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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-based or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

The StealthStation® System includes hardware and software that enables realtime surgical navigation using radiological patient images. The navigation system creates a translation map between points in the patient anatomy and the corresponding points on radiologic images of the patient. Once this map is established (through a process called registration), the software can display the relative position of a tracked instrument to a representation of the patient's anatomy. In this way the images can help guide the surgeon's planning and approach. Prior to operating, the surgeon may then create, store, and simulate progression along one or more surgical trajectories. As an aid to visualization, the surgeon may also create and manipulate one or more 2D or 3D models of the anatomy. During surgery, the system tracks the position of specialized surgical instruments in or on the patient anatomy and continuously updates the instrument position on these images either by optical tracking or electromagnetic tracking.

The operating system is software that controls the execution of programs, and that provides services such as resource allocation, scheduling, input/output control, and data management. This includes managing computer system hardware and software resources and providing a common set of services for software applications to interface with computing hardware.

Here's an analysis of the acceptance criteria and study information for the StealthStation® System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

This 510(k) is for a minor modification to an existing device (predicate device K050438), specifically a change in the operating system from a proprietary Linux (GemOS) to Debian Linux. The rationale presented is that "No changes have been made to the StealthStation® operating principle or hardware due to the change to the operating system." Therefore, the primary acceptance criteria revolve around ensuring that this operating system change does not negatively impact the established performance of the predicate device and that the new system functions as expected.

Table of Acceptance Criteria and Reported Device Performance

Study Details for StealthStation® System (K133444)

The study described here is primarily focused on verification and validation (V&V) of a software update (operating system change), rather than a de novo clinical trial demonstrating efficacy of the device itself. The core performance of the device (e.g., accuracy) is established by the predicate device (K050438).

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

   • Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients." The testing involved verification and validation activities on the software system itself. Given the nature of an operating system update, the "test set" would refer to a comprehensive suite of software tests, system configurations, and simulated or actual usage scenarios.
   • Data Provenance: Not applicable in the context of patient data for this specific 510(k). The data comes from internal testing and verification activities of the software and system.

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

   • This information is not provided in the summary. For software V&V, "ground truth" would be the expected behavior and output of the system according to its design specifications. This is typically established by design documentation and testing protocols, not necessarily clinical expert consensus in the way a diagnostic AI model would require. Software engineers and testers are the "experts" in this context, but their number and specific qualifications are not detailed.

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

   • Not applicable in the context of clinical adjudication for this type of software V&V testing. Software testing typically involves automated tests, manual testing by quality assurance engineers, and review against specifications. There's no mention of a "2+1" or similar adjudication process.

4. 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 was not done. This 510(k) is for a surgical navigation system, not a diagnostic AI device that assists human readers in interpreting images. The device itself is an aid for surgeons, and this submission focuses on a technical update, not a clinical effectiveness study.

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

   • Yes, in essence, standalone performance was assessed in terms of "System Accuracy" referenced from the predicate device (K050438). While this 510(k) does not provide new standalone accuracy data, it relies on the existing standalone accuracy data from K050438. The submission implicitly argues that since the operating system change doesn't affect the core algorithms or hardware, the standalone accuracy performance remains the same. The "functional" and "regression" verification also assess the system's performance in a standalone context (i.e., the software and hardware working correctly).

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

   • For the core functional accuracy of the navigation system itself (as established by the predicate K050438), the ground truth would typically be highly precise physical measurements (e.g., using a coordinate measuring machine (CMM) or other calibrated metrology equipment) to compare the system's reported position to the true physical position of a tracked instrument.
   • For the current submission (K133444) focusing on the OS update, the "ground truth" for the verification and validation tests would be:
     • Product Requirements/Specifications: The system is expected to perform according to its documented requirements.
     • Expected Software Behavior: The new OS environment should not alter the functionality, stability, or performance of the application software compared to the previous OS.
     • End-User Needs: The system should remain usable and effective for surgical navigation.

7. The sample size for the training set:

   • Not applicable. This device is a surgical navigation system, not a machine learning or AI model that requires a "training set" in the conventional sense. The "software" being updated is the operating system, which is a foundational component, not an algorithm trained on data.

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

   • Not applicable, as there is no training set in the context of this device.

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The Stealth 360° Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Stealth 360° Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.

