Search Results

Upon intravenous administration of TRADENAME (ICG drug product), the PINPOINT Endoscopic Fluorescence Imaging System is used with TRADENAME to perform intraoperative fluorescence angiography, and it is also indicated for use in fluorescence imaging of biliary ducts, and when intraoperative cholangiography.

The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging. The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct or common hepatic duct), using nearinfrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Upon interstitial administration of TRADENAME (ICG drug product), the PINPOINT System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymphatic vessels and lymph nodes.

The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light guide cable. The following laparoscope models are included as part of the PINPOINT System: SC9104, SC9134, SC9144, SC9504, SC9534, SC9544, SC9101 and SC9131. These are the major components of the PINPOINT System.

During surgical procedures. PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text focuses on the 510(k) submission for the PINPOINT Endoscopic Fluorescence Imaging System, particularly emphasizing its substantial equivalence to a predicate device and expanded indications for use. While it mentions performance testing and a clinical trial, it does not explicitly detail acceptance criteria or the study's findings in a quantitative manner. Therefore, I cannot fully complete the requested table and answer all questions with the provided information.

However, I can extract and infer some information.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated. The submission focuses on demonstrating substantial equivalence.

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

• The text mentions a "Phase III, randomized controlled clinical trial" to support the new lymphatic indications.
• Sample Size: The sample size for this clinical trial is not provided in the given document.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a Phase III trial, it would be prospective.

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

• This information is not provided in the document.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

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

• The document mentions a "Phase III, randomized controlled clinical trial" but does not explicitly state if it was an MRMC study or if it measured the comparative effectiveness of human readers with vs. without AI assistance. The device description suggests an imaging system for surgeons, implying human-in-the-loop use, but the study described is for new indications rather than comparative effectiveness for human readers.
• Effect Size: Not provided.

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

• The PINPOINT Endoscopic Fluorescence Imaging System is described as enabling surgeons to perform minimally invasive surgery and visual assessment. The "device is not intended for standalone use for biliary duct visualization." This strongly suggests the device is an assistive tool for human use, not a standalone AI algorithm. Therefore, a standalone performance study without human-in-the-loop is unlikely for the core device function, though specific aspects of its internal processing might have been validated. The text does not describe a standalone study for an AI algorithm.

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

• For the "Phase III, randomized controlled clinical trial" supporting the lymphatic indications, the type of ground truth used is not specified. For a clinical trial of this nature, it would typically involve clinical outcomes, pathology/histology, or established clinical standards as ground truth.

8. Sample Size for the Training Set

• The device being cleared is an imaging system, not an AI algorithm that would typically require a training set in the conventional sense (e.g., for machine learning model development). While the system likely has internal algorithms for image processing, the submission focuses on its hardware and its use with an imaging agent.
• If "training set" refers to data used to develop any internal algorithms, this information is not provided. The text emphasizes substantial equivalence to a predicate device, implying similar underlying technology.

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

• As the device is an imaging system and not explicitly an AI/ML product developed with a training set for a specific diagnostic task, this information is not applicable or provided in the context of this 510(k) summary.

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The peripheral nerve block Pinpoint™ GT Needle is intended for use in injecting local anesthetics and/or analgesics into a patient to provide regional anesthesia and/or to facilitate the placement of a catheter.

The peripheral nerve block Pinpoint™ GT Needle may be used in any appropriate patient population.

Bard Access Systems, Inc's Pinpoint™ GT Needle is designed to inject anesthetic for regional anesthesia. The Pinpoint™ GT Needle contains a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with Pinpoint™ GT Needle Technology. The Pinpoint™ GT Needle, when used with an ultrasound system equipped with Pinpoint™ GT Needle Technology, creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The subject device can be used with or without ultrasound assisted procedures and may be used with the Pinpoint™ GT Needle Technology at the discretion of the clinician.

The document describes the Pinpoint™ GT Needles, which are peripheral nerve block needles intended for injecting local anesthetics and/or analgesics for regional anesthesia or catheter placement. The device contains a passive magnet that can be detected by compatible ultrasound systems to provide a virtual image of the needle.

All the information provided in the input is related to the Pinpoint™ GT Needles and its comparison against a predicate device (SonoTAP Needle) and a reference device (Pinpoint™ GT Safety Introducer Needle).

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

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

The document states that the subject device configurations met all predetermined acceptance criteria derived from the listed verification tests, demonstrating substantially equivalent performance as compared to the predicate device. However, specific numerical acceptance criteria and their corresponding reported performance values are not explicitly provided in a direct table format with thresholds. Instead, a list of performance tests conducted and the standards utilized is given, implying that meeting these standards constitutes the acceptance criteria.

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

The document does not specify the sample sizes used for each individual test or the overall "test set." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing methods are primarily focused on device performance tests against recognized standards (e.g., ISO, ASTM, USP) and internal protocols, rather than clinical data from human subjects.

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 document. The testing described is primarily focused on engineering performance and material compatibility, not clinical ground truth established by experts.

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

This information is not provided in the document. Adjudication methods are typically associated with clinical studies involving human interpretation or assessment, which is not the primary focus of the performance tests described here.

