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The Evolution Spine navigation instruments are indicated for use during the preparation and placement of Whistler Modular Pedicle Screw System polyaxial screws or Stowe Pedicle Screw System polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The navigation instruments are intended to be used with the Medtronic® StealthStation® S8 Navigation System (Software Version 1.3.0)., 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Evolution Spine Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® S8 Navigation System. The system is designed to assist surgeons in the precise localization of anatomical structures, preparation and placement of pedicle screw implants during spinal procedures.

The Evolution Spine navigation Instruments include awls, probes, taps and drivers. The navigated instruments are to be used with Whistler Modular Pedicle Screw System (K182478) and Stowe Pedicle Screw System (K181554).

All instruments are made of stainless steel per ASTM F899. The Evolution Spine navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation® S8 Navigation System hardware and software.

The provided FDA 510(k) clearance letter for the Evolution Spine Navigation Instruments focuses on establishing substantial equivalence to predicate devices, primarily through non-clinical performance testing. It indicates that clinical testing was not performed. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess human reader improvement with AI assistance, nor was a standalone algorithm performance study performed as part of this submission for establishing substantial equivalence.

The submission relies on a non-clinical test to demonstrate performance, specifically focusing on positional accuracy of the instruments when used with a specific navigation system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The exact numerical values for positional accuracy criteria from ASTM F2554-18 and Rampimura et al. are not explicitly stated in the provided text. The document only confirms that the device "meets and exceeds" these established benchmarks.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document does not specify a numerical "sample size" in terms of cases or patients. Instead, it refers to "the worst-case instruments constructs" being tested. This implies a limited number of physical instrument configurations were chosen for rigorous testing, representing the most challenging scenarios for accuracy.
   • Data Provenance: The study described is a non-clinical, laboratory-based performance test. This means the "data" is derived from controlled measurements in a lab setting, not from human subjects or clinical data. Therefore, concepts like "country of origin" or "retrospective/prospective" do not apply in the typical sense; it's an engineering test.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

   • This is a non-clinical performance test of a physical device's accuracy. "Ground truth" in this context refers to the engineering specifications and established test methods (ASTM F2554-18 and Rampimura et al. reference values) for positional accuracy. No human experts (e.g., radiologists) were used to establish the ground truth for this performance test. The "truth" is an objective, measurable accuracy.

3. Adjudication Method for the Test Set:

   • Not applicable as this was a non-clinical instrument performance test, not a subjective assessment requiring human adjudication. The results are quantitative measurements against established engineering standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. The document explicitly states: "Clinical testing was not necessary to demonstrate the substantial equivalence of the subject devices." This implies that an MRMC study involving human readers and AI assistance was not performed or submitted for this specific clearance.

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

   • No. The device is a set of "navigation instruments" used with a navigation system (Medtronic® StealthStation® S8). It's a physical instrument, not an AI algorithm. Its performance is evaluated in conjunction with the navigation system, but the focus is on the instrument's mechanical and tracking accuracy.

6. The Type of Ground Truth Used:

   • Engineering Specifications / Established Test Standards: The ground truth for this non-clinical study was defined by the performance criteria established in:
     • ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems"
     • Rampimura et al: "Accurate pedicle screw insertion under the control of a computer-assisted guiding system: Laboratory test and clinical study"
   • These are recognized industry standards and published research that define acceptable accuracy limits for such devices.

7. The Sample Size for the Training Set:

   • Not applicable. This is a physical medical device (surgical instruments), not an AI/machine learning algorithm that requires a "training set" of data.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set" for this type of device.

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Atlas Spine Project X Expandable Posterior Lumbar Interbody Spacers are intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Atlas Spine Project X Expandable Posterior Lumbar Interbody Spacers are to be filled with autogenous bone graft material. This device is intended to be used with supplemental fixation, such as the Apelo™ Pedicle Screw System.

Not Found

The provided FDA 510(k) clearance letter for the "Atlas Spine Project X Expandable Posterior Lumbar Interbody System" does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria.

The letter is a regulatory document confirming that the device has been reviewed and found substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, classification, and applicable regulations (such as Quality System regulations, UDI rules, and adverse event reporting).

Therefore, I cannot provide the requested information from the given input because the document does not contain details about:

1. Acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, or adjudication methods for any test set.
3. MRMC comparative effectiveness study results.
4. Standalone performance studies.
5. Type of ground truth used.
6. Training set sample size or how its ground truth was established.

