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The disposable guide KDNG00 is dedicated for endocavity diagnosis ultrasound needle guided procedure. It is intended for clinicians and assistant clinic and hospital, to guide linear instrument with a transrectal approach.

The products concerned are plastic guides designed to be clipped on an endocavity ultrasound probe (KOELIS probes K3DEC00/K3DEC00-2 cleared under K170521), to guide a linear instrument through transrectal access. The disposable guides KDNG00 are packaged individually in pouches and delivered sterile. Pouches are then gathered in dispenser boxes (24 guides/dispenser box).

This is a 510(k) premarket notification for a medical device called "Disposable Guide KDNG00". The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, especially in the context of an AI/human-in-the-loop system, is not available in the provided text. The document explicitly states: "The subject of this premarket submission did not require clinical studies to support substantial equivalence."

This device, a disposable guide for ultrasound-guided needle procedures, is a hardware accessory and not an AI or software-driven diagnostic tool. The "performance" discussed is primarily related to its physical characteristics, biocompatibility, and sterilization, which are evaluated through non-clinical testing and comparison to existing predicate devices.

Here's a breakdown of why each requested point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document demonstrates substantial equivalence through a comparison of technological characteristics, materials, and safety/effectiveness principles, not against a predefined set of performance metrics of an AI system.
2. Sample size used for the test set and the data provenance: Not applicable. No test set for an AI model or clinical study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI model is established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or ground truth adjudication process is mentioned.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth generation for an AI model is mentioned. The "effectiveness" mentioned refers to its mechanical function and secure fit, analogous to hardware performance, not diagnostic accuracy.
8. The sample size for the training set: Not applicable. This is not an AI device requiring a training set.
9. How the ground truth for the training set was established: Not applicable. No ground truth for a training set is established.

The provided document details a 510(k) submission for a physical medical device. The "performance" is assessed through comparison to predicate devices, focusing on:

• Intended Use and Indications for Use: Both the subject device and predicates provide a fixed path for the needle for transrectal ultrasound-guided procedures (Pages 4, 5).
• Design: Plastic vs. Inox (stainless steel) with similar clipping mechanisms for stability (Page 6).
• Materials: Polycarbonate (medical grade) for the subject device compared to stainless steel and thermoplastics for predicates (Page 6).
• Safety (Biocompatibility): Tested for cytotoxicity, irritation, and sensitization in accordance with ISO 10993-1 and FDA Good Laboratory Practices (GLP). Sterilization effectiveness (EtO) tested per ISO 11135-1. These tests concluded the device is biologically safe (Pages 6-7).
• Effectiveness (Mechanical): Designed for secure and aligned fit, accurate needle path, and contoured for patient comfort (Page 7).

The conclusion explicitly states: "KOELIS considers the subject device to be as safe, as effective and with performance substantially equivalent to the predicate devices." (Page 7)

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The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions.

1. Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range)
   The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for guiding needles during ultrasound-guided interventions for diagnosis and treatment.

2. a. CON-LEAD range and LIN-LEAD range
   The guides from CON-LEAD range and LIN-LEAD range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment.

3. b. PERINE range
   The guides from the PERINE range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment on adult males.

4. Steady Pro range
   The Steady Pro range provides physician a tool for performing ultrasound-guided interventions with the use of an endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and cancer treatment.

The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are intended to provide a fixed path for needle insertion during ultrasound-guided interventions. The path is aligned with the ultrasound scan plane for needle imaging during the procedure. The ultrasound system can visualize the prospective path (as an on-screen guideline) in the ultrasound image to help needle positioning.

CON-LEAD range and LIN-LEAD range: The guides have an attachment system in which a perforated part is attached in order to place a needle. It is a system with removable parts (nails) to adapt to the different diameters of needles. The guides shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices. It is delivered cleaned but not sterile.

PERINE range: The guides have an attachment system in which a perforated part is attached in order to place a needle. For some applications, there is a system with removable parts (nails) to adapt to the different diameters of needles. There is a possibility to have a fix or a movable system depending on the guide chosen. The guides shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices. It is delivered cleaned but not sterile.

Steady Pro range: The Steady Pro range is a system which holds a 2D/3D lateral-fire endocavitary or 2D/3D endfire endocavitary ultrasound probe. It is an accessory of KOELIS systems. The main functions are to move the probe freely inside the working space of the probe holder in unlocked state, to maintain the probe in a specific position for an extended time when locked, to provide 6 degrees of freedom (rotation + translation) for arm and probe positioning, easy to use, sterilizable and cleanable, easy to cover and protect.

