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The StealthStation® System, with StealthStation® Cranial Software, is intended to aid in locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy.

This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):

• Cranial Biopsies
• Deep Brain Stimulation (DBS) Lead Placement
• Depth Electrode Placement
• Tumor Resections
• Craniotomies/Craniectomies
• Skull Base Procedures
• Transsphenoidal Procedures
• Thalamotomies/Pallidotomies
• Pituitary Tumor Removal
• CSF Leak Repair
• Pediatric Ventricular Catheter Placement
• General Ventricular Catheter Placement

The user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

The StealthStation® System, with Station® Cranial v3.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation® Cranial v3.0 software works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. StealthStation® Cranial v3.0 software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size (e.g., number of phantoms, number of trials) used for the performance testing. It mentions using "anatomically representative phantoms" and "a subset of system components and features that represent the worst-case combinations."

The data provenance is from laboratory and simulated use settings, implying prospective testing conducted by Medtronic Navigation, Inc. The country of origin is not explicitly stated, but the company is located in Louisville, Colorado, USA.

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

The document does not mention the use of experts to establish ground truth for the performance validation tests. The "ground truth" for positional and trajectory accuracy in this context would likely be established by precise measurements within the engineered phantoms themselves, not by human experts.

4. Adjudication Method for the Test Set

Not applicable. The performance validation used objective measurements against engineered phantoms, not human assessment requiring adjudication.

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, an MRMC comparative effectiveness study involving human readers or AI assistance in that context was not performed. This device is an image-guided surgery system, not an AI diagnostic tool that assists human readers in interpreting images. Its function is to provide real-time navigation during surgical procedures based on pre-operative imaging.

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

Yes, the performance validation described is a standalone evaluation of the algorithm and system's accuracy. The tests measured the system's ability to accurately determine 3D positional and trajectory angle, independent of direct human-in-the-loop performance during the measurement process. It's evaluating the mechanical and software accuracy of the navigation system itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used was based on engineered phantoms with known anatomical representations and precise target locations. The "ground truth" for accuracy measurements would be the known, precisely defined coordinates and trajectories within these phantoms.

8. The Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. This implies that the device's accuracy is being verified against its design specifications, likely through a deterministic system or one with pre-calibrated components, rather than a machine learning model that requires a distinct training phase.

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

Not applicable, as a distinct "training set" and associated ground truth establishment for a machine learning model are not described in the context of this device's validation. The device's performance is driven by its inherent design and calibration, not by learning from a training dataset.

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The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

The Navigated Disc Preparation Instruments are intended to be used to facilitate a discectomy during spinal surgery. The Navigated Trials are intended to be used to facilitate implant size selection of Medtronic intervertebral body fusion devices during spinal surgery.

The Navigated Probe is intended to be used during pedicle and disc preparation during spinal fusion procedures.

Navigated instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC® POWEREASE® System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASE™ System.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The subject CD HORIZON® Spinal System offers cannulated, multi-axial bone screws that have an opened head (MAS) or closed head (CMAS). The subject screws offer additional angulation for anatomies or trajectories that require a sharper angle than what is typically used when placing a rod into the screw head. The subject MAS and CMAS are provided both sterile and non-sterile.

The subject Medtronic Navigated Reusable probe is specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The subject probe is used to prepare for placement of the subject bone screws into the bone.

The subject Medtronic Reusable drivers, torque multiplier adapter, and taps are spine preparation instruments made of high grade stainless steel. The subject drivers, torque multiplier adapter, and taps are compatible with Medtronic's IPC® POWEREASE® System may be connected to the IPC® POWEREASE® handpiece. The subject drivers, and taps can be used manually using existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece.

The subject Medtronic Navigated Reusable drivers and taps are spine preparation instruments made of high grade stainless steel. These instruments were specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The subject drivers and taps are also compatible with Medtronic's IPC® POWEREASE™ System when connected to the POWEREASE™ handpiece or may be used manually with existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece or the NavLock™ tracker.

The document provided is a 510(k) premarket notification from the FDA for several Medtronic spinal system components and instruments. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and study results for a new AI/Software as a Medical Device (SaMD).

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/SaMD is not present in this document.

