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510(k) Data Aggregation
(243 days)
ClarifEye is intended to be an intra-operative image-guidance tool used during surgical and interventional therapy. It provides assistance to the performing physician to align a device with a virtual path that is planned on a 3D volume of the anatomy. This alignment is provided in the following ways:
-The virtual path is superimposed with a live video image of the area of interest.
-The position of the ClarifEye Needle is superimposed with the video images of the area of interest and/or the 3D images of the anatomy.
ClarifEye is intended to be used on patients who have been elected for procedures where a straight, rigid device is placed in the spine, such as sacral, lumbar and thoracic pedicle screw placement. ClarifEye is indicated for procedures where a reference to bony anatomical structures can be established using skin markers as a reference.
The ClarifEye Needle is a manual, surgical instrument intended to be used during spine surgery to facilitate placement of guidewires. The needle may be used as part of a planning and intraoperative guidance system (i.e. Philips intra-operative image guidance tool) to enable open or percutaneous image guided therapy. The ClarifEye Needle is indicated for use during posterior pedicle screw procedures, such as in the sacral, lumbar and thoracic spinal regions, in which the use of image guided surgery may be appropriate.
The ClarifEye Needle is EtO sterilized, for single use only and have to be disposed after use, according to local waste disposal methods for potentially bio hazardous material.
ClarifEye is a software medical device that is intended to be an intra-operative image-guidance tool used during surgical and interventional therapy.
It will be offered as an optional accessory to the Philips interventional fluoroscopic X-ray system, from which it receives 2D X-ray and video images. ClarifEye implements an automatic reconstruction (algorithm) to create 3D CBCT images from a rotational scan acquired on the X-ray system.
Clarif Eye integrates the live video images of the surgical view and live 2D X-rav image which it overlays on the planned path shown in the reconstructed 3D CBCT image to provide navigational assistance, in real-time. ClarifEye provides assistance to the performing physician to align a device, such as a needle with a virtual path that is planned on a 3D image of the anatomy. The created 3D planning can be overlaid on live video images ("Augmented View") or live 2D fluoroscopy images, to monitor device deployment during the procedure.
ClarifEye is intended to be used in combination with the compatible ClarifEye Needle and ClarifEye Markers.
The ClarifEye Needle is for optional use only, when needle tip tracking is desired.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Reported Device Performance |
|---|---|
| Phantom Tests (Navigational Accuracy - Device Positional Displacement) | ≤ 2 mm |
| Phantom Tests (Navigational Accuracy - Trajectory Angular Displacement) | ≤ 2° |
| Pig Cadaver Study (Pedicle Screw Placement - Screw Tip Accuracy) | 2.0 ± 1.1 mm |
| Pig Cadaver Study (Pedicle Screw Placement - Screw Head Accuracy) | 1.6 ± 0.8 mm |
| Pig Cadaver Study (Pedicle Screw Placement - Angular Accuracy (Axial)) | 1.7 ± 1.7° |
| Pig Cadaver Study (Pedicle Screw Placement - Angular Accuracy (Sagittal)) | 1.6 ± 1.2° |
| Human Cadaver Study (Needle Placement - Entry Point/Needle Tip Accuracy, without device tracking) | 2.2 ± 1.3 mm |
| Human Cadaver Study (Needle Placement - Angular Accuracy (Axial and Sagittal), without device tracking) | 0.9 ± 0.8° |
| Clinical Study (Accuracy of pedicle screw placement using ClarifEye, according to Gertzbein classification, grades 0 and 1 considered accurate) | 94.1% (238/253 accurately placed screws) |
| Clinical Study (Distance between planned path and device position - Screw Tip) | 2.2 ± 1.56 mm |
| Clinical Study (Distance between planned path and device position - Screw Head) | 2.0 ± 1.31 mm |
| Clinical Study (Angular Accuracy - Axial) | 2.0 ± 2.0° |
| Clinical Study (Angular Accuracy - Sagittal) | 1.7 ± 1.5° |
| Software Verification Testing | All executed verification tests passed. |
| Usability Validation (ClarifEye) | Found to be safe and effective for intended use, users, and environment. |
| Usability Validation (ClarifEye Needle) | Found to be safe and effective for intended use, users, and environment. |
| In-house Simulated Use Design Validation | All executed validation protocols passed; ClarifEye conforms to intended use. |
| Service User Needs Validation | All executed validation protocols passed. |
| FDA Recognized Consensus Standards and Guidance Documents | Complies with listed standards and guidance documents. |
Study Details:
The document describes several non-clinical studies (phantom, pig cadaver, human cadaver) and one clinical study to demonstrate the device's performance and meet acceptance criteria.
1. Non-Clinical Performance Data (K9, K10):
- Test Set Sample Size:
- Phantom Tests: Not specifically enumerated, but refers to "phantom tests" (multiple tests indicated by plural).
- Pig Cadaver Study: Not explicitly stated, but measured on "thorocolumbar vertebrae."
- Human Cadaver Study: Not explicitly stated, but measured on "thoracolumbar."
- Data Provenance:
- Phantom Tests: In-house (implied by context of non-clinical testing for compliance with ASTM F2554-10).
- Pig Cadaver Study: In-house (implied by "a pig cadaver study demonstrated...").
- Human Cadaver Study: In-house (implied by "a human cadaver study demonstrated...").
- Number of Experts & Qualifications for Ground Truth: Not specified for these non-clinical studies. The ground truth would likely be established by precise measurements and engineering methods.
- Adjudication Method: Not specified.