The provided text is a 510(k) summary for Koelis' reusable guides, specifically the PERINE range, NAIL range, CON-LEAD range, LIN-LEAD range, and the STEADY PRO range. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, test reports, or specific study designs with detailed performance metrics.

Therefore, many of the requested items cannot be extracted directly from this document. However, I can still provide information based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "Verification and validation were performed to ensure that devices meet requirements" for the CON-LEAD, LIN-LEAD, and PERINE ranges, and "The design ensures accurate holding of the transducer. Verification and validation were performed to ensure that devices meet requirements" for the Steady Pro range. However, it does not specify what these requirements or acceptance criteria were, nor does it provide quantitative performance data. The device's primary function is guiding needles or holding an ultrasound probe, implying accuracy and stability as key performance indicators, but no specific metrics are given.

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

The document explicitly states: "The subject of this premarket submission did not require clinical studies to support substantial equivalence." This means there was no "test set" in the context of clinical performance evaluation with human data. The "tests" performed were non-clinical (biocompatibility, cleaning, disinfection effectiveness, and compliance with safety standards). No sample sizes or data provenance for these non-clinical tests are provided in this summary.

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

Since no clinical studies were performed and thus no "test set" with ground truth from human data was established, this information is not applicable and not available in the provided document.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No MRMC study was mentioned. The submission states that no clinical studies were required.

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

Not applicable as this is not an AI/algorithm-based device. It is a physical guide and holder for medical procedures.

7. The Type of Ground Truth Used:

For the non-clinical tests (biocompatibility, cleaning, disinfection effectiveness, and safety standards compliance), the "ground truth" would be established by the specifications defined in relevant international and national standards and regulations. The document states that the devices were "found to be compliant with applicable medical device safety standards" and "comply with voluntary standards," implying that these standards served as the basis for evaluation.

8. The Sample Size for the Training Set:

Not applicable, as this is not an AI/machine learning device that would require a training set.

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

Not applicable.

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Ultrasound System TRINITY and its embedded 3D PROSTATE SUITE software are intended to be used by clinicians and their assistants. qualified to perform ultrasound diagnosis and ultrasound-guided procedures, in public or private hospitals. TRINITY is indicated to: · Generate ultrasound images for structural analysis and fluid flow analysis for o urology, o gynecology, o vascular. o abdominal, o small organs. o soft tissues and o musculoskeletal exams TRINITY is not indicated for ophthalmic and cranial ultrasonography. Medical Imaging Processing System 3D-PROSTATE SUITE, embedded on TRINITY or other KOELIS systems that do not integrate a 3D ultrasound module, is indicated to: · Process, visualize and record various 2D and 3D image modalities (such as Ultrasound images, MRI) · Fuse images of various modalities · Display organ and perform measurements · Display cartographies of prostate interventions (instrument positions) · Manage patient data · Import and export of data and images

TRINITY is an electro medical system considered as a system composed of: - A mobile workstation composed by a central unit with ultrasound beamformer, a tactile ● screen, a mouse, a touch pen and a footswitch, all assembled on a mobile cart. Options, as keyboard and trackball mouse, can be delivered. - 0 Ultrasonic probe: 2D/3D end-fire endocavity probe and/or 2D/3D side-fire endocavity probe. 2D probes can be optionally delivered. - 3D PROSTATE SUITE software composed of the base software and PROMAP –Ty that drives the 0 ultrasound module and performs additional measuring functions. The system generates ultrasound waves in the low megahertz range, typically from 1 Mhz to 20 Mhz. Two main ultrasound modes are provided by the system: B-mode imaging for structural analysis and Doppler imaging (including color flow sub-mode and power sub-mode) for body fluid flow analysis. - B-mode imaging measures the time and waveform differences between wave emission and o wave reception to reconstruct an image. - 0 Doppler imaging uses in addition the Doppler Effect to show flow direction and to inform about relative velocity (no measurement) (color flow sub-mode) or to show flow strength (power sub-mode). The system also provides 3D B-mode imaging for high quality ultrasound acquisition of anatomical volumes. The technology employed is volume-swept 3D ultrasound.

This document is a 510(k) Summary for the KOELIS TRINITY / 3D PROSTATE SUITE device. It establishes substantial equivalence to previously cleared devices rather than providing performance data against specific acceptance criteria for new features or AI-driven improvements. As such, it does not contain the detailed study information typically associated with proving a device meets acceptance criteria for novel algorithms, especially those involving AI.

