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The SPINEART Navigation System reusable instruments are intended to be used during the preparation and placement of SPINEART screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the Medtronic® StealthStation® System or the Brainlab® Spine & Trauma Navigation System which are 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 long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system instruments. Current cleared Spineart® Navigation reusable instruments (K241644, K210472 & K183630) feature a connecting area for the tracker compatible with the Navlock Tracker to be navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spineart's Brainlab® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the Brainlab® Spine & Trauma Navigation System to the cleared range of SPINEART® Navigation Instrument System.

The provided FDA 510(k) clearance letter describes the "SPINEART Navigation Instrument System." This document is a clearance letter and a 510(k) summary, which may not always detail the full extent of the testing that would typically be found in a full submission. However, based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document states: "Performance data showed the addition of the SPINEART Brainlab® Navigation Adaptor (Subject device) on the SPINEART Navigation reusable instruments for a use with the Brainlab® Spine & Trauma System, provides an accuracy at least equivalent to the initial intended use defined for Brainlab® and provides results in simulated use more accurate than the acceptance criteria."

However, specific numerical acceptance criteria for accuracy are not explicitly stated in the provided text. The performance is reported as meeting or exceeding unspecified acceptance criteria.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set. It mentions "Comparison of accuracy between the Brainlab® tracker and clamps directly attached on the SPINEART Navigation Reusable Instruments and the Brainlab® tracker and clamps attached on the SPINEART Navigation Reusable Instrument using the SPINEART Brainlab® Navigation Adaptor (subject device)" and "Accuracy in simulated use (protocol adapted from ASTM F2554-22)."

The data provenance is not explicitly stated as originating from a specific country or as retrospective/prospective. The testing appears to be non-clinical performance bench testing conducted by the manufacturer, Spineart SA, located in Switzerland.

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

The document does not mention the use of experts or their qualifications for establishing ground truth in the non-clinical testing. The ground truth (or reference standard) in this type of accuracy testing is typically established through precise metrological instruments and methods.

4. Adjudication method for the test set

Not applicable. The described testing is non-clinical performance testing (bench testing for accuracy), not a study involving human interpretation that would typically require an adjudication method.

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. The device is a "Navigation Instrument System" intended to assist surgeons in precisely locating anatomical structures. It is not an AI-assisted diagnostic device that would typically involve human readers interpreting images, therefore, an MRMC study is not relevant to this device.

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

This device appears to be an instrument system and not an algorithm in the traditional sense of AI. The "standalone" performance tested was the accuracy of the navigation system components (specifically the new adapter with the instruments and Brainlab system), which is essentially the performance of the technical system without direct human variability in judgment as the primary outcome. The testing performed was a "Comparison of accuracy" and "Accuracy in simulated use," which are standalone technical evaluations.

7. The type of ground truth used

The ground truth for the accuracy testing would typically be established by highly precise measurement systems (e.g., coordinate measuring machines, optical tracking systems) that can determine the true position and orientation of instruments with sub-millimeter accuracy in a controlled testing environment. The document mentions "dimensional analysis" as also confirming accuracy.

8. The sample size for the training set

Not applicable. This device is not described as an AI/ML device that requires a training set. It is a navigation instrument system, and its performance is evaluated based on its mechanical and optical tracking accuracy.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

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The SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the eCential Op.n PERLA® TL Nav System. It is indicated for population with medical conditions requiring the placement of spinal screws and for which the use of stereotactic surgery may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The quidance is based on an intra-operative surgical plan developed with Op.n PERLA® TL Nav Software and based on intraoperative 3D images provided by a compatible imaging system.

The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. Currently cleared Spineart® Navigation reusable instruments (K210472) feature a connecting area for the tracker compatible with the Navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spinear's eCential® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the eCential® Op.nº Navigation System to the cleared range of SPINEART® Natrument System.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state the numerical acceptance criteria from the ASTM F2554 protocol or the eCential protocol. However, it indicates that the device met these criteria.

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

The document does not specify the sample size for the test set used in the ASTM F2554 verification or the eCential protocol accuracy verification.
The data provenance is not explicitly stated in terms of country of origin, but the company (Spineart SA) is based in Switzerland. The studies are non-clinical (verification and accuracy testing), so concepts like "retrospective" or "prospective" are not applicable in the same way they would be for clinical trials.