- MRMC Comparative Effectiveness Study: No, this section describes standalone performance of the device in controlled environments.
- Standalone Performance: Yes, these are standalone (algorithm only or device-only) performance evaluations.
- Type of Ground Truth:
- Phantom Tests: Positional and angular accuracy measurements against known targets.
- Cadaver Studies: Accuracy of screw/needle placement relative to planned paths, measured with imaging or physical means.
- Training Set Sample Size: Not applicable. These are performance evaluations of the device, not descriptions of algorithm training.
- Ground Truth for Training Set: Not applicable.
2. Usability Validation (K9, K10):
- Test Set Sample Size:
- ClarifEye: "both orthopedic/neuro spine surgeons and monitoring nurse/technicians." Not a specific number, but mentions representative user groups.
- ClarifEye Needle: "representative users." Not a specific number.
- Data Provenance: Simulated use environment, implying in-house or controlled testing facility.
- Number of Experts & Qualifications for Ground Truth: Orthopedic/neuro spine surgeons and monitoring nurse/technicians as test users, evaluating usability and effectiveness. The "ground truth" here is the user's experience and assessment against predetermined usability criteria.
- Adjudication Method: Not specified, but likely based on user feedback and recorded observations against objective usability criteria.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: Yes, this is a standalone usability evaluation of the device.
- Type of Ground Truth: User feedback and expert assessment within a simulated clinical workflow.
- Training Set Sample Size: Not applicable.
- Ground Truth for Training Set: Not applicable.
3. In-house Simulated Use Design Validation (K9):
- Test Set Sample Size: "Clinical Scientists/Marketing specialists that fulfill the intended user profile." Not a specific number.
- Data Provenance: In-house simulated use environment.
- Number of Experts & Qualifications for Ground Truth: Clinical Scientists/Marketing specialists, acting as surrogate users to validate workflow and user needs.
- Adjudication Method: Not specified, but likely based on successful execution of predefined validation protocols.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: Yes.
- Type of Ground Truth: Successful execution of predefined device workflows in a phantom model.
- Training Set Sample Size: Not applicable.
- Ground Truth for Training Set: Not applicable.
4. Clinical Study (Summary of Clinical Performance Data) (K10, K11):
- Test Set Sample Size: Twenty (20) subjects.
- Data Provenance: Prospective, single-arm, single-center observational study with patients outside the United States.
- Number of Experts & Qualifications for Ground Truth: An unspecified number of experts (implied to be clinical personnel, likely radiologists or surgeons) evaluated the screw placement based on post-procedural CBCT. The grading criteria were the "recognized Gertzbein classification" (and its adaptation for cervical screws).
- Adjudication Method: "Grading of pedicle screw placement was done according to the recognized Gertzbein classification for the lumbar and thoracic region and slightly adapted for the cervical screw placements." The details of how agreement was reached among multiple graders, if any, are not provided.
- MRMC Comparative Effectiveness Study: No. This was an observational study evaluating the accuracy of the device in clinical use, not comparing human readers with and without AI assistance.
- Standalone Performance: While used by surgeons, the study primarily assesses the accuracy of the "navigation software" (ClarifEye) in guiding pedicle screw placement, making it a standalone assessment of the device's accuracy capabilities in a clinical context. The outcome measure (accuracy of screw placement) directly measures the system's performance.
- Type of Ground Truth: Post-procedural CBCT images, evaluated against the Gertzbein classification by clinical experts. This is considered expert consensus/imaging-based ground truth (radiographic outcome).
- Training Set Sample Size: Not applicable. This is a clinical validation study, not algorithm training.
- Ground Truth for Training Set: Not applicable.
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(105 days)
The Stryker Navigation System, when used with the SpineMap® 3D software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.
The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure such as the pelvis or spine can be identified.
The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
- Screw Placement in the spine, ilium, or pelvis
The OrthoLock Anchoring System is intended to be used as an accessory to the Stryker Orthopedic, Trauma, and Spine Navigation Systems. It is a manual instrument intended to be used in surgery to anchor a patient tracker.
The OrthoLock Anchoring System may be used as part of the Stryker Orthopedic, Trauma, and Spine Navigation Systems, which are indicated for any medical condition in which the use computer assisted surgery may be appropriate. The System can be used for intraoperative guidance where a regid anatomical structure can be identified.
The nGenius Spine Clamp is intended to be used as an accessory to the Stryker Spine Navigation System. The nGenius Spine Clamp is a manual instrument and intended to be used in spine surgery to attach a patient tracker to lumbar or thoracic spinous processes.
The nGenius Spine Clamp may be used as part of the Stryker Spine Navigation, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Drill Guide Set is intended to be used as an accessory to the Stryker Spine Navigation System. The Navigated Drill Guide Set consists of manual instruments that are intended to be used in spine surgery by providing guidance during drilling.
The Navigated Drill Guide Set may be used as part of the Stryker System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Xia 3 Awl Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Awl Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Xia 3 Awl Taps are intended for use with the Rotation Adaptor and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3, Xia 4.5, MANTIS Redux, and ES2 Spinal Fixation Systems using the Stryker Spine Navigation System.
The Navigated Xia 3 Serrato Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Serrato Taps may be used as part of the Stryker System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Xia 3 Serrato Taps are intended for exclusive use with the Rotational Navigation Adapter and associated trackers to facilitate the placement of the Stryker Spine Xia 3 System - Serrato using the Stryker Spine Navigation System.
