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The Evolution Spine navigation instruments are indicated for use during the preparation and placement of Whistler Modular Pedicle Screw System polyaxial screws or Stowe Pedicle Screw System polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigation instruments are intended to be used with the Medtronic® StealthStation® S8 Navigation System (Software Version 1.3.0)., 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Evolution Spine Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® S8 Navigation System. The system is designed to assist surgeons in the precise localization of anatomical structures, preparation and placement of pedicle screw implants during spinal procedures.

The Evolution Spine navigation Instruments include awls, probes, taps and drivers. The navigated instruments are to be used with Whistler Modular Pedicle Screw System (K182478) and Stowe Pedicle Screw System (K181554).

All instruments are made of stainless steel per ASTM F899. The Evolution Spine navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation® S8 Navigation System hardware and software.

The provided FDA 510(k) clearance letter for the Evolution Spine Navigation Instruments focuses on establishing substantial equivalence to predicate devices, primarily through non-clinical performance testing. It indicates that clinical testing was not performed. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess human reader improvement with AI assistance, nor was a standalone algorithm performance study performed as part of this submission for establishing substantial equivalence.

The submission relies on a non-clinical test to demonstrate performance, specifically focusing on positional accuracy of the instruments when used with a specific navigation system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The exact numerical values for positional accuracy criteria from ASTM F2554-18 and Rampimura et al. are not explicitly stated in the provided text. The document only confirms that the device "meets and exceeds" these established benchmarks.

Study Details

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

   • Sample Size: The document does not specify a numerical "sample size" in terms of cases or patients. Instead, it refers to "the worst-case instruments constructs" being tested. This implies a limited number of physical instrument configurations were chosen for rigorous testing, representing the most challenging scenarios for accuracy.
   • Data Provenance: The study described is a non-clinical, laboratory-based performance test. This means the "data" is derived from controlled measurements in a lab setting, not from human subjects or clinical data. Therefore, concepts like "country of origin" or "retrospective/prospective" do not apply in the typical sense; it's an engineering test.

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

   • This is a non-clinical performance test of a physical device's accuracy. "Ground truth" in this context refers to the engineering specifications and established test methods (ASTM F2554-18 and Rampimura et al. reference values) for positional accuracy. No human experts (e.g., radiologists) were used to establish the ground truth for this performance test. The "truth" is an objective, measurable accuracy.

3. Adjudication Method for the Test Set:

   • Not applicable as this was a non-clinical instrument performance test, not a subjective assessment requiring human adjudication. The results are quantitative measurements against established engineering standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. The document explicitly states: "Clinical testing was not necessary to demonstrate the substantial equivalence of the subject devices." This implies that an MRMC study involving human readers and AI assistance was not performed or submitted for this specific clearance.

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

   • No. The device is a set of "navigation instruments" used with a navigation system (Medtronic® StealthStation® S8). It's a physical instrument, not an AI algorithm. Its performance is evaluated in conjunction with the navigation system, but the focus is on the instrument's mechanical and tracking accuracy.

6. The Type of Ground Truth Used:

   • Engineering Specifications / Established Test Standards: The ground truth for this non-clinical study was defined by the performance criteria established in:
     • ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems"
     • Rampimura et al: "Accurate pedicle screw insertion under the control of a computer-assisted guiding system: Laboratory test and clinical study"
   • These are recognized industry standards and published research that define acceptable accuracy limits for such devices.

7. The Sample Size for the Training Set:

   • Not applicable. This is a physical medical device (surgical instruments), not an AI/machine learning algorithm that requires a "training set" of data.

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

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

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The CORUS™ Navigation System-GX for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation System-GX is specifically designed for use with the Globus Medical ExcelsiusGPS™ which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.

The CORUS™ Navigation System-GX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel-G and Navigation Chisel Rasp-G are specifically designed for use with Globus Medical ExcelsiusGPS™ for navigation of the instruments to the facet joint. The instrument set provides access to the posterior spinal facet joint and decortication for bone preparation.

The provided FDA Clearance Letter and 510(k) Summary for the CORUS™ Navigation System-GX (K251060) do not contain detailed information about specific acceptance criteria, study methodologies (like sample sizes for test/training sets, data provenance, ground truth establishment, or expert involvement), or the results of a multi-reader multi-case (MRMC) comparative effectiveness study.

