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The Genesys Spine Sacroiliac Joint Fusion System with Navigation is intended to be used with the Genesys Spine Sacroiliac Joint Fusion System to assist the surgeon in precisely locating anatomical structures in SIros and SIros O procedures, in which the use of stereotactic surgery may be appropriate, and where reference to anatomical structures, such as the pelvis or vertebra, can be identified relative to acquired imaging (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or image data based models of the anatomy. Navigation instruments are intended to be used with the Medtronic O-arm® Imaging System and StealthStation® Navigation System.

The Genesys Spine Sacrolliac Joint Fusion with Navigation consist of instruments compatible with the Medtronic O-arm® Imaging System and StealthStation™ Navigation System to assist the surqeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Medtronic O-arm® Imaging System and StealthStation™ Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.

The Genesys Spine Sacrolliac Joint Fusion System consists of implants designed to secure the sacroiliac joint and minimize micromotion to enable bony fusion. All Implants are cannulated and self-tapping; they are offered with different diameters and lengths to accommodate variations in patient anatomy and surgeon preference. The Slros OTM Sacrolliac Joint Fusion System implants are manufactured from implant grade titanium (Ti-6AL-4V ELI).

This document, K233595, describes a 510(k) premarket notification for the "Genesys Spine Sacroiliac Joint Fusion System with Navigation". This device is an orthopedic stereotaxic instrument intended to assist surgeons in precisely locating anatomical structures during sacroiliac joint fusion procedures using navigation systems. The information provided heavily emphasizes the substantial equivalence of the device to legally marketed predicate devices, rather than presenting a detailed independent study with specific acceptance criteria and performance metrics typically found for AI-based or novel diagnostic devices.

Therefore, many of the requested details about acceptance criteria, study design for proving performance, and expert involvement are not explicitly present in this 510(k) summary, as the submission focuses on demonstrating equivalence through non-clinical testing rather than complex clinical performance studies.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not provide a table of precise quantitative acceptance criteria in the format of thresholds for specific metrics (e.g., accuracy percentages, sensitivity, specificity). Instead, the performance testing focuses on functional and compatibility aspects:

1. Acceptance Criteria (Implied from Testing Objectives):

• Registration: The instruments must be able to successfully register with the Medtronic StealthStation®.
• Accuracy: The accuracy of the subject instruments must be comparable to the reference instruments (predicates).
• Rigidity: The connection between the Medtronic NavLock and the subject instruments must demonstrate sufficient rigidity.
• Compatibility: The subject instruments must be compatible with the Genesys Spine Sacroiliac Fusion System Implants.

2. Reported Device Performance:

The document states, "The performance testing completed:

1. Registration - Registration testing was performed to ensure that the instruments can be registered to the StealthStation®.
2. Accuracy - Accuracy testing was completed for comparison to the reference instruments.
3. Rigidity - Rigidity testing evaluated the connection between the Medtronic NavLock and the subject instruments.
4. Compatibility with Genesys Spine Sacroiliac Fusion System Implants - Compatibility with the Implant System has been evaluated to ensure that the isubject instruments are compatible with the Implant System."

It then concludes: "The verification and validation results support substantial equivalence of the subject instruments compared to the predicate devices."

Summary Table (Derived/Inferred):

Study Details:

Many of the requested details are not applicable or not provided, as the study described is a non-clinical performance testing study focused on demonstrating functional compatibility and equivalence, rather than a clinical trial or performance study comparing a new algorithm's diagnostic performance against human experts.

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

   • Sample Size: Not specified in the provided text. The testing focuses on mechanical/functional aspects of the instruments, not data samples like images for an AI.
   • Data Provenance: Not applicable in the context of this device. The testing is described as "performance testing" of the physical instruments with the navigation system.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. Ground truth for an AI/diagnostic device is typically established by medical experts reviewing data. This device is a surgical instrument system, and its "ground truth" relates to its mechanical and functional performance, verified through engineering tests.

