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The "eFOLDi Navigator Powerchair STPC-A" is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The eFOLDi Navigator Powerchair STPC-A is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. The wheelchair has two front wheels, two rear wheels, two electric motors with electromagnetic brake, and one rechargeable Lithium-Ion batteries with an off-board charger. The movement of the wheelchair is controlled by the joystick controller or attendant control. When attendant control is in use, the wheelchair no longer responds to the joystick controller. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually. The wheelchair only can be operated on the flat road for both outdoor and indoor use, hospital, senior center, family or similar circumstances use only. The Powerchair only can be operated on the flat road or slopes less than 6 degrees. The Powerchair is foldable.

The Powerchair has a physical dimension of 108 (depth) x 59 (width) x 89 (height) cm, with the seat itself has a dimension of 35 (depth) x 45 (width) x 50 (height) cm. The footrest is 10 cm in height. The Powerchair is foldable, and the folded dimension is 34 (Long) x 59 (width) x 89 (height) cm.

The device has a weight capacity of 120 kilograms, and weighs 14 kilograms with battery (12 kilograms without battery). The color is black.

The Powerchair consists of four wheels, a magnesium alloy mechanical main frame, seat, handle, and 100% polyester flame retardant cloth for upholstery that is ignition resistant.

The Powerchair uses solid Polyurethane wheels and the front wheel has a diameter of 20 cm (8 inch) and the back wheel has a diameter of 30 cm (11.5 inch). Both front wheel and back wheels use solid tires.

The Powerchair has two motors of 24V and 180 Watt, which allows a maximum speed of 5.6 kilometers per hour, and maximum travel range of 13 kilometers. It brakes in the form of electromagnetic force to apply mechanical resistance to the back wheels to force stop.

The wheelchair is equipped with anti-tipper device.

This FDA 510(k) clearance letter is for a physical medical device (eFOLDi Navigator Powerchair), not an AI/software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement for AI performance is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with relevant ISO and IEC standards for wheelchairs.

However, I can extract the acceptance criteria and study information related to the device's physical performance as detailed in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size (number of units) used for each non-clinical performance test. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is from non-clinical tests performed by the manufacturer (SunTech UK Ltd.) likely in a controlled laboratory or testing facility setting, rather than human data. There is no mention of country of origin for the data or whether it's retrospective or prospective in the context of data acquisition, as it's not human data.

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

Not applicable. For a physical device like a powerchair, "ground truth" as it relates to expert consensus for diagnostic accuracy or similar AI contexts is not relevant. Performance is determined by objective physical tests against established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI studies (e.g., medical image interpretation). For physical device testing, the outcome is determined by whether the device passes or fails the specified standard criteria.

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 is not an AI/SaMD device, so MRMC studies involving human readers or AI assistance are irrelevant.

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

Not applicable, as this is not an AI/SaMD device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by compliance with internationally recognized engineering and safety standards for wheelchairs and their components (ISO 7176 series, ISO 10993-1, ISO 16840-10, IEC 62133-2). These standards define objective, measurable criteria that the device must meet.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/SaMD device. There is no "training set" in the context of a physical powerchair's mechanical and electrical performance.

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

Not applicable, as this is not an AI/SaMD device and has no training set.

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The Navigator HD Ureteral Access Sheath is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

Navigator™ HD Ureteral Access Sheath Set consists of a semi-rigid outer sheath and a semi-rigid inner dilator with interlocking hub. The set permits utilization of a guidewire to assist in device placement.

Sheath: The Navigator™ HD Sheath has a sheath hub which is over-molded onto the sheath shaft has three layers: Outer Pebax layer, Reinforced stainless steel coil enhancing torqueability and maneuverability, Inner PTFE liner. The sheath outer layer contains Barium Sulphate as a radiopacifier. In addition to the stainlesssteel coil, a radiopaque marker band is sandwiched between the Pebax and PTFE layers. The radiopaque marker band is located at the sheath tip and, along with the radiopacifier added to the sheath outer layer, enhances fluoroscopic visualization of sheath placement during the procedure. A hydrophilic coating is applied to the entire length of the shaft to reduce friction and facilitate placement of the device.