The document states that the device was evaluated through "an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance." It also mentions "a functional assessment was conducted to evaluate compatibility and simulated use testing." However, it does not provide the quantitative acceptance criteria or the specific performance metrics achieved in these evaluations.

Therefore, based solely on the provided text, I cannot complete many sections of your request. I will indicate where the information is not present.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

Due to the lack of quantitative performance data in the provided document, I cannot create a table of acceptance criteria and reported device performance. The document states:

• "The CORUS™ Navigation System-GX instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
• "A functional assessment was conducted to evaluate compatibility and simulated use testing."
• "The results of these engineering analysis and evaluations show that the subject is substantially equivalent to the cleared predicate."

This language indicates that the device met the necessary performance for clearance by demonstrating substantial equivalence, but it does not disclose the specific numerical thresholds or achieved performance metrics.

Study Information Based on Provided Text:

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

Not Available in the Provided Text. The document generally states that "engineering analysis and evaluations show that the subject is substantially equivalent to the cleared predicate," implying that performance criteria were met, but does not list specific criteria or results.

2. Sample sizes used for the test set and the data provenance

Not Available in the Provided Text for "accuracy performance" or "functional assessment" studies. The document mentions "engineering analysis and geometric comparison" and "functional assessment" and "simulated use testing," but it does not specify sample sizes or data provenance (e.g., retrospective/prospective, country of origin).

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

Not Applicable/Not Available. The device is a "Stereotaxic Instrument" intended to assist surgeons in locating anatomical structures. The described evaluations ("engineering analysis," "geometric comparison," "functional assessment," and "simulated use testing") suggest a focus on mechanical accuracy, compatibility, and functionality rather than diagnostic interpretation requiring human expert ground truth. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation is not directly applicable here. The ground truth might be defined by engineering specifications or physical measurements.

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

Not Applicable/Not Available. Given the nature of the device and the described evaluations, an adjudication method for image interpretation or diagnosis is not relevant.

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 indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. This device is a navigation system instrument, not an AI-assisted diagnostic tool that would typically undergo such a study.

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

Partially Applicable / Inferred. The evaluations described ("engineering analysis and geometric comparison," "functional assessment," "simulated use testing") would inherently involve testing the device's performance in a standalone or controlled environment, ensuring its mechanical and functional specifications are met, independent of a specific surgical procedure on a live patient. The device "does not include its own navigation platform" but works with the Globus Medical ExcelsiusGPS™. The testing would focus on the navigation instruments' accuracy and compatibility with this platform.

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

Inferred to be Engineering/Physical Specifications. For a stereotaxic instrument, the ground truth for "accuracy performance" would typically be derived from engineering specifications, physical measurements using highly precise measurement tools, or established anatomical models/phantoms. It is not expert consensus on images, pathology, or outcomes data.

8. The sample size for the training set

Not Applicable / Not Available. The document describes "engineering analysis and geometric comparison" and "functional assessment," and "simulated use testing." This type of evaluation is typically for mechanical devices and does not describe a machine learning algorithm that would require a "training set" in the conventional sense.

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

Not Applicable. See point 8.

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The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis pedicle screws during non-cervical spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients. These instruments are designed for use with the Globus ExcelsiusGPS 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical ExcelsiusGPS® Robotic Navigation Platform to aid in implantation of the Innovasis pedicle screw system (Vector Pedicle Screw System and Excella Spinal System) implants. The instruments are manufactured from medical grade stainless steels and plastic.

The provided FDA clearance letter concerns the Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments). This letter primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and engineering analysis rather than a human reader study or AI performance evaluation.

Therefore, many of the requested details, such as those pertaining to AI model training, human reader studies (MRMC), or a comprehensive standalone algorithm performance, are not explicitly available within this document. The device in question is a set of surgical instruments, not an AI or imaging device requiring such detailed performance evaluation in the context of this 510(k) submission.

However, based on the provided text, we can extract information regarding the performance data used to demonstrate safety and effectiveness for these specific instruments.

Acceptance Criteria and Reported Device Performance

The letter states that the instruments were evaluated for their accuracy performance and their ability to register with the navigation system and fit within the guide tube of the end-effector.

