in precisely locating anatomical structures during surgery. It is not an AI diagnostic algorithm for image reading. The clinical accuracy assessment focusing on the Gertzbein-Robbins score post-op is an objective measure of screw placement, not a comparative reading study.

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

• The "System Level Accuracy" (mean 3D positional error and mean trajectory error) and "tracking accuracy verified per ASTM F2554-22" tests are fundamentally standalone (algorithm only) performance evaluations of the navigation system's precision, without direct human-in-the-loop variable performance being assessed in these specific metrics. The human factors testing assesses usability with humans, but the precision measurements themselves are of the system.

7. The Type of Ground Truth Used

• For System Accuracy (Positional and Trajectory Error): The ground truth was established by comparing the "actual and virtual screw tip position, and the difference between the screw orientation and its recorded virtual trajectory." This implies a measurement against a known physical ground truth (actual screw placement) compared to the system's virtual representation.
• For Clinical Accuracy (Gertzbein-Robbins score): The ground truth was established by "viewing the post-op scans." This implies expert consensus/interpretation of post-operative imaging, typically CT scans, to evaluate the accuracy of screw placement in relation to the vertebral canal. This is a common clinical scoring system.

8. The Sample Size for the Training Set

• The document describes performance testing for a medical device, not explicitly an AI model that requires a "training set" in the machine learning sense. The software mentioned (OnPoint Augmented Reality Spine System Software) is part of a navigation system, not a deep learning model that would typically undergo a separate training and validation split. Therefore, a "training set" as understood in AI/ML is not applicable or mentioned in this context. The testing described focuses on system accuracy, software verification, and human factors, which are standard for surgical navigation devices.

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

• As a "training set" for an AI/ML model is not applicable to the device description in the document, this question is not relevant based on the provided information.

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"POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

The device is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

"POINT" Kinguide Agile Hybrid Navigation System (Kinguide Agile) is an imageguided system (IGS) that consists of an infrared navigation camera, a system workstation (computer), navigation software, and surgical instruments. This medical device system can also be referred to as an orthopedic stereotaxic instrument (OLO) according to the U.S. FDA Device Classification.

Kinguide Agile uses optical positioning technologies to track the position of surgical instruments in relation to patient anatomy by means of Dynamic Reference Frames (DRFs) and identify the patient anatomical structure on intraoperative images (obtained using the 3D C-arm or CT*). The user loads the software to plan the surgical procedure and then registers the patient anatomy during surgery to allow the software to track the patient's anatomy and the navigable surgical instruments in real-time.

The software application primarily provides the stereotactic navigation function to match the coordinates of the patient anatomical structure and establishes a surgical navigation map. The user can perform the operation according to the surgical navigation map through the use of navigable surgical instruments. During surgery, the positions of navigable surgical instruments are continuously updated on the imaging system via optical tracking.

*CT image DICOM file reconstructed from the 3D C-arm or the same function equipment.

The "POINT" Kinguide Agile Hybrid Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Specifically, it is indicated for pedicle screw entry point alignment and angular orientation when using a posterior approach into T12 and L1 vertebrae, and where reference to the rigid anatomical structure can be identified by intraoperative 3D reconstruction images.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample size used for the test set for the accuracy verification. It mentions a "Cadaveric Validation Report," suggesting that testing was performed on cadaveric specimens, which would be retrospective data. The provenance (country of origin) of this data is not specified.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned. The device is a "Kinguide Agile Hybrid Navigation System," which is an image-guided system for surgical navigation, not an AI-assisted diagnostic tool that would typically involve human reader studies for comparative effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance evaluation of the device's accuracy was conducted. The "Non-clinical Performance (Accuracy)" section specifically states: "The system has a mean accuracy of ≤ 2.0 mm for location error and ≤ 2.0° for trajectory angle error." This refers to the intrinsic accuracy of the navigation system itself, independent of human interaction during the measurement process, aside from the initial setup and data acquisition.

7. The Type of Ground Truth Used:

The ground truth for the positional and trajectory accuracy would have been established through precise measurements using a highly accurate reference system (e.g., a calibrated measurement device or a pre-defined anatomical landmark with known coordinates) during the "Performance and Accuracy Verification Report" and "Cadaveric Validation Report." This is typically a technical ground truth rather than expert consensus or pathology.

8. The Sample Size for the Training Set:

The document describes the device as an image-guided navigation system and does not explicitly mention "training set" in the context of machine learning or AI models with distinct training phases. Therefore, no information is provided regarding the sample size for a training set.

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

As the document does not discuss a training set in the context of machine learning, it also does not elaborate on how ground truth for such a set would have been established. The core technology lies in optical positioning and image-to-patient registration, not typically in a machine learning model that requires a distinct training phase in the same way a diagnostic AI would.

