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Op.n™ Navigation is indicated for the positioning of compatible surgical instruments to be used by surgeons during general spinal surgery.

The guidance is based on an intra-operative surgical plan developed with Op.n™ Navigation Software and based on intraoperative 3D images provided by a compatible imaging system.

The device is indicated for the placement of pedicle screws, in instrument navigation mode, in vertebrae with a posterior approach in the thoracolumbar region.

Op.n™ Navigation Software is indicated for the navigation of compatible surgical instruments to be used by surgeons.

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The provided text does not contain information about the acceptance criteria, device performance, study details, expert qualifications, or ground truth establishment for a specific device. The document is an FDA 510(k) clearance letter for a stereotaxic instrument called "Op.n Perla TL Nav" and "Op.n Navigation." This letter primarily addresses regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance study results.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The requested information (table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, and training set details) is not present in this regulatory document.

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Spine Navigation and Robotic-Assistance Device is indicated for the spatial positioning and orientation of compatible surgical instruments, used by surgeons in Freehand Navigation Mode and/ or in Robotic-Assisted Guidance Mode. Spine Navigation and Robotic-Assistance Device is used for spine surgeries, in open or percutaneous procedures, with patient in prone or in lateral position. Freehand Navigation Mode and Robotic-Assisted Guidance Mode are based on a three-dimensional image volume (3D CT or CBCT image), on which the surgeon may perform the Intraoperative Surgical Planning.

Spine Navigation and Robotic-Assistance Device is indicated to provide quidance for the placement of spinal bone screws relative to bony structures of the spine, in Freehand Navigation Mode and/or in Robotic-Assisted Guidance Mode, and for intervertebral disc access and preparation, including discectomy and bony resection, in Freehand Navigation Mode.

The Spine Navigation and Robotic-Assistance Device is a medical device that provides stereotaxic quidance for spinal surgery. The Subject Device assists the surgeon to quide and position surgical instruments through two modes: Freehand Navigation and Robotic-Assisted Guidance.

The Subject Device includes:

• A Navigation Station

• A Robotic-Assisted Station

• A Camera Station

• Embedded Software

• Integrated Guiding System components, composed of single use items, such as navigation Arrays, and reusable items, such as Patient Array fixation solutions.

The navigation of the instruments is based on the standard and established techniques of navigation systems utilizing optical position determination technology. As currently marketed optical tracking navigation systems, the operating principle of the navigation feature is based on the use of an infra-red camera allowing to determine a 3D position of markers, either passive reflective markers or active LED markers. This allows real-time tracking of the navigated instruments.

The Subject Device is compatible with:

• Specific Instruments of DePuy Synthes, a Johnson & Johnson company. These Instruments are aimed to be quided with Robotic-Assisted Guidance Mode and/or with Freehand Navigation Mode.

• Several third-partv 3D Imaging Systems.

Based on the provided FDA 510(k) summary, the device is a Spine Navigation and Robotic-Assistance Device. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics for AI algorithms.

The document does not describe an AI/ML-driven diagnostic or assistive device that requires a study to prove its performance against acceptance criteria typically associated with such technologies (e.g., sensitivity, specificity, AUC). Instead, it describes a robotic surgical assistance system.

Therefore, the requested information regarding acceptance criteria, specific study designs (like MRMC), expert ground truth establishment, and training/test set details for proving AI/ML model performance is not present in this document.

The document primarily focuses on:

• Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device.
• Performance and Safety Testing: This section primarily lists the types of tests and the standards to which they were conducted (e.g., electrical safety, usability, mechanical testing, software verification, sterilization, biocompatibility, packaging validation). It mentions that "All test requirements were met, no new issues of safety or effectiveness were raised, and substantial equivalence was demonstrated." However, it does not provide specific quantitative acceptance criteria or results for the device's accuracy or performance in a clinical scenario (like an AI algorithm's diagnostic performance).

Therefore, I cannot populate the table or answer the specific questions about AI/ML performance study details based on the provided text. The document does not describe a study that would generate such data.

