Search Results

The indications for use for the RL-S20S-TWC include:
The Super Hair Removal (SHR) Mode are intended for temporary hair reduction.
The indications for use for the RL-S20S-755A include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes)
The indications for use for the RL-S20S-810B include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

Not Found

The provided FDA 510(k) clearance letter and Indications for Use document for the Artemis Diode Laser System do not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

The document primarily focuses on:

• Confirming the substantial equivalence of the device to legally marketed predicates.
• Listing the specific Indications for Use, which primarily involve temporary or permanent hair reduction across different skin types.
• Outlining regulatory compliance requirements (e.g., Quality System regulation, adverse event reporting).

Therefore, based solely on the provided text, it is not possible to answer your questions about the acceptance criteria, device performance study details, or ground truth establishment. This information would typically be found in the full 510(k) submission, which is not included here.

Ask a specific question about this device

Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management.

Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers. Artemis is also intended to be used for patients in active surveillance to keep track of previous procedures information and outcomes.

Artemis Cryo Treatment Planning module is an add on to the existing Artemis software that allows physicians to prepare for cryo treatment planning based on positive pathology cores obtained during Artemis guided biopsies and registration results with other imaging modalities such as MRI, CT. The module allows accurate placement of cryo probes on targets, 3D tracking, real-time feedback on extend of cryo ice formation. The technology provided by Artemis generates ice models based on the specifications provided by the cryo device manufacturers and displays the models on the live ultrasound to provide guidance to the users during the procedure.

The module also allows outlining or segmenting other organs that surround the prostate. Organs include bladder and urethra.

Artemis is designed to display the 2-D live video received from commercially available ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, probe, commercially available biopsy needle guide, needle gun combination, and cryoablation systems. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement, reporting and 3-D image registration.

Artemis is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position. The mechanical tracker is connected to a PC-based workstation containing a video digitizing card and running the image processing software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Artemis. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3-D image and 3-D rendered surface model of the prostate.

The reconstructed 3-D image can be further processed to perform various measurements including volume estimation, which can be examined for abnormalities by a physician. Patient information, notes, and images may be stored for future retrieval, and locations for biopsies may be selected by the physician. The system also allows previously acquired 3-D models to be recalled, aligned, or registered to the current 3-D model of the prostate, which is especially useful for patients under active surveillance.

The physician may attach a commercially available biopsy needle guide compatible to the ultrasound probe and use the probe and needle to perform tissue biopsy and or cryoablation. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of Artemis during the procedure. As the ultrasound probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe with respect to the organ is tracked. Artemis is able to add, display and edit loaded plans for the procedure as well as provide the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate.

In addition to standard transrectal needle guidance procedures, Artemis also supports transperineal needle guidance by mounting a Needle Guide Attachment (NGA). A commercially available needle guide compatible with the NGA is used. This NGA will be used for both biopsy and cryo needles. The NGA provides additional data to track the needle direction angle. When using transperineal mode, the procedure planning, segmentation, registration and navigation are performed in the same way as the standard transrectal procedure. The only difference lies in how the needle guide needs to be moved to target the different planned locations. For the transrectal procedure, the needle guide is always attached to the probe. Therefore moving the probe moves the needle guide. In transperineal needle guidance procedures the needle is not attached to the probe. Therefore the NGA needs to be moved to move the needle guide. Artemis highlights the closed target to the current needle guide position.

Artemis offers the physician additional 3-D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous Ultrasound probe based procedures, and the physician always has access to the live 2-D ultrasound image during prostate assessment or biopsy procedure. The device also provides automated reports with information and pictures from the procedure.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the Artemis medical imaging system.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance results. Instead, it broadly states that "Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met." It mentions that "Measurement validation using, phantoms, clinical CT, and MRI images were used to show that Artemis performs as well as or better than the predicate devices and furthermore shows that Artemis was safe and effective."

Below is a table summarizing the types of tests and the overall conclusion regarding acceptance, as the specific numerical criteria and results are not detailed in this public summary.

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

• Sample Size for Test Set: The document does not specify the exact sample size (number of phantoms or clinical images) used for the measurement validation or other performance tests. It states "Measurement validation using, phantoms, clinical CT, and MRI images were used."
• Data Provenance: The provenance (e.g., country of origin, retrospective or prospective) of the clinical CT and MRI images used for measurement validation is not specified in the provided text. The testing appears to be non-clinical and performed at the manufacturer's facility ("at the manufacturer's facility and has passed all in-house testing criteria").