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

There is no mention of an MRMC comparative effectiveness study involving human readers or AI assistance in this document. The Pinpoint™ GT Needle incorporates a "passive magnet" feature that works with an "ultrasound system equipped with Pinpoint™ GT Needle Technology" to create a "virtual image of the needle." This describes a technology for enhanced visualization during a procedure, not an AI-assisted diagnostic or interpretive system that human readers would interact with in an MRMC study.

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

This is not applicable to the device described. The Pinpoint™ GT Needle is a physical medical device (a needle) that assists in a medical procedure, not a standalone algorithm. Its magnetic feature is designed to be used in conjunction with an ultrasound system and the clinician, so there is always a human in the loop.

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

The "ground truth" for the performance tests described is rooted in established international standards (ISO, ASTM, USP) and internal Bard protocols for medical device quality, safety, and functionality. These standards define physical, chemical, and mechanical properties that the device must meet, effectively serving as the ground truth for engineering and material performance. For example, "Needle Lumen Patency" is tested against requirements specified in ISO 7864:1993. Biocompatibility is tested against ISO 10993 series.

8. The sample size for the training set

This information is not provided and is not applicable. The Pinpoint™ GT Needle is a physical device, and the described evaluation involves functional and safety testing, not machine learning model training.

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

This information is not provided and is not applicable as there is no mention of a "training set" or machine learning model.

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Pinpoint™ GT Needle Guide Kits are intended to be used with Site~Rite® Ultrasound Systems.

Pinpoint™ GT Needle Guides provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.

Site~Rite® Probe Covers sheathe the transducer and isolate a site of surgical penetration from microbial and other contamination.

Pinpoint™ GT Needle Guide Kits consist of the following single use sterile disposables: a set of Pinpoint™ GT Needle Guides, conductive gel, a Site~Rite® Probe Cover, and elastic bands to secure the probe cover to the ultrasound probe.

The provided text describes a 510(k) premarket notification for the Pinpoint™ GT Needle Guide Kits. It outlines the device's intended use, technological characteristics, and safety and performance testing. However, the document does not contain information about an AI/algorithm-driven device, nor does it present "acceptance criteria" and "reported device performance" in the context of an AI study with human readers and ground truth established by experts.

The document primarily focuses on the physical and mechanical aspects of a sterile, single-use needle guide kit used with ultrasound systems, comparing it to a predicate device. The "tests" mentioned are for device validation and verification, such as "Needle Guide Depth Accuracy," "Force to Insert a Needle," and "Packaging Integrity." These are engineering and manufacturing tests, not clinical performance studies involving AI or human interpretation of diagnostic images.

Therefore, I cannot fulfill your request for the specific information regarding AI models, sample sizes for test/training sets, expert consensus, adjudication methods, or MRMC studies, as none of this information is present in the provided text.

The document discusses:

• Device: Pinpoint™ GT Needle Guide Kits
• Intended Use: To be used with Site~Rite® Ultrasound Systems to guide a needle for placement of its tip in a specific structure, and probe covers to sheath the transducer and isolate the surgical site.
• Predicate Device: Site~Rite® Needle Guide Kits and Probe Cover Kit.
• Modifications from Predicate: New packaging, modified needle guides (including insertion funnel and stabilizing notches, and different colorant formulations but same base materials), additional probe cover offering (96" vs 48" length, dimensional changes and different material formulation), and labeling updates.
• Testing: Verification and validation tests conducted per design controls, guidance documents, and internal protocols. These tests focus on the physical performance and safety of the needle guides and probe covers (e.g., loading, force to insert/remove needle, depth accuracy, material compatibility, damage, retention, packaging integrity, sterile barrier integrity, and biocompatibility/sterilization standards).

In summary, the provided document does not support a response to your prompt because it describes a physical medical device (needle guides), not a software or AI-driven diagnostic device that would necessitate the type of performance study criteria you've outlined.

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The Pinpoint™ GT Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Introducer Needle may be used in any appropriate patient population.

Bard Access Systems, Inc.'s, PinpointTM GT Introducer Needle is an 18G x 2.75 inch needle designed for percutaneous access to introduce a guidewire. The PinpointTM GT Introducer Needle contains a magnet which emits a passive magnetic field that can be detected by ultrasound systems equipped with PinpointTM GT Technology. The PinpointTM GT Introducer Needle, when used with the PinpointTM GT System creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The provided text describes modifications to an introducer needle and asserts that the device meets acceptance criteria through various performance tests. However, it does not provide the detailed acceptance criteria and reported device performance in a table format, nor does it present a specific study with sample sizes, data provenance, ground truth establishment, or expert involvement as requested.

The document is primarily a 510(k) summary for the Pinpoint™ GT Introducer Needle, arguing for its substantial equivalence to a predicate device (Pinpoint™ GT Safety Introducer Needle). It lists the types of tests conducted and the standards/guidance documents followed, but not the results against specific acceptance metrics.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will, however, extract the information that is present and clearly state what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states:
"The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."
However, the specific "predetermined acceptance criteria" and the "demonstrated performance" are not detailed in a table or any other format.