If the request was based on a misunderstanding and assumed this was an AI/ML diagnostic device, please clarify.

However, I can extract information relevant to the types of tests performed and general statements about the device's performance from a regulatory perspective:

Types of "Performance Data" and "Acceptance" (as detailed in the document):

The document defines "Performance Data" not as clinical accuracy metrics in the AI sense, but rather as data demonstrating compliance with various engineering, safety, and quality standards. The "acceptance criteria" are implied by the successful completion of these tests in accordance with the listed international standards (e.g., IEC 60601-1, ASTM F2554-22).

Regarding the specific questions about an AI/ML performance study:

1. A table of acceptance criteria and the reported device performance: As explained above, the "acceptance criteria" are compliance with various engineering and safety standards, and the "reported performance" is that these tests were conducted and "all test requirements were met." No specific quantifiable performance metrics for an AI algorithm (e.g., sensitivity, specificity, accuracy) are provided or indicated as part of the evaluation.
2. Sample sizes used for the test set and the data provenance: Not applicable. The document describes compliance with engineering and safety standards, not a data-driven AI performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment is relevant for AI/ML performance studies, which this document does not describe.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 type of study is for evaluating the impact of AI on human reader performance, which is not described for this robotic guidance device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a regulatory submission for a robotic surgical assistance system, focusing on its functional, safety, and quality characteristics, and its substantial equivalence to predicate devices, rather than a data-driven performance evaluation of a diagnostic AI/ML algorithm.

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The SURGIVISIO Device is indicated to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized

The SURGIVISIO Device through its freehand navigation feature is indicated as an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.

It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.

It is indicated to precisely position the Navigated Targeting Needle SPX I during general spinal procedures with a posterior approach.

The SURCIVISIO Device through its robotic guidance feature is indicated for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery.

Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.

It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.

The SPX1 Instrument and Spine CoBot instruments are designed to be used with the SURGIVISIO Device.

The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The subject device offers two stereotaxic quidance features: freehand navigation and robotic guidance.

The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space.

The robotic quidance feature utilizes the same principle of optical position determination technology. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.

The provided text describes a 510(k) premarket notification for the SURGIVISIO Device, focusing on a design modification to the Spine CoBot instruments used with its robotic guidance feature. The core of the submission addresses the device's substantial equivalence to previously cleared versions and predicates.

Here's a breakdown of the acceptance criteria and study information, as much as can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The SURGIVISIO Device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis, or articulation structures are visualized
The SURGIVISIO Device through its freehand navigation feature is an intraoperative guidance system to enable open or percutaneous computer-assisted surgery.
It is indicated for conditions of the spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical bony structure can be identified relative to the intraoperatively generated 3D image of the anatomy provided by the SURGIVISIO Device.
It is indicated to precisely position the Navigated Targeting Needle SPX1 during general spinal procedures with a posterior approach.
The SURGIVISIO Device through its robotic guidance feature is intended for the positioning of instrument holders or tool guides to be used by surgeons to guide the Spine CoBot instruments during general spinal surgery.
Guidance is based on an intra-operative plan developed with three-dimensional imaging software based on intra-operative 3D images provided by the SURGIVISIO Device.
It is indicated for positioning of surgical instruments in vertebrae with a posterior approach in the thoracolumbar region.
The SPX1InstrumentsSPX1 Instrument and Spine CoBot instruments are intended to be used with the SURGIVISIO Device.

The SURGIVISIO Device is a medical device that provides 2D/3D medical imaging and stereotaxic guidance. The subject device offers two stereotaxic guidance features: freehand navigation and robotic guidance.
The freehand navigation feature is based on the standard and established technique of navigation systems utilizing optical position determination technology. Like currently marketed optical tracking navigation systems, the operating principle of the freehand navigation feature is based upon the use of a stereoscopic camera emitting infrared light which can determine a 3D position of reflective marker spheres. This allows for real-time tracking of the marker spheres. The system components include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and navigation software (3D Spine Universal Workflow software application) and instruments equipped with marker spheres to enable an exact localization in space.
The robotic guidance feature utilizes the same principle of optical position determination technology. The system componentss include a stereoscopic camera (SURGIVISIO Camera Pole), a computer platform with monitors (SURGIVISIO Station) and a navigation software (3D Spine Robotic Workflow software application), a robotic arm (CoBot), and instruments equipped with marker spheres to enable an exact localization in space.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the SURGIVISIO Device:

Note: The provided text is an FDA 510(k) summary, which often focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailing the design and execution of individual performance studies, especially clinical ones. As such, some of the requested information (like specific sample sizes for test/training sets, detailed expert qualifications, adjudication methods, and MRMC study details) is not explicitly present or fully elaborated in this type of document. I will extract what is directly stated and highlight where information is absent.

Acceptance Criteria and Device Performance

The acceptance criteria for the SURGIVISIO Device are implicitly defined by its comparison to the predicate devices, specifically regarding "System accuracy" and "Device accuracy." The device claims to meet these criteria.

Table 1: Acceptance Criteria and Reported Device Performance

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The SURGIVISIO device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures during which the spine, pelvis or articulation structures are visualized.

The SURGIVISIO Device is a mobile x-ray system which provides 2D imaging and allows the generation of intraoperative 3D information of high contrast objects and anatomical structures. The system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation. These units are moved manually and are interconnected by a single cable that provides power and transfer of data and controls. The mobile C-Arm comprises a high voltage generator, foot switches for radiation release, laser target devices, electronics cabinet, collision avoidance system, and a C-shaped structure mounting the X-ray tube assembly and the flat X-ray detector on distal end of the 'C'. The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling.

The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures.

The SPX1 Instruments are a set of dedicated accessories intended to be used in conjunction with the SURGIVISIO Device in order to enable stereotaxic guidance. More specifically, and when used with the 3D imaging, they support the registration of patient anatomy with the 3D reconstructed image. the Submissions K202547/ K220627 consider SPX1 instruments set with the standard 3D Imaging Set SPX1 accessory.

This submission aims at clearing a new imaging set accessory possibility: the 3D Offset Imaging Set SPX1 accessory, containing same patient reference and wedges as 3D imaging Set SPX1 accessory already 510(k) cleared, and an offset phantom (new instrument). The principle of use of the Offset Phantom SPX1 is identical to the already 510(k) cleared Phantom SPX1 (belonging to 3D Imaging set). However, the Offset Phantom SPX1 additional value is to offset the imaging area that will be navigated during surgery by 10 cm from the standard configuration. The 3D Imaging Set SPX1 accessory will be considered as the predicate for the 3D Offset Imaging Set SPX1 accessory.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is primarily a 510(k) summary for a medical device (SURGIVISIO Device) and focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and the comprehensive study results that prove the device meets those criteria.

Here's why I cannot extract the requested information:

• Lack of Specific Acceptance Criteria: The text avers to "standards, acceptance criteria and results" in the "Performance Data" section but explicitly states that those details can be found in a "Design Control Activities Summary," which is not included in the provided document. Therefore, the specific numerical or qualitative acceptance criteria for the device's performance are missing.
• Focus on Substantial Equivalence, Not De Novo Performance Study: The document's core purpose is to show that a new accessory (3D Offset Imaging Set SPX1) for an existing device (SURGIVISIO Device) is substantially equivalent to a previously cleared version. It states, "No clinical tests were conducted to demonstrate substantial equivalence." The non-clinical tests mentioned are primarily design verification, accuracy verification, software verification, and packaging validation, all aimed at confirming the new accessory functions similarly and safely to the predicate, not necessarily to establish de novo performance against a set of independent acceptance criteria for the entire system from scratch.
• Missing Study Details: While some non-clinical tests are listed (design verification, accuracy verification, software verification, packaging validation), the text does not provide the methodology, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or direct performance metrics in the way you've requested for a detailed study. It merely states that these tests "have been performed as intended" or "have been conducted as intended."

