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The SI-LOK® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) 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 Medronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The ExcelsiusGPS® 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 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.

The SI-LOK® Sacroiliac Joint Fixation System (including SI-LOK® Select) consists of cannulated, fully or partially threaded screws that are available with or without slots and optional pre-assembled contouring washers. One, two or three screws may be placed in one sacroiliac joint, depending on the approach.

The screws and washers are manufactured from titanium alloy, as specified in ASTM F136 (Ti6Al4V) and F1295 (Ti6Al7Nb). SI-LOK® screws are available with or without hydroxyapatite (HA) coated, as specified in ASTM F1185.

SI-LOK® Sacroiliac Joint Fixation System include surgical instruments manufactured from stainless steel, as specified in ASTM F899.

SI-LOK® ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with the ExcelsiusGPS® robotic arm, or may be used for a freehand navigated surgical procedure.

SI-LOK® Navigation Instruments are nonsterile, reusable instruments that can be operated manually or under power using a power drill such as POWEREASE that are intended to be used with the Medtronic StealthStation® System.

This FDA 510(k) K183119 summary does not describe a study involving device performance metrics related to diagnostic accuracy, sensitivity, specificity, or reader studies utilizing AI. Instead, it focuses on the substantial equivalence of the "SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments" to previously cleared predicate devices based on mechanical, biocompatibility, and technological characteristics.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from the provided text. The device in question is a surgical fixation system and related navigation instruments, not an AI-powered diagnostic or assistive tool in the typical sense for which an MRMC study or standalone algorithm performance metrics would be assessed.

Here's a breakdown of what can be extracted based on the provided document:

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

The document does not specify quantitative acceptance criteria in terms of accuracy metrics for an AI system. Instead, the "acceptance criteria" are implied through the successful completion of specified mechanical and biocompatibility tests, demonstrating substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in terms of human subjects or diagnostic cases, as this is primarily a mechanical and material performance evaluation for a surgical device. The "sample size" would refer to the number of devices or components tested in the mechanical evaluations, which is not detailed.
• Data Provenance: Not applicable in the context of diagnostic data. The provenance for the device materials and testing standards is US (ASTM, ANSI/AAMI).

3. 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 in the context of device performance in this submission refers to adherence to mechanical and material standards, not expert medical opinion on diagnostic images.

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

Not applicable. There is no adjudication process involving expert readers described.

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 MRMC comparative effectiveness study was done or described. This submission is not for an AI-assisted diagnostic device. The ExcelsiusGPS® and Navigation Instruments are tools to assist surgeons in locating anatomical structures and positioning instruments, often used with imaging but not as a primary diagnostic AI.

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

Not applicable. This device is not a standalone algorithm. Its function is to aid a human surgeon.

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

The "ground truth" for the device's substantial equivalence is based on:

• Engineering standards (ASTM F2193, ASTM F543, ANSI/AAMI ST-72:2011) for mechanical and biocompatibility properties.
• Comparison of technological characteristics (design, intended use, material composition, function, range of sizes) to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

Not applicable, as there is no training set for an AI model.

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Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle 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, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.

Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress, Threshold V2, and Palisade Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation System 57 (v2.1.0).

The provided text is a 510(k) Summary for the Spineology Navigation Instruments. While it describes the device, its intended use, and indicates that design verification testing was conducted, it does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria.

Here's an analysis of the information available and what is missing:

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

• Missing: The document states that "Design verification testing, including mating, registration, and accuracy, was conducted to ensure that Spineology Navigation Instruments are safe and effective for their intended use..." However, it does not list the specific acceptance criteria for "mating," "registration," or "accuracy." It also does not report the performance results (e.g., specific accuracy metrics, successful mating rates, or registration success rates) for the Spineology Navigation Instruments.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Missing: The document mentions "testing" but does not specify any sample sizes for the test sets used for mating, registration, or accuracy testing. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective/prospective). This type of device typically uses in-vitro or bench testing, not patient data in the same way an AI/software device would.

3. 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/Missing: For a stereotaxic instrument, "ground truth" is typically established through precise engineering measurements and metrology, not expert review of images or clinical outcomes in the same way an AI diagnostic device would. If the "accuracy testing" involved human assessment of alignment, the number and qualifications of those individuals are not mentioned.

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

• Not Applicable/Missing: Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, often for establishing ground truth. For this type of device, which involves mechanical and software-based accuracy, "adjudication" in this sense 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

• Not Applicable: This is a physical navigation instrument intended for use with a pre-existing medical device (Medtronic StealthStation® System), not an AI algorithm designed to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

• Not Applicable: This is a physical instrument. While the StealthStation® System has an algorithm component, the Spineology Instruments themselves are not standalone algorithms. The testing here focuses on the instruments' compatibility and physical performance when used with the StealthStation.

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

• Not explicitly stated/Implied by Device Type: For "accuracy testing" of navigation instruments, the ground truth would typically be established through highly precise mechanical measurements against known reference points, using CMMs (Coordinate Measuring Machines) or similar metrology equipment, rather than clinical ground truth like pathology or outcomes data. The document does not explicitly state the method for establishing this ground truth.

8. The sample size for the training set

• Not Applicable: This is a medical device, not a machine learning or AI model that requires a training set.

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

• Not Applicable: As above, this is not an AI/ML device requiring a training set.

Summary of what is present in the document regarding the study:

• Study Description: Design verification testing was performed, including "mating, registration, and accuracy."
• Purpose of Study: To ensure the instruments are safe and effective, functional, compatible with the Medtronic StealthStation®, and substantially equivalent to the predicate device.
• Comparison: Accuracy testing included a "side-by-side comparison of Spineology Navigation Instruments to the predicate device."

In conclusion, while the document confirms that testing was performed, it lacks the detailed information requested regarding specific acceptance criteria, performance results, sample sizes, and detailed methodology for establishing ground truth, which are typically found in more comprehensive study reports or test protocols. This 510(k) Summary focuses on demonstrating substantial equivalence primarily through design and technological characteristics and high-level summaries of testing, rather than an in-depth clinical or performance study report.

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NuVasive® Navigation Instruments are intended to be used during the preparation and placement of NuVasive screws (Armada, Reline, Precept, MAS PLIF, and VuePoint fixation systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. NuVasive® Navigation Instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

NuVasive Navigation Instruments are manual, non-sterile, re-usable, surgical instruments intended for use with Medtronic StealthStation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of NuVasive screws during spinal surgery.

The document provided does not contain a study that proves the device meets specific acceptance criteria in terms of reported device performance based on quantitative metrics. The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.

The "Performance Data" section (G) on page 4 mentions "Accuracy testing," "Compatibility testing," and "Performance testing" were performed, and concludes that "results demonstrate that the subject NuVasive Navigation Instruments are substantially equivalent to the predicate." However, it does not provide details about the specific acceptance criteria for these tests, the reported performance metrics, the sample sizes, data provenance, ground truth establishment, or any information related to expert involvement or comparative effectiveness.

Therefore, I cannot provide the requested information from the given document as it is not present.

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