Dilator: The Navigator™ HD dilator has a hub with a standard luer lock at the proximal end. The tab on the dilator hub allows it to lock into the sheath hub. The dilator shaft is made of extruded tube Pellethane to allow for dimensional stability, low moisture absorption, and chemical resistance. The dilator tip is made of a softer grade of Pellethane to improve tip flexibility to assist in atraumatic placement. Both the dilator shaft and tip contain Barium Sulfate as a radiopacifier, enhancing visualization under fluoroscopy during the procedure. A hydrophilic coating is applied to the entire length of the dilator to reduce friction and facilitate placement of the device, either when assembled with the sheath or when used separately as a dilatation device.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML are not applicable here.

The document discusses the substantial equivalence of the Navigator™ HD Ureteral Access Sheath Set to a previously cleared predicate device.

Here's the relevant information that can be extracted, addressing the spirit of the request as much as possible for a non-AI/ML device:

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

The document doesn't present "acceptance criteria" in the typical AI/ML sense (e.g., specific sensitivity/specificity thresholds). Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The performance is assessed by comparing technological characteristics and performing design verification and usability testing related to a minor change.

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

This is a physical medical device. The "test set" would refer to samples of the device undergoing engineering performance testing. The document does not specify sample sizes for the "Design Verification" or "Summative Usability" testing, nor does it mention data provenance (e.g., country of origin, retrospective/prospective clinical data). These would typically be detailed in internal test reports referenced by the submission but not included in this summary.

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

This is not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for the device's performance relies on engineering specifications and established safety/efficacy profiles of similar devices.

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

Not applicable for a physical medical device. Adjudication methods are relevant for subjective interpretations of data, typically in clinical studies or AI/ML ground truth establishment.

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 is not an AI/ML device, and no human reader study with or without AI assistance was performed or needed.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for the device's acceptable performance is based on:

• Engineering specifications and standards: Ensuring the device meets its design requirements.
• Performance testing results: Demonstrating functional equivalence and safety (e.g., mechanical performance, biocompatibility).
• Historical performance of predicate device: The K140323 device, which has a proven track record.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, safety belt, pedal, battery box and charger. The device is powered by Li-ion Battery pack (24V 6Ah*2) with 16 Km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

The provided document, a 510(k) Pre-market Notification for the Navigator and Navigator XL powered wheelchairs, does not describe a study involving an AI/Machine Learning device, expert adjudication, or complex ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to a predicate device through adherence to established performance standards for medical devices like powered wheelchairs.

Therefore, many of the requested details, such as those related to AI/ML performance, human readers, training/test sets, and expert consensus for ground truth, are not applicable to this document.

However, I can extract the acceptance criteria and the "device performance" in terms of meeting those criteria.

Here's a breakdown of the information that is available in the document, formatted to the extent possible according to your request:

Acceptance Criteria and Device Performance (for a Powered Wheelchair)

This section describes the performance evaluation of the Forcemech International LLC Navigator and Navigator XL powered wheelchairs against established international standards for wheelchairs. The study's purpose was to demonstrate substantial equivalence to a predicate device (K232193) by meeting these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to various parts of the ISO 7176 series of standards and ISO 10993 series for biocompatibility. The reported device performance is that the device meets or complies with these standards.

The document also provides specific performance values for some parameters, as compared to the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "comparison elements" that need to demonstrate substantial equivalence:

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document describes non-clinical testing performed on the device itself. For each standard mentioned (e.g., ISO 7176 series, ISO 10993 series), tests are conducted on a statistically appropriate number of units or materials according to the specific standard's requirements. This is not a patient-based test set but rather a device-based test set. The exact number of units tested for each standard is not specified in this summary but would be detailed in the full test reports.
• Data Provenance: The tests are "non-clinical tests" conducted to verify compliance with design specifications and substantially equivalence. The location of testing is implicitly China, given the applicant's contact person is in Shanghai, China, and the submission correspondent is also from Shanghai, China. The data would be prospective in the sense that the manufacturer specifically conducted these tests on their device models.

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

Not applicable. This is a non-clinical device performance study against engineering and safety standards, not a diagnostic AI/ML study requiring expert radiologists for image interpretation or clinical ground truth. The "ground truth" here is the adherence to the published ISO/IEC standards, which are developed by international expert committees through a consensus process.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical device performance study. The "adjudication" is met by passing the specified tests against the published standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No. This document explicitly states: "No clinical study is included in this submission." This type of study is for evaluating human performance, typically in diagnostic imaging, and is not relevant for a powered wheelchair's non-clinical safety and performance testing.