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

   • Not applicable. This is not a study requiring adjudication of expert interpretations.

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 is not an AI-assisted diagnostic device. It's a stereotaxic instrument for surgical guidance.

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

   • Not applicable. This is not a standalone algorithm. It's a system with a human surgeon in the loop, intended to assist the surgeon.

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

   • The "ground truth" for this device's performance would be engineering specifications, established physical properties, and the known performance baseline of the predicate devices and compatible navigation systems (Medtronic O-arm® and StealthStation™). It's based on engineering and functional validation, not medical expert consensus on patient data.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

   • Not applicable. As there's no training set for an AI model, this question is irrelevant to the described device and its testing.

In summary, this 510(k) submission demonstrates the device's substantial equivalence through non-clinical performance testing focused on its functional compatibility and mechanical properties when used with specified predicate navigation systems, rather than through clinical or AI performance studies against diagnostic criteria.

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The Genesys Spine Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

Genesys Spine's Sacroiliac Joint Fusion System consists of partially threaded and fully threaded implants designed to secure the sacroiliac joint and minimize micromotion in order to enable bony fusion. All screws and anchors are cannulated and self-tapping; they are offered with different diameters (up to 13.5mm), lengths (up to 70mm), and styles to accommodate variations in patient anatomy and surgeon preference. Fusion across the graft space can be aided by the addition of bone graft material to the lumen of each screw; fenestration in each screw allow for direct allograft apposition across the sacroiliac joint. Dual thread screws and fully threaded screws provide joint compression by utilizing a compressive thread pattern. Optional Washers are included to aid in conforming to patient anatomy and to help distribute the load onto a larger area. All implants are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI). The delivery system uses guide pins for accurate surgical placement into pre-drilled bone. All implants will be provided non-sterile and are intended for single use only.

This document, K191748, is a 510(k) Premarket Notification from Genesys Spine for their Sacroiliac Joint Fusion System. As such, it does not contain details of clinical studies, acceptance criteria, or ground truth establishment typically associated with AI/ML-driven medical devices.

Medical devices cleared through the 510(k) pathway, especially those like bone fixation fasteners, are primarily evaluated based on equivalence to legally marketed predicate devices through non-clinical performance evaluations (mechanical testing), rather than human clinical trials or complex algorithms requiring extensive performance studies with acceptance criteria for sensitivity, specificity, etc.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance: This document does not present such a table. The acceptance criteria for this device are implied by its substantial equivalence to predicate devices, meaning it must meet similar mechanical and material properties.
• Sample size used for the test set and data provenance: Non-clinical mechanical testing does not involve human subjects or "data provenance" in the clinical sense. Test "samples" would refer to the number of devices tested, but specific numbers are not provided, only the standards used (e.g., ASTM F2193-18a).
• Number of experts used to establish ground truth: Not applicable for a mechanical device.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an image-based diagnostic or AI-assisted device.
• Standalone (algorithm only) performance: There is no algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as there's no machine learning model.
• How the ground truth for the training set was established: Not applicable.

What the document does provide in terms of performance evaluation:

The document states that non-clinical testing was performed on "worst-case devices" and "demonstrated substantially equivalent performance to the predicate systems." The mechanical tests performed are listed:

• Static Bending Strength (ASTM F2193-18a)
• Fatigue Bending Strength (ASTM F2193-18a)
• Torsional strength/breaking angle (ASTM F543-17)
• Insertion/removal torque (ASTM F543-17)
• Pullout force (ASTM F543-17)

The acceptance criteria for these tests would be defined by the specified ASTM standards and the performance of the predicate devices. The "reported device performance" is summarized by the statement that it "demonstrated substantially equivalent performance to the predicate systems," meaning it met or exceeded the performance benchmarks set by the predicates under these test conditions. However, specific numerical results or detailed pass/fail thresholds are not included in this summary.

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