Study Details (Based on available information)

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

   • Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the context of a clinical study. The evaluation appears to be primarily an engineering analysis and verification testing on the instruments themselves.
   • Data Provenance: The study described is a technical evaluation of the instruments, not a clinical trial with patient data. It is an "engineering analysis and geometric comparison to predicate devices," and "pass/fail verification testing." The location of this engineering and testing work is not specified, but the applicant (Innovasis, Inc.) is based in Salt Lake City, Utah, and their regulatory consultant in Colorado Springs, Colorado, suggesting a U.S.-based context for the submission. The information implies a retrospective approach in terms of comparing to existing designs and prospective in terms of conducting new verification tests on the manufactured instruments.

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

   • Not Applicable. This submission does not describe a study involving expert readers or medical professionals establishing ground truth for diagnostic interpretation. The "ground truth" for this device relates to its physical and functional specifications (e.g., dimensions, fit, compatibility with the navigation system), established through engineering methods.

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

   • Not Applicable. Adjudication methods are typically used in studies where human experts are interpreting medical images or data and discrepancies need to be resolved. This study is an engineering and verification test.

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. This device is a surgical instrument set and the submission does not mention an MRMC study or any AI component that would assist human readers in image interpretation or diagnosis.

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

   • No. This device is not an algorithm. The "performance data" refers to the instrument's mechanical and functional compatibility.

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

   • Engineering Specifications and Functional Compatibility. The ground truth for this device's performance is based on established engineering principles, design specifications, and the functional requirements for compatibility with the predicate navigation system (Globus ExcelsiusGPS). This includes geometric tolerances, material properties, and successful registration/fit with the navigation platform.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not Applicable. As above, this is not an AI/machine learning device. The "ground truth" for the device's design and function would be based on engineering design principles and specifications, tested through verification.

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The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.

The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.

The TMINI® Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications:

• Enovis™ EMPOWR Knee System®
• Ortho Development BKS® and BKS TriMax® Knee System
• Total Joint Orthopedics Klassic® Knee System
• United U2™ Knee Total Knee System
• Medacta® GMK® Sphere / SpheriKA Knee Systems
• Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
• b-ONE MOBIO® Total Knee System
• Maxx Orthopedics Freedom® Total & Titan Knee
• LINK® LinkSymphoKnee System

The TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN® Planning Station) including THINK Case Manager (TCM) the web-based method for surgeons to review, approve and download approved surgical plans, an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components.

The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.

The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively using TNav.

The provided FDA 510(k) clearance letter pertains to the TMINI Miniature Robotic System, a device used to assist surgeons in total knee replacement (TKA) surgery. The submission describes modifications to the system, primarily software enhancements to improve tibial registration performance, along with data logging updates, open-source software report updates, and cybersecurity updates. The application claims substantial equivalence to a previously cleared predicate device (K243481) and focuses on demonstrating that these modifications do not alter the intended use, safety, or effectiveness of the device.

Based on the provided document, here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria for performance metrics (e.g., specific thresholds for accuracy, precision). Instead, it states that "Testing to verify the function of the subject device was conducted following the same test methods and acceptance criteria as those used for the predicate device. The testing demonstrated that the TMINI® Miniature Robotic System met all test criteria and specifications."

The performance tests conducted and their qualitative results are summarized in Table 2: Substantial Equivalence, under the "Performance Testing" section.

* *Note: For Pin & Block Placement Accuracy, System Gap Balance Accuracy, User Needs Validation Testing, and Usability Testing, the document explicitly states "**Passed" and clarifies in a footnote, "These tests did not need to be repeated as a result of the changes to the software included in this submission." This implies that the acceptance criteria were met by the previous testing on the predicate device, and the current modifications did not necessitate re-testing these specific performance aspects.

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

The document does not explicitly state the sample size used for the performance testing. For tests like "Cadaver Lab Validation Testing," while it mentions "Reanalyzed data passed," it does not specify the number of cadavers or cases.

The document does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) for the test sets.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given the nature of a robotic surgical system, ground truth would typically refer to highly accurate measurements obtained from advanced imaging or physical measurements in a controlled environment, likely assisted by surgical and engineering expertise.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

No, an MRMC comparative effectiveness study was not done or reported. This type of study is more common for diagnostic AI algorithms where human interpretation is a key component. The TMINI Miniature Robotic System is a surgical assistance robot, and the study focuses on its performance and accuracy rather than its impact on human reader performance.