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

Not applicable. This is a medical device (powered wheelchair), not an AI/ML algorithm. The performance evaluation is for the physical device and its electrical/mechanical systems.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is adherence to well-defined, internationally recognized engineering and safety standards (ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, and IEC 60601-1-2 for EMC). These standards dictate specific test methods and acceptance criteria that the device must meet to be considered safe and effective for its intended use.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no AI/ML training set.

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Cube Navigator is a non-invasive software intended for planning the needle trajectory of CT-guided, percutaneous punctures using DICOM-images and a Navigation Cube attached to a patient. It is indicated for the planning the needle trajectory of CT-guided, percutaneous punctures for therapeutic and diagnostic purposes. The software's functionality allows to automatically recognize orientation, position and type of the Navigation Cube present in the DICOM-images and to manually define virtual needle trajectories to a physician-identified target through the Navigation Cube. Based on this planning, Cube Navigator provides physician information for such purpose.

Cube Navigator can only be used in combination with a Navigation Cube, specifically, either the Access Cube for instruments 10-20G (article number mt-ac-ct-20, Class 1 exempt, product code GDF) or the Puncture Cube for instruments 18-22G (article number mt-pc-ct-25, Class 1 exempt, product code GDF). Cube Navigator is a standalone software that integrates the CE-marked and FDA-cleared diagnostic Medical Imaging Viewer medDream manufactured by Softneta that provides all DICOM-related functionality like displaying and manipulating DICOM-images.

The Cube Navigator is intended for interventional radiologists, who perform CT-guided interventions for therapeutic and diagnostic purposes. The intended use environment is the CT control room, which can be in a hospital or a medical office.

Cube Navigator is a non-invasive medical device software used in interventional radiology for planning the needle trajectory of CTguided, percutaneous punctures. Cube Navigator provides planning functionality for needle placement through a separate device, called a Navigation Cube. Cube Navigator allows the user to register the Navigation Cube in a feasible needle traiectory using a virtual needle. Based on this planned trainctor displays needle depth and the enty points on the Navigation Cube in its user interface. The Cube Navigator software is only used for planning the needle trajectory, but requires a CT-scan with a Navigation Cube mounted on a patient for the purposes of visualization.

Navigation Cubes are sterile, disposable needle quides which are attached to the planning scan is acquired. Currently two variants exist: Puncture Cube or Access Cube, both Class 1 exempt, product code GDF. The Navigation Cubes support the use of needle sizes 10-20G (Access Cube) or 18-22G (Puncture Cube), Needle length is dependent on the trained from the displayed needle depth. Cube Navigator detects which Navigation Cube is present in the takes the average of the supported needle diameters for that Navigation Cube when calculating the thickness of the virtual needle.

Cube Navigator is a standalone software that integrates with the CE-marked and FDA-cleared diagnostic Medical Imaging Viewer medDream manufactured by Softneta (Class II, K22232), see Software Architecture Design Cube Navigator for integrated version). Gube Navigator allows the user to access the functionality of medicing images locally or through a remote DICOM-connection, by viewing and manipulating DICOM-images through the user interfaces of the Cube Navigator, as well as accessing the functionality of Cube Navigator itself. The DICOM integration is part of the base software package medDream (see the Statement recarding the DICOM-Standard - Cube Navigator for detailed information about DICOM conformity).

Cube Navigator as well as the Navigation Cubes are manufactured by Medical Templates AG. medDream is manufactured by Softneta and for the described purpose, distributed by Medical Templates AG as bundle together with Cube Navigator. When the user installs Cube Navigator, medDream is also installed, without any additional installation or configuration necessary.

Here's an analysis of the acceptance criteria and study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary for Cube Navigator:

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

The provided document does not explicitly list formal "acceptance criteria" with quantitative thresholds for performance. Instead, it describes verification methods and their outcomes. However, we can infer the implicit criteria from the tests performed.

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

• Automated Registration Accuracy: "Data from phantom studies and retrospectively collected patient cases." The specific number of phantom studies or patient cases is not disclosed. The country of origin is not disclosed. The data provenance is stated to be retrospective for patient cases, and phantom studies (which are typically prospective/controlled).
• Accuracy of Displayed Needle Depth: "a dataset is loaded." The specific number of datasets is not disclosed. Provenance is not disclosed.
• Accuracy of Virtual Needle Path Planning: "For each cube 5 datasets from different tests or studies have been selected." Since there are two types of cubes (Access Cube and Puncture Cube), this implies a sample size of at least 10 datasets (5 for Access Cube, 5 for Puncture Cube) for this test. These were described as "retrospective" on "existing data." The country of origin is not disclosed.
• Usability Study: 5 interventional radiologists used the software. The provenance of the patient cases or phantoms used during this usability study is not disclosed, but the study itself (user interaction) is prospective.