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications. The testing described is "nonclinical and performance testing" and "measurement validation," suggesting a focus on technical accuracy rather than human interpretation studies.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for establishing ground truth, such as 2+1 or 3+1.

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

There is no mention of an MRMC comparative effectiveness study being performed, nor any effect size regarding how human readers might improve with AI vs. without AI assistance. The study described focuses on the device's technical performance and comparison to predicate devices, not on human-in-the-loop performance.

6. Standalone (Algorithm Only) Performance

The testing primarily focuses on the device's technical performance, including "measurement validation." This strongly implies that a standalone (algorithm only) performance evaluation was conducted to ensure the device's core functionalities, such as image reconstruction, segmentation, registration, and ice model generation, meet design specifications independently. The statement "Artemis has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications" supports this. Specific performance metrics (e.g., accuracy, precision) for these standalone functions are not provided, only a general statement of meeting acceptance criteria.

7. Type of Ground Truth Used

The type of ground truth used for performance validation included:

• Phantoms: For measurement validation.
• Clinical CT images: For measurement validation.
• Clinical MRI images: For measurement validation.

The basis for the "ground truth" on these phantoms and clinical images (e.g., known measurements for phantoms, expertly annotated features on clinical images) is implied but not explicitly detailed.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size used for any potential training set. The descriptions of "nonclinical and performance testing" and "measurement validation" focus on evaluation (test set) rather than model training. It's possible that a training set was used for specific software features involving image processing or reconstruction, but this is not mentioned.

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

As no information about a training set is provided, there is also no information on how its ground truth might have been established.

Ask a specific question about this device

The Artemis Proximal Femoral Nail System is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.

Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch.

The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Proximal Femoral Nail Kit Long, Locking Screw, Lag Screw, and optional anti-rotational locking pins) as well as non-sterile, reusable, Class I and II surgical instruments.

The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).

The Artemis Nails are available in short or long lengths from 180mm to 440mm and are cylindrical rods with preassembled Set Screws. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm. Optional Anti-rotational Locking Pins are also available to aid in rotational stability.

The provided document describes the FDA 510(k) clearance for the Artemis Proximal Femoral Nail System. This document is a regulatory submission for a medical device that does not involve AI/ML components for diagnostic purposes, and therefore, the acceptance criteria and study proving device performance are based on mechanical and physical properties rather than algorithmic performance on image data.

Therefore, I cannot provide information on the following points:

• 1. A table of acceptance criteria and the reported device performance (in terms of AI/ML metrics): The document reports mechanical testing results, not AI/ML performance metrics.
• 2. Sample size used for the test set and the data provenance: There is no "test set" in the context of AI/ML for this device. The testing refers to mechanical and physical properties.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant for this type of device 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: Not applicable.
• 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.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

However, based on the provided text, I can infer the "acceptance criteria" and "study proving device meets acceptance criteria" in the context of a non-AI medical device submission:

Acceptance Criteria and Study for the Artemis Proximal Femoral Nail System:

The acceptance criteria for the Artemis Proximal Femoral Nail System are based on its mechanical performance and material characteristics, demonstrating that the device is substantially equivalent to a predicate device. This is a common pathway for Class II medical devices where performance can be validated through engineering and physical testing, rather than clinical studies or AI algorithm performance.

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical/Material Focus):

Study Proving the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is primarily non-clinical performance testing, specifically mechanical testing.

• Type of Study: Mechanical Testing
• Specific Tests Conducted:
  • ASTM F1264: Standard Specification for Extramedullary Splints and Bone Plates (likely referenced for general principles or associated components, though the primary device is intramedullary).
  • ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws.
  • ISO 7206-4: Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components. (This standard refers to hip prostheses, but its principles for static and dynamic bending of constructs are applied to the femoral nail system).
• Data Provenance: The nature of mechanical testing means the "data provenance" is derived from laboratory tests conducted on samples of the device itself. This is typically done in a controlled, prospective manner. Country of origin of the data is not specified but would be the location of the GLW Medical Innovation's testing facilities or contracted labs.
• Sample Size Used for the Test Set: While not explicitly stated for each test, mechanical testing typically involves a sufficient number of samples (e.g., typically 3-6 or more samples per test condition, depending on the standard and variability) to ensure statistical significance and reproducibility of results for the physical properties being evaluated.
• Ground Truth: For mechanical testing, the "ground truth" is defined by the acceptance criteria established within the referenced ASTM and ISO standards. The device 'passes' if its performance (e.g., strength, fatigue life) meets or exceeds the minimum requirements specified in these industry standards for similar devices. There are no human experts establishing ground truth in terms of diagnostic interpretation or clinical outcomes for this specific submission.
• Clinical Data: The submission explicitly states: "No clinical data was necessary." This reinforces that the substantial equivalence determination was based entirely on non-clinical performance data (mechanical testing and comparison to the predicate).

