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Spineology Navigation Instruments are indicated for use during the preparation and placement of:

• Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ pedicle screws .
• Spineology's OptiMesh® Portal Assembly .

during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous orthopedic procedures.

These instruments are designed for use with the Medtronic StealthStation® Spine 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 the spine or pelvis, can be identified relative to images of the anatomy.

Spineology Navigation Instruments are non-sterile, reusable surgical instruments that are manufactured from stainless steel and operated manually.

Spineology Navigation Instruments for Pedicular Fixation include Awls, Bone Taps, Drills, and Screwdrivers. The navigable instruments are equipped with a dimensional feature that allows connection to Medtronic's NavLock Trackers. A Navigation Adapter is also available with dimensional features that allows the same instruments to Medtronic's SureTrak" II Universal Trackers. These instruments are compatible with Spineology's Fortress", Threshold" Threshold™ V2, and Palisade™ Pedicular Fixation Systems and Medtronic's StealthStation® S7 (v2.1.0) and S8 (v1.0.0) Spine System.

Spineology Navigation Instruments for Portal Placement include a Dilator, Portal, Tightener, Wrench, and a Portal Surrogate. The navigable instruments are equipped with dimensional features that allow connection to Medtronic's SureTrak II Universal Trackers. These instruments are compatible with Spineology's OptiMesh Expandable Interbody Fusion System for Access Portal Placement and Medtronic's StealthStation® S8 (v1.2.0) Spine System.

Spineology Navigation Instruments are intended to be used during the preparation and placement of spinal implants in optically navigated procedures.

This document (K213876) is a 510(k) premarket notification for Spineology Navigation Instruments. While it describes non-clinical testing performed to establish substantial equivalence to a predicate device, it does not detail a clinical study with an AI component or the specific acceptance criteria and performance data for an AI-powered device.

The document discusses "Spineology Navigation Instruments" which are physical surgical tools used for navigation during spinal surgery. The testing described (mating, registration, accuracy) relates to the mechanical and optical tracking performance of these instruments when used with Medtronic's StealthStation system, not the performance of an AI algorithm.

Therefore, I cannot extract the information required to answer your prompt because the provided input does not describe an AI/ML-based medical device.

**To answer your prompt, I would need a document describing the clearance/approval of an AI/ML device, ideally one that includes: **

• Specific performance metrics (e.g., sensitivity, specificity, AUC) for the AI model.
• Details about the datasets used (training and test sets, including provenance and size).
• Information on ground truth establishment (expert review, pathology, etc.).
• If applicable, details of MRMC studies or human-in-the-loop performance.

Without such information, any attempt to answer would be speculative and not based on the provided document.

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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™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation® System S7 (v2.1.0).

The provided text describes a 510(k) premarket notification for Spineology Navigation Instruments, specifically concerning the addition of an Adapter to an existing cleared instrument set.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

This document does NOT describe the performance of an AI-powered device or a study with specific performance metrics (like sensitivity, specificity, AUC, etc.) typically associated with AI/ML systems. Instead, it describes a medical device (surgical instruments) cleared under the 510(k) pathway, where the primary demonstration of safety and effectiveness relies on "substantial equivalence" to a predicate device.

Therefore, many of the requested items (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance, training set details) are not applicable in the context of this specific regulatory submission. The "study" described is primarily non-clinical testing focused on design verification and risk assessment for the adapter, rather than clinical performance of an AI algorithm.

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of device clearance:

Acceptance Criteria and Device Performance (as demonstrated for this type of device):

The "acceptance criteria" for a 510(k) submission for a non-AI medical device like this are primarily demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety/effectiveness.

Detailed Study Information (largely N/A for this 510(k) submission):

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

   • N/A. This clearance is for surgical instruments, not an AI model evaluated on a "test set" of patient data. The "testing" involved non-clinical design verification (e.g., instrument mating, performance confirmation) for the adapter. The exact sample size for these non-clinical tests is not specified in the summary, but it would typically involve a sufficient number of units to demonstrate design integrity, not a patient data sample.
   • Data Provenance: N/A. No patient data provenance specified as clinical data was not required.

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

   • N/A. Ground truth establishment by experts for a test set of patient data is not relevant to this submission, as no clinical study evaluating interpretation or diagnosis was performed.

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

   • N/A. Not applicable, as there was no test set requiring expert adjudication.