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

The document does not mention the use of experts to establish a ground truth for the test set. The testing described (ASTM F2554 verification and eCential protocol accuracy verification) appears to be objective, physical testing of the device's accuracy and performance against defined technical standards and internal protocols, rather than relying on human expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the testing described does not involve human interpretation or subjective assessment that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. The testing mentioned is non-clinical performance and accuracy verification of the device itself.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the testing described appears to be a standalone study of the device's performance. The "Verification of the eCential Navigation Adaptor designed by Spineart used in a worst case scenario, with the eCential® Op.n® Perla TL Nav system, according to the ASTM F2554 protocole" and "Accuracy Verification: Verification of the SPINEART Navigation reusable instruments with the eCential® Op.nº Peda TL Nav system, according a Protocole defined by eCential®" describe the device's inherent accuracy and technical performance without human intervention as part of the measured outcome. The device itself assists in navigation, but the testing focuses on the accuracy of the navigation system and instruments, not the accuracy of a human using it.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing would be the established technical specifications and measurements outlined in the ASTM F2554 standard and the eCential protocol. It's based on objective, measurable physical parameters such as precision, accuracy, and mechanical performance under specific test conditions.

8. The Sample Size for the Training Set

Not applicable. The described device is a navigation instrument system, not an AI/ML algorithm that requires a training set. The "eCential Op.n PERLA TL Nav System" includes software, but the provided text focuses on the instruments and adaptor and their performance with the navigation system, not the training of an AI component within the software itself.

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

Not applicable, as there is no training set mentioned for this device.

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The Spineart Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Spineart Navigation Instrument System reusable instruments are specifically 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 long bone or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The SPINEART® Navigation Instrument System reusable instruments are surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants.

The SPINEART® Navigation system includes the following instruments dedicated to screw placement: Screwdrivers, Taps, Drills.
The SPINEART® Navigation Instrument System is to be used with the following Spineart Systems:
RomeoⓇ2 Romeo®2 MIS PerlaⓇ Perla® TL Perla® TL MIS All instruments are made of stainless steel per ASTM F899. All instruments are reusable instruments provided non sterile.

The SPINEART® Navigation Instrument System instruments are not compatible with implants from other manufacturers.

The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation® System (V2.1.0) and the Medtronic NavLock® Tracker System.

This document (K241644) is an FDA 510(k) premarket notification for the "SPINEART Navigation Instrument System." This is a Class II medical device (Orthopedic Stereotaxic Instrument) with product code OLO, which includes surgical instruments intended to assist surgeons in precisely locating anatomical structures during spinal surgery for the placement of Spineart screws.

Based on the provided text, the submission is a "Special 510k" for a line extension, indicating that the device in question is a modification of a previously cleared device. The "Discussion of Testing" section explicitly states: "Addition of navigated instruments to SPINEART® Navigation Instrument System (K183630, K210472) does not require testing. An Engineering Analysis has been submitted to support substantial equivalence."

This clearly indicates that no new clinical study or performance study demonstrating the device meets specific acceptance criteria was conducted or submitted for this particular 510(k). Instead, the manufacturer relied on an engineering analysis to demonstrate substantial equivalence to previously cleared predicate devices (K183630 and K210472).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, because this specific 510(k) submission states that no testing was required or performed for the new instrument additions.

The manufacturer's argument for clearance here is based on the new instruments having the same technological characteristics, indications for use, function, material composition, design, range of sizes, and presumed accuracy performance as the predicate devices that were previously cleared. The "engineering analysis" would have focused on demonstrating that these new instruments do not introduce new questions of safety or effectiveness.

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The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable instruments are specifically 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 for the anatomy.

The SPINEART® Navigation Instrument System reusable instruments are surgical instruments for use with the Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants.
The SPINEART® Navigation Instrument System includes the following: Screwdrivers, Taps, Drills, and Drill Guides.
The SPINEART® Navigation Instrument System are to be used with the following Spineart Systems:

• Romeo® 2
• Romeo® 2 MIS
• Perla® Cervico-thoracic Fixation System
  All instruments are made of stainless steel per ASTM F899. All instruments are reusable instruments provided not sterile.
  The SPINEART® Navigation Instrument System instruments are not compatible with implants from other manufacturers.
  The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation® System (V2.1.0) and the Medtronic NavLock® Tracker System.