The letter mentions the "Indications for Use" for the device, detailing the patient population and conditions for which it is intended, but this is distinct from performance criteria and study results.

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VEA Align:
This cloud-based software is intended for orthopedic applications in both pediatric and adult populations.

2D X-ray images acquired in EOS imaging's imaging systems is the foundation and resource to display the interactive landmarks overlayed on the frontal and lateral images. These landmarks are available for users to assess patient-specific global alignment.

For additional assessment, alignment parameters compared to published normative values may be available.

This product serves as a tool to aid in the analysis of spinal deformities and degenerative diseases, and lower limb alignment disorders and deformities through precise angle and length measurements. It is suitable for use with adult and pediatric patients aged 7 years and older.

Clinical judgment and experience are required to properly use the software.

spineEOS:
spineEOS is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. The product provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.

VEA Align:
VEA Align is a software indicated for assisting healthcare professionals with global alignment assessment through clinical parameters computation.

The product uses biplanar 2D X-ray images, exclusively generated by EOS imaging's EOS (K152788) and EOSedge (K202394) systems and generates an initial placement of the patient anatomic landmarks on the images using a machine learning-based algorithm. The user may adjust the landmarks to align with the patient's anatomy. Landmark locations require user validation. The clinical parameters communicated to the user are inferred from the landmarks and are recalculated as the user adjusts the landmarks. 3D datasets may be exported for use in spineEOS for surgical planning.

The product is hosted on a cloud infrastructure and relies on EOS Insight for support capabilities, such as user access control and data access. 2D X-ray image transmissions from healthcare institutions to the cloud are managed by EOS Insight. EOS Insight is classified as non-device Clinical Decision Support (CDS) software.

spineEOS:
spineEOS is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. spineEOS provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for VEA Align.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All the studies performed indicate acceptable performances of the algorithm for its intended population," implying that both acceptance criteria (Median error ≤ 3mm and 3rd Quartile ≤ 5mm) were met. Actual reported numerical values for the performance metrics are not explicitly provided in this document, only that the criteria were met.

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

• Test Set Sample Size: 361 patients.
• Data Provenance: Images were collected from EOS (K152788) and EOSedge (K202394) systems at a variety of sites from 2007-2023. The subgroups analysis includes "Data site location - Different US states," indicating that at least some of the data originates from the US. The document does not explicitly state whether the data was retrospective or prospective, but given the collection period (2007-2023), it is likely retrospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The document states that the ground truth was established by "EOS 3DServices reconstruction (model) from sterEOS (K172346)." This implies that the ground truth is derived from a previously cleared and validated 3D reconstruction system.
• The number and qualifications of experts involved in creating these "EOS 3DServices reconstruction" models are not specified in this document.

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method for the test set involving multiple human reviewers. The ground truth for the test set is established by the "EOS 3DServices reconstruction (model) from sterEOS."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• A formal MRMC comparative effectiveness study comparing human readers with and without AI assistance is not explicitly mentioned in this document. The performance evaluation is focused on the standalone AI algorithm compared to ground truth.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone (algorithm only) performance study was done.
  • Description: "To assess the standalone performance of the AI algorithm of the VEA Align, the test was performed with:
    • A dedicated test data set containing different data from the training data set...
    • For each patient of this data set, a ground truth EOS 3DServices reconstruction (model) from sterEOS (K172346) that was available for comparison with VEA Align reconstruction generated by the AI algorithm."
  • This confirms that the study focused on the AI algorithm's performance without direct human intervention in the loop for the performance metrics measured.

7. Type of Ground Truth Used

• The ground truth used for the test set was based on "EOS 3DServices reconstruction (model) from sterEOS (K172346)." This refers to 3D anatomical models and landmark placements generated by a previously cleared medical imaging and reconstruction system (sterEOS). This can be categorized as a type of expert-system-derived ground truth, as sterEOS itself relies on validated methodologies and presumably expert input/validation in its operation.

8. Sample Size for the Training Set

• Training Set Sample Size: 10,376 X-ray images, with a total of 5,188 corresponding 3D reconstructions.

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

• The document states, "The AI algorithm was trained using 10,376 X-ray images and a total of 5,188 corresponding 3D reconstructions." It also notes that the images were collected from EOS and EOSedge systems. While it doesn't explicitly detail the method for establishing the ground truth for each training image, the context implies that these 3D reconstructions served as the ground truth. Similar to the test set, it's highly probable these "corresponding 3D reconstructions" were also derived from the established and validated EOS 3DServices/sterEOS pipeline.