The Stryker Navigation System with the SpineMap® 3D 3.1 software application is intended for use as an image guided surgery system to enable open or percutaneous computer assisted spinal surgery. It assists the surgeon in positioning of instrumentation during spinal surgeries. The system provides intraoperative guidance to the surgeon using wireless optical tracking technology and displaying the position of navigated surgical instruments relative to medical images such as CT images.
The Stryker Navigation System with SpineMap 3D 3.1 software is comprised of a platform, SpineMap 3D software, navigated instruments (e.g. patient/instrument trackers, pointers), and accessories. The system uses wireless optical tracking technology to display the intraoperative location of navigated surgical instruments relative to medical images, such as a CT image. The platform consists of a computer, camera, monitor and IO (input/output) Tablet. The SpineMap 3D 3.1 software is dedicated for spinal procedures as defined in the Indications for Use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, and pointers. An instrument battery also required when a battery powered navigated instrument or calibration device is used.
The SpineMap 3D 3.1 software application is a required part of the Stryker Navigation System. It is installed by a Stryker representative on the platform. The SpineMap 3D 3.1 software application is used on a platform and interfaces with Stryker navigated instruments and accessories. It is compatible with the Nav3i Platform family, which includes the NAV3i, NAV3, and NavSuite3.
SpineMap 3D 3.1 is an interactive software application that provides the functions necessary to conduct the indicated spinal procedures. The software application implements methods for planning, patient registration, and instrument navigation. It also guides the user through the preoperative and intraoperative workflow process.
The SpineMap 3D 3.1 Software Application provides new features including improved patient registration with non-Hounsfield calibrated imaging devices, updated screw database that includes new Stryker Spine spinal implant screws, an updated Coordinate Engine to improve the visibility of the nGenius Universal Tracker when used on the Rotational Navigation Adapter, implements an Automatic Intraoperative Mask (AIM) Registration fallback workflow to allow the surgeon to identify LEDs when the automatic LED detection for AIM registration fails due to poor image quality or when using non-Hounsfield calibrated systems, implements a new indirect vector calibration workflow to calibrate the new Navigated Drill Guides, and implements new cybersecurity measures.
The nGenius Spine Clamps are manual surgical instruments that are intended to be used in spine surgery to attach a patient tracker to the lumbar or thoracic spinous processes to enable surgical navigation. They are intended to be accessories to the Stryker Spine Navigation System. The nGenius Spine Clamps are available in two different sizes (i.e., short and long). They can be used in open or percutaneous procedures. The nGenius Spine Clamps are compatible with the nGenius Universal Tracker and the Spine Tracker.
The OrthoLock is a manual surgical instrument intended to be used to anchor a patient tracker. It is an anchoring system that is used to anchor a patient tracker during computer assisted orthopedic, trauma, and spinal surgeries. It can be used with the Stryker Orthopedic, Trauma, and Spine Navigation Systems.
The OrthoLock anchoring system is intended to be used with the Stryker Navigation Pins and OrthoLock Ex-Pins. It can be tightened or loosened with the screwdriver or Universal Joint Screwdriver.
The OrthoLock Indications for Use are being updated as part of this Traditional 510(k) to allow them to be used during spinal surgical procedures.
The Navigated Drill Guide Set consists of short and long Navigated Drill Guides, short and long Navigated Drill Guide Calibrators, short and long Navigated Drill Bits, a Navigated Drill Bit Stop, and a Navigated Drill Guide Set Container (class 1 exempt). The instruments of the Navigated Drill Guide Set are intended to be used with the Stryker Navigation System with the SpineMap 3D 3.1 software application.
The Navigated Drill Guides are manual instruments that are intended to provide guidance during drilling. They can be used in open or percutaneous procedures. The Navigated Drill Guides can be used as accessories to the Stryker Spine Navigation System. The Navigated Drill Guides can be navigated using the nGenius Universal Tracker as an instrument tracker.
The Navigated Drill Guides are available in two sizes (i.e., short and long). The Navigated Short Drill Guide is intended for use with the Navigated Short Drill Bits and in spine surgical procedures on the cervical, thoracic, and lumbar spine. The Long Navigated Drill Guide is intended for use with the Long Navigated Drill Bits and in spine surgical procedures on the cervical, thoracic and lumbar spine.
The Navigated Drill Guides can be calibrated using the Navigated Drill Guide Calibrators. Calibration of the Navigated Drill Guides has been incorporated into the SpineMap 3D 3.1 software application workflow. The Navigated Drill Guides can also be calibrated using the Vector Calibration Device (VCD) or the Point Calibration Device (PCD).
The Navigated Drill Guide Calibrators are manual instruments that are intended to be used to calibrate the Navigated Drill Guides when used with the SpineMap 3D 3.1 software in combination with the Point Calibration Device or Vector Calibration Device. The Navigated Drill Guide Calibrators come in short and long lengths and are intended to be used with the corresponding Navigated Drill Guide. They are not intended to be used for calibrating the Navigated Drill Guides when they are not being used with Navigation.
The Navigated Drill Guide Calibrator cannot be navigated.
The Navigated Drill Bits are manual instruments that are intended to drill holes of a specified diameter. They drill non-threaded holes. They are designed for use with the Navigated Drill Bit Stop. While the design is based on the Xia CT Drill Bits, they are not designed to be used exclusively with any Stryker Spine Implant System.
The short and long Navigated Drill bits come in a variety of sizes. They must be used with a handle and are designed to be used with Stryker Spine's Short Quick Release Handle (class 1, exempt) and Quick Release Handles (class 1, exempt) which have previously been released to market as Class 1, exempt devices.
The Navigated Drill Bits are single-use only. They will be provided non-sterile, but will need to be sterilized prior to use.