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

• For the "Accuracy of Displayed Needle Depth" test, the "line measurement tool provided by MedDream (FDA certified product)" was used, implying a software-based ground truth measurement.
• For the "Accuracy of Virtual Needle Path Planning" test, the comparison was made against "actual coordinates used for the physical needle." This suggests a physical ground truth, likely established during the original acquisition of the "existing data," but not further detailed as involving expert consensus specific to this study.
• The usability study involved 5 interventional radiologists as users, and their feedback contributed to the "ground truth" regarding usability. Their qualifications are stated as "interventional radiologists," but no further details such as years of experience are provided.

4. Adjudication method for the test set

The document does not explicitly describe an adjudication method with multiple readers or a consensus process for establishing ground truth for the core performance tests (registration accuracy, needle depth, path planning). The tests appear to rely on objective measurements (e.g., comparison to existing physical coordinates, measurements with a certified tool, or an implied internal standard for automatic registration).

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

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed or that human readers' performance with and without AI assistance was evaluated. The studies described are primarily focused on the software's standalone accuracy and usability, rather than its impact on human reader performance.

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

Yes, the described tests for "Automated Registration Accuracy," "Accuracy of Displayed Needle Depth," and "Accuracy of Virtual Needle Path Planning" appear to be standalone (algorithm only) performance evaluations. For example, the automatic detection/registration is an algorithm-only function, and the calculation of needle depth/coordinates also relies on the algorithm. While human interaction is required to use the software (planning the trajectory), the accuracy of the software's output is what's being evaluated in these specific tests, separating it from the human's contribution to the overall clinical outcome.

7. The type of ground truth used

The types of ground truth used include:

• Physical/Retrospective Data: For virtual needle path planning, comparison to "actual coordinates used for the physical needle" from existing data.
• Software-Certified Tool: For displayed needle depth, comparison to measurements made with "MedDream (FDA certified product)."
• Phantom Studies: For automated registration accuracy, implicitly involving known phantom geometries.
• User Feedback: For usability, "feedback along the line of the system" from interventional radiologists.

8. The sample size for the training set

The document does not disclose the sample size for the training set used for the Cube Navigator's algorithms (if any AI/ML components were trained).

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

Since the training set size is not disclosed, the method for establishing its ground truth is also not disclosed.

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The Immuno Concepts IgG Anti-nDNA Fluorescent Test System is for in vitro diagnostic use for the qualitative detection and semi-quantitation of anti-nDNA antibodies of the IgG class in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence Semiautomated Microscope. The Immuno Concepts IgG Anti-IDNA Fluorescent Test System is to be used as an aid in the diagnosis of Systemic Lupus Erythematosus (SLE) in conjunction with other clinical and laboratory findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.

Not Found

The provided text is a 510(k) premarket notification clearance letter from the FDA for the "Immuno Concepts IgG Anti-nDNA Fluorescent Test System" and the "Image Navigator® Fluorescence Semiautomated Microscope." It details the device's indications for use and general regulatory information but does not contain the specific acceptance criteria, study details, or performance data that would allow for a complete answer to your request.

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
• Whether a standalone (algorithm only) performance study was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. To find the detailed study information, one would typically need to review the full 510(k) summary or the pivotal study report submitted by the manufacturer to the FDA, which is not included in this clearance letter.

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The TMS Navigator TS helps users to plan, implement treatment involving TMS of the brain.

The system provides planning and navigation functions using anatomical MR data.

Regions of the brain to be stimulated can be determined on the basis of anatomy, functional areas or by entering previously calculated coordinates from brain atlases.

The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum, Denmark), more precisely the R20 and R30 stimulator with MagOption, the X100 stimulator and the X100 stimulator with MagOption only with following magnetic coils: C-100, C-B60, Cool-B70, Cool D-B80, MC-125, MC-B70, MCF-75, MCF-125, MCF-B65 and MMC-140-II.