The Stealth 360° Orbital PAD System consists of the following components:

• 1. Orbital Atherectomy Device (OAD)
• 2. Atherectomy Guide Wire
• 3. Saline Infusion Pump (SIP)
• 4. Atherectomy Lubricant (e.g. ViperSlide)

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Stealth 360° Orbital PAD System:

1. Table of Acceptance Criteria and Reported Device Performance

• Life/Stall Testing
• Orbit Testing
• Switch Logic/End of Life Testing
• Distribution Testing
• Shelf Life Testing |
  | Biocompatibility | "ISO MEM Elution Assay"
  "ISO Intracutaneous Reactivity Test" |
  | Electrical Safety | "Electrical Safety Testing" |
  | Electromagnetic Compatibility (EMC) | "Electromagnetic Compatibility (EMC) Testing" |
  | Software/Firmware Performance | "Firmware testing: Modular, Integration, Functional" |
  | Overall Equivalence | "The Stealth 360° Orbital PAD System with the CSI developed PCBA met all predetermined acceptance criteria of design verification and validation testing as specified by applicable standards, test protocols, and/or customer inputs. Testing results demonstrate that the Stealth 360° Orbital PAD System with the CSI developed PCBA is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness questions." |

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

The provided 510(k) summary focuses on performance bench testing rather than clinical study data involving human subjects or extensive retrospective/prospective data. Therefore, the concept of "test set sample size" in the context of patients/data provenance as typically understood for AI/diagnostic devices is not directly applicable here.

• Sample Size: Not explicitly stated in terms of individual devices tested for each bench test, but implied to be sufficient for each specific test mentioned (e.g., "Life/Stall Testing," "Orbit Testing"). These would likely involve a statistically relevant number of devices or components to demonstrate reliability and performance metrics, but the exact number isn't quantified in the summary.
• Data Provenance: This relates to bench testing performed by the manufacturer, Cardiovascular Systems, Inc. The data is thus internal, from a controlled environment, rather than clinical patient data from specific countries. It is prospective in the sense that the tests were designed and executed to verify the modified device's performance against pre-defined criteria.

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

• Not applicable. This device is a mechanical atherectomy system, and the "testing" described is bench testing of physical, electrical, and firmware components, along with biocompatibility tests. The "ground truth" for these tests is established by engineering specifications, international standards (e.g., ISO), and functional requirements, not by expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

• Not applicable. As the testing involves objective, quantifiable bench tests (e.g., electrical measurements, mechanical endurance, orbital rotation, elution assays), there is no need for expert adjudication in the way it would be applied to subjective clinical evaluations or image interpretations. Test results are compared directly against pre-defined acceptance limits.

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

• No. An MRMC study is relevant for diagnostic devices, particularly those involving human readers interpreting outputs (e.g., radiologists reading images with or without AI assistance). This 510(k) is for a mechanical surgical device and its modification. Clinical effectiveness is typically established via larger clinical trials, not solely MRMC studies, although this 510(k) relies on substantial equivalence primarily through bench testing. The summary does not provide any information about human readers or their improvement with AI assistance.

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

• Not applicable. This device is a mechanical and electrical system, not an AI algorithm. Its performance is inherent to its design and manufacturing, and while it has "firmware," it doesn't function as a standalone diagnostic algorithm in the way this question implies for AI or software as a medical device. Its operation is always "human-in-the-loop" as it's a surgical tool operated by a physician.

7. The Type of Ground Truth Used

• For the bench tests: Engineering specifications, design requirements, and compliance with recognized industry standards (e.g., ISO for biocompatibility, electrical safety standards) serve as the "ground truth." For example, a "Life/Stall Test" would have an established number of cycles or operating hours the device must withstand before failure, and passing this threshold is the "ground truth."

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" in the context of machine learning. The design and validation are based on traditional engineering principles, physical testing, and prior knowledge of the predicate device.

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

• Not applicable. As there is no training set, this question is not relevant.

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The Stealth™ Monitor is a prescription only single use, continuous recording ECG monitor that can be worn up to least 24 hours. It is indicated for use with patients where it would be desirable to record ECG signals for this period of time.

Stealth™ Monitor, Docking Cable and Display and Storage Device

The provided text is a 510(k) premarket notification letter from the FDA to Cardiac Insight Inc. for their Stealth™ Monitor. This document, while indicating the device's regulatory approval, does not contain the detailed information required to answer the request about acceptance criteria, study findings, and ground truth establishment for a device study.

Specifically, the document focuses on regulatory approval and equivalence to predicate devices, rather than providing a performance study report.

Therefore, I cannot extract the requested information from the provided text.