The Navigated Drill Bits cannot be navigated and can be used during non-navigated spine surgical procedures.
The Navigated Drill Bit Stop is a manual instrument that is intended for use with the short and long Navigated Drill Bits. The Navigated Drill Bit Stop allows the drilling depth of the Navigated Drill Bits to be controlled by pre-setting the drill depth. The Navigated Drill Bit Stop cannot be navigated.
The Navigated Xia 3 Awl Taps are manual surgical instruments intended to facilitate placement of Stryker Spine implants. They are a combination of an awl and a tap. The Awl Taps have an awl tip that includes a range of tap diameter sizes with thread designs that are only compatible with bone screws from Stryker Spine's Xia 3, Xia 4.5 (not including Xia Bone CT), ES2, MANTIS, and MANTIS Redux implant systems.
The Navigated Xia 3 Awl Taps are intended as accessories to the Stryker Spine Navigation System. The Awl Taps are designed for use with the Rotational Navigation Adaptor when used for navigated spinal procedures. The Navigated Xia 3 Awl Taps can be used with the Navigated Xia 3 Round Ratchet Handle, Navigated Xia 3 Ratchet T-Handle, and the Navigated Mantis Short Ratchet T-Handle, which have previously received market clearance via letter to file for both navigated and non-navigated spine surgical procedures.
The Serrato Navigated Taps are manual surgical instruments intended to facilitate placement of Stryker Spine's Xia 3 - Serrato screw implants. They have a dual-lead thread geometry and come in a variety of diameter sizes. The thread profile is designed to match that of the Serrato screw implants which is critical in achieving a rigid bone fixation. The Xia 3 Serrato Navigated Taps have a color-anodized titanium ring that corresponds to a specific diameter size for each tap.
The Navigated Xia 3 Serrato Taps are intended as accessories to the Stryker Spine Navigation System. They are designed for use with the Rotational Navigation Adaptor when being used for navigated spinal procedures. The Navigated Xia 3 Serrato Taps are designed to be used with a Modular Handle (Class 1, exempt) if used for non-navigated surgical procedures.
Here's a breakdown of the acceptance criteria and the study information for the Stryker Navigation System with SpineMap 3D software application and its accessories, based on the provided FDA 510(k) document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Target Performance) | Reported Device Performance |
|---|---|
| Mean accuracy of 2 mm for positional displacement and 2° for trajectory angle displacement within the working space. | Mean Positional Displacement: 1.07 mm |
| Mean Trajectory Angle Displacement: 0.61 degrees | |
| 95th percentile of the point displacement ≤ 3 mm and ≤ 3° for angular axis displacement within the registration zone. | The document provides 99th percentile, which is stricter: |
| 99th Percentile Positional Displacement: 2.70 mm | |
| 99th Percentile Trajectory Angle Displacement: 1.07 degrees | |
| Effectiveness of all risk controls determined in the device risk analysis. | Verified and all requirements met. No new issues of safety or effectiveness were raised. |
| Compliance with design specifications for all components. | Verified and all requirements met. No new issues of safety or effectiveness were raised. |
| Software verification and validation (IEC 62304 and FDA guidance on general principles of software validation). | All requirements met. No new issues of safety or effectiveness were raised. |
| Biocompatibility of all patient contact materials (ISO 10993-1:2009 and FDA draft guidance on the use of ISO 10993-1). | Verified. No new issues of safety or effectiveness were raised. |
| Electrical Safety (ANSI/AAMI ES60601-1:2005/ (R)2012, AND C1:2009 AND A2:2010(R)2012). | Conformance verified. |
| Electromagnetic Compatibility (IEC 60601-1-2: 2007 +AC: 2010, CISPR 11 Group 1, Class B, and compatibility with RFID). | Conformance verified and additional testing for RFID compatibility confirmed. |
| Functionality of devices after simulated shipping conditions. | Verified. No new issues of safety or effectiveness were raised. |
| Sterility assurance level (SAL) of 10-6 or greater after processing for reusable devices (steam sterilization). | All requirements met. No new issues of safety or effectiveness were raised. |
| User needs and intended use requirements (validated with intended users in cadaver labs or simulated use tests). | All requirements met and no new issues of safety or effectiveness were raised. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in numerical terms (e.g., number of cadavers, number of subjects). However, it mentions that the "subject devices were validated with intended users in cadaver labs or simulated use tests." This indicates that the testing was conducted in a laboratory or simulated environment, likely using anatomical models or cadavers.
The data provenance is retrospective/simulated/laboratory-based, as "No clinical testing was performed" (page 20). The country of origin of the data is not specified, but the applicant, Stryker Leibinger GmbH & Co. KG, is located in Freiburg, Germany.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It mentions validation "with intended users," implying surgeons or similar medical professionals, but lacks detail.
4. Adjudication Method
The document does not specify any adjudication method for the test set results (e.g., 2+1, 3+1, none).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document states that "No clinical testing was performed" (page 20), which would typically be a prerequisite for such a study involving human readers. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.
6. Standalone (Algorithm Only) Performance
The main accuracy claims (positional and angular displacement) are presented as standalone performance metrics for the navigation system itself, specifically "tracking in the workspace" and "within the registration zone," without direct human intervention as part of the measured accuracy. The system's performance is inherently about the algorithm's ability to accurately track instruments.
7. Type of Ground Truth Used
The ground truth for the accuracy measurements was established using physical measurements related to positional and angular displacement within a controlled environment (working space/registration zone). This would typically involve highly precise measurement devices to establish the true position/angle against which the system's output is compared. For user needs and intended use, the ground truth would be the satisfaction of requirements/successful completion of tasks in simulated environments or cadaver labs.
