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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 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 Xenix Medical RIVA Posterior Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system or anterolateral fixation, in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine:

• Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
• Spondylolisthesis
• Trauma (i.e. fracture or dislocation).
• Spinal Stenosis
• Deformities or curvatures (i.e scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion

Xenix Medical fenestrated screws are intended to be used with saline or radiopaque dye.

Xenix Medical RIVA Posterior Fixation System Navigation Instruments are intended to be used with the Xenix Medical RIVA Posterior Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic® StealthStation™ S8 System, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Xenix Medical RIVA Posterior Fixation System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur.

The Xenix Medical RIVA Posterior Fixation System includes a variety of single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of polyaxial pedicle screws, as well as connecting spinal rods, connectors, crossbars, and a separate set screw locking element. The instruments included in the Xenix Medical RIVA Posterior Fixation System facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document, a 510(k) Clearance Letter for the RIVA Posterior Fixation System, is a submission for a physical medical device (pedicle screw system and navigation instruments), not a software or AI-driven medical device. Therefore, the specific information requested in your prompt regarding acceptance criteria and study proving performance for AI/software-based devices (such as statistical metrics, test/training sets, expert consensus, MRMC studies) cannot be directly derived from this document.

The document focuses on proving substantial equivalence to existing predicate devices, primarily through mechanical performance testing for the physical implants and accuracy testing for the navigation instruments. It does not describe a clinical study in the way an AI/software device would.

However, I can extract and interpret the available information to best fit your requested structure, making assumptions where necessary based on typical 510(k) submissions for physical devices:

Analysis of Acceptance Criteria and Performance for RIVA Posterior Fixation System

Given that the RIVA Posterior Fixation System is a physical medical device (spinal implant and surgical instruments), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" differ significantly from those for an AI/software device. For physical devices like this, acceptance is primarily based on meeting mechanical performance standards and demonstrating substantial equivalence to existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Static and dynamic compression bending
• Static torsion
• Axial and torsional grip
• Tulip shank dissociation
• Flexion-extension | These are industry-standard tests for spinal implants to ensure strength, durability, and resistance to common stresses. "Substantially equivalent" means the performance is comparable to and not worse than the predicate devices, not necessarily meeting a specific numerical threshold beyond that. |
  | Mechanical Performance | Adherence to ASTM F1798 standards | Demonstrated substantially equivalent mechanical performance. | ASTM F1798 covers resistance to unscrewing for spinal implants. |
  | Navigation Instrument Accuracy | Instruments register and function properly with Medtronic® StealthStation™ S8 System | Accuracy testing confirmed instruments register and function properly. | This implies that the instruments provide sufficiently accurate anatomical location data when used with the specified navigation system. |
  | Navigation Instrument Dimensional Analysis | Dimensions are comparable to predicate instruments. | Dimensional analysis performed against predicate instruments. | This ensures compatibility and similar performance characteristics to established navigation instruments. |
  | Biocompatibility | Use of Biocompatible Materials | Implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562). | These are well-established, biocompatible materials commonly used in medical implants, conforming to relevant ASTM standards. Although not explicitly stated as "acceptance criteria," material conformity is a fundamental requirement. |
  | Sterilization | Compatibility with Steam Sterilization | Accessories include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process. | Confirms the device/accessories are designed for appropriate sterilization. |

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

• Sample Size: The document does not specify the exact number of devices or components tested for mechanical or accuracy performance. For mechanical testing, samples typically involve multiple units of each component type (e.g., screws, rods, connectors) to ensure statistical validity across batches. For navigation instrument accuracy, it would involve a certain number of instrument uses with the navigation system.
• Data Provenance: The data provenance is from laboratory testing (mechanical and accuracy testing) performed by the manufacturer, HT Medical d.b.a. Xenix Medical. This is not patient data; it's engineering test data.
  • Country of Origin: Not specified, but generally performed at the manufacturer's R&D facilities or contracted testing labs, typically in the country of manufacture or where submission is being sought (implied US, given FDA 510(k)).
  • Retrospective or Prospective: This is not applicable in the context of laboratory mechanical/accuracy testing.