Ask a specific question about this device

The Artemis Proximal Femoral Nail System is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.

The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Locking Screw, and Lag Screw) as well as non-sterile, reusable, Class I and II surgical instruments. The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).

The Artemis Nail is a cylindrical rod with a preassembled 4mm Set Screw, available in one size with a distal diameter of 11mm, a proximal diameter of 16.4mm, and a length of 180mm. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm.

This FDA 510(k) premarket notification describes the Artemis Proximal Femoral Nail System, an intramedullary fixation system. It confirms that clinical data was not needed for this device. The information provided heavily relies on comparisons to predicate devices and mechanical testing, rather than studies involving human participants or AI performance. Therefore, many of the requested details about acceptance criteria and study design are not applicable in this context.

Here's a breakdown of the available and unavailable information based on your request:

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

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

Not applicable. This device is an implantable medical device, and its performance was evaluated through mechanical testing, not clinical studies with human test sets.

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

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement accuracy, not expert human interpretation.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic or AI-assisted performance evaluation, not for mechanical testing of an orthopedic implant.

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-enabled device or a diagnostic tool.

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

Not applicable. This is not an AI-enabled device.

7. The type of ground truth used

For the safety and effectiveness assessment, the ground truth was based on:

• Mechanical Testing Standards: Adherence to established international and American standards such as ISO 7206-4, ASTM F1264, and ASTM F543.
• Predicate Device Performance: Performance data from legally marketed predicate devices served as a benchmark for comparison to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This document refers to the evaluation of a medical device (an intramedullary nail system), not an AI algorithm. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of device evaluation.

Ask a specific question about this device

The Artemis™ Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures.

The Artemis Eye System is indicated to provide visualization and illumination of intracranial tissue and fluids during diagnostic and therapeutic procedures. The System consists of two components:

• Artemis Eye a single-use neuro-endoscope consisting of a camera, two pathways for . irrigation and/or drain, and a working channel for a surgical tool.
• Artemis Eye Tablet a reusable component that connects to the Artemis Eye and . displays live imaging captured by the Artemis Eye camera.

This document is a 510(k) summary for the Penumbra Artemis Eye System, a neurological endoscope. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for algorithm performance.

Therefore, many of the requested details about acceptance criteria for device performance, especially those related to AI or algorithm performance, cannot be extracted directly from this document. The document primarily discusses non-clinical testing for manufacturing, safety, and physical performance of the neuro-endoscope itself.

Here's what can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related):

The document does not present a formal table of acceptance criteria with corresponding performance for the overall device's clinical efficacy or algorithm performance. Instead, it describes various non-clinical tests passed.

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

• This information is not provided in the document. The document describes non-clinical engineering and safety tests rather than performance evaluations on a patient test set.

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

• This information is not provided as the document does not describe a clinical study or an AI/algorithm-based performance evaluation involving expert ground truth.

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

• This information is not provided as there is no mention of a test set requiring adjudication in this document.

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

• No, an MRMC comparative effectiveness study is not mentioned in this document. This document is for a neurological endoscope, not an AI-assisted diagnostic tool in the typical sense that would involve human readers.

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

• This document is for a physical medical device (neuro-endoscope) with associated software for display. It does not describe a standalone algorithm performance in the context of diagnostic AI. The software is for displaying live imaging, not for autonomous analysis or diagnosis.

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

• This information is not applicable in the context of this document, as it focuses on the substantial equivalence of device components and safety, not on diagnostic accuracy against a ground truth.

8. The sample size for the training set:

• This information is not provided as the document does not describe the development or training of an AI algorithm.

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

• This information is not applicable as the document does not describe the development or training of an AI algorithm.

Ask a specific question about this device

The Artemis™ Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.

Penumbra Aspiration Pump:
The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.