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The Stealth 360° Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Stealth 360° Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.

The Stealth 360° Orbital PAD System consists of the following components:

• 1. Orbital atherectomy device (OAD)
• 2. Atherectomy guide wire
• 3. Externally operated saline pump
• 4. Atherectomy Lubricant (e.g. ViperSlide)

The provided text describes the regulatory clearance of the Stealth 360° Orbital PAD System and mentions performance data used to support its substantial equivalence to a predicate device. However, it does not contain the requested information regarding acceptance criteria, a detailed study proving the device meets those criteria, or specific performance metrics in the format requested.

The submission is for a modification to an existing device where the "crown blanks" will be molded instead of machined. The primary goal of the submission is to demonstrate that this modified device is substantially equivalent to the predicate device (K110389, also the Stealth 360° Orbital PAD System).

Here's an analysis based on the provided text, highlighting what is missing for each requested point:

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

• Missing. The document states that "performance bench testing" was conducted, specifically "Life/Stall Testing" and "Orbit Testing," to confirm performance characteristics compared to the predicate device. However, it does not provide specific acceptance criteria (e.g., "device must operate for X hours without failure") nor report any quantitative device performance metrics from these tests. It only states that the testing "demonstrate[s] that the modified Stealth 360° Orbital PAD System is as safe and effective as the predicate device."

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

• Missing. No information on sample sizes for any test sets is provided. The tests mentioned ("Life/Stall Testing" and "Orbit Testing") appear to be bench tests, not clinical studies on human subjects. Therefore, data provenance related to human subjects (country, retrospective/prospective) is not applicable or provided.

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)

• Missing. This information is relevant for studies involving expert review or interpretation, typically in diagnostic or imaging devices. This document describes an atherectomy device and physical bench testing, not a study requiring expert ground truth establishment in this manner.

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

• Missing. As above, this is not applicable for the type of bench testing 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

• Missing. This type of study is completely unrelated to the device described (an atherectomy system) and the type of testing performed (bench testing for substantial equivalence of a manufacturing change). This question is typically relevant for AI-powered diagnostic tools.

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

• Missing. This is also irrelevant to the device and testing described. The Stealth 360° Orbital PAD System is a mechanical atherectomy device, not an algorithm.

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

• Missing. For the "Life/Stall Testing" and "Orbit Testing," the "ground truth" would likely be engineering specifications or performance baselines established by the predicate device's performance. However, these specific "ground truths" or benchmarks are not detailed.

8. The sample size for the training set

• Missing. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Missing. This is also irrelevant as there is no "training set."

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through bench testing to a predicate device, primarily to address a manufacturing change (molded vs. machined crown blanks). It does not provide the detailed study results, acceptance criteria, or expert review/AI-related information requested.

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The Stealth 360° Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Stealth 360™ Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis.

The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body.

The Stealth 360° Orbital PAD System consists of the following components:

• 1. Orbital atherectomy device
• 2. Atherectomy guide wire
• 3. Externally operated saline pump
• 4. Atherectomy Lubricant (e.g. ViperSlide)

The provided document describes the Stealth 360™ Orbital PAD System, a peripheral atherectomy device. This 510(k) summary focuses on validating the device's substantial equivalence to previously cleared predicate devices through extensive bench testing and biocompatibility studies, rather than clinical performance studies involving human subjects or AI algorithms. As such, many of the requested criteria, such as MRMC comparative effectiveness studies, ground truth establishment for training sets, or expert adjudication, are not applicable to the information provided.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of biocompatibility assays and comprehensive performance bench tests. The report concludes that "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Stealth 360° Orbital PAD System met the established specifications necessary for consistent performance during its intended use."

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

• Sample Size for Test Set: Not specified. The document refers to "bench testing" and "test results" but does not provide precise sample sizes for each specific test.
• Data Provenance: The data provenance is from laboratory and bench testing performed by the manufacturer, Cardiovascular Systems, Inc. This is not derived from human patient data, therefore, it cannot be classified as retrospective or prospective in that context, nor does it have a country of origin in terms of patient data.

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

• Not Applicable. This device submission relies on engineering specifications, material science, and safety standards rather than clinical expert consensus for establishing ground truth. The "ground truth" here is adherence to these predefined technical and safety standards.

4. Adjudication Method for the Test Set

• Not Applicable. As the evaluation is based on objective measurements against engineering and safety specifications, an adjudication method for a test set (as typically seen in clinical studies with human interpretative components) is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with vs. without AI Assistance

• No. This type of study is not relevant to the clearance of this mechanical atherectomy device, which does not involve AI or human interpretation of medical images.