This document pertains to traditional medical devices (spinal implants and surgical instruments), and the evaluation methods described are typical for such devices, involving biocompatibility and mechanical testing against recognized standards (e.g., ASTM F1717, ASTM F1798).

Here's the information that can be extracted, albeit not in the context of AI/SaMD:

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

Missing Information (as it relates to AI/SaMD):

• Specific numerical values or thresholds for the acceptance criteria for mechanical testing are not detailed (e.g., "Pass" is stated, but the exact pass/fail criteria and specific measured values are not provided).
• The document does not describe the types of studies typically conducted for AI/SaMD (e.g., diagnostic accuracy studies).

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

• This information is not present as the studies described are in vitro mechanical and biocompatibility tests of physical devices, not data-driven performance evaluations of an algorithm. There is no "test set" in the context of data for an AI/SaMD.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not present. Ground truth in the context of AI/SaMD refers to expert-validated labels or outcomes. For traditional medical devices and the tests described, ground truth is established by objective measurements against engineering standards.

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

• This information is not present. Adjudication is relevant for resolving discrepancies in expert labeling of data, which is not applicable to the types of tests described in this document.

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

• This information is not present. MRMC studies are specific to evaluating diagnostic devices, particularly those involving human readers and AI assistance. This document describes physical spinal system components and instruments.

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

• This information is not present. There is no standalone algorithm being evaluated in this submission.

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

• For the biocompatibility evaluation, the "ground truth" is defined by established international standards (ISO-10993) and the known safe history of the materials used in medical implants.
• For mechanical testing, the "ground truth" is established by adherence to recognized ASTM standards (e.g., ASTM F1717, ASTM F1798) and pre-determined engineering acceptance criteria.

8. The sample size for the training set

• This information is not present. There is no "training set" as this is not an AI/SaMD submission.

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

• This information is not present. As there is no training set for an AI/SaMD, this question is not applicable.

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The Disposable Passive Accessory is intended to be used for anatomy palpation in image guided surgeries with Medtronic StealthStation® System. The device is sterile and designed for single use.

The IZI Disposable Passive Accessory contains one disposable point probe mounted with five passive reflective sphere markers, as well as ten additional passive reflective sphere markers. The Disposable Passive Accessory is intended to be used for anatomy palpation and registration in image guided surgeries with the Medtronic StealthStation® system. The device is sterile and designed for single use.

The Disposable Passive Accessory provides a single-use alternative to Medtronic reusable parts. The Disposable Passive Accessory is constructed by a dimension stable thermoplastic handle where five passive reflective sphere markers are mounted on, with a stainless steel tip that is used to register and locate patient anatomical structure in an image guided surgery using the Medtronic StealthStation® System. The permanently mounted passive reflective spheres are at the same three dimensional locations as the Medtronic predicate product. In an IGS procedure, the two cameras of the StealthStation® captures the reflective light from the five sphere markers for the System to calculate and determine the location of the stainless tip and the position of the probe.

The provided document, K142344, describes the substantial equivalence of the IZI Disposable Passive Accessory to predicate devices for use in image-guided surgeries with the Medtronic StealthStation System. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that two non-clinical bench tests were conducted. However, it does not provide specific details on the sample sizes (e.g., number of devices tested, number of measurements taken) for these tests.

• Design Verification - Dimensional Analysis: No specific sample size is mentioned, only that "All critical dimensions...were measured in the Study."
• Design Verification - IZI Disposable Accessory with the Medtronic StealthStation S7: No specific sample size is mentioned for the number of accessories or the number of tests performed on the dummy head. The study used "a pre-scanned Medtronic IGS dummy head."

The data provenance is retrospective, as these are bench tests conducted by the manufacturer for regulatory submission, rather than prospective clinical trials. The country of origin for the data is implicitly the United States, given the submission to the FDA by a US-based company (IZI Medical Products LLC, Maryland).

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

No explicit information is provided regarding the use of external experts to establish ground truth for the bench tests. The ground truth for the dimensional analysis would likely be engineering specifications and measurements. For the StealthStation compatibility test, the ground truth for navigation accuracy would be established by the known true positions within the pre-scanned dummy head, and the operational functionality would be against the expected behavior of the Medtronic StealthStation System. These are internal engineering and performance benchmarks rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the studies are non-clinical bench tests. The performance metrics (CpK, navigation error) are quantifiable and objective, not requiring human interpretation or adjudication in the medical sense.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a passive accessory (a probe) for an image-guided surgery system, not an AI-based diagnostic tool that assists human readers in interpreting medical images. Therefore, the concept of "human readers improving with AI assistance" does not apply to this device.