The Artemis™ Neuro Evacuation Device, is a surgical instrument designed to aid a physician in the removal of tissue and/or fluid during image-guided neurosurgery. The Artemis Wand has two functions. These functions are control and transfer of aspiration and generation of rotational energy. Aspiration is generated by a Penumbra Aspiration Pump, which the Artemis Wand connects to through its flexible tubing. The Artemis Wand has a rigid hypotube containing a wire to facilitate removing tissue and/or fluid with the assistance of rotational energy and aspiration.

The Artemis Wand is designed to be image-guided, allowing visualization of the procedure. The method of removal is vacuum aspiration, which draws the tissue and/or fluid into the lumen of the Wand hypotube. The integrated wire is fully contained within the lumen of the Wand hypotube, and has rotational capability facilitating movement of any tissue and/or fluid that may otherwise clog the hypotube lumen.

The provided text describes the Penumbra Artemis™ Neuro Evacuation Device and its substantial equivalence to a predicate device, the Apollo System. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting a comparative effectiveness study with human readers or a standalone algorithm performance study.

Therefore, the information required to answer the following points is not available in the provided text:

• A table of acceptance criteria and the reported device performance: While some tests are listed with "100% Pass" or descriptions like "Non-toxic," specific numerical acceptance criteria (e.g., minimum aspiration rates, maximum force tolerances) and their corresponding performance values are not detailed. The provided information summarizes categories of tests and their overall success.
• Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The text mentions "Design Verification (Bench-Top Testing)" and "Simulated Use" but does not specify the sample sizes (number of devices or simulated clots) used for these tests. Data provenance is also not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not relevant to the non-clinical, bench-top testing described.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to the non-clinical testing.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This study type is not mentioned or implied, as the device is a mechanical neuro evacuation device, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is a mechanical instrument.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be established engineering specifications and successful execution of the test methods (e.g., passing a specific force test, achieving a certain vacuum level, being non-toxic per ISO standards).
• The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

However, based on the provided text, here is a summary of the acceptance criteria and study information that is mentioned:

Acceptance Criteria and Reported Device Performance (Based on available summary data):

Additional Information from the text:

• Study Types: The studies conducted are primarily non-clinical bench-top testing and biocompatibility testing. This is a type of standalone performance testing in the sense that it evaluates the device's physical and biological properties in a controlled environment, not its performance in humans or with human interaction for diagnostic purposes.
• Ground Truth for Non-clinical Tests: For biocompatibility, the ground truth is established by the specified international and FDA guidelines (EN ISO 10993-1, 21 CFR, Part 58 Good Laboratory Practices). For bench-top testing, the ground truth is against pre-defined product specifications and engineering requirements.
• No Multi-Reader Multi-Case (MRMC) Study or AI/ML Algorithm Performance: The Artemis™ Neuro Evacuation Device is a physical medical instrument, not an AI-powered diagnostic tool. Therefore, studies involving human readers, AI algorithms, training sets, or expert consensus for image interpretation are not applicable and were not performed or reported in this document.

Ask a specific question about this device

Artemis along with the Needle Guide Attachment is used for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and register these images with those from other imaging modalities such as Ultrasound, Magnetic Resonance, Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target organ and the projected future path of the interventional instrument taking into account patient movement. The software also provides a virtual grid on the live ultrasound for performing systematic sampling of the target organ. Other software features include patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management.

Artemis is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diaical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers. Artemis is also intents in active surveillance to keep track of previous procedures information and outcomes.

Artemis is designed to display the 2-D live video received from commercially available ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, TRUS probe, commercially available needle guide, and needle gun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement, reporting and 3-D image registration.

Artemis is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position. The mechanical tracker is connected to a PC-based workstation containing a video digitizing card and running the image processing software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Artemis. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3-D image and 3-D rendered surface model of the prostate.

The reconstructed 3-D image can be further processed to perform various measurements including volume estimation, and can be examined for abnormalities by the physician. Patient information, notes, and images may be stored for future retrieval. Locations for biopsies may be selected by the physician, displayed on the 3-D image and 3-D rendered surface model, and stored. Previously stored 3-D models may be recalled and a stored 3-D model may be aligned or registered to the current 3-D model of the prostate. This is especially useful for patients under active surveillance.

The physician may attach a commercially available biopsy needle guide compatible to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of Artemis during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe with respect to the organ is tracked. Artemis is able to add, display and edit loaded plans for biopsy as well as provide the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate.