Therefore, many of the requested fields cannot be directly populated from the provided text. The device is primarily an ultrasound system with associated software for processing and visualizing images, and the application focuses on expanding its indications for use and adding a new probe. The "Summary of Clinical Tests" explicitly states: "The subject of this premarket submission did not require clinical studies to support substantial equivalence."

Based on the provided text, here's an attempt to answer the questions:

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

The document does not provide a table of acceptance criteria with reported quantitative performance metrics for the TRINITY / 3D PROSTATE SUITE in the context of novel algorithmic performance or AI. The acceptance is based on demonstrating substantial equivalence to existing predicate devices for similar clinical applications and modalities, and compliance with various safety and performance standards.

The criteria for acceptance appear to be:

• Substantial Equivalence: Demonstrated through comparison of intended use, imaging capabilities, technological characteristics, scientific backgrounds, safety, and effectiveness to predicate devices (K160357 TRINITY and K160182 Logiq S7 expert).
• Safety Standards Compliance: Meeting voluntary standards for acoustic output, biocompatibility, cleaning/disinfection, thermal, electromagnetic, and mechanical safety (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set).
• Quality Assurance Measures: Application of risk analysis, requirements reviews, design reviews, varying levels of testing (unit, integration, final acceptance, performance, safety).

Since no new algorithmic performance (e.g., AI accuracy) is being claimed or evaluated, there are no reported quantitative performance metrics against these criteria beyond the statement that the device is "as safe, as effective, and performance is substantially equivalent to the predicate devices."

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

As stated, "The subject of this premarket submission did not require clinical studies to support substantial equivalence." Therefore, there is no clinical "test set" with patient data in the typical sense for evaluating a novel algorithm's performance. The "testing" referred to is against engineering and safety standards, not clinical performance on a dataset of images with ground truth.

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 test set with ground truth established by experts for algorithmic performance evaluation was described as part of this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) 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

No such study was conducted or reported in this 510(k) summary. The device's substantial equivalence is based on its core functionality as an ultrasound system and imaging processing system, not on AI assistance to human readers.

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

This is not an AI-driven diagnostic algorithm. It's an imaging system and processing software. Therefore, the concept of "standalone performance" for an AI algorithm is not applicable here. The system's performance is intrinsically tied to its ability to generate, process, and display images for human interpretation and procedures.

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

Not applicable, as no clinical performance study involving ground truth for an algorithm was conducted.

8. The sample size for the training set

Not applicable, as this is not an AI/ML submission describing a model trained on a dataset.

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

Not applicable.

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TRINITY® Ultrasound and Medical Imaging Processing System is intended to be used by clinicians and their assistants.

The device is indicated to generate, visualize and record 2D and 3D ultrasound images.

In the particular context of prostate biopsy, the device embedding the 3D PROSTATE SUITE SOFTWARE is indicated to process, visualize and record 3D digital ultrasound images in a view to map the organ.

Additional features include 2D/3D image and organ display, measurement, data management, multimodal image fusion (ultrasound, MRI, etc.).

Patient population: all patients requiring an ultrasound scan or ultrasound-based intervention particularly in urology.

TRINITY is an electro medical system considered as a system composed of:

• A mobile workstation composed by a central unit with ultrasound beamformer, a tactile . screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart. Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse.
• Ultrasonic probe: 2D/3D end-fire endocavity probe. Optionally 2D probes can be delivered: linear probe and abdominal probe.
• 3D PROSTATE SUITE PROMAP software composed of the base software and PROMAP –Ty that drives the ultrasound module and perform additional measuring functions.

The system generates ultrasound waves in the low megahertz range, typically from 1 Mhz to 20 Mhz.

Two main ultrasound modes are provided by the system: B-mode imaging for structural analysis and Doppler imaging for body fluid flow analysis.

• B-mode imaging measures the time and waveform differences between wave emission and . wave reception to reconstruct an image.
• . Doppler imaging uses in addition the Doppler Effect to show flow direction and to inform about relative velocity (no measurement).

The system also provides 3D B-mode imaging for high quality ultrasound acquisition of anatomical volumes. The technology employed is volume-swept 3D ultrasound.

The clinician can control acoustic output intensity with the TI and MI indices provided by the system. They indicate the level of thermal and mechanical stress that the system causes to the tissues, allowing the clinician to apply an ALARA-principle based exposure reduction strategy.