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The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

The UNiD™ Spine Analyzer is a web-based application developed to perform preoperative and postoperative patient image measurements and simulate preoperative planning steps for spine surgery. It aims to make measurements on a patient image, simulate a surgical strategy, draw patient-specific rods or choose from a pre-selection of standard implants. The UNiD™ Spine Analyzer allows the user to:

1. Measure radiological images using generic tools and "specialty" tools
2. Plan and simulate aspects of surgical procedures
3. Estimate the compensatory effects of the simulated surgical procedure on the patient's spine

The planning of surgical procedures is done by Medtronic as part of the service of pre-operative planning. The surgical plan may then be used to assist in designing patient-specific implants. Surgeons will have to validate the surgical plan before Medtronic manufactures any implant.

The UNiD™ Spine Analyzer interface is accessible in either standalone mode or connected mode.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for the UNiD™ Spine Analyzer:

Overview of Device and Study Focus:

The UNiD™ Spine Analyzer is a web-based application designed to assist healthcare professionals in viewing, measuring, and planning orthopedic spine surgeries. This 510(k) submission primarily focuses on the update to the AI-enabled degenerative predictive model (Degenerative Predictive model). The study aims to demonstrate that this new version is non-inferior to the previous version (predicate device).

1. Table of Acceptance Criteria and Reported Device Performance

The core of the performance evaluation for this AI-enabled software function is focused on demonstrating non-inferiority of the updated "Degenerative Predictive model" to the predicate version.

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

• Test Set Sample Size: 274 patient surgery cases.
• Data Provenance:
  • Country of Origin: US only.
  • Retrospective/Prospective: The document states "Preoperative and post operative images from 1050 patient surgery cases were collected." This implies existing data, making it a retrospective collection.

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

• Number of Experts: Not explicitly stated as "experts." Instead, the document mentions "highly trained Medtronic measurement technicians."
• Qualifications of Experts: "Highly trained Medtronic measurement technicians, operating within a quality-controlled environment." The specific professional background (e.g., radiologist, orthopedist) or years of experience are not provided. They were responsible for vetting image viability and performing measurements.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1 for consensus). It states that "After the images were collected, they were then provided to and measured by highly trained Medtronic measurement technicians, operating within a quality-controlled environment." This suggests a single evaluation per case by these technicians, which then forms the basis for the ground truth. There's no mention of multiple technicians independently measuring and then adjudicating discrepancies.

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

• No, a formal MRMC comparative effectiveness study involving human readers assisting with AI vs. without AI assistance was not mentioned or described in this document. The study specifically focused on the AI model's performance (algorithm only) compared to its previous version, not the impact on human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone (algorithm only) performance study was done. The entire "AI-enabled device software functions (AI-DSF)" section describes the evaluation of the new Degenerative Predictive model's output against the ground truth, comparing its performance (MAEs) directly to the predicate AI model. This evaluates the algorithm itself.

7. The Type of Ground Truth Used

• Derived from Measured Images by Technicians: "Ground truth was derived from the measured images." These measurements were performed by the "highly trained Medtronic measurement technicians." This is a form of expert consensus/review, albeit by technicians rather than clinicians, and described as measurements on images. It is not pathology or outcomes data.

8. The Sample Size for the Training Set

• Training Set Sample Size: 776 patient surgery cases.

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

• The document implies the ground truth for the training set was established in the same manner as the test set: through measurements performed by "highly trained Medtronic measurement technicians." The statement "Ground truth was derived from the measured images" applies to the overall data collection process before splitting into training and testing sets.

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The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as:

• Pedicle Screw Placement (Thoracic and Lumbosacral spine)
• Sacro-Iliac Screw Placement

NextAR Spine is also intended to provide planning tools for measuring and selecting the fixation rod for the thoracic and lumbosacral spine.

The NextAR Spine platform is intended to be used in combination with NextAR™ Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning, surgical planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

NextAR Spine sterile drill and pins

The sterile drills, pins and iliac pins are part of the NextAR Spine platform which is intended as an aid for precisely locating anatomical structures in either open / mini open or percutaneous spine procedures. The NextAR Spine sterile drills pins and iliac pins are intended for use with the NextAR Spine platform according to its approved indications for use. All the drills are motorized. Pins may be used either motorized or manually. Iliac pins are manual.