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

This section is not applicable in the context of this device and submission type. "Ground truth" as defined for AI/software (e.g., expert consensus on medical images) is not relevant here. The "truth" is established by the physical and mechanical properties of the device and its ability to function as intended in a controlled laboratory environment according to established engineering standards (ASTM). The "experts" involved would be engineers, material scientists, and quality assurance personnel conducting the tests and interpreting the results against the ASTM standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements in labeling or classifying data, typically by human experts reviewing complex medical images or clinical cases. For mechanical testing, the "adjudication" is against the pre-defined ASTM standards and the performance of the predicate device. Test results are quantitative and either meet or do not meet the criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) submission. MRMC studies are typically done for diagnostic imaging devices or AI tools that assist human readers in making clinical decisions. This device is a surgical implant and navigation system, not a diagnostic tool requiring MRMC.

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

Not Applicable. This concept applies to AI algorithms. The "RIVA Posterior Fixation System" is a physical implant and surgical navigation instrumentation. There is no standalone "algorithm" to evaluate in this context. The navigation instruments are designed for "human-in-the-loop" use with a surgeon and the Medtronic StealthStation system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment is based on accepted engineering standards (ASTM F1717, ASTM F1798) and the established performance of the predicate devices. This means:

• Mechanical Integrity: The ability to withstand specified static and dynamic forces as defined by ASTM standards.
• Functional Accuracy: For the navigation instruments, the ability to register and provide accurate location information within the Medtronic StealthStation system, demonstrated through bench testing.
• Material Conformity: Conformance to specified biocompatible material standards.

It is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be validated. Clinical outcomes data would typically be gathered in post-market surveillance or specific clinical trials for PMA devices, which this is not.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning. There is no algorithm being trained.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for one. The "truth" for the design and manufacturing of this physical device is based on engineering principles, material science, and established manufacturing processes.

Summary Caveat:

It is crucial to understand that the provided document is a 510(k) clearance letter for a traditional physical medical device (implant and instruments). The questions in your prompt are specifically tailored towards the validation of Artificial Intelligence (AI) or software as a medical device (SaMD). Therefore, many of the requested details (like ground truth establishment from experts, MRMC studies, training/test sets for algorithms) are not relevant to this type of device and are consequently not found in the 510(k) clearance letter. The FDA's assessment for this device focuses on substantial equivalence in terms of intended use, indications for use, design, materials, function, manufacturing, and most importantly, mechanical performance as demonstrated through rigorous engineering bench testing.

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The Salvo® Robotic Navigation Instruments are indicated for use during the preparation and placement of Salvo® Spine System screws in open or minimally invasive procedures. The Salvo® Robotic Navigation Instruments are specifically designed for use with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform, 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 Salvo® Robotic Navigation Instruments are surgical instruments that are designed to be used with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform. These instruments are intended to facilitate the placement of screws during spinal surgery. The instruments are reusable and offered as non-sterile, to be cleaned and steam sterilized by the end user.

The provided FDA 510(k) clearance letter describes the Salvo® Robotic Navigation Instruments and asserts their substantial equivalence to predicate devices. However, the document does not contain the detailed information required to fill out all requested sections about acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth details. The letter primarily focuses on the regulatory submission process and the conclusion of substantial equivalence based on dimensional analysis and geometric comparison and compatibility validation testing, rather than a comprehensive performance study that would typically include the requested metrics for AI-powered devices.

Specifically, this device appears to be surgical instruments used with a robotic navigation platform, not an AI or software algorithm itself that would typically have performance metrics like sensitivity, specificity, or AUC. The "dimensional analysis and geometric comparison" and "validation testing to demonstrate compatibility" are more aligned with traditional medical device testing for form, fit, function, and safety, rather than evaluating the diagnostic or predictive performance of an AI system.