This document is a 510(k) Premarket Notification from the FDA regarding the TRINITY Ultrasound and Medical Imaging Processing System. While it provides detailed information about the device's intended use, technological characteristics, and compliance with safety standards, it explicitly states that "The subject of this premarket submission did not require clinical studies to support substantial equivalence."

Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria because a clinical study was not performed as part of this submission. The submission relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study.

Here's what can be inferred from the document regarding the information requested, based on the absence of a clinical study:

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

• This information is not provided because no clinical study was conducted. The document focuses on demonstrating equivalence to predicate devices based on technical specifications and non-clinical tests.

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

• Not applicable, as no clinical test set was used for a study proving device performance.

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 test set requiring ground truth was used for a study proving device performance.

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

• Not applicable, as no clinical test set requiring adjudication was used for a study proving device performance.

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. No MRMC study was performed. The device is an ultrasound system and processing software, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study comparing human readers with and without AI assistance for a specific clinical task.

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

• Not applicable. The TRINITY system is an ultrasound and medical imaging processing system intended to be used by clinicians. It is not an algorithm-only standalone diagnostic tool. Its performance is inherent to the generation, visualization, and recording of ultrasound images, and processing of 3D digital ultrasound images for tasks like organ mapping (with the 3D PROSTATE SUITE SOFTWARE).

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

• Not applicable, as no clinical study required establishing ground truth for performance evaluation of "new" clinical results.

8. The sample size for the training set:

• Not applicable, as no clinical study with a training set was performed for this submission. The device leverages existing technology and previously cleared software (UROSTATION - 3D PROSTATE SUITE, K131448).

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

• Not applicable, as no clinical study with a training set was performed for this submission.

Summary from the document:

• Basis for Approval: Substantial equivalence to predicate devices (LOGIQ S7 Expert and LOGIQ S7 Pro (GE Healthcare) K141261, and UROSTATION - 3D PROSTATE SUITE (KOELIS) K131448).
• Non-Clinical Tests: Acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety were evaluated and found compliant with applicable medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set).
• Clinical Studies: None were required or performed for this premarket submission to support substantial equivalence.

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The reusable guide is intended to provide physicians a tool for performing needle/instrument guided procedures with the use of the ultrasound endocavity transducer. The guide is attached over the endocavity transducer/probe/scanhead instruments. This device provides a fixed path for the needle or the instrument that when coupled by the ultrasound system software corresponds to on-screen imaging guidelines for visualizing guided instrument placement procedures. KOELIS endorectal ultrasound guides are supplied cleaned and are reusable.

The reusable guide is dedicated for transrectal diagnosis ultrasound needle /instrument guided procedure.

The reusable guide is designed to be clipped onto an ultrasonic endocavity probe, to guide a needle along the said probe, and to be cleaned and re-sterilized after use.

The provided text describes a 510(k) summary for a "Reusable Guide" manufactured by KOELIS. This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed clinical study data or acceptance criteria related to device performance in a clinical setting.

Therefore, many of the requested sections about acceptance criteria, detailed study designs, and performance metrics are not present in the provided text. The submission focuses on device characteristics, intended use, and materials to establish equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided as a formal table with acceptance criteria. The submission focuses on demonstrating substantial equivalence to a predicate device (CIVCO Transrectal Needle biopsy Guide, K875128/A) by comparing technological characteristics, intended use, and materials.

The 'Effectiveness' section states:

• "Both the subject and predicate devices are designed for secure and aligned fit to the transducer, while not altering the transducer design integrity or function."
• "Positive registration features of the design ensures accurate needle / instrument path and placement in relation with the transducer."
• "Exterior shapes of the guide are contoured for patient comfort with no sharp edges."

These statements describe design goals and anticipated performance, but not quantifiable acceptance criteria or reported device performance metrics from a formal study.

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

Not applicable. This submission does not describe a clinical study with a test set of data. It is a 510(k) summary focused on device design and comparison to a predicate.

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

Not applicable. No clinical study or ground truth establishment is described.

4. Adjudication Method for the Test Set

Not applicable. No clinical study or adjudication process is described.

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

No. No MRMC study or comparative effectiveness study involving human readers is mentioned.

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

Not applicable. This device is a mechanical guide, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. No ground truth for device performance is described. The submission relies on design specifications and material safety evaluations.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm is relevant to this mechanical device.

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

Not applicable. No ground truth for a training set is relevant to this mechanical device.