The NextAR™ Spine platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:

• Navigation software which displays information to the surgeon
• Augmented Reality glasses
• Optical tracking system
• PC based hardware platform
• Fiducial Block
• Surgical instruments for spine surgery procedures

The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block, and a group of pins and drills are provided sterile.

NextAR™ Spine aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor. The platform uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D scan in order to register the spine to navigation elements. The registration can be performed with one of the following approaches: 1) Direct 3D: based on the use of an intra-operative 3D scan, or 2) 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D scan.

Where the Direct 3D approach is utilized, NextAR™ Spine allows for planning of screw positioning on the patient's intraoperative DICOM images just before system setup. The application allows for navigating the spine with a screw planning superimposed on the acquired scan.

The NextAR™ Spine platform also includes the rod planning tool, which gives the surgeon information about the length and the rod type to best fit the spine anatomy and to perform the desired curvature correction.

The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.

The FDA 510(k) clearance letter for NextAR™ Spine (K250477) provides limited details on a comprehensive study proving acceptance criteria. However, based on the provided text, we can infer some aspects of the performance data and the methods used to demonstrate the device's substantial equivalence.

Here's an attempt to structure the information based on your request, highlighting what is explicitly stated and what can be inferred or is missing from this document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list acceptance criteria in a quantitative table format nor does it provide numerical performance metrics. Instead, it relies on comparative evaluations and qualitative assessments to demonstrate substantial equivalence to predicate devices. The "Performance Data" section primarily focuses on non-clinical studies.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of cases or subjects. "Cadaver workshops" imply surgical procedures performed on anatomical models (cadavers), but the number is not provided.
• Data Provenance: The document does not specify the country of origin for the cadaver studies or the software testing. The studies were non-clinical. The studies were likely prospective in nature, as they were "performed in support of a substantial equivalence determination."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. However, the mention of "Cadaver workshops" suggests that surgeons or other qualified medical professionals would have been involved to assess the adequacy of the instruments and system for surgical use.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. Given that these were "cadaver workshops" to demonstrate adequacy, it's likely qualitative assessments by the participating surgeons, rather than a formal, multi-reader quantitative adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The document explicitly states: "No clinical studies were conducted." This indicates that no MRMC study comparing human readers with and without AI assistance was performed. The device, NextAR™ Spine, is a surgical navigation platform, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies for reader performance improvement (e.g., radiologists interpreting images).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Not explicitly detailed with performance metrics. The "Software testing" and "Comparative evaluations" could be considered forms of standalone assessment of the algorithmic components and instrument performance, but no specific quantitative standalone performance (e.g., accuracy, precision) of the navigation algorithms themselves is provided in this summary. The device's primary function is as a navigation aid where a human surgeon is always in the loop.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • For instrument performance, the ground truth would likely be established through engineering specifications and comparative measurements against predicate instruments.
  • For the cadaver workshops, the ground truth was likely surgical outcomes/adequacy as determined by the participating surgeons in a realistic (cadaveric) surgical environment. This is a form of expert assessment of functional performance. It is not pathology, or clinical outcomes data, as no clinical studies were performed.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The document describes a traditional medical device (navigation system) with software components, not an AI/Machine Learning device that undergoes a train-test split methodology with large datasets for model training. The software functionality and instrument performance are verified through testing and comparative evaluation, not
  ML model training on patient data.

9. How Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as this is not an AI/ML system requiring a dedicated training set with established ground truth in the typical sense for image interpretation or diagnosis. The "ground truth" for the device's functionality would stem from its design specifications, engineering principles, and the known anatomical relationships it aims to navigate.

In summary, the FDA 510(k) summary for NextAR™ Spine focuses on demonstrating substantial equivalence through non-clinical performance data, primarily through comparative evaluations with predicate devices and cadaveric workshops, rather than extensive clinical studies or AI model performance metrics.

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The HydroCision SpineSite System is intended to be used as a single-use endoscopic video camera in a variety of endoscopic diagnostic and surgical procedures for spine applications. The device is also intended to be used as an accessory for microscopic surgery.

The HydroCision SpineSite System is comprised of (i) sterile disposable endoscope and (ii) reusable Video Processing Unit (VPU). The HydroCision SpineSite System provides illumination, image processing and digital documentation for endoscopic procedures. The HydroCision SpineSite System is not suitable for use in the MR environment.

The SpineSite Endoscope provides distal LED illumination via LEDs surrounding a high-resolution video sensor. The SpineSite Endoscope contains a working channel for the passage of micro instrumentation to the surgical site. The SpineSite Endoscope is provided sterile, via ethylene oxide sterilization.