8. Sample Size for the Training Set
The document does not provide a sample size for a training set. This is a navigation system and associated instruments, not a machine learning model that typically undergoes a distinct training phase with a labeled dataset for image recognition or similar tasks. The "software verification and validation testing" (page 19) would involve testing against predefined specifications and requirements, rather than training data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As there isn't a traditional "training set" in the context of an AI/ML model for this device, the concept of establishing ground truth for a training set does not apply directly. The software development process would involve various stages of testing and validation against defined functional and performance requirements, but not typically a labeled training dataset like in machine learning.
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(168 days)
The VIPER PRIME navigated inserter is a navigated instrument for insertion of VIPER PRIME screws in open or percutaneous procedures. The VIPER PRIME navigated inserter is indicated for use in spinal surgical procedures, in which:
- use of the VIPER System is indicated,
- use of stereotactic surgery may be appropriate, and
- where reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes universal tracking arrays supplied by the navigation manufacturer.
These procedures include but are not limited to spinal fusion. The VIPER PRIME navigated inserter requires manual calibration.
The VIPER PRIME™ navigated inserter is a reusable manual screwdriver for insertion of the VIPER PRIME screws of the VIPER System in open and percutaneous procedures. The VIPER PRIME navigated inserter also features attachment sites for universal tracking arrays supplied by the navigation manufacturer to enable use with the respective spine navigation system. The VIPER PRIME navigated inserter must be manually calibrated with the third-party navigation system.
This document is not about an AI/ML powered device, but rather a navigated inserter for spinal surgery. Therefore, the questions related to AI/ML specific concepts like training sets, ground truth establishment for training, MRMC studies, and effect size of human reader improvement with AI assistance are not applicable.
However, I can extract information related to the device's acceptance criteria and the study proving it meets these criteria based on the provided text.
Based on the provided text for the VIPER PRIME navigated inserter, the primary method for demonstrating acceptable performance is through non-clinical sawbones testing. The document does not provide a formal table of acceptance criteria with specific numerical thresholds, nor does it detail a comparative study with a "reported device performance" against explicit criteria beyond general confirmation of function.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table with quantitative acceptance criteria and corresponding reported performance metrics. Instead, the performance evaluation is described qualitatively as "confirm[ing] device performance for the intended use."
The study confirmed the following functions:
- Acceptance Criteria (Implicit): The device should successfully allow for:
- Assembly with third-party universal tracking arrays.
- Manual calibration with the third-party navigation system.
- Navigated insertion of VIPER PRIME screws in a sawbones model.
- Final screw position in the software should be verifiable by a second imaging modality.
- Reported Device Performance (Qualitative): The non-clinical sawbones testing "confirmed device performance for the intended use" by demonstrating successful assembly, manual calibration, and navigated insertion of screws, with verification of screw position using a second imaging modality.
2. Sample size used for the test set and the data provenance
- Sample Size: The document only states "non-clinical sawbones testing" and "insertion of VIPER PRIME screws in a sawbones model." It does not specify the number of sawbones models used, the number of screws inserted, or the number of trials performed.
- Data Provenance:
- Country of Origin: Not specified, but given the submission is to the FDA in the USA, the testing would likely adhere to US regulatory standards.
- Retrospective or Prospective: This was likely a prospective study designed to demonstrate performance for regulatory submission.
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 human experts to establish "ground truth" for the test set in the way one might for an AI/ML diagnostic device (e.g., radiologist reads).
- The ground truth in this context appears to be the physical confirmation of the screw's final position via a second imaging modality. It is implied that the test was performed by qualified individuals, but their specific roles or qualifications (e.g., orthopedic surgeons, engineers) are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the context of this device. There is no mention of consensus reading or multi-reader adjudication for establishing ground truth, as the "ground truth" is the physical location of the screw confirmed by imaging.
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 device is a surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with/without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device requiring human interaction and navigation system input. There is no standalone algorithm to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was established by physical verification of the final screw position using a second imaging modality after insertion in a sawbones model. This is a form of objective measurement/outcomes data within the controlled test environment.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
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(126 days)
The Stryker Navigation System, with the CranialMap software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer-assisted surgery.
The system is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The system should be operated only by trained personnel such as surgeons and clinic staff.
The system assists in the positioning of instruments for cranial procedures, including:
- Cranial bionsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Removal of foreign objects
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement
- Placement of electrodes for recording, stimulation and lesion generation
- Endoscopic Sinus Surgery (ESS)
- Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction procedures
- Orbital cavity reconstruction procedures
The user should consult Chapter "System Accuracy" of the safety information to assess if the accuracy of the system is suitable for their needs.
The Stryker CranialMap Planning software application, when used on a compliant computer, is intended as a planning software to enable open or percutaneous computer-assisted surgery.
The software application is indicated for any medical condition in which the use of computer-assisted planning may be appropriate.
The software application should be operated only by trained personnel such as surgeons and clinic staff.
This can include the following cranial procedures:
- Cranial biopsies
- Puncture of abscesses
- Craniotomies
- Craniectomies
- Resection of tumors and other lesions
- Removal of foreign objects
- Skull base procedures
- Transnasal neurosurgical procedures
- Transphenoidal pituitary surgery
- Shunt placement, including pediatric shunt placement
- Placement of electrodes for recording, stimulation and lesion generation
- Endoscopic Sinus Surgery (ESS)
- Intranasal procedures
- Ear implant procedures
- Craniofacial procedures
- Skull reconstruction procedures
- Orbital cavity reconstruction procedures
The Stryker CranialMask Tracker is intended to be used as an accessory to the Stryker Navigation System, with the CranialMap software application. It is placed onto the patient's face on top of the skin.