The TMS Navigator TS is a navigation system specifically designed to support transcranial magnetic stimulation (TMS).

It uses position data of the patient's head and the TMS coil acquired by an optical tracking system for display and navigation. The realtime display of the position of the TMS coil in the displayed MR data set provides visual support for navigation. With the help of the software, one or more locations for the TMS treatment can be planned as well as stimulated locations can be recorded in the used data set and thus documented.

These functionalities support the following use case:

Planning, execution and documentation of a TMS stimulation in the human brain.

Transcranial magnetic stimulation (TMS) uses so-called TMS coils to generate alternating electromagnetic fields to target brain areas. The depth of penetration, extent and nature of this effect (inhibitory or exhibitory) is influenced by the strength and shape of the magnetic field and the repetition frequency used.

The provided text describes the Localite TMS Navigator TS device and its 510(k) submission for FDA clearance. The information focuses on non-clinical bench performance testing rather than human-in-the-loop or multi-reader multi-case studies using AI.

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

The device in question, the Localite TMS Navigator TS, is a navigation system designed to support transcranial magnetic stimulation (TMS). Its primary function is to provide planning and navigation using anatomical MR data to determine and locate target areas in the brain for TMS treatment.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be related to its system accuracy in navigating to target locations. The study assessed this accuracy using a measurement phantom in a simulated use environment.

2. Sample Size and Data Provenance

• Sample Size Used for Test Set: "In total, 288 coordinate comparisons were deduced from eight test locations across 36 navigated TMS sessions."
• Data Provenance: The study was a "bench performance test" using a "measurement phantom and a TMS coil test probe in a simulated use environment." This indicates the data is retrospective and synthetic (from a phantom), not from human subjects. The location of the test environment is not explicitly stated, but the applicant's address is listed as Bonn, Germany.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth was established by the physical coordinates of the measurement phantom and the known positioning of the test probe, not by human expert consensus or clinical assessment.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" was the objective, precisely defined physical locations on the measurement phantom. There was no need for human adjudication of image interpretations or clinical outcomes.

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

• Was an MRMC study done? No. The study described is a bench performance test assessing the device's accuracy in a simulated environment, not a multi-reader, multi-case clinical study involving human readers and AI assistance.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes, in essence. The described study evaluates the "system accuracy" of the TMS Navigator TS in performing its navigation function. While it's a device that guides human users, the performance metrics (mm accuracy) are for the system's ability to locate and track precisely, independent of a specific human operator's skill in interpreting the display. It's a measure of the device's inherent precision.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was physical measurement or phantom-derived coordinates. The study states "based on eight test locations on the phantom, to which the test probe was navigated." This implies the physical, known coordinates of these test locations on the phantom served as the ground truth against which the device's navigated positions were compared.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated. The provided text describes the non-clinical bench performance testing for the test set. Information about the training set size for any underlying algorithms used in the device (if applicable, though the device description focuses on optical tracking and real-time display rather than a self-learning AI algorithm) is not included in this document.

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

• How Ground Truth for Training Set Was Established: Not explicitly stated. As with the training set size, this information is not provided in the document, likely because the performance study described is the validation of the final device, not a description of its development process or training data. Given the device's description, which emphasizes navigation and tracking rather than an AI model learning from medical images, it's possible that a "training set" in the AI sense isn't a primary component of its development, or at least not relevant to the described premarket bench testing.

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The Breast Volume Navigator (BVN) is an add-on accessory for existing ultrasound imaging systems and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2-dimensional image slices throughout a volume of interest. The BVN is intended to acquire, analyze, store and retrieve digital ultrases for computerized 3-dimensional image processing.

The BVN is intended to assist health care providers trained in breast ultrasound with tools for electromagnetic tracking of instruments with respect of breast ultrasound images generated from FDA cleared hand-held ultrasound devices. The BVN is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with a linear array transducer.

The BVN is indicated for use as an adjunct to hand-held breast ultrasound to assist the health care providers trained in breast ultrasound in their scanning process. The scanning paths are displayed on a route map and provide quality control of scanning to provide an overall observation of scanning process.

The BVN Software Application is intended as a standalone software device installed on a windows-based computer to assist physicians with manipulation and analysis tools in reviewing breast ultrasound images. Images and data are previously recorded from various imaging systems and other sources such as calibrated spatial positioning devices. The BVN Software Application provides the capability to visualize ultrasound images along with the scanning paths and position information of the probe that is stored in the DICOM file in advance.