The SpineSite Endoscope is designed to be connected to the SpineSite VPU via a proprietary edge card connector which provides power to the endoscope and supports video processing capability. The SpineSite VPU is powered via connection to an external wall outlet via a 12V power adapter.

The provided text is a 510(k) clearance letter and a 510(k) summary for the HydroCision SpineSite System. It details the device's indications for use, its components, and various non-clinical performance tests conducted to meet regulatory requirements. However, this document does not contain any information about a study proving the device meets specific acceptance criteria related to its performance in a clinical or AI-assisted context.

The "Performance Testing" section lists only non-clinical tests:

• Biocompatibility per ISO 10993-1
• Design verification/validation to mechanical and optical specifications
• Electrical, Mechanical and Thermal (EMT) safety testing per IEC 60601-1, IEC 60601-2-18
• Human Factors/ Usability per IEC 60601-1-6
• Electromagnetic compatibility testing per IEC 60601-1-2
• Software validation

The "Substantial Equivalence Summary" focuses on comparing the HydroCision SpineSite System to its predicate device (Arthrex Nanoscope System) on aspects like intended use, technological design, sterilization, electrical safety, materials, and technical features (optical resolution, field of view, depth of field, etc.). It states: "The safety and effectiveness of the HydroCision SpineSite System are adequately supported by the non-clinical performance data, substantial equivalence information, and comparison of design characteristics provided within this premarket notification."

Therefore, based solely on the provided text, I cannot answer the specific questions related to acceptance criteria and a study proving the device meets those criteria, particularly those concerning:

1. A table of acceptance criteria and reported device performance (in a clinical/AI context).
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study (AI vs. human).
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The device described is an endoscopic video camera system, not an AI-powered diagnostic device, which is what the questions regarding "AI assistance," "effect size," "standalone algorithm performance," and "training set" typically refer to. The document suggests a traditional medical device clearance based on substantial equivalence and non-clinical performance testing for a physical device, not an AI/ML algorithm.

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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 device is intended for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment and indicated for cranial, head and neck and extracranial lesions.

RT Elements are computed-based software applications for radiation therapy treatment planning and dose optimization for linac-based conformal radiation treatments, i.e. stereotactic radiosurgery (SRS), fractionated stereotactic radiotherapy (SRT) or stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT) for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.

The device consists of the following software modules: Multiple Brain Mets SRS 4.5, Cranial SRS 4.5, Spine SRS 4.5, Cranial SRS w/ Cones 4.5, RT Contouring 4.5, RT QA 4.5, Dose Review 4.5, Brain Mets Retreatment Review 4.5, and Physics Administration 7.5.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for RT Elements 4.5, specifically focusing on the AI Tumor Segmentation feature:

Acceptance Criteria and Reported Device Performance

Note: For "Gliomas and glio-/neuronal tumors," the reported lower bound 95% CI for Recall (0.74) is slightly below the stated acceptance criteria of 0.8. Additional clarification from the submission would be needed to understand how this was reconciled for clearance. However, for all other categories and overall, the reported performance meets or exceeds the acceptance criteria.

Study Details for AI Tumor Segmentation

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

• Sample Size: 412 patients (595 scans, 1878 annotations)
• Data Provenance: De-identified 3D CE-T1 MR images from multiple clinical sites in the US and Europe. Data was acquired from adult patients with one or multiple contrast-enhancing tumors. ¼ of the test pool corresponded to data from three independent sites in the USA.

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

• Number of Experts: Not explicitly stated as a number, but referred to as an "external/independent annotator team."
• Qualifications of Experts: US radiologists and non-US radiologists. No further details on years of experience or specialization are provided in this document.

4. Adjudication method for the test set:

• The document mentions "a well-defined data curation process" followed by the annotator team, but it does not explicitly describe a specific adjudication method (e.g., 2+1, 3+1) for resolving disagreements among annotators.

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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not reported for the AI tumor segmentation. The study focused on standalone algorithm performance against ground truth.

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

• Yes, a standalone performance study was done. The validation was conducted quantitatively by comparing the algorithm's automatically-created segmentations with the manual ground-truth segmentations.

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

• Expert Consensus Segmentations: The ground truth was established through "manual ground-truth segmentations, the so-called annotations," performed by the external/independent annotator team of radiologists.

8. The sample size for the training set:

• The sample size for the training set is not explicitly stated in this document. The document mentions that "The algorithm was trained on MRI image data with contrast-enhancing tumors from multiple clinical sites, including a wide variety of scanner models and patient characteristics."