In summary, the provided FDA document is a regulatory submission for substantial equivalence, not a detailed scientific study report containing the specifics of acceptance criteria and the comprehensive data proving the device meets them. The crucial information you've asked for (e.g., actual performance values against acceptance criteria, detailed methodologies, sample sizes for test sets, ground truth establishment details, MRMC study results) is explicitly stated to be elsewhere ("Design Control Activities Summary") or is simply not part of this type of regulatory summary.

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The SURGIVISIO medical device is intended to be used during surgical procedures in which the physician would benefit from the visualization of 2D medical imaging and/or intraoperatively generated 3D medical imaging of anatomical structures or objects with high x-ray attenuation such as bony anatomy or metallic objects. Such procedures include procedures during which the spine, pelvis or articulation structures are visualized.

The SURGIVISIO Device is a mobile x-ray system which provides 2D imaging and allows the generation of intraoperative 3D information of high contrast objects and anatomical structures. The system consists of two mobile interconnected units: a mobile C-arm and a mobile viewing Workstation. These units are moved manually and are interconnected by a single cable that provides power and transfer of data and controls. The mobile C-Arm comprises a high voltage generator, foot switches for radiation release, laser target devices, electronics cabinet, collision avoidance system, and a C-shaped structure mounting the X-ray tube assembly and the flat X-ray detector on distal end of the 'C'. The mobile viewing workstation comprises a computer, an image detector process unit, the main power supply, radiation indicator, dual viewing monitors and a user interface for patient management and image handling. The system integrates a Computer Aided Surgery (CAS) feature that supports instruments positioning during surgical procedures.

The provided text describes the SURGIVISIO Device, which is a mobile interventional fluoroscopic x-ray system, and states that it relies on the substantial equivalence to a previously cleared predicate device (SURGIVISIO system K202547). The primary change in the current submission is a software version update from 1.5.1 to 1.8.1.

While the document mentions "Software Verification testing verifying the software requirements perform as intended," it does not explicitly state specific acceptance criteria or provide a detailed study report that proves the device meets particular acceptance criteria beyond the software verification. The core of the argument for acceptance is substantial equivalence to the predicate device, implying that since the software update maintains the same intended use and performance, it meets the inherent criteria of the predicate.

Given this, I will infer the implied acceptance criteria from the claim of substantial equivalence and the listed comparison of technological characteristics.

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

Since specific numerical acceptance criteria for performance are not explicitly stated for this 510(k), and the device essentially claims "same as predicate" for performance, the acceptance criteria are implicitly that the software update does not degrade the performance characteristics of the predicate device.

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

The document states, "No clinical tests were conducted to demonstrate substantial equivalence." Therefore, there is no test set of patient data mentioned for evaluating performance in the context of this software update. The verification focused on software requirements and compliance with IEC 62304.

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)

Since no clinical tests using patient data were conducted, no experts were used to establish ground truth for a test set. The validation was against software specifications.

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

Not applicable as no clinical test set requiring adjudication was used.

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, as no clinical tests or human reading evaluations are mentioned for this software update. The device itself is an imaging system with an integrated Computer Aided Surgery (CAS) feature, but the submission doesn't detail performance studies of this CAS feature, instead focusing on the equivalence of the overall system after a software update.

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

The "Software Verification testing verifying the software requirements perform as intended" and "Results of these validations and verifications confirm that the SURGIVISIO software complies with its specifications" indicate that standalone software testing was performed against specified requirements. However, the specifics of what those requirements are (e.g., accuracy, precision of specific measurements or detections if any) are not detailed. It's a general statement of software verification and validation.

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

For the software verification and validation, the ground truth would be the software specifications and requirements themselves. The software was tested to ensure it met its predefined functional and non-functional requirements.

8. The sample size for the training set

Not applicable/Not provided. This submission is for a software update to an existing imaging system, claiming substantial equivalence based on verification and validation against specifications, not a new AI algorithm that would typically involve a distinct training set. The device description does not imply a machine learning component requiring a training set in the conventional sense for this submission.

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

Not applicable as no training set is mentioned in the context of this submission.

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