The BVN will allow exporting to any third-party application that has the appropriate level of DICOM compliance. The BVN is intended as a general-purpose digital 3D breast ultrasound image processing tool for radiology and surgery.

The device is not intended to be used in the environment of strong magnetic fields, such as in Magnetic Resonance Imaging (MRI) room.

The device is not intended to be used as a replacement for screening mammography.

The Breast Volume Navigator (BVN™) Model G-2000, hereinafter maybe referred to as the BVN™ G-2000 System or the BVN™ System, comprises hardware components and a software element, including the following components: a magnetic position tracking device, sensor attaching pieces used to attach magnetic sensors to the skin and ultrasound probe, a central control unit computer, and software for controlling the system, collecting, and processing ultrasound images and positional data, and performing automated annotations.

The BVN™ System has a touch-screen user interface and push-button for power on the system.

The Use Interface (touchscreen display and central control unit computer) are placed on a medical grade cart that can be positioned next to a standard adjustable examination table for ease of use and ergonomic adaptation.

The BVN™ System has a USB port available for transferring files via USB Memory Stick.

The BVN™ System has an Ethernet port for connection to a PACS system, using DICOM.

The BVN™ System has a VGA/DVI Input Ports for capturing images from an ultrasound imaging scanner.

The BVN™ System receives ultrasound DICOM images from the US machine via the network connection and telemetry data from a position tracking system. The BVN™ automatically detects when the image is being frozen on the US machine and takes a snapshot of the telemetry data at that time. Later, when the BVN™ receives the DICOM image, it associates the telemetry data to the image from the time when the image was frozen on the US machine.

A Completeness-of-Scan Assessment ensures that all breast tissue has been sufficiently covered, the BVN™ System will achieve this by tracking the real-time position of the probe relative to the breast and chest wall to ensure the entire breast volume has been covered with sufficient detail to allow the detection of sub centimeter lesions. As the probe is swept over the breast region, the technician will be provided a completeness map highlighting the portions of the breast that have not been sufficiently scanned. The BVN™ System will provide the operator a display of regions with insufficient coverage, prompting the operator to rescan these regions. The BVN™ System can retrieve previous examinations DICOM images allowing the user to enter positional data from another/previous ultrasound examination for follow-up purposes. Any anomalies discovered during the follow-up process can be evaluated using the localization and measurement tools included in the software.

The customer's existing ultrasound probe securely attaches to the BVN™ System probe sensor. During a scan, the operator applies constant pressure to the transducer against the patient's breast tissue and can rotate the transducer (pitch and roll) to accommodate for the physical characteristics of the breast.

Exam data is subsequently reviewed on standard radiological viewing stations.

The provided text describes the acceptance criteria and study results for the MetriTrack Breast Volume Navigator (BVN™) Model G-2000.

Acceptance Criteria and Performance Study Table

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The Neural Navigator is a neuronavigation system indicated for accurate positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Neural Navigator is indicated for use with the following CloudTMS Therapy System coils manufactured by Neurosoft Ltd: AFEC-02-100 and AFEC-02-100-C.

The Neural Navigator combines MRI-based, 3-D localization of cortical motor areas of the brain with non-invasive TMS and simultaneous EMG measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target area for depression therapy. The Neural Navigator software is used to import a patient's MR image slices through standard DICOM communication protocols, and automatically generates an accurate 3-D model of the patient's head, and a custom automatic tissue segmentation routine to reveal anatomical structures of the brain surface in 3D.

The provided text describes the 510(k) premarket notification for the Neural Navigator device. While it asserts substantial equivalence based on performance testing, it does not explicitly define "acceptance criteria" in a quantitative table with specific thresholds as would be typical for a detailed study report. However, it implicitly presents performance metrics and their comparison to predicate devices, which serve as the basis for acceptance.

Here's an attempt to extract and rephrase the information to fit the requested format, acknowledging the limitations of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit acceptance criteria with defined pass/fail thresholds. Instead, it compares the Neural Navigator's performance to its predicate devices, implying that performance comparable to or better than the predicate is considered acceptable.