- In combination with preoperative and intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery.
- The Stryker CranialMask Tracker can be used as a noninvasive patient tracker to support open or percutaneous cranial procedures.
The devices subject to this Traditional 510(k) are within the Stryker Navigation System with CranialMap software application. Subject devices include the CranialMap software application, CranialMap Planning software application, and CranialMask Tracker.
The Stryker Navigation System with CranialMap software is a computer-assisted, stereotaxic, image-guided, planning and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precise positioning of instrumentation during Cranial surgeries. The system provides intraoperative guidance to the surgeon by displaying the position of navigated surgical instruments relative to the medical images.
The Stryker Navigation System with CranialMap software is comprised of a platform, CranialMap software application, navigated instruments, and accessories. The predicate CranialMap Neuro navigation system includes the same parts. The platform consists of a computer, camera, and IO-Tablet (input/output). The CranialMap software is dedicated for the Cranial procedures as defined in the indications for use and identical to the predicate. Required navigated instruments include: a patient tracker; a pointer, suction tube, or seeker; shunt placement tool, and a frameless guide. A battery is the only required accessory of the system, and is used in the navigated instruments only.
The CranialMap software application is a required part of the Stryker Navigation System. It is installed by a Stryker representative on the platform. The CranialMap software is used with a Stryker platform and interfaces with Stryker navigated instruments and accessories. The software displays the intraoperative location of navigated surgical instruments relative to imported medical images via wireless optical tracking technology. The subject CranialMap software does not provide direct or indirect patient-contact.
CranialMap is an interactive software application, which provides the functions needed to conduct the indicated cranial procedures. The software application implements the methods for planning, patient registration, and instrument navigation. Furthermore, the software guides the user through preoperative and intraoperative workflow steps. The significant changes made to the subject CranialMap software when compared with the predicate include adding planes and mirroring functionalities and adding compatibility with the CranialMask Tracker.
The CranialMap Planning software is an optional accessory to the Stryker Navigation System with CranialMap software application. The CranialMap Planning software application is a standalone software device intended for use on compliant computers as defined in the Safety Information document. It is a new device introduced with this Traditional 510(k).
The subject CranialMap Planning software application is an identical subset of functionality copied from the subject CranialMap software. The planning version serves to preoperatively plan a navigated surgery, outside of the operating room, on a compliant computer. It does not provide registration functionality or surgical navigation guidance, and it does not interface with instruments or accessories. The preplanned patient record can only be exported to the Stryker Navigation System with CranialMap software. The subject CranialMap Planning software does not provide direct or indirect patient-contact.
The CranialMask Tracker is a non-invasive patient tracker. It is indicated as an optional accessory to the Stryker Navigation System with CranialMap software application. The subject CranialMask Tracker directly contacts the patient skin, which is identical to the predicate Patient Registration Mask.
The CranialMask Tracker includes a flexible printed circuit board (PCB) mask and closed housing unit. It consists of tracking diodes, green status light emitting diode (LED), communication receiver, battery, an on/off switch, and adhesive backing. The electronic components in the communication unit of the CranialMask Tracker are identical to the components used in the reference device, SpineMask Tracker, cleared by K141941.
This Traditional 510(k) requests clearance for changes made to the CranialMap software used with the Stryker Navigation System. It also seeks clearance for the new CranialMap Planning software and CranialMask Tracker devices as optional accessories to the system.
The provided document is a 510(k) summary for the Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning Software Application, and Stryker CranialMask Tracker. It details the device's intended use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices.
Here's the breakdown of acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the system's accuracy as a key performance metric.
| Acceptance Criterion | Reported Device Performance (Mean) | Reported Device Performance (99th Percentile) |
|---|---|---|
| Positional displacement accuracy ≤ 2mm | 1.11 mm | 2.85 mm |
| Trajectory angle displacement accuracy ≤ 2° | 1.02° | 2.56° |
Note: While the document states the system has a "mean navigation accuracy of ±2mm and angular axis displacement of ±2°," the reported performance data shows that the 99th percentile for both positional and trajectory angle displacement exceeds the 2mm/2° threshold. This discrepancy might imply that the acceptance criterion was intended for the mean accuracy, or it could be an area that would typically lead to further questions from the FDA if not adequately addressed. However, for the purpose of this response, we are reporting the information as presented.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the accuracy test set (e.g., number of measurements or cases). It only provides the mean, standard deviation, and 99th percentile of positional and trajectory angle displacement.
Regarding data provenance: The document does not specify the country of origin for the data. The study was conducted as a "Nonclinical verification and validation testing," implying it was an internal test, not a retrospective or prospective human clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The ground truth for the system accuracy was established through physical measurements and calculations, not human expert consensus, as this is a navigation system.
4. Adjudication Method for the Test Set
Not applicable. This was a technical accuracy study, not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was deemed not required to support the safety and effectiveness of the subject devices for the intended use." The studies conducted were non-clinical verification and validation tests focused on technical performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the performance data provided (positional and trajectory angle displacement) refers to the system accuracy, which represents the algorithm's (and integrated hardware's) standalone performance in guiding instruments relative to images. While the device is intended for human use, these accuracy metrics reflect the fundamental technical capability of the system itself, independent of a specific human user's performance.