Therefore, many sections below will state "Not applicable" or "Not specified in the provided document" because the input document does not detail these aspects as would be expected for an AI/ML-driven device study.

Acceptance Criteria and Device Performance Study Details

Given the nature of the device (robotic navigation instruments, not an AI diagnostic/predictive tool), the acceptance criteria and study detailed in the provided document focus on physical characteristics, compatibility, and safety rather than AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/Not specified. The document refers to "dimensional analysis and geometric comparison" and "validation testing," which implies testing of instrument prototypes or production units, not a patient or image dataset.
• Data Provenance: Not applicable/Not specified.

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

• Not applicable/Not specified. The evaluation involved engineering analyses (dimensional, geometric, compatibility) of the instruments themselves, not interpretation of clinical data requiring expert consensus.

4. Adjudication Method for the Test Set

• Not applicable. As no clinical images or patient data were interpreted, no adjudication method was mentioned or implied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

• No. An MRMC study was not done. The device is a surgical instrument, not an AI-assisted diagnostic or interpretative system for human readers. "Clinical testing is not applicable" is explicitly stated.

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

• Not applicable. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

• Engineering specifications and predicate device characteristics. The "ground truth" for the tests appears to be established engineering tolerances, mechanical specifications, and the established characteristics of the predicate devices for comparison. For compatibility, the ground truth would be the functional requirements of the ExcelsiusGPS® system's safety features.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The "design and dimensions" of the instruments would be engineered and iterated upon, not "trained" in the machine learning sense.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S7 and StealthStation System S8, 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 are reusable instruments used for the preparation and insertion of Innovasis Pedicle Screw System implants, in either open or percutaneous procedures. These instruments are designed for navigated use with the Medtronic StealthStation. The Innovasis Navigation Instruments include the Vector M-S Navigation Instruments for use with the Vector Pedicle Screw System and the Excella Navigation Instruments for use with the Excella II, Excella 3, and Excella MIS pedicle screws. The Innovasis Navigation Instruments are manufactured from medical grade stainless steels. The purpose of this 510(k) is to add the Vector M-S Navigation Instruments to the system.

The provided text from the FDA 510(k) summary (K250182) for "Innovasis Navigation Instruments" contains information required to answer some of the questions. However, critically, this submission focuses on a medical device (navigational instruments) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical "acceptance criteria" and "study types" associated with AI/SaMD performance evaluation (such as sensitivity, specificity, MRMC studies, ground truth establishment for algorithms, training sets, etc.) are not applicable and not detailed in this document.

The study described here is primarily an engineering analysis and geometric comparison to predicate devices, along with a validation of navigation compatibility. It does not involve AI performance evaluation or clinical outcomes in the way an AI/SaMD submission would.

Here's an attempt to answer the questions based on the provided text, while explicitly noting what information is not present or applicable.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This device is not an AI/Software as a Medical Device (SaMD). The acceptance criteria and studies described are for physical surgical navigation instruments, not for an algorithm's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a physical instrument, the "acceptance criteria" are related to its design, materials, and compatibility, rather than performance metrics like sensitivity or specificity.

• Indications for Use are identical to predicate.
• Manufacturing and Biocompatibility are identical to predicate.
• Instrument Types and Sizes are identical to predicate.
• Critical Geometry (Instrument functional length, Instrument Nav Lock Connection Feature Geometry) are identical to predicate.
• Sterility is identical to predicate. | "The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates: Principles of Operation, Indications for Use, Manufacturing and Biocompatibility, Instrument Types and Sizes, Critical Geometry (Instrument functional length, Instrument Nav Lock Connection Feature Geometry), and Sterility." |
  | Navigation Compatibility | - Compatibility with Medtronic StealthStation™ System S7 and S8. | "A validation was also conducted to demonstrate navigation compatibility with the Medtronic StealthStation™ System S7 and S8."
  "The results show that the subject device is substantially equivalent to cleared predicated." |
  | Mechanical Performance | - Overall mechanical performance is equivalent to predicate devices. | "The overall technology characteristics and mechanical performance data lead to the conclusion that the Innovasis Navigation Instruments are substantially equivalent to the predicate device." |

Note: The text explicitly states, "The Innovasis Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to the predicate devices." This implies that the 'performance' is largely demonstrated by meeting design specifications and showing equivalence to existing, cleared devices.