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INTENDED USE: This is an indirect Fluorescent antibody test for the qualitative and semi-quantitative detection of IgG autoantibodies in human serum by manual fluorescent microscopy or with the Image Navigator® Fluorescence SemiAutomated Microscope. This test system is to be used as an aid in the detection of anti-mitochondrial (AMA), antiparietal cell (APCA), and anti-smooth muscle (ASMA) autoantibodies associated with Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator® semi-automated device and software.

Not Found

This FDA 510(k) clearance letter for K180202, the HISTOFLUOR RODENT LKS FLUORESCENT ANTIBODY TEST SYSTEM Image Navigator by Immuno Concepts, provides information about its intended use but does not include a detailed description of the acceptance criteria or a study proving that the device meets those criteria, nor does it provide specifics about the test set, ground truth, or training set parameters.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. The "Indications for Use" section describes what the device is intended for (qualitative and semi-quantitative detection of certain autoantibodies) and how it's to be used (manual fluorescent microscopy or with the Image Navigator® Fluorescence Semi-Automated Microscope, with a trained operator confirming results).

Therefore, based solely on the provided text, I cannot complete the requested table and detailed study information. The details about the performance study, acceptance criteria, sample sizes, expert qualifications, and ground truth methodologies would typically be found in the 510(k) submission document itself, which is a much larger and more technical document than this clearance letter.

Here's what can be inferred or stated from the provided text, along with the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Information that cannot be determined from the provided FDA clearance letter:

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

• Cannot be determined from the provided text. The clearance letter does not include details on the study design, sample sizes, or data origin.

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 determined from the provided text. The letter states that a "trained operator must confirm results generated with the Image Navigator® semi-automated device and software," implying human oversight, but it does not specify the number or qualifications of experts for establishing ground truth during the validation studies.

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

• Cannot be determined from the provided text. No information on adjudication methods is present.

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 determined from the provided text. The letter does not explicitly mention an MRMC study or quantify human performance improvement with AI assistance. It indicates the device can be used with a semi-automated microscope and software, but the impact on human readers is not detailed.

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

• Implied not standalone by "A trained operator must confirm results." The text states, "A trained operator must confirm results generated with the Image Navigator® semi-automated device and software." This indicates that the device is intended for use with human-in-the-loop and not as a fully standalone diagnostic tool for final results. Whether a standalone performance evaluation was conducted internally for algorithm development is not stated.

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

• Cannot be determined from the provided text. While the device aids in detecting autoantibodies associated with specific conditions (Type 1 Autoimmune Hepatitis, Primary Biliary Cholangitis, and Pernicious Anemia/Autoimmune Gastritis) "in conjunction with other laboratory and clinical findings," the specific method for establishing ground truth in the device's validation studies is not described.

8. The sample size for the training set

• Cannot be determined from the provided text. Information about the training set size is not included in this document.

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

• Cannot be determined from the provided text. No details are provided regarding the establishment of ground truth for any training data used for the device's algorithm.

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Instrument: The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides. The Image Navigator can only be used with cleared or approved Immuno Concepts in vitro diagnostic assays that are indicated for use on the microscope. All suggested results generated by the Image Navigator software must be confirmed by trained laboratory personnel.

Assay: This is an indirect fluorescent antibody test for the semi-quantitative detection of IgG antinuclear antibody (ANA) in human serum by manual fluorescent microscopy or with the Image Navigator Fluorescence Semi-Automated Microscope. This test system uses transfected HEp-2000® cells, which allow specific identification of autoantibodies to the SSA/Ro antigen. Autoantibodies to SSA/Ro may show a distinctive staining pattern on the transfected cells. When this pattern is present, it is considered to be confirmatory evidence that anti-SSA/Ro antibodies are present. Absence of this distinctive pattern does not rule out the possible presence of anti-SSA/Ro antibodies. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease in conjunction with other laboratory and clinical findings. A trained operator must confirm results generated with the Image Navigator semi-automated device and software.

The Immuno Concepts Image Navigator is an automated system consisting of a fluorescent microscope and software that acquires, interprets, stores, and displays digital indirect immunofluorescent slides.

The provided document serves as an FDA 510(k) clearance letter for the HEp-2000® Fluorescent ANA/Ro Test System; Image Navigator by Immuno Concepts. While it outlines the device's indications for use and classification, it does not include detailed information regarding acceptance criteria, study design, specific performance metrics, or ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is an administrative clearance, not a scientific study report.

To answer your request, a different type of document, such as a summary of safety and effectiveness (SSED) from the FDA or the original submission's performance data, would be needed.

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