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

The performance tests listed, such as "Pin & Block Placement Accuracy," "Cadaver Lab Validation Testing," and "System Gap Balance Accuracy," directly assess the standalone performance of the robotic system in achieving its intended surgical accuracies. While a surgeon operates the system, these accuracy measurements inherent to the robot's capabilities would constitute standalone performance in a sense, as they evaluate the robot's ability to execute pre-planned actions with precision. However, it's important to note that the system is intended to assist the surgeon, so "standalone" in the context of a robotic surgical system usually refers to the accuracy and precision of the robotic movements and tool positioning, which appear to have been tested.

7. The Type of Ground Truth Used

The document implicitly suggests that the ground truth for surgical accuracy tests (e.g., "Pin & Block Placement Accuracy," "System Gap Balance Accuracy") would be established through highly precise measurement techniques in a controlled lab or cadaveric setting, likely using CMM (Coordinate Measuring Machine) data, optical tracking references, or other metrology tools to determine the true positions and orientations relative to the planned surgical targets. For the "Cadaver Lab Validation Testing," the ground truth would be based on anatomical measurements in those cadavers after the robotic intervention.

8. The Sample Size for the Training Set

The document does not provide any information on the sample size for a training set. This submission is for modifications to a previously cleared device, and the focus is on verification and validation of those specific changes rather than the initial development and training of a new AI model for the core robotic functions. While "software enhancements to improve tibial registration performance" are mentioned, it's not specified if this involved a machine learning model that required a distinct training set.

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

As no training set information is provided, there is no information on how ground truth for a training set was established.

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The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System or the Brainlab® Spine & Trauma Navigation System which are 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 long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system instruments. Current cleared Spineart® Navigation reusable instruments (K241644, K210472 & K183630) feature a connecting area for the tracker compatible with the Navlock Tracker to be navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spineart's Brainlab® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the Brainlab® Spine & Trauma Navigation System to the cleared range of SPINEART® Navigation Instrument System.

The provided FDA 510(k) clearance letter describes the "SPINEART Navigation Instrument System." This document is a clearance letter and a 510(k) summary, which may not always detail the full extent of the testing that would typically be found in a full submission. However, based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document states: "Performance data showed the addition of the SPINEART Brainlab® Navigation Adaptor (Subject device) on the SPINEART Navigation reusable instruments for a use with the Brainlab® Spine & Trauma System, provides an accuracy at least equivalent to the initial intended use defined for Brainlab® and provides results in simulated use more accurate than the acceptance criteria."

However, specific numerical acceptance criteria for accuracy are not explicitly stated in the provided text. The performance is reported as meeting or exceeding unspecified acceptance criteria.

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

The document does not specify the sample size used for the test set. It mentions "Comparison of accuracy between the Brainlab® tracker and clamps directly attached on the SPINEART Navigation Reusable Instruments and the Brainlab® tracker and clamps attached on the SPINEART Navigation Reusable Instrument using the SPINEART Brainlab® Navigation Adaptor (subject device)" and "Accuracy in simulated use (protocol adapted from ASTM F2554-22)."

The data provenance is not explicitly stated as originating from a specific country or as retrospective/prospective. The testing appears to be non-clinical performance bench testing conducted by the manufacturer, Spineart SA, located in Switzerland.

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

The document does not mention the use of experts or their qualifications for establishing ground truth in the non-clinical testing. The ground truth (or reference standard) in this type of accuracy testing is typically established through precise metrological instruments and methods.

4. Adjudication method for the test set

Not applicable. The described testing is non-clinical performance testing (bench testing for accuracy), not a study involving human interpretation that would typically require an adjudication method.

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. The device is a "Navigation Instrument System" intended to assist surgeons in precisely locating anatomical structures. It is not an AI-assisted diagnostic device that would typically involve human readers interpreting images, therefore, an MRMC study is not relevant to this device.

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

This device appears to be an instrument system and not an algorithm in the traditional sense of AI. The "standalone" performance tested was the accuracy of the navigation system components (specifically the new adapter with the instruments and Brainlab system), which is essentially the performance of the technical system without direct human variability in judgment as the primary outcome. The testing performed was a "Comparison of accuracy" and "Accuracy in simulated use," which are standalone technical evaluations.

7. The type of ground truth used

The ground truth for the accuracy testing would typically be established by highly precise measurement systems (e.g., coordinate measuring machines, optical tracking systems) that can determine the true position and orientation of instruments with sub-millimeter accuracy in a controlled testing environment. The document mentions "dimensional analysis" as also confirming accuracy.