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

• Sample Size for Test Set: Not applicable or not specified in the context of an AI/SaMD test set. The evaluation was an "engineering analysis and geometric comparison" and "validation." This suggests testing of instrument prototypes or production samples, but there is no "test set" of patient data as would be used for AI/SaMD.
• Data Provenance: Not applicable in the context of patient data. The evaluation is on the manufactured instruments themselves.

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

• Number of Experts: Not applicable. Ground truth, in the AI/SaMD sense (e.g., image annotations, disease labels), is not established for this type of device submission. The "ground truth" here is the design specification and the functionality of the predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretation or labeling of data that would require adjudication.

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

• MRMC Study: No. This is not an AI/SaMD and therefore an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

• Standalone Performance: No. This is a physical medical instrument, not an algorithm.

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

• Type of Ground Truth: For this device, the "ground truth" is primarily based on design specifications, engineering principles, and the established safety and effectiveness of the predicate devices. The "validation" would confirm that the instruments correctly interface and function with the Medtronic StealthStation System. There is no "disease ground truth" derived from expert consensus, pathology, or outcomes data in this submission.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/SaMD, so there is no training set for an algorithm.

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

• Ground Truth for Training Set Establishment: Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided FDA 510(k) pertains to physical "Innovasis Navigation Instruments" for spinal surgery, which are Class II devices. The regulatory pathway relies on demonstrating substantial equivalence to predicate devices through engineering analysis, geometric comparison, and compatibility validation, rather than the performance metrics and study designs typically associated with AI/Software as a Medical Device (SaMD) clearances.

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INNOVERSE Navigation Instruments are intended to be used during the preparation and placement of INNOVERSE Spinal System implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in spinal procedures. These instruments are designed for use with the stereotactic navigation system Medtronic® StealthStation™, 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 INNOVERSE Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation™ Navigation System to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of pedicle screw implants.

The INNOVERSE Navigation Instruments include awls, probes, taps, and drivers and are to be used with the INNOVERSE Spinal System.

All instruments are made from Stainless Steel per ASTM F899. The INNOVERSE Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation™ Navigation System hardware and software.

The provided text is a 510(k) Summary for the "INNOVERSE Navigation Instruments." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and, in this case, a single performance test. It does not contain information about a study designed to prove the device meets specific acceptance criteria in the way one might expect for an AI algorithm or diagnostic tool.

Instead, the performance data section of this document describes non-clinical testing for positional accuracy of the instruments themselves, not a clinical study involving human-in-the-loop performance or AI-driven diagnostic capabilities.

Therefore, many of the requested categories for the description of "the study that proves the device meets the acceptance criteria" are not applicable to the information provided.

Here's an attempt to answer based on the available text, with significant caveats where information is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document only explicitly mentions one performance test and its results.

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

The document describes "non-clinical testing" for positional accuracy (per ASTM F2554-18). This typically involves testing the instruments in a laboratory setting, not on a "test set" of patient data.

• Sample size for the test set: Not applicable in the context of patient data for an algorithm. The "sample" would refer to the number of instruments tested or the number of measurements taken, which is not specified.
• Data provenance: Not applicable. The testing is non-clinical, likely performed in a lab.