Summary of available information related to performance and safety:

The submission focuses on inherent device characteristics and comparison to the predicate device to establish safety and effectiveness, rather than a quantifiable performance study against specific acceptance criteria.

• Intended Use & Indications for Use: The device is intended for "transrectal diagnosis ultrasound needle/instrument guided procedures."
• Design & Effectiveness (as stated):
  • Secure and aligned fit to the transducer without altering its function.
  • Positive registration features ensure accurate needle/instrument path and placement.
  • Contoured exterior shapes for patient comfort with no sharp edges.
• Material Safety: The device uses Stainless steel (304, 316L, 17/4 PH). KOELIS conducted a biological safety evaluation based on risk analysis, literature data, and manufacturing process according to ISO10993-1. The report concluded adequate data to demonstrate biological safety. This is a critical aspect for a reusable device with limited body contact (intact skin/mucosal membranes,

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UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is a computer-based software application intended to process, visualize and record 3D digital ultrasound images of the prostate.

UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of the prostate gland and for the 3D transrectal ultrasound based fusion of multiple imaging modalities (ultrasound, MRI) in order to map such prostate gland. Additional software features include patient data management, multimodal data communication, multiplanar reconstruction, surface and volume rendering, organ delineation, region of interest delineation, 3D image registration and data reporting.

UROSTATION - 3D PROSTATE SUITE is a computer-based software application designed to process, visualize and record 3D digital ultrasound images of the prostate, and to manage patient and clinical data in the context of transrectal prostate biopsy. Software options provide the fusion of 3DTRUS with MRI or with other 3DTRUS modalities.

Hardware Platform and Operating System
The application runs on a standard Personal Computer under Microsoft Windows® operating system (version 7 or higher).

Peripheral and accessories
The application is controlled by a footswitch and manual input devices (mousc, kevboard),
It is designed to work in connection with commercially available 3D ultrasound scanners with Ethernet connection, 3D transrectal ultrasound probe and needle guide.

Software Features
UROSTATION - 3D PROSTATE SUITE implements image fusion and display algorithms to provide 3D representation of prostate biopsies.

A typical workflow enables the physician to intraoperatively visualize the 3D mapping of biopsies with respect to a 3DTRUS reference image of the patient's prostate.

For that purpose. 3D digital images may be transferred at any time from the 3D ultrasound scanner to the Urostation for registration and display, while the physician keeps track of the organ on the ultrasound scanner using the usual 2D live B mode.

Optionally, MRI/3DTRUS fusion allows the elastic registration of the 3DTRUS reference image with other imaging modalities (MRI here) in order to display the 3D biopsy mapping on multiple imaging modalities.

Optionally, Second Look 3DTRUS Fusion allows the elastic registration of the 3DTRUS reference image with a previously acquired 3DTRUS reference image of the same patient in order to superimpose two 3D biopsy mappings on a unique 3DTRUS reference image.

Alternatively, UROSTATION - 3D PROSTATE SUITE also provides a review mode that allows the mapping of histologic results on the said 3D reference image of the patient's prostate. Patient information, images and 3D biopsy mapping may be stored or printed for future retrieval and examination.

The acceptance criteria for the UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and Second Look 3DTRUS fusion option are based on its performance and accuracy in image fusion and organ tracking. The device aims to assist physicians in targeting different regions of the prostate by registering biopsy cores and optionally MR lesions on a reference 3DTRUS image.

The studies presented validate the performance and accuracy of the KOELIS fusion technology on both phantom and patient data.

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Elastic MR/3DTRUS image fusion (Brolis et al, 2012):
     • Test set: 17 contoured TRUS patient volumes for simulated deformations, resulting in 850 simulated deformations.
     • Clinical Validation: 49 patients.
     • Data Provenance: Not explicitly stated, but "5 clinical sites" suggests multi-center data, likely prospective clinical data given the "clinical validation" and "landmark pairs were identified and approved by physicians".
   • Elastic 3DTRUS/3DTRUS image fusion and organ tracking (Baumann et al, 2012):
     • Test set: 786 biopsy volumes acquired from 47 patients.
     • Accuracy evaluation: 687 registered volumes stemming from 40 patients.
     • Data Provenance: Not explicitly stated, but implies prospective data ("during biopsy sessions").
   • Targeting Accuracy of Urostation (Ukimura et al, 2012):
     • Test set: 6 prostate phantoms (3 containing 3 hypoechoic lesions and 3 containing 3 isoechoic but MRI-visible lesions).
     • Data Provenance: Phantoms (simulated environment). This study also references "clinical validation" in other sections, but for targeting accuracy, it's explicitly phantom-based.