7. Type of Ground Truth Used
The ground truth used was physical measurements and calculations related to the spatial accuracy of the navigation system. This is a technical ground truth rather than a clinical ground truth like pathology, outcomes data, or expert consensus. For example, measurements involving known reference points or phantom models would be used to objectively determine displacement and angular errors.
8. Sample Size for the Training Set
The document does not specify a training set size. This is likely because the device is a computer-assisted surgical navigation system and planning software, not an AI/ML model that typically undergoes explicit "training" on a dataset in the same way a diagnostic image analysis algorithm would. The development likely involved software engineering, calibration, and verification rather than machine learning model training on a large dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, the concept of a "training set" and associated "ground truth establishment" derived from data points, as would be relevant for an AI/ML diagnostic algorithm, does not directly apply to this type of medical device which is a navigation system. Its development involves software and hardware engineering, calibration, and rigorous verification and validation against defined performance specifications.
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(260 days)
The Stryker Xia 4.5 Polyaxial Screwdriver is a Stryker Navigated Manual Surgical Instrument.
Stryker Navigated Manual Surgical Instruments are intended to be used as accessories to the Stryker Spine Navigation System, when used with the SpineMap 3D Navigation software. They are manual surgical instruments intended to be used in spine surgery to facilitate placement of Stryker Spine implants.
Stryker Navigated Spine Instruments may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
Stryker Navigated Spine Instruments are intended for exclusive use with the Rotational Adaptor and associated Trackers to facilitate the placement of the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, and ES2® Spinal Fixation Systems using the STRYKER SpineMap® 3D Navigation System.
The surgeon must also refer to the Stryker Spine XIA® 3, XIA® 4.5, MANTIS®, MANTIS® Redux, or ES2® package insert/instructions for use, product label, and surgical technique guide to obtain detailed product information and recommended surgical procedure.
The Navigated XIA® 4.5 Polyaxial Screwdriver, a Stryker Navigated Spine Instrument, is a manual tool for bone screw placement, insertion, and removal. The tip of the navigated screwdriver inserts into the screw head to turn it. The screwdriver also has an interface to allow a connection to the Rotational Navigation Adapter, a Stryker Spine Navigation System accessory, and to a handle.
The provided text is a 510(k) summary for the Navigated XIA® 4.5 Polyaxial Screwdriver. It describes the device, its intended use, and the performance data submitted to support its substantial equivalence to predicate devices. However, the document does not contain the specific level of detail required for a comprehensive answer to your request, especially regarding acceptance criteria and the specifics of a study proving device performance against those criteria as you would find for an AI/ML powered device.
This document describes a medical instrument, not an AI/ML powered device. Therefore, many of your requested points (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, ground truth used) are not applicable to this type of submission.
Based on the information provided for this instrument, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Navigation Accuracy: ± 2 mm and ± 2° | Tracking accuracy: 80th percentile |
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(152 days)
The NavSuite®3 Kit is a computer workstation that, when used with CranialMap Neuro Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing a cranial surgical procedure using stereotactic techniques.
The NavSuite®3 Kit is a computer workstation that, when used with SpineMap 3D Navigation software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The clinical setting and target population for the NavSuite®3 Kit is that of a patient undergoing an orthopaedic spinal surgical procedure using stereotactic techniques.
The Stryker Navigation System is a planning and intraoperative guidance system which assists in various surgical procedures. It allows for the localization of surgical instruments and visualization of their position relative to patient specific images and/or patient specific anatomical landmark information assisting the surgeon in performing the intervention at a high level of precision. For localization, active optical tracking based on infrared light is used. Using three linear sensors, the Navigation Camera detects signals from infrared light emitting diodes which are attached to the instruments to be localized. The Computer Monitor displays the navigation information to the user.
The NavSuite®3 Kit is a minor modification of the previously cleared Stryker NAV3i Platform. The NavSuite®3 Kit consists of the same main components that were cleared as the NAV3i Platform in K130874. The NAV3i Platform (K130874) consisted of a mobile cart, a computer system, a monitor, an IO Tablet and a navigation camera. The subject of this Special 510(k) is that the system is now modified to provide these same components, without the mobile cart and without the monitor. The computer, IO Tablet and navigation camera are now provided as separate components that can be configured and affixed in the operation room suite based on user preferences. The monitor that was provided with the NAV3i Platform is not provided with the NavSuite®3 Kit. The NavSuite®3 Kit is compatible with any monitor that meets the specifications provided in the Instructions for Use.
Like the predicate Nav3i platform, the NavSuite3 Kit platform is compatible with the following previously cleared Stryker Software Application Modules:
The provided text describes a 510(k) premarket notification for the Stryker NavSuite®3 Kit, which is a computer workstation used with navigation software for cranial and orthopedic spinal surgical procedures. The notification asserts substantial equivalence to a predicate device (Stryker NAV3i Platform K130874), focusing on minor modifications to the physical components rather than the core navigation algorithms.
Based on the provided information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device under review, the NavSuite®3 Kit, is a modified version of a previously cleared device (NAV3i Platform, K130874). The modifications primarily involve the physical components (e.g., removing the mobile cart and monitor, changing camera mounting and cabling, removing the UPS and LiveCAM). The core navigation software and its functionalities (CranialMap Neuro Navigation and SpineMap 3D Navigation) are stated to be compatible and previously cleared.
Therefore, the "acceptance criteria" here are not about specific performance metrics for a novel algorithm's accuracy, sensitivity, or specificity, but rather about demonstrating that the physical modifications do not introduce new risks or alter the fundamental scientific technology or intended use, and therefore the device remains as safe and effective as the predicate.