8. The sample size for the training set

Not applicable. This device is not described as an AI/ML device that requires a training set. It is a navigation instrument system, and its performance is evaluated based on its mechanical and optical tracking accuracy.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

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Stealth™ Spine Clamps

When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:

• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The Stealth™ spine clamps are indicated for skeletally mature patients.

ModuLeX™ Shank Mounts

When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:

• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery.
• The ModuLeX™ shank mounts are indicated for skeletally mature patients.

The Stealth™ Spine Clamps are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.

The ModuLeX™ Shank Mounts are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.

This document, an FDA 510(k) Clearance Letter, does not contain the specific details about acceptance criteria and study data that would be found in a full submission. 510(k) summary documents typically provide a high-level overview.

Based on the provided text, here's what can be extracted and what information is not available:

Information from the document:

• Device Type: Stealth™ Spine Clamps and ModuLeX™ Shank Mounts, which are orthopedic stereotaxic instruments used with computer-assisted surgery systems (specifically the Medtronic Stealth™ System).
• Purpose: To provide rigid fixation between the patient and a patient reference frame for the duration of spine surgery, and to serve as navigated instruments for surgical guidance.
• Predicate Devices:
  • Stealth™ Spine Clamps: StealthStation™ Spinous Process Clamps (K211442)
  • ModuLeX™ Shank Mounts: Rod Clamps (K131425)
• Testing Summary (XI. Discussion of the Performance Testing):
  • Mechanical Robustness and Navigation Accuracy
  • Functional Verification
  • Useful Life Testing
  • Packaging Verification
  • Design Validation
  • Summative Usability
  • Biocompatibility (non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic)

Information NOT available in the provided document (and why):

This 510(k) summary describes physical medical devices (clamps and mounts) used in conjunction with a computer-assisted surgery system, but it does not describe an AI/software device whose performance is measured in terms of accuracy, sensitivity, or specificity for diagnostic or guidance purposes. Therefore, many of the requested points related to AI performance, ground truth, and reader studies are not applicable or not detailed in this type of submission.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance (with specific numerical metrics for "Navigation Accuracy"): While "Navigation Accuracy" is listed as a test conducted, the actual acceptance criteria (e.g., "accuracy must be within X mm") and the quantitative results are not provided in this summary. This would typically be in a detailed test report within the full 510(k) submission.
2. Sample sizes used for the test set and data provenance: No information on the number of units tested, or if any patient data was used for "Navigation Accuracy" (it's likely bench testing).
3. Number of experts used to establish ground truth and their qualifications: Not applicable as this is a mechanical device submission, not an AI diagnostic submission. Ground truth for mechanical accuracy would be established by precise measurement tools, not human experts in this context.
4. Adjudication method for the test set: Not applicable for mechanical/functional testing.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned or applicable. This type of study is for evaluating human performance (e.g., radiologists interpreting images) with and without AI assistance.
6. Stand-alone (algorithm only) performance: Not applicable; this is not an algorithm for diagnosis or image analysis.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): For "Navigation Accuracy," the ground truth would be based on highly precise measurement systems (e.g., optical tracking validation) in a lab setting, not clinical outcomes or expert consensus.
8. Sample size for the training set: Not applicable; there is no "training set" as this is not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is known concerning acceptance criteria and proof of adherence:

• Acceptance Criteria/Proof (General): The document states that "Testing conducted to demonstrate equivalency of the subject device to the predicate is summarized as follows: Mechanical Robustness and Navigation Accuracy, Functional Verification, Useful Life Testing, Packaging Verification, Design Validation, Summative Usability, Biocompatibility."
• Implied Acceptance: The FDA's clearance (K242464) indicates that Medtronic successfully demonstrated that the new devices are "substantially equivalent" to predicate devices based on the submitted testing. This means the performance met the FDA's expectations for safety and effectiveness, likely by demonstrating equivalent or better performance against the predicates in the specified tests (e.g., meeting established benchmarks for sterility, material strength, and precision when interfaced with the navigation system). However, the specific numerical criteria for "Navigation Accuracy" are not disclosed in this summary letter.

Conclusion based on the provided text:

This 510(k) summary is for a Class II mechanical stereotaxic instrument and, as such, focuses on demonstrating mechanical, functional, and biocompatibility equivalency to predicate devices. It does not contain the detailed performance metrics, ground truth establishment methods, or human reader study results that would be pertinent to an AI/software medical device submission.