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

• No. This device is a mechanical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" in this context refers to pre-defined engineering specifications, international and national biocompatibility standards (e.g., ISO, ASTM, EN 60601), and the performance characteristics of the predicate devices. The device's performance was compared against these established technical criteria to demonstrate safety and effectiveness.

8. The Sample Size for the Training Set

• Not Applicable. This is a mechanical device, not an AI model requiring a training set.

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

• Not Applicable. This is a mechanical device, not an AI model, so there is no training set or associated ground truth establishment process in that context.

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Stealth Viz is a software application indicated for use in 2D/3D surgical planning and image review and analysis. It enables:

• importing digital diagnostic and functional imaging datasets (e.g. . MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, US )
• . reviewing and analyzing the data in various 2D and 3D presentation formats.
• . performing image fusion (co-registration) of datasets,
• . segmenting structures in the images with manual and automatic tools and converting them into 3D objects for display,
• . exporting results to other Medtronic Navigation planning applications, to a PACS or to Medtronic Navigation surgical navigation systems such as the StealthStation System.

The StealthDTI Package is a subset of StealthViz that implements a special case of segmenting 3D structures from the datasets. It is indicated for use in the processing of diffusion-weighted MRI sequences into 3D objects that represent white-matter tracts.

Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

StealthViz is a general purpose 2D/3D surgical planning and image review and analysis software application running on a standard computer. It enables:

• importing digital diagnostic and functional imaging datasets (e.g. MR, MRA, CT, CTA, fMRI, X-ray, DSA, PET, SPECT, MEG, MSI, US) across a LAN, the internet or a modem, or via local transfer from physical media (e.g. CD, DVD, USB drive),
• reviewing and analyzing the data (e.g. making measurements) in various 2D and 3D presentation formats,
• performing image fusion (co-registration) of datasets using automated or a manual image-matching technique,
• segmenting structures in the images with manual and automatic tools and converting them into 3D objects for display,
• creating hybrid datasets by filling in segmented regions slice-by-slice on anatomical datasets, and
• exporting results to other Medtronic Navigation planning applications, to a PACS or to other Medtronic Navigation surgical navigation systems such as the StealthStation System.

The StealthDTI Package provides the following additional capabilities:

• import diffusion-weighted sequence datasets (gradients),
• co-register the gradients with anatomical studies using an automatic algorithm or a manual technique,
• perform diffusion tensor calculations to create intermediate datasets such as Fractional Anisotropy and Apparent Diffusion Coefficient and the ability to display these results with, for example, Directionally Encoded Color or grayscale mapping,
• enable the user to define regions-of-interest (ROI) from which to . perform white matter tractography (WMT, also known as fiber tracking). The user can define multiple ROIs or use previously segmented objects as ROIs (e.g. an fMRI activation area that has been segmented into a 3D object).
• calculated fiber tracts can be displayed and converted into 3D . objects,
• all results can be exported as noted for the base StealthViz . application description.

The provided text describes a 510(k) premarket notification for Medtronic Navigation, Inc.'s StealthViz Advanced Planning Application with StealthDTI Package. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a study that proves the device meets those criteria.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Test Testing was performed in two phases. Testing was performed by Visage Imaging, the third party developer, to ensure that all Requirements were met by the product." However, the specific "Requirements" (acceptance criteria) and their corresponding reported device performance values are not detailed in this summary.

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

The document mentions "a subset of testing was also performed in-house," but does not specify the sample size used for the test set or the provenance (country of origin, retrospective/prospective) of the data.

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

This information is not available in the provided text.

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

This information is not available in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

This document describes a 2008 submission. The StealthViz Advanced Planning Application with StealthDTI Package is a tool to process and visualize diffusion-weighted MRI sequences into 3D objects representing white-matter tracts for surgical planning and image review/analysis. It is not an AI diagnostic tool and does not involve human readers interpreting results with or without AI assistance in the way modern AI devices do. Therefore, a MRMC comparative effectiveness study in that context would not be applicable to this device. The document does not mention such a study.

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

The document states, "Testing was performed by Visage Imaging, the third party developer, to ensure that all Requirements were met by the product. This testing is referenced in the Trace Matrix which ensures that all requirements were successfully verified." This implies standalone testing of the software's functionality. However, specific details about the "standalone" performance metrics (e.g., accuracy, precision of fiber tracking) are not provided.