The acceptance criteria implicitly derive from ensuring that the modified components function as intended and do not compromise the safety or performance of the integrated system.
| Acceptance Criteria (Implicit) | Reported Device Performance and Study Findings |
|---|---|
| No new risks introduced by modifications. | A functional risk analysis was conducted according to ISO 14971, 2nd Edition (2007). The results determined that the device modifications do not introduce any new risks compared to the predicate device. All existing risks were identified and mitigated to a level "as low as reasonably possible." The effectiveness of these mitigation measures was verified by the detailed testing. |
| Power Supply (Removal of UPS): System stability and behavior during power events must not be compromised. | System Test: Shutdown and crash behavior was tested with the Navigation Software Application Modules integration tests to ensure stability without the UPS. The justification for removing the UPS is that the subject device is a fixed installation and not intended to be mobile, hence the UPS is not needed. |
| Operating System (Minor configuration changes): OS must remain effective and compatible with navigation software. | Component Test: Showed that configurations were implemented and effective. |
| System Test: Showed that fixed resolution was used on several monitors, verifying compatibility and functionality. | |
| Monitor (No longer provided, user-supplied compatible monitor): Display quality and compatibility maintained. | System Test: Various compatible monitors (meeting 1920x1080 pixels native resolution, DVI signal) were tested with Native Resolution and with the Navigation Software Application Modules integration tests, confirming proper display and functionality. The instructions for use specify the required monitor specifications, which are the same as the predicate device's monitor. |
| Navigation Camera Mounting (Ceiling-mounted arm): Robustness, reliability, and range of motion must be maintained. | System Test: Automated mechanical stress tests were performed to demonstrate reliability through simulated intraoperative use over the device's lifetime. This included rotational and vertical adjustment capabilities and ensuring the camera joint could move without restrictions within its range of motion. Statistical methods were used. A lifetime of 1000 movement cycles was estimated for a camera joint. Tests were conducted on five test samples, each over 5687 test cycles, exceeding the estimated lifetime. |
| Navigation Camera Cables (Optical fibers, extended length): Data transfer and power supply must be reliable. | Component Test: Verified voltage and data transfer for the new optical fiber cables. |
| System Tests: Automated mechanical stress tests demonstrated the reliability of the Navigation camera cables (power and data) through simulated intraoperative use over their specified lifetime using statistical methods. A lifetime of 1000 movement cycles was estimated for a camera cable set. Tests were conducted on five test samples of camera cable sets, each over 5687 test cycles, exceeding the estimated lifetime. | |
| LiveCAM (Not provided): Absence must not affect navigation software functionality. | System Test: Verified that the applicable Software Application Module (CranialMap Neuro Navigation, SpineMap 3D Navigation) was not affected by the absence of LiveCAM. This was tested with Navigation Software Application Module integration tests. The LiveCAM was an optional component in the predicate and not required for optimal system performance. |
| Cart with Castors (Not provided): The absence of mobility must align with the intended fixed installation. | No testing was required for the absence of the cart. The justification is that the NavSuite®3 Kit components are intended for fixed installation in the OR and not for mobility, differentiating it from the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the mechanical stress tests on the camera mounting and cables, five test samples of camera joints and five test samples of camera cable sets were used. Each of these samples underwent 5687 test cycles. For other system and component tests (UPS, OS, Monitor, LiveCAM), the documentation refers to "integration tests" or "various compatible monitors," implying testing across the system's operational parameters rather than a specific number of unique cases or patients.
- Data Provenance: Not explicitly stated for all tests. For the hardware component and system tests, it is reasonable to assume these were conducted in a laboratory or engineering testing environment by the manufacturer (Stryker Leibinger GmbH & Co. KG in Germany). The studies are primarily engineering validation tests for hardware modifications, not clinical efficacy studies involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts for ground truth) is not applicable to the performance data presented. The studies described are engineering and functional tests to confirm the hardware modifications do not negatively impact the system's performance or safety from an engineering perspective. They do not involve clinical diagnosis or interpretation of medical images where expert consensus would establish ground truth for algorithm performance.
4. Adjudication Method for the Test Set
This is not applicable as the studies are engineering validation tests for hardware components, not clinical studies requiring adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done or is mentioned. The submission is for hardware modifications to an existing navigation system, not for a novel diagnostic AI algorithm that would typically undergo such a study. The "AI" component (the navigation software) was previously cleared.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "algorithm only" performance (i.e., the navigation software's accuracy in tracking instruments and displaying images) was implicitly addressed during the prior 510(k) clearances for the CranialMap Neuro Navigation (K131214) and SpineMap 3D Navigation (K141941) software modules and the predicate NAV3i Platform (K130874). This current submission is not focused on re-evaluating the standalone performance of the navigation algorithms themselves, but rather on demonstrating that the new hardware configuration does not degrade that previously established performance.
7. The Type of Ground Truth Used
For the engineering tests conducted:
- For the robustness and lifetime tests of the camera arm and cables, the "ground truth" was the expected physical durability and functionality of the components under simulated stress, often defined by engineering specifications and industry standards.
- For the system integration tests (UPS, OS, Monitor, LiveCAM), the "ground truth" was the expected functional behavior and compatibility with the existing navigation software, verified against predefined system requirements and successful operation of the software.
8. The Sample Size for the Training Set
Not applicable. This submission is for hardware modifications and engineering validation. There is no mention of a "training set" in the context of machine learning or AI algorithm development for this specific 510(k). The navigation software itself would have had its own development and validation processes, but that is not the subject of this document.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated in point 8.
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