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

Not applicable. The ground truth for positional accuracy would be established by precision measurement equipment in a laboratory setting, not by human experts interpreting data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for human interpretation or multi-expert assessment, which is not described here. Positional accuracy is typically measured objectively.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on the instruments themselves and their positional accuracy, not on human reader performance with or without AI assistance.

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

No, this is not a study of an algorithm's standalone performance. The device is a set of surgical instruments, not an AI or imaging algorithm.

7. The Type of Ground Truth Used

The ground truth for the single mentioned performance test (positional accuracy) would be based on precise physical measurements using calibrated equipment, as per the ASTM F2554-18 standard. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This device is a set of physical surgical instruments and does not involved a "training set" in the context of machine learning or AI.

9. 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 Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spationing 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 Invictus Robotic Navigation Instruments are surgical instruments that is designed to be compatible with Globus Medical's Excelsius GPS® Robotic Navigation Platform. The subject device is intended to facilitate the placement of screws during spinal surgery. The subject device are reusable instruments and offered non-sterile to be cleaned and steam sterilized by the end user.

The provided text is a 510(k) summary for the Invictus Robotic Navigation Instruments. It explains that the determination of substantial equivalence (SE) is not based on an assessment of clinical performance data. Instead, it states that the device was evaluated through dimensional analysis and geometric comparison to the predicate devices to establish safety and effectiveness for accuracy performance.

Therefore, the document does not contain the information requested concerning acceptance criteria, device performance, test set sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details for training sets.

The relevant section states:
"Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

VII. PERFORMANCE DATA
The Invictus Robotic Navigation Instruments have been evaluated through a dimensional analysis and geometric comparison to the predicate devices to establish the safety and effectiveness for accuracy performance."

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CoreLink Robotic Navigation Instruments are indicated to be used during the preparation screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients, where reference to a rigid anatomical structure such as vertebra can be identified. These instruments are designed for use with the Globus ExcelsiusGPS system, which is indicated 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 system is indicated for the placement of spinal and orthopedic bone screws.

CoreLink Robotic 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 Excelsius GPS® Robotic Navigation Platform to aid in implantation of CoreLink Pedicle Screw System implants (NextGen Pedicle Screw System, CoreLink Midline Fixation System (CentraFix), and Tiger Spine System). The instruments are manufactured from stainless steel.

The provided document is a 510(k) summary for the CoreLink Robotic Navigation Instruments. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. As such, the focus of the submission is primarily on demonstrating this substantial equivalence through engineering analysis and comparison to existing cleared devices, rather than on extensive clinical performance data or a standalone performance study as would be seen for novel AI/ML-enabled devices.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance (beyond engineering analysis for equivalence), sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document states:

• "The CoreLink Robotic Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
• "The results of this engineering analysis show that the subject is substantially equivalent to the cleared predicate."

This means the device's acceptable performance is demonstrated by its similarity to already cleared devices, and it's not being assessed as a novel AI/ML device requiring the robust performance study details typical for such submissions.

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The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System modular screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, 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 quide tube to be used by surgeons for navigating and/or quiding 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 Invictus Robotic Navigation Instruments are surgical instruments that is designed to be compatible with Globus Medical's Excelsius GPS® Robotic Navigation Platform. The subject device is intended to facilitate the placement of screws during spinal surgery. The subject device are reusable instruments and offered non-sterile to be cleaned and steam sterilized by the end user.

The provided text is a 510(k) summary for the "Invictus Robotic Navigation Instruments." This document is a regulatory submission to the FDA, demonstrating substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/SaMD.

Specifically:

• There is no table of acceptance criteria and reported device performance.
• There is no mention of a test set, training set, sample sizes, data provenance, or ground truth.
• The document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
• It also states that performance data relied on "dimensional analysis and geometric comparison to the predicate devices."

The device described is a set of "surgical instruments" intended for use with a robotic navigation platform, not an AI or software algorithm that analyzes data or images. The "performance data" refers to engineering analyses to show substantial equivalence of physical instruments, not the performance of an AI model.

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