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:

   • N/A. This device is a set of surgical instruments, not an AI or imaging diagnostic aid. No MRMC study was performed.

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

   • N/A. Not applicable, as this is not an algorithm.

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

   • N/A. No ground truth from patient data was established or used, as no clinical performance study was conducted. The "ground truth" for the non-clinical testing was based on design specifications and engineering requirements.

7. The sample size for the training set:

   • N/A. This device does not involve a "training set" in the context of machine learning or artificial intelligence.

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

   • N/A. Not applicable.

Summary of the "Study" (Non-Clinical Testing for Substantial Equivalence):

The "study" conducted for this 510(k) submission was a series of non-clinical design verification activities focused on the newly added Adapter to the Spineology Navigation Instruments.

• Purpose: To demonstrate that the design outputs of the subject Spineology Navigation Instruments (with the adapter) met the design input requirements and that the adapter did not introduce new issues of safety or effectiveness.
• Methods:
  • Assessment of instrument mating (how the adapter fits with other instruments).
  • Confirmation that the performance of Spineology Navigation Instruments is unaffected by the use of the Adapter.
  • A risk assessment to confirm no new safety or effectiveness issues.
• Conclusion: Spineology demonstrated substantial equivalence to the predicate device, confirming the same intended use and that any differences in technological characteristics (specifically the addition of the adapter) did not raise new issues of safety and effectiveness.
• Clinical Testing: Explicitly stated as "Clinical testing was not performed or required to establish the substantial equivalence of Spineology Navigation Instruments to the predicate device."

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Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold, 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™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation® System S7 (v2.1.0).

The provided text describes the 510(k) premarket notification for Spineology Navigation Instruments. This document demonstrates the substantial equivalence of the new instruments to a legally marketed predicate device, rather than proving a device meets specific clinical acceptance criteria through a standalone study.

Therefore, many of the requested details regarding acceptance criteria, device performance, sample size, ground truth, and expert involvement are not applicable as this is a regulatory submission for substantial equivalence based on technological characteristics and non-clinical testing, not a clinical effectiveness study.

Here's what can be extracted from the provided text based on your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the format of a typical clinical study. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device. The performance is assessed through non-clinical testing focused on compatibility and accuracy within the context of the Medtronic StealthStation System.

Study Details

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

   • Test Set Sample Size: Not specified in terms of numerical count for instruments or specific test scenarios. The non-clinical testing generally refers to "Spineology Navigation Instruments."
   • Data Provenance: The "Non-Clinical Testing" section describes in-house design verification activities performed by Spineology Inc. No specific country of origin for data is mentioned, and the testing is described as internal verification rather than external data collection. The tests are retrospective in the sense that they are internal design verification activities.

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

   • This information is not applicable. The "ground truth" for non-clinical engineering tests (like instrument mating, registration, and accuracy) is typically established by engineering specifications, validated measurement systems, and comparison to known good standards or predicate device performance, not by clinical experts establishing ground truth in the way it's done for diagnostic AI. The document does not mention external experts or their qualifications for establishing ground truth in these non-clinical tests.

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

   • This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments. The non-clinical tests described (instrument mating, registration, accuracy comparison) would involve objective measurements and comparisons against established metrics or predicate device performance, not clinical adjudication.

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, an MRMC comparative effectiveness study was not done. This document pertains to the clearance of surgical navigation instruments, not an AI-assisted diagnostic or interpretative device. Therefore, there is no mention of human readers, AI assistance, or effect sizes in this context.

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

   • This information is not applicable. The device (Spineology Navigation Instruments) is a physical surgical instrument intended for use with the Medtronic StealthStation System and by a surgeon (human-in-the-loop). It is not an algorithm that operates in a standalone capacity.

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

   • For the non-clinical tests described, the "ground truth" would be based on:
     • Engineering Specifications: For instrument mating and registration, the "ground truth" is that the instruments must correctly connect and register according to pre-defined engineering standards for the Medtronic StealthStation System.
     • Predicate Device Performance: For accuracy, the "ground truth" is the established accuracy of the equivalent Medtronic Navigation Instruments, to which the new Spineology instruments were compared.
   • This is not clinical ground truth like pathology or outcomes data.

7. The sample size for the training set:

   • This information is not applicable. There is no mention of a "training set" because this device is a physical instrument, not an AI or machine learning model that requires training data.

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

   • This information is not applicable as there is no training set mentioned or implied for this device.

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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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