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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 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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