The provided text is a 510(k) summary for a medical device (SPINEART Navigation Instrument System) seeking FDA clearance for a device modification (addition of new instruments). It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The key statement regarding testing is: "Addition of navigated instruments to SPINEART Navigation Instrument System (K183630) does not require testing." This implies that the modification is considered minor enough that the performance data from the predicate device (SPINEART Navigation Instrument System K183630) is deemed sufficient. The submission relies on the "substantial equivalence" argument, stating that the new instruments have the "same technological characteristics" and "accuracy performance" as the previously cleared predicate.

Therefore, I cannot provide the requested information from the given text because the document explicitly states that no new testing was required for this specific submission.

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The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable instruments are specifically 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 for the anatomy.

The SPINEART® Navigation Instrument System reusable instruments are surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants.

The SPINEART® Navigation Instrument System includes the following: Screwdrivers, Taps, Drills, and Drill Guides.

The SPINEART® Navigation Instrument System are to be used with the following Spineart Systems:

• ■Romeo® 2
  ▪Romeo® 2 MIS

▪Perla® Cervico-thoracic Fixation System

All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø4mm to Ø7.5mm for the Romeo® 2 systems and from Ø3mm to Ø4mm for the Perla system.

The SPINEART® Navigation Instruments are not compatible with implants from other manufacturers.

The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation Navigation System hardware and software.

The provided text describes the regulatory clearance for the "SPINEART® Navigation Instrument System" and includes information about its intended use, technological characteristics, and performance data. However, it does not describe a study to prove the device meets acceptance criteria in the format requested, particularly for an AI/algorithm-driven device with detailed metrics like sensitivity, specificity, or AUC based on expert reads.

The device described is a surgical navigation instrument system, which is a physical device used during surgery to assist in precisely locating anatomical structures. The performance data section refers to non-clinical testing such as connection, registration, simulated use, and accuracy testing, which are relevant to the physical instrument's functionality and compatibility, rather than the performance of an AI/algorithm in interpreting medical data.

Therefore, I cannot fulfill the request as framed, as the provided document details the clearance of a physical medical instrument, not an AI/algorithm, and the information required for AI acceptance criteria and study design (e.g., sample size for test/training sets, expert consensus for ground truth, MRMC studies) is not present.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Identical Technological Characteristics: Indications for use, materials, principle of operation, device technology, sizes, mechanical performance, packaging.
• Performance Data: Connection, registration, simulated use, and accuracy testing (per ASTM F2554-10) to ensure functionality and compatibility with the Medtronic StealthStation®.

To illustrate why I cannot answer the specific questions:

• 1. Table of acceptance criteria and reported performance: The document only mentions "accuracy testing per ASTM F2554-10" and states results "show that the performance...is sufficient for its intended use and is substantially equivalent." It doesn't provide specific numerical acceptance criteria (e.g., "accuracy > 95%") or reported performance values.
• 2. Sample sized for the test set and data provenance: Not applicable in the context of physical instrument testing. "Test set" here refers to the instruments themselves and their interaction, not a dataset for an AI.
• 3. Number of experts and qualifications: Not applicable. Ground truth for a physical instrument's accuracy is typically measured engineeringly, not through human expert interpretation of images.
• 4. Adjudication method: Not applicable.
• 5. MRMC comparative effectiveness study: Not applicable, as this is a physical instrument, not an AI assisting human readers.
• 6. Standalone (algorithm only) performance: Not applicable, as there is no standalone algorithm being evaluated in the document.
• 7. Type of ground truth: For a physical instrument, ground truth for accuracy testing would be engineering measurements against known standards, not expert consensus, pathology, or outcomes data in the sense of an diagnostic AI.
• 8. Sample size for the training set: Not applicable, as this is not an AI model.
• 9. How ground truth for training set was established: Not applicable.

In conclusion, the provided text describes the regulatory submission for a physical surgical instrument system, not an AI or algorithm. Therefore, the specific criteria and study design elements typically associated with AI/algorithm acceptance (e.g., sensitivity, specificity, expert consensus, MRMC studies) are not applicable and are not found in the document.

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