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

The document lists "Performance Testing - Bench" which implies physical bench tests of the device components.

• Sample size for test set: Not specified.
• Data provenance: Bench testing results, likely conducted internally by the manufacturer (C.R. Bard, Inc. / Bard Access Systems, Inc.). No information on country of origin of data, or if it was retrospective or prospective, as these are typically applicable to clinical studies, not bench tests like these.

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

This information is not applicable to the type of testing described (bench testing of a medical device's physical and functional properties). Ground truth and expert consensus are usually relevant for studies evaluating diagnostic accuracy or clinical outcomes, which are not detailed here.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above (bench testing, not clinical evaluation requiring human reader adjudication).

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

There is no indication of an MRMC study. The device is an introducer needle, not an AI diagnostic tool. While it interacts with an "ultrasound system equipped with Pinpoint™ GT Technology" to display a virtual image of the needle, the focus of this 510(k) is the needle itself and its substantial equivalence in physical and functional characteristics to a predicate device. The information provided does not suggest AI assistance for human readers in a diagnostic context.

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

This is not applicable. The device is a physical introducer needle, not a standalone algorithm.

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

As this involves bench testing of physical device attributes (e.g., tensile strength, dimensions, stiffness, echogenicity), the "ground truth" would be established by engineering and material standards, measurement tools, and physical inspection techniques to verify that the device meets its design specifications and relevant industry standards (e.g., ISO standards listed).

8. The sample size for the training set

This is not applicable. The context is the evaluation of a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

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The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.

The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light quide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134, SC9144, SC9504, SC9534 and SC9544. These are the major components of the PINPOINT System.

During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocvanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets these criteria in the format requested. The document is a 510(k) summary for the PINPOINT Endoscopic Fluorescence Imaging System, which primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical performance testing section, we can infer some general acceptance criteria related to safety and performance through adherence to standards.

Here's an attempt to extract and present the information, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study proving the device meets acceptance criteria:

The document describes "Non-Clinical Performance Testing" which includes adherence to various IEC standards and animal testing. This is the "study" demonstrating performance against safety and basic functional criteria. However, it's not a typical clinical study with patient outcomes or a reader study.

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

• Test Set Sample Size:
  • For the in vivo fluorescence imaging capability, the "test set" was a porcine model. The exact number of animals is not specified.
  • For the other performance tests (IEC standards), these are typically performed on hardware and software and do not involve a "test set" in the sense of patient data.
• Data Provenance:
  • The animal testing (porcine model) appears to be prospective and conducted by NOVADAQ.
  • The standards conformance testing was conducted by NOVADAQ and accredited third-party laboratories.

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

• This information is not provided in the document. The animal model study used to validate in vivo fluorescence imaging would likely have involved veterinarians or surgical experts, but their number and qualifications are not detailed. For the standards testing, "ground truth" is typically defined by the standard itself rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

• This information is not provided. Given the nature of the tests described (animal model and standards conformance), a formal adjudication method like 2+1 or 3+1 is unlikely to have been used, as these are typically reserved for image interpretation studies.

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 MRMC comparative effectiveness study is mentioned. This device is an imaging system, not an AI-powered diagnostic tool, so such a study would not be directly applicable in the sense of "human readers improve with AI." The document focuses on the system's ability to provide visual assessment of vessels, blood flow, and bile ducts using near-infrared imaging alongside visible light.

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

• This device is an imaging system used in real-time by surgeons; it is not an algorithm that performs a standalone diagnostic function. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The device's "performance" is its ability to acquire and display images.

7. The type of ground truth used

• For the in vivo fluorescence imaging validation, the ground truth was likely physiological observation within the porcine model by trained personnel, confirming the system's ability to visualize expected fluorescence in living tissue after ICG administration.
• For the standards conformance tests, the "ground truth" is the requirements outlined in the respective IEC and UL standards.

8. The sample size for the training set

• This device is an imaging system, not a machine learning algorithm that requires a "training set" in the conventional sense. Therefore, information about a training set sample size is not applicable and not provided.

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

• As there is no mention of a training set, this information is not applicable.

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The PINPOINT Endoscopic Fluorescence Imaging System is indicated for use to provide real time endoscopic visible and near-infrared fluorescence imaging.

The PINPOINT System enables surgeons to perform minimally invasive surgery using standard endoscope visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the PINPOINT System is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

The PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT, PINPOINT System) is comprised of an endoscopic video processor/ illuminator (VPI) which is capable of providing visible and near-infrared illumination to a surgical laparoscope, surgical laparoscopes optimized for visible (VIS) and near-infrared (NIR) illumination and imaging, a camera head that is also optimized for visible and near-infrared imaging, and a flexible light guide cable. The following laparoscope models are included as part of the PINPOINT System: SC9100, SC9104, SC9130, SC9131, SC9134 and SC9144. These are the major components of the PINPOINT System.

During surgical procedures, PINPOINT may be operated to provide visualization similar to that provided by conventional imaging systems used in surgical endoscopy. The area of interest is illuminated with visible light from the illuminator and the resulting reflected light is imaged by the camera and displayed