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

This information is not available in the provided text. Given the nature of white-matter tractography, "ground truth" would likely involve anatomical atlases, direct anatomical correlation, or expert neuroanatomical review, but this is not stated.

8. The sample size for the training set:

Medtronic Navigation, Inc.'s StealthViz Advanced Planning Application with StealthDTI Package, as described in this 2008 510(k) summary, is a software tool for image processing, co-registration, segmentation, and visualization, particularly for diffusion tensor imaging (DTI). It uses algorithms to perform these functions (e.g., automatic co-registration, diffusion tensor calculations, white matter tractography based on user-defined ROIs).

While such algorithms are developed, they are not typically "trained" in the machine learning sense with a large "training set" of patient data as modern AI/ML devices are. The algorithms are based on established image processing and mathematical principles (e.g., for DTI calculations). Therefore, the concept of a "training set sample size" as relevant to AI/ML is not applicable to this type of device as described in this document.

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

As mentioned above, the concept of a "training set" in the context of modern AI/ML is not directly applicable to this device. Therefore, how ground truth for such a set was established is not discussed in the document.

In summary, while the document confirms testing was performed to verify requirements for the StealthDTI package, it lacks the detailed quantitative information on acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment that would typically be found in a comprehensive study report for a modern AI/ML medical device. The context is a 2008 510(k) summary for a software planning tool, not an AI diagnostic algorithm.

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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 intended use of the Stealth Products Powered Seating System is to provide pressure relief to persons confined to a wheelchair, by providing a method of tilting and reclining the wheelchair seat and back.
The intended function and use of the Stealth Products Powered Seating System for Power Wheelchairs is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.

The Stealth Products Powered Seating System for power wheelchairs is a battery powered, motorized seating system, designed for use with power wheelchairs. It's intended function and use is to provide pressure relief to power wheelchair users, by providing a means of tilting and reclining the seat and back.

The system consists primarily of a main frame assembly, a system mounting plate, linear actuators and a toggle switch assembly. The main frame assembly supports the patient during use of the seating system. The system mounting plate is the interface between the Stealth Seating System and the wheelchair. The linear actuator provides the motion needed to position the system, and the toggle switch assembly is the means by which the tilt/recline functions are activated.

The Stealth Powered Seating System is designed to adapt to wheelchairs with round, square, or rectangular frames. Minimum frame requirements are 1 ½" diameter x .09 wall for round frames and a 1" mounting surface x .09 wall for square and rectangular frames.

The provided text describes a 510(k) Premarket Notification for the "Stealth Products Powered Seating System for Power Wheelchairs." While it states that performance and functional testing were conducted, the document does not provide specific acceptance criteria or detailed study results demonstrating how the device meets those criteria.

It only states: "In all cases, the Stealth System passed its' performance requirements and met specifications."

Therefore, I cannot populate the requested table and details because the information is not present in the provided text.

Here's a breakdown of the specific information that is missing from the document:

1. A table of acceptance criteria and the reported device performance: This is not present. The document generally states the system "passed its' performance requirements and met specifications" but does not enumerate these requirements or specific performance metrics.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with a "ground truth" seems to have been conducted or reported. The tests conducted were "performance and functional testing," implying engineering or bench testing.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a powered seating system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as detailed above.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

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The Stealth Fusion System and its accessory components are intended to be used on adults or pediatric patients as required and are intended to be used for ankle and foot joints fusion; to stabilize fractures of foot bones; (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis or non-union of foot bones; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue foot defects; joint arthrodesis; and management of comminuted intra-articular foot bone fractures.

The Stealth Fusion System is an orthopedic device indicated for the use of bone fusion and other bone abnormalities and deformities. As with most external fixation devices, the standard Stealth Fusion System fixator assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The Stealth Fusion System design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the lower extremity and immediate range of motion of all adjacent joints.

I am sorry, but the document provided does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. This document is a 510(k) summary for a medical device (Stealth Fusion System), which primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance study results.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Information on experts used to establish ground truth.
• Adjudication methods.
• Results from multi-reader multi-case (MRMC) comparative effectiveness studies.
• Results from standalone performance studies.
• Details on the type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

The document mainly describes the device, its intended use, technological characteristics, and states its substantial equivalence to predicate devices based on similar design, materials, and intended use. Performance data, if collected, would typically be summarized in a more detailed technical report which is not part of this 510(k) summary.

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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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