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

   • Elastic MR/3DTRUS image fusion (Brolis et al, 2012): "Physicians" identified and approved 112 landmark pairs. Specific number and qualifications beyond "physicians" are not provided.
   • Elastic 3DTRUS/3DTRUS image fusion and organ tracking (Baumann et al, 2012): Not explicitly stated how ground truth for accuracy evaluation (using fiducials) was established, but implies fiducial markers as objective ground truth.
   • Targeting Accuracy of Urostation (Ukimura et al, 2012): The ground truth for lesion location in phantoms is inherent to the phantom design. The accuracy of biopsy "hitting the lesion" is a direct measurement based on the physical phantom. No external experts are mentioned for ground truth establishment for this specific study.

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

   • Not explicitly stated for any of the studies. For the clinical validation in Brolis et al., "landmark pairs were identified and approved by physicians," which suggests a consensus or verification process, but the specific method is not detailed.

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:

   • The provided information does not include an MRMC comparative effectiveness study that assesses the improvement of human readers with AI assistance versus without. The studies focus on the intrinsic accuracy and performance of the fusion technology itself.

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

   • Yes, the "Performance summary" section primarily describes standalone algorithm performance in terms of registration accuracy, error rates, and hit probabilities for both fusion capabilities and targeting accuracy. The Brolis et al. study on "simulated deformations" and the Baumann et al. study on "system robustenss" and "accuracy was evaluated to 0.76mm±0.52mm using fiducials" directly assesses the algorithm's performance. Similarly, the phantom study by Ukimura et al. measures the algorithmic accuracy of targeting.

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

   • Brolis et al. (Elastic MR/3DTRUS): Expert-identified landmark pairs and contours (from 3DTRUS patient volumes) for registration accuracy.
   • Baumann et al. (Elastic 3DTRUS/3DTRUS): Fiducials (objective physical markers) for evaluating tracking accuracy.
   • Ukimura et al. (Targeting Accuracy): Physical lesion locations within prostate phantoms. Biopsy success was likely determined by confirming needle placement relative to the known lesion locations in the phantoms.

7. The sample size for the training set:

   • The document does not explicitly state the sample size for the training set for any of the algorithms. These studies primarily describe validation/testing.

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

   • Since the training set size and details are not provided, how its ground truth was established is also not detailed in this document.

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UROSTATION - 3D PROSTATE SUITE is a computer-based software application intended to process, visualize and record 3D digital ultrasound images of the prostate.

UROSTATION - 3D PROSTATE SUITE is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multi-planar reconstruction and 3D image registration.

UROSTATION - 3D PROSTATE SUITE is a computer-based software application designed to process, visualize and record 3D digital ultrasound images of the prostate, and to manage patient and clinical data in the context of transrectal prostate biopsy.

This 510(k) summary does not contain the acceptance criteria or a study proving that the device meets acceptance criteria in the traditional sense of a clinical performance study with statistical endpoints.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (3-D Imaging Workstation, K081093) based on shared intended use, technological characteristics, and functions. The "study" here is a comparison of features and capabilities.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Acceptance Criteria: The acceptance criteria are implied by the features of the predicate device. The goal of this 510(k) is to show UROSTATION performs similarly or introduces no new risks despite differences. There are no explicit quantitative performance metrics or thresholds mentioned as "acceptance criteria" for a study to meet.

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

• Sample Size: Not applicable. The document describes a comparison to a predicate device's functionalities, not a clinical test set for performance evaluation.
• Data Provenance: Not applicable. No specific data or images were used for performance evaluation in a clinical study context.

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

• Number of Experts: Not applicable. No ground truth was established by experts for a test set in this submission.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. No test set requiring expert adjudication was conducted.

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:

• MRMC Study: No. This submission does not include an MRMC comparative effectiveness study. The device is image processing software, not an AI diagnostic tool requiring evaluation of human reader performance.
• Effect Size: Not applicable.

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

• Standalone Study: No. This submission does not describe a standalone performance study. The device's function is to process and visualize images for physician use, not to make independent diagnoses.

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

• Type of Ground Truth: Not applicable. No ground truth data (e.g., pathology, outcomes) was used for performance validation in this context. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Sample Size: Not applicable. The document does not mention any machine learning or AI components that would require a "training set" in the context of performance evaluation. It describes software with image processing and display algorithms.

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

• How Ground Truth Was Established: Not applicable, as there is no mention of a training set.

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