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

• How the ground truth for the training set was established is not explicitly stated in this document. It can be inferred that it followed a similar process to the test set, involving expert annotations, but the details are not provided.

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Stealth™ Spine Clamps

When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:

• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The Stealth™ spine clamps are indicated for skeletally mature patients.

ModuLeX™ Shank Mounts

When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:

• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery.
• The ModuLeX™ shank mounts are indicated for skeletally mature patients.

The Stealth™ Spine Clamps are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.

The ModuLeX™ Shank Mounts are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.

This document, an FDA 510(k) Clearance Letter, does not contain the specific details about acceptance criteria and study data that would be found in a full submission. 510(k) summary documents typically provide a high-level overview.

Based on the provided text, here's what can be extracted and what information is not available:

Information from the document:

• Device Type: Stealth™ Spine Clamps and ModuLeX™ Shank Mounts, which are orthopedic stereotaxic instruments used with computer-assisted surgery systems (specifically the Medtronic Stealth™ System).
• Purpose: To provide rigid fixation between the patient and a patient reference frame for the duration of spine surgery, and to serve as navigated instruments for surgical guidance.
• Predicate Devices:
  • Stealth™ Spine Clamps: StealthStation™ Spinous Process Clamps (K211442)
  • ModuLeX™ Shank Mounts: Rod Clamps (K131425)
• Testing Summary (XI. Discussion of the Performance Testing):
  • Mechanical Robustness and Navigation Accuracy
  • Functional Verification
  • Useful Life Testing
  • Packaging Verification
  • Design Validation
  • Summative Usability
  • Biocompatibility (non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic)

Information NOT available in the provided document (and why):

This 510(k) summary describes physical medical devices (clamps and mounts) used in conjunction with a computer-assisted surgery system, but it does not describe an AI/software device whose performance is measured in terms of accuracy, sensitivity, or specificity for diagnostic or guidance purposes. Therefore, many of the requested points related to AI performance, ground truth, and reader studies are not applicable or not detailed in this type of submission.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance (with specific numerical metrics for "Navigation Accuracy"): While "Navigation Accuracy" is listed as a test conducted, the actual acceptance criteria (e.g., "accuracy must be within X mm") and the quantitative results are not provided in this summary. This would typically be in a detailed test report within the full 510(k) submission.
2. Sample sizes used for the test set and data provenance: No information on the number of units tested, or if any patient data was used for "Navigation Accuracy" (it's likely bench testing).
3. Number of experts used to establish ground truth and their qualifications: Not applicable as this is a mechanical device submission, not an AI diagnostic submission. Ground truth for mechanical accuracy would be established by precise measurement tools, not human experts in this context.
4. Adjudication method for the test set: Not applicable for mechanical/functional testing.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned or applicable. This type of study is for evaluating human performance (e.g., radiologists interpreting images) with and without AI assistance.
6. Stand-alone (algorithm only) performance: Not applicable; this is not an algorithm for diagnosis or image analysis.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): For "Navigation Accuracy," the ground truth would be based on highly precise measurement systems (e.g., optical tracking validation) in a lab setting, not clinical outcomes or expert consensus.
8. Sample size for the training set: Not applicable; there is no "training set" as this is not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is known concerning acceptance criteria and proof of adherence:

• Acceptance Criteria/Proof (General): The document states that "Testing conducted to demonstrate equivalency of the subject device to the predicate is summarized as follows: Mechanical Robustness and Navigation Accuracy, Functional Verification, Useful Life Testing, Packaging Verification, Design Validation, Summative Usability, Biocompatibility."
• Implied Acceptance: The FDA's clearance (K242464) indicates that Medtronic successfully demonstrated that the new devices are "substantially equivalent" to predicate devices based on the submitted testing. This means the performance met the FDA's expectations for safety and effectiveness, likely by demonstrating equivalent or better performance against the predicates in the specified tests (e.g., meeting established benchmarks for sterility, material strength, and precision when interfaced with the navigation system). However, the specific numerical criteria for "Navigation Accuracy" are not disclosed in this summary letter.

Conclusion based on the provided text:

This 510(k) summary is for a Class II mechanical stereotaxic instrument and, as such, focuses on demonstrating mechanical, functional, and biocompatibility equivalency to predicate devices. It does not contain the detailed performance metrics, ground truth establishment methods, or human reader study results that would be pertinent to an AI/software medical device submission.

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