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The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.

The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement.

The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories.

The Paradigm System is used with an external monitor.

The provided FDA 510(k) Clearance Letter for the Paradigm System (K250879) indicates substantial equivalence to a predicate device (K243258). While it mentions that "Verification and Validation activities have been conducted to provide assurance that the device meets the performance requirements," and lists various standards used in testing, it does not provide specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.

The document primarily focuses on demonstrating substantial equivalence based on the device's intended use, indications for use, fundamental scientific technology, and technical characteristics being the same as the predicate. It states that "Performance, safety and usability testing demonstrate that the differences between the subject device and the predicate device do not raise new risks of safety and effectiveness," but does not present the granular data of what those performance, safety, and usability tests entailed or their quantitative outcomes against defined acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sizes used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
4. Adjudication method for the test set: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not specified.
7. The type of ground truth used: Not specified.
8. The sample size for the training set: Not specified.
9. How the ground truth for the training set was established: Not specified.

The provided document is a 510(k) clearance letter, which summarizes the FDA's finding of substantial equivalence based on information submitted by the manufacturer. It typically does not contain the detailed raw data, study designs, or complete results of every verification and validation test performed by the manufacturer. That detailed information would be found in the manufacturer's submission to the FDA, not in the clearance letter itself.

The document lists standards used, such as ASTM F2554-22 "Standard Practice For Measurement Of Positional Accuracy Of Computer Assisted Surgical Systems." This standard likely defines methods for measuring positional accuracy, which would be a key performance metric for a stereotaxic navigation system. However, the document does not report the specific results of applying this standard or the acceptance criteria for those results.

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The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery. Example procedures include: Posterior-approach spinal implant procedures, such as pedicle screw placement, with the lumbar region.

The subject devices, Image calibrator-21F and Image calibrator-31F are designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). The subject devices are modified from previously cleared devices to be compatible with the 21 cm/ 31 cm flat panel C-arm for CT image position and calibration.

The software upgrade is due to these newly added Image calibrators and one added function of auto-labeling for CT/C-arm image registration.

This 510(k) clearance letter and summary discuss the Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II. However, the provided document does not contain the detailed acceptance criteria and the specific study data proving the device meets these criteria in the format requested.

The document states:

• "Verification and validation activities have been completed to provide sufficient assurance that the subject device meets the performance requirements under its indications for use conditions."
• "The test methods are the same as the previously cleared 510(k), K233513."
• "All the results are passed."

This indicates that performance testing was conducted and passed, but the specific metrics, criteria, and the results themselves are not enumerated in this public summary. This level of detail is typically found in the full 510(k) submission, which is not publicly released in its entirety.

Therefore, I cannot extract the information needed to fill out the requested table and answer the specific questions about the study design, sample sizes, expert qualifications, and ground truth establishment from the provided text.

Based on the provided text, here's what can be inferred or explicitly stated regarding performance testing, but not the detailed acceptance criteria or results:

• Type of device: Spine Surgery Navigation System. These systems are typically evaluated based on their accuracy in guiding surgical instruments or implants relative to anatomical structures.
• Performance Data Section: The document mentions "Verification and validation activities have been completed" for the subject device.
• Test Descriptions mentioned:
  • Software: Verified and validated in accordance with FDA guidance for software in medical devices and IEC 62304.
  • Risk Assessment: Effectiveness of risk control measures verified in accordance with ISO 14971.
  • Design Verification: Design output fulfills design input requirements.
• Comparison to Predicate: "The intended use and fundamental technology of the subject device are identical to the predicate devices and could share the same testing methods as the predicate devices. All the results are passed." This implies that the performance was at least as good as the predicate device (K233513).
• Nature of changes: The current 510(k) is for a modification to the device, including compatibility with new Image Calibrators (21F and 31F for flat panel C-arm CT imaging) and an auto-labeling function for CT/C-arm image registration. Performance testing would have focused on verifying these changes do not adversely affect safety and effectiveness, and that the existing fundamental performance (e.g., accuracy of navigation) is maintained.

Conclusion: The provided text confirms that performance testing was conducted and passed, but does not provide the specific acceptance criteria or the reported performance data in a quantifiable manner. The document acts as a summary and approval letter, not a detailed study report.

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