In addition to standard transrectal needle guidance procedures, Artemis also supports transperineal needle guidance by mounting a Needle Guide Attachment (NGA). A commercially available needle guide compatible with the NGA is used. The NGA provides additional data to track the needle direction angle. When using transperineal mode, the procedure planning, segmentation, registration and navigation are performed in the same way as the standard transrectal procedure. The only difference lies in how the needs to be moved to target the different planned locations. For the transrectal procedure, the needle guide is always attached to the probe. Therefore moving the probe moves the needle guide. In transperineal needle guidance procedures the needle is not attached to the probe. Therefore the NGA needs to be moved to move the needle guide. Artemis highlights the closed target to the current needle guide position.

Artemis offers the physician additional 3-D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2-D ultrasound image during prostate assessment or biopsy procedure. The device also provides automated reports with information and pictures from the procedure.

The provided document is a 510(k) summary for the medical device "Artemis". This document focuses on demonstrating substantial equivalence to predicate devices and outlines nonclinical testing performed. However, it does not contain detailed acceptance criteria, specific reported device performance metrics (e.g., sensitivity, specificity, accuracy, dice score), or a study that directly proves the device meets specific performance acceptance criteria related to clinical efficacy or diagnostic accuracy.

The document states: "Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met. The Artemis has been designed to comply with the applicable standards." However, these detailed results and acceptance criteria are not elaborated within this specific K162474 summary. The provided text primarily focuses on regulatory compliance, safety, and a comparison of technological characteristics with predicate devices to establish substantial equivalence.

Based on the available text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met," but the specific numerical acceptance criteria for performance (e.g., accuracy of measurement, registration error tolerance, segmentation precision) and the corresponding quantitative results are not included in this summary. The "Reported Device Performance" column above summarizes the claim of meeting criteria rather than the data itself.

Regarding the study proving the device meets acceptance criteria:

The document mentions "Measurement validation using, phantoms, clinical CT, and MRI images were used to show that Artemis preforms as well as or better than the other predicate devices and furthermore shows that Artemis was safe and effective." This indicates that nonclinical testing was performed.

However, the specific "study" details are limited in this summary. This document is a summary and refers to more detailed "Nonclinical and performance testing results...provided in the 510(k)." The information below is based only on what is explicitly stated in the provided text.

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

• Test Set Sample Size: Not specified in the provided summary.
• Data Provenance: The document mentions "phantoms, clinical CT, and MRI images." It does not specify the country of origin of the clinical data. It is implied these were retrospective images used for validation, as it doesn't mention a prospective clinical trial for this 510(k).

3. 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.

4. Adjudication method for the test set

• This information is not provided in the summary.

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

• A MRMC comparative effectiveness study involving human readers with and without AI assistance is not mentioned in this summary. The device's primary function is image-guided interventional and diagnostic procedures (e.g., visualization, registration, navigation, segmentation, measurement for prostate biopsies/treatment), which are often tools for physicians rather than AI for interpretation of images. The comparison focuses on the device's technical performance against predicate devices, not on physician performance improvement.

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

• The document describes Artemis as providing "2D and 3D visualization," "ability to fuse and register images," "display a simulated image of a tracked insertion tool," "virtual grid," "patient data management, multi-planar reconstruction, segmentation, image measurements, 2D/3D image registration, reporting, and pathology management." These functionalities are tools to assist a human physician. The text "Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of Artemis" further indicates a human-in-the-loop system. While several features (segmentation, registration, measurement) are algorithmic, the context suggests these are components of a larger system used by a physician, rather than a standalone diagnostic AI algorithm. Therefore, a standalone performance evaluation in the typical sense of a diagnostic AI is not specifically detailed or claimed in this summary.

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

• The summary states "Measurement validation using, phantoms, clinical CT, and MRI images." For phantoms, the ground truth would be the known physical dimensions or properties of the phantom. For clinical CT and MRI images, the method for establishing ground truth (e.g., pathology, surgical findings, expert measurement, or other imaging modalities) is not specified.

8. The sample size for the training set

• The document describes "nonclinical testing" and "measurement validation." It does not provide details on a "training set" for a machine learning algorithm, which suggests the device might not heavily rely on a machine learning model that requires a distinct training/test split in the way modern AI algorithms do for clinical inference. The discussion around "software source code for basic system functionality" points to more traditional image processing and navigation algorithms. Therefore, a "training set" in the context of deep learning is not applicable or mentioned in this summary.

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

• As a training set is not explicitly mentioned or clearly applicable based on the summary, how its ground truth was established is not provided.