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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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Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology System interbody cages with macro-, micro-, and nano- roughened surface textures are intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease (DDD, defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis, and/or spinal stenosis, at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device.

Additionally, the Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity.

The Anteralign™ Spinal System™ with Titan nanoLOCK™ Surface Technology is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a combination thereof. These implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach. The Anteralign Spinal System must be used with a posterior supplemental internal spinal fixation cleared for use in the lumbar spine.

Miniplate and bone screw components are provided as an option for the lumbosacral levels oblique or lateral above the bifurcation (L2-L5) of the vascular structures. Indications of spinal instrumentation systems should be understood by the surgeon.

Medtronic Navigated Surgical Instruments are intended to be used during 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 Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems.

Navigated surgical 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, long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses described on the label and the instruments.

The Anteralign™ Spinal System with Titan nanoLOCK" Surface Technology consists of interbody cages, mini plates, bone screws and non-navigated instruments. The Anteralign™ Spinal System interbody cage, known as Anteralign™ TL, is an additive manufactured titanium cage available in various heights, widths, and lengths with different lordosis options to accommodate patient anatomy. The interbody cages are inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The Anteralign™ TL interbody fusion device is rectangular shaped with a large hollow region in the center to house autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The interbody design incorporates honeycomb windows and an open void to allow bone growth through the implant.

The interbody device is treated with Titan Surface Technology, where nanoLOCK™ Surface Technology (MMN) is designed to improve fixation to the adjacent bone. The nanoLOCK" Surface Technology provides a microscopic-roughened surface with nano-scale features. The nanoLOCK™ Surface Technology is specifically engineered to have nano-textured features at a nanometer (10°) level, which have demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. The nanoLOCK™ Surface Technology demonstrates the elements to be considered a nanotechnology as outlined in the FDA nanotechnology guidance.

Anteralign™ TL implants are provided sterile and are intended to be used with supplemental fixation cleared for use in lumbar spine (L2-S1) procedures and may be implanted via a minimally invasive OLIF or minimally invasive or open DLIF approach.

Mini plates and screws are provided as options for anti-migration of the Anteralign™ TL interbody. The miniplate is additively manufactured from titanium powder with a machined-wrought titanium bolt. The miniplate may be positioned either laterally or obliquely and oriented in either cephalad or caudal direction on the Anteralign™ TL cage. The bone screw, which is manufactured from wrought titanium, is then placed through the miniplate intrinsic screw hole. Mini plates and bone screws are offered in various sizes and are provided sterile.

Stainless steel and titanium implants are not compatible. They must not be used together in a construct.

The purpose of this Traditional 510(k) submission is to seek clearance for the Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology devices and demonstrate compatibility of the Anteralign™ Navigated inserter with the Stealth Station™ System S8 Spine Software (K201189, S.E. 05/29/2020).

I am sorry, but the provided text from the FDA 510(k) Premarket Notification for the "Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology" does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria, especially not for an AI/ML powered device.

The document primarily focuses on:

• Device Description: What the device is, its components (interbody cages, mini plates, bone screws), and its material.
• Indications for Use: The medical conditions the device is intended to treat and how it's used (e.g., spinal fusion for DDD, spondylolisthesis).
• Predicates: Other similar devices already on the market to which this new device is compared for substantial equivalence.
• Performance Data (General): It lists types of performance tests conducted (e.g., ASTM standards for mechanical properties like compression fatigue, subsidence, expulsion) and mentions verification and validation activities for navigated instruments.

Here's why the requested information cannot be extracted from this document:

1. Nature of the Device: The Anteralign™ Spinal System is an interbody spinal fusion device and navigated surgical instruments. It is a physical implant and associated tools, not an AI/ML-powered diagnostic or assistive software that would have "acceptance criteria" related to performance metrics like sensitivity, specificity, or accuracy, nor would it involve a "test set" with ground truth established by experts.

2. No AI/ML Component Described: The document makes no mention of artificial intelligence, machine learning, or algorithms that would perform diagnostic or assistive functions. The "Titan nanoLOCK™ Surface Technology" refers to a physical surface feature designed to enhance bone fixation, not an AI component. The "StealthStation™ System" is a navigation system, but the document does not describe its use as an AI-powered diagnostic tool, but rather as one to assist in precise anatomical location during surgery.

3. Type of Performance Testing: The performance data mentioned (ASTM standards) are for mechanical and physical properties (e.g., how the implant withstands force, resists subsidence) and sterile/use compatibility, which are typical for medical implants and instruments. They are not "study" results that would involve patient data interpretation or multi-reader studies.

Therefore, I cannot provide the requested table and study details because the provided document does not describe an AI/ML device or its associated performance study against defined acceptance criteria for such a device.

To answer your prompt, I would need a regulatory document (like a 510(k) summary or a similar report) for an AI/ML-based medical device that clearly outlines its clinical performance study.

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