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

This device is a hardware accessory (a probe), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The device's function is inherently human-in-the-loop as it is used by a surgeon for palpation and registration.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for these non-clinical bench tests was based on:

• Engineering Specifications and Measurements: For the "Design Verification - Dimensional Analysis," the ground truth was the engineering specifications of the predicate device and the physical measurements taken.
• Known Physical Coordinates/System Functionality: For the "Design Verification - IZI Disposable Accessory with the Medtronic StealthStation S7," the ground truth for navigation accuracy was derived from the known positions within the pre-scanned Medtronic IGS dummy head and the expected operational parameters of the StealthStation® System itself.

8. The Sample Size for the Training Set

This device is not an AI/machine learning model, so there is no training set.

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

As there is no training set for an AI/machine learning model, this question is not applicable.

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The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The AxiEM™ Imageless Hip Module for the StealthStation® is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures: Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision)

The AxiEM™ Imageless Hip Module for the StealthStation® System provides a mechanism for the establishment of stereotactic coordinates without the use of a pre-operative or intra-operative image using electromagnetic navigation

The provided text does NOT include acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the AxiEM™ Imageless Hip Module for the StealthStation® System, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

The document discusses:

• Manufacturer and Contact Information
• Product Name and Classification
• Date Summary Submitted
• Description of Device Modification: States that the AxiEM™ Imageless Hip Module uses electromagnetic navigation instead of optical tracking (the primary difference from its predicate).
• Substantial Equivalence: Claims substantial equivalence to the Imageless Hip Module for the StealthStation® System (K052623) and highlights the difference from the AxiEM™ Imageless Knee Module (hip vs. knee procedures). It vaguely mentions that "all verification and validation activities will be performed... and will demonstrate the safety and effectiveness of the device," but does not provide details about these activities, specific acceptance criteria, or study results.
• Indications for Use
• FDA Letter of Substantial Equivalence: This letter confirms that the FDA reviewed the 510(k) and determined the device is substantially equivalent to predicate devices, thus allowing it to be marketed. It reiterates that substantial equivalence does not mean the device complies with all other requirements of the Act, such as GPM, labeling, etc.

Therefore, I cannot populate the requested table or provide information on the study, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness, as this information is not present in the provided text.

The document only serves as a regulatory submission for market clearance based on substantial equivalence, not a detailed technical report of performance testing against specific acceptance criteria.

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Imageless Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures:
Minimally Invasive Orthopedic Procedures
Total Hip Replacement (Primary and Revision)
Tumor Resection and Bone/Joint Reconstruction
Placement of Iliosacral Screws
Femoral Revision
Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

The Imageless Hip Module for the StealthStation® System is the Imageless Hip Module provides a mechanism that enables the establishment of stereotactic coordinates without the use of a preoperative or intra-operative images.

The provided text does not contain detailed information about acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, number of experts, their qualifications, and adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Details on the type of ground truth used, training set sample size, and how training set ground truth was established.

The document is a 510(k) premarket notification for the "Imageless Hip Module for the StealthStation® System." It states that the device is substantially equivalent to a predicate device (Hip Module for the StealthStation® System, K021980) based on accuracy testing provided in the filing and a risk analysis. However, the specifics of this accuracy testing are not described in the provided text.

The text focuses on the device's description, classification, and indications for use, and the FDA's determination of substantial equivalence. It confirms that "all verification and validation activities performed by designated individuals and the results demonstrated substantial equivalence," but does not elaborate on these activities or their outcomes in a way that would answer the specific questions posed.

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This submission does not change the indications for use for the StealthStation System.

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

For the optical-based and EM-based system, example procedures include, but are not limited to:

Cranial Procedures: Cranial Biopsies Tumor Resections Craniotomies/ Craniectomies Skull Base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Pediatric Catheter Shunt Placement General Catheter Shunt Placement

Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement

ENT Procedures: Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies. Ethmoidectornies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

Additional example procedures for the optical-based system include, but are not limited to:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Procedures Pediatric Orthopaedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Placement of Iliosacral Screws Stabilization and Repair of Pelvic Fractures (Including but not limited to Acetabular Fractures)

This submission provides an update to the StealthStation® System, including a new computer hardware and operating system options, a passive-only optical digitizer option, new cranial reference frame and EM reference frame.