Ask a specific question about this device

The Artemis Handheld Imaging System is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, reconstructive and organ transplant surgeries.

The system uses direct visualization for open procedures, or via a laparoscope for minimally invasive procedures.

The Artemis Handheld System is intended for intraoperative and minimal invasive visual assessment of blood vessels and related tissue perfusion, by enabling surgeons to observe fluorescent images of blood vessels and related tissue.

The Artemis System consists of a hand held camera, Artemis Fast Lens; ring light for open procedures, and a laparoscope for minimally invasive procedures, controller (lap top) and a light source or Light Engine. The Artemis Light Engine (K141164) is Class II device for illumination of surgical sites for diagnostic purposes. The light Engine has imaging capabilities for fluorescence as well. The laparoscope is an OEM item branded for Quest and cleared via 510(k) Number K945266.

The Artemis Handheld Imaging System is a fluorescent imaging system intended for the visual assessment of blood flow for tissue perfusion and related tissue-transfer circulation in tissue and free flaps during plastic, reconstructive, and organ transplant surgeries. It can be used for direct visualization in open procedures or via a laparoscope for minimally invasive procedures.

The device's performance was evaluated through a series of tests, including in vitro characterization, in vivo animal models, and clinical case series studies.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of quantitative acceptance criteria with corresponding reported device performance values. Instead, it broadly states that "Performance Testing" was conducted to verify conformance to user/design requirements and that "Design Test and Verification demonstrates that the device functions as it is intended and its performance does not raise any issues of safety and effectiveness."

However, based on the description, the implicit acceptance criteria are related to the ability of the device to:

• Visually assess blood flow and tissue perfusion using fluorescence.
• Demonstrate concentration-dependent sensitivity of Indocyanine Green (ICG).
• Satisfactorily demonstrate perfusion in various tissues.

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

The document mentions different test sets:

• In vitro characterization: The sample size is not specified, but it involved "ICG dissolved in human serum albumin."
• In vivo animal models: The sample size is not specified, but it involved "nude Balb/c mice."
• Human vital structure imaging: The sample size is not specified.
  • Provenance: Performed at a "medical research facility in the Netherlands." This implies prospective data collection, but it's not explicitly stated.
• Clinical case series studies: The sample size is not specified.
  • Provenance: Performed "in Germany." These were "case series studies," implying prospective data collection in a clinical setting.

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

The document does not provide information on the number of experts used or their specific qualifications for establishing ground truth for any of the test sets.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the test sets.

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed or provide any effect size of how much human readers improve with AI vs. without AI assistance. The study focuses on the device's capability for imaging and perfusion assessment.

6. Standalone (Algorithm Only) Performance:

The device described is an "imaging system" used for visual assessment by surgeons. It is not an AI algorithm intended for standalone diagnostic performance without human input. Therefore, a standalone (algorithm-only) performance study, in the typical sense of AI, was not conducted or is not applicable in the context of this device. The performance relates to the hardware's ability to capture and display fluorescent images.

7. Type of Ground Truth Used:

The ground truth used appears to be a combination of:

• Known concentrations/properties: For the in vitro characterization of ICG sensitivity.
• Observations in animal models: For in vivo performance, likely assessed by researchers/veterinarians involved in the animal studies.
• Clinical assessment/surgical observations: For human vital structure imaging and clinical case series, where "satisfactorily demonstrating perfusion" would be based on the clinical judgment of the medical professionals involved. It likely relies on expert observation and clinical parameters rather than a single definitive ground truth like pathology for specific disease detection.

8. Sample Size for the Training Set:

The document does not mention a training set in the context of machine learning or AI algorithms. The performance testing described relates to the verification and validation of the imaging system's hardware and software functionality, not an AI model.

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

Since there is no mention of a training set for an AI algorithm, the establishment of ground truth for a training set is not applicable in this document.

Ask a specific question about this device

The Artemis Light Engine is a primary LED light source when used in conjunction with laparoscopes or surgical cameras to illuminated surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals.

The Light Engine is a family of light engines that are designed for laboratory and clinical use in applications. The Light Engine provides a light source of which the intensity can be controlled via a PC. The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time. The Light Engine can be controlled by an external software device, or directly with the serial port provided by the USB interface (RS232-via-USB).

This 510(k) premarket notification for the Artemis Light Engine primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to voluntary standards, rather than extensive clinical performance studies with specific statistical acceptance criteria for a diagnostic algorithm.

Therefore, many of the requested categories regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies validating diagnostic AI, are not explicitly provided or are not applicable in the context of this submission. The device is an LED light source, not a diagnostic algorithm.

Here's a breakdown of the information available and what is not applicable based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an LED light source and not a diagnostic AI, the acceptance criteria are not in terms of diagnostic metrics like sensitivity, specificity, or AUC, but rather functional performance.

The "study that proves the device meets the acceptance criteria" is referred to as "Performance Testing", specifically "Bench Testing protocol attached." While the summary mentions this, the details of the protocol are not provided in the excerpt.

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

Not Applicable. As a medical device (LED light source), the testing mentioned refers to bench testing of the device's physical and software performance, not a clinical test set with patient data.

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

Not Applicable. Ground truth, in the context of diagnostic algorithms, involves expert labeling of patient data. This is an LED light source, so such a "test set" and "ground truth" are not relevant. The testing would have involved engineering and quality control personnel validating the device's technical specifications.

4. Adjudication method for the test set

Not Applicable. There is no "test set" of patient data requiring adjudication in this submission.

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. The Artemis Light Engine is an LED light source for illuminating surgical sites, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study comparing human readers with or without AI assistance is irrelevant to this device.

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

Not Applicable. The Artemis Light Engine is a hardware device (LED light source with software control), not a standalone diagnostic algorithm.

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

Not Applicable. For a light source, "ground truth" would be related to objective physical measurements of light output, color temperature, intensity, control accuracy, and adherence to safety standards, verified through calibrated instruments and engineering specifications. It's not clinical "ground truth" as understood for diagnostic systems.

8. The sample size for the training set

Not Applicable. The device is not an AI algorithm that requires a "training set."

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

Not Applicable. No training set exists for this device.

Ask a specific question about this device

To measure dimensions of components of the human eye. To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye. It is also designed to measure these tissues and structures, such as anterior chamber depth, angle to-angle width and sulcus-to-sulcus width. Measurement also may be made of pathologic structures such as solid masses or cysts and it therefore is useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma and hypotony.

The technological characteristics of this device are the same as those for the predicate device except for the models of some of the components, and the method by which the arc-scanning motion is achieved. The materials from which the patient-contact portions of the device are made are the same as in the predicate device. The acoustic output of this device is similar to that of predicate devices and well below the preamendment levels described in the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."

The provided text is a 510(k) summary for the Artemis™ VHF Ultrasonic Arc-Scan System, an ultrasound bio microscope. It largely focuses on establishing substantial equivalence to a predicate device based on intended use, technological characteristics, materials, and acoustic output. The document does not contain information about specific acceptance criteria or a study proving the device meets them in terms of performance metrics like accuracy, sensitivity, or specificity.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

1. Table of acceptance criteria and reported device performance: This information is not present. The document focuses on regulatory equivalence rather than performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned. Since no performance study is detailed, there's no test set described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No ground truth establishment is described for a performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not 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 mentioned. The device is a diagnostic imaging system, and the document doesn't discuss AI assistance or human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The document describes an ultrasound system, not an algorithm, and doesn't detail any standalone performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.

8. The sample size for the training set: Not applicable. This is a 510(k) for a physical medical device, not an AI/ML algorithm that typically has a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does state related to capability:

The device's intended use is described as:

• To produce high-resolution ultrasound images of the anterior portion of the eye.
• To measure these tissues such as the thickness of the cornea and its individual layers, the epithelium stroma and surgically induced surfaces.
• To measure pathologic structures such as solid masses or cysts.
• To provide tomographic, high-resolution ultrasound images of the anterior portion of the eye.
• To measure tissues and structures, such as anterior chamber depth, angle-to-angle width, and sulcus-to-sulcus width.
• Measurement also may be made of pathologic structures such as solid masses or cysts, making it useful in evaluation and/or planning of refractive surgery and evaluation of pathologies of the anterior segment such as trauma, tumors, cysts, glaucoma, and hypotony.

The basis for clearance is substantial equivalence to an existing predicate device (Artemis™ VHF Ultrasonic Arc-scan System cleared in K003890), not a de novo performance study demonstrating achievement of specific acceptance criteria. The review states that the devices have the same intended use and similar technological characteristics, materials, and acoustic output. The FDA also requested a post-clearance special report containing acoustic output measurements based on production line devices.

Ask a specific question about this device