I am sorry, but the provided text from K050438, "Summary of Safety and Effectiveness StealthStation® System Update," does not contain the specific details about acceptance criteria, device performance, or human study methodologies that you've requested.

This document primarily focuses on:

• Device Identification: Naming the device, classification, and contact information.
• Device Modification: Describing the updates to the StealthStation® System (new computer hardware, operating system, digitizer options, and reference frames).
• Substantial Equivalence: Stating that the updated system was shown to be substantially equivalent to previously cleared versions and that verification and validation activities were performed.
• Indications for Use: Reiterating the established indications for use for the StealthStation System, which remain unchanged by this update, and listing various cranial, spinal, ENT, and orthopaedic procedures for which it is indicated.
• FDA Correspondence: The FDA's letter confirming the 510(k) clearance and substantial equivalence.

There is no information within this document about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or the number/qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human improvement with AI.
• Standalone algorithm performance studies.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

This document describes a regulatory submission for a device update, asserting substantial equivalence rather than presenting detailed performance study data against specific acceptance criteria.

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The indications for use for the Imageless Knee Module for the StealthStation® System are identical to the StealthStation® System indications for use. The indications for use are as follows:

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures: Cranial Biopsies Tumor Resections Craniotomies/ Craniectomies Skull Base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Pediatric Catheter Shunt Placement General Catheter Shunt Placement

ENT Procedures: Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures

Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement

Orthopedic Procedures:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopedic Procedures Total Hip Replacement (Primary and Revision) Tumor Resection and Bone/Joint Reconstruction Femoral Revision Placement of Hiosacral Screws Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

This submission describes updates made to the StealthStation® System to include software algorithms that enable the establishment of stereotactic coordinates without the use of preoperative or intra-operative image datasets.

This document is a 510(k) premarket notification for a device modification, specifically the "Imageless Knee Module for the StealthStation® System." The document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices. The listed sections primarily cover:

• Manufacturing and Contact Information
• Product Name and Classification
• Date Summary Submitted
• Description of Device Modification: The key change is software algorithms to establish stereotactic coordinates without preoperative or intra-operative image datasets, which was previously required for the predicate device.
• Substantial Equivalence: This section explicitly states, "The Imageless Knee Module for the StealthStation® System was shown to be substantially equivalent to the StealthStation System cleared in previous 510(k)'s. As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." This means the manufacturer believes the new software does not raise new questions of safety or effectiveness compared to the predicate.
• Indications for Use: These are identical to the predicate device.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth, expert qualifications, or MRMC studies. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

If you are looking for this type of information, it would typically be found in a separate performance study report or verification and validation documentation, which is generally not included in the public 510(k) summary provided by the FDA.

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures:
Cranial Biopsies
Tumor Resections
Craniotomies/ Craniectomies
Skull Base procedures
Thalamotomies/Pallidotomies
Pituitary Tumor Removal
CSF Leak Repair
Pediatric Catheter Shunt Placement
General Catheter Shunt Placement

ENT Procedures:
Transphenoidal Procedures
Intranasal Procedures
Orbital Nerve Decompression Procedures
Optic Nerve Decompression Procedures
Polyposis Procedures
Endoscopic Dacryocystorhinostomy
Encephalocele Procedures
Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

Spinal Procedures:
Spinal Implant Procedures, such as Pedicle Screw Placement

Orthopedic Procedures:
Total Knee Arthroplasty (Primary and Revision)
Unicompartmental Knee Arthroplasty
Minimally Invasive Orthopedic Procedures
Total Hip Replacement (Primary and Revision)
Tumor Resection and Bone/Joint Reconstruction
Femoral Revision
Placement of Iliosacral Screws
Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

This submission describes updates made to the StealthStation® System to include software algorithms that facilitates a different registration method.

Acceptance Criteria and Study for StealthStation® System Advanced Contour Registration Software Module

Unfortunately, the provided document {0} - {4} does not contain information related to specific acceptance criteria or an explicit study proving the device meets particular performance metrics. The document is a 510(k) summary for the StealthStation® System Advanced Contour Registration Software Module, focusing on its substantial equivalence to a predicate device and its indications for use.

It primarily states: "As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." While this confirms that some form of testing was done, the specifics of those tests, including quantitative acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert involvement, are not detailed in this summary.

Therefore, I cannot populate the requested table and answer many of the questions directly. The information below reflects what can be inferred or is explicitly stated within the provided text, along with the acknowledgement of missing crucial details.

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative performance metrics are provided in the document. The document only states that "verification and validation activities were performed... and the results demonstrated substantial equivalence."

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

Not specified in the provided document. The document mentions "verification and validation activities" but does not detail the sample sizes for any test sets used, nor the provenance (country of origin, retrospective/prospective) of any data used for testing.

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

Not specified in the provided document. The document does not mention the use of experts for establishing ground truth or their qualifications.

4. Adjudication method for the test set

Not specified in the provided document. No details are provided regarding any adjudication methods used for a test set.

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 specified and highly unlikely for this type of device and submission. The provided document is a 510(k) summary for a software module facilitating a different registration method for a stereotactic navigation system. It does not describe an AI system, nor does it mention any MRMC study comparing human performance with and without the device. The focus is on the device's ability to aid in precise anatomical localization during surgery.

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

Not explicitly described. The device is a "software module" for a "StealthStation® System," described as "an aid for precisely locating anatomical structures in either open or percutaneous procedures." This implies human-in-the-loop use. While the algorithm itself would have been tested in a standalone fashion for its function, the document does not distinguish between standalone algorithm testing and system-level performance. The testing for "substantial equivalence" would have focused on the full system's performance, which is inherently with a human operator.

7. The type of ground truth used

Not specified in the provided document. The document does not provide details on how ground truth was established for any verification or validation activities. For a stereotactic system, common ground truths might involve physical measurements against known phantoms, cadaver studies with implanted markers, or intraoperative imaging correlations, but none are mentioned here.

8. The sample size for the training set

Not applicable/Not specified. The document describes a "software module that facilitates a different registration method" and focuses on "substantial equivalence." There is no indication that this device uses machine learning or requires a "training set" in the modern sense of AI/ML. The "verification and validation activities" would likely involve testing the software's functionality and accuracy, not training an algorithm.

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

Not applicable/Not specified, as no training set is indicated.

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures:
Cranial Biopsies Placement Tumor Resections Craniotomies/ Craniectomies Skull Base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair Pediatric Catheter Shunt Placement General Catheter Shunt Placement

Spinal Procedures:
Spinal Implant Procedures, such as Pedicle Screw

ENT Procedures:
Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections.and Frontal Sinusotomies

Orthopedic Procedures:
Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopedic Procedures Pediatric Orthopedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

This submission allows a surgeon an image guided instrument to place catheter shunts. The Catheter Introducer for the StealthStation® System is technically equivalent to the StealthStation® System. All systems use either active(LED's), passive reflective markers or electromagnetic coils to track surgical instruments in relation to an image guided reference frame. This information is correlated to the patient's CT, MR or fluoroscopic images of the anatomy.

The provided text is a 510(k) summary for a Catheter Introducer for the StealthStation® System. It describes the device, its indications for use, and a determination of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, specific device performance metrics, or details of a study demonstrating fulfillment of such criteria.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with defined acceptance criteria. Therefore, most of the requested information cannot be extracted from this text.

Here's a breakdown of what can and cannot be answered based on the provided input:

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

• Cannot be provided. The document does not define specific acceptance criteria (e.g., accuracy thresholds, failure rates) or report detailed device performance metrics from a study against such criteria. The "verification and validation activities" mentioned generally indicate testing was done but no specific results or targets are shared.

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

• Cannot be provided. The document does not describe a clinical study or a test set, hence no sample size, data provenance, or study design (retrospective/prospective) is available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No information about ground truth establishment or experts involved is present, as no specific test set is detailed.

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

• Cannot be provided. No adjudication method is mentioned, as no test set or expert review process is described.

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

• Cannot be provided. This document is for a surgical navigation system, not an AI diagnostic tool. No MRMC study is mentioned, nor is there any AI component that would involve human readers improving with AI assistance.

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

• Cannot be provided. This device is an instrument for a surgical navigation system, which inherently involves human interaction (a surgeon using the instrument). The concept of "standalone" algorithm performance without human-in-the-loop is not applicable in this context.

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

• Cannot be provided. No ground truth type is mentioned as no specific performance study is detailed.

8. The sample size for the training set

• Cannot be provided. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission. "Verification and validation activities" were performed, but these are typically engineering tests, not machine learning model training.

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

• Cannot be provided. As there is no training set for a machine learning model, this question is not applicable.

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

The Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures:

Minimally Invasive Orthopedic Procedures

Total Hip Replacement (Primary and Revision)

Tumor Resection and Bone/Joint Reconstruction

Placement of Iliosacral Screws

Femoral Revision

Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

This submission allows a surgeon to utilize a modified version of the FluoroNav™ Software to place hip implants and repair and/or stabilize trauma sustained to the pelvic area. The Hip Module for the StealthStation® System is technically equivalent to the StealthStation® System, and the FluoroNav™ Module for the StealthStation®. All systems use either active or passive infrared markers to track a reference frame attached to the anatomy and to track surgical instruments. This information is correlated to the patient's CT, MR or fluoroscopic images of the anatomy.

This submission, K021980, pertains to the Hip Module Software for the StealthStation® System. The information provided is limited and focuses on establishing substantial equivalence to predicate devices rather than detailing specific performance studies with acceptance criteria for the new module. This is typical for a 510(k) submission where the primary goal is to demonstrate that a new device is as safe and effective as existing legally marketed devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and expert validation are not explicitly present in the provided document. The document primarily states that "all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." This is a high-level statement that doesn't provide the granular detail requested.

Here's a breakdown based on the available information and what we can infer:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, specific, quantitative acceptance criteria and detailed device performance metrics for the Hip Module software itself are not explicitly stated. The document focuses on demonstrating substantial equivalence to predicate devices. This implies that the performance of the Hip Module is considered acceptable if it is comparable to that of the predicate devices.

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

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission focused on equivalence, it's possible that internal testing data (e.g., in-house verification and validation) might have been used, but no details are provided about the nature or origin of this data.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The document mentions "designated individual(s)" performed verification and validation, but their specific qualifications (e.g., surgeon experience, engineering expertise) are not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated.

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

• MRMC Study Conducted: Not stated and highly unlikely for this type of 510(k) submission focused on a software module's equivalence. MRMC studies are generally used for assessing the impact of new diagnostic tools on reader performance, which isn't the primary focus here.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no such study is indicated. This device is a navigation aid, not an AI for image interpretation.

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

• Standalone Study Conducted: Not explicitly detailed in terms of performance metrics. The submission focuses on device functionality and equivalence within the surgical navigation workflow. It's implied that the software's algorithms function correctly and accurately when used as intended, but no specific "standalone" performance study results (e.g., accuracy of algorithmic calculations against a ground truth without human intervention as a separate study) are provided. The "verification and validation activities" would likely have covered this in a general sense.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated. For a surgical navigation system, ground truth during verification and validation would typically involve:
  • Phantom studies: Using precisely manufactured anatomical phantoms with known fiducial marker locations and instrument paths to assess accuracy.
  • Cadaveric studies: Using cadavers to simulate surgical scenarios and verify instrument accuracy.
  • Technical specifications: Comparing device output to known or expected engineering specifications and tolerances.
    The document only broadly refers to "verification and validation activities," implying these types of methods were used to confirm its function, but without specific details.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable in the context of this document. This is not an AI/machine learning model where a separate training set is typically discussed in this manner. The software is a navigation aid that processes imaging data (CT, MR, fluoroscopy) and tracks instruments. Its functionality is based on established geometric algorithms and image processing, not on learning from a "training set" of cases in the AI sense.

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

• Ground Truth for Training Set Establishment: Not applicable for the reasons stated above.

In summary: The provided document is a 510(k) summary for a software module, primarily focusing on demonstrating substantial equivalence to predicate devices. It does not contain the detailed performance study results, acceptance criteria, sample sizes, or expert validation methods that would be expected for a comprehensive clinical effectiveness or AI algorithm validation study. The statement "all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence" serves as the overarching conclusion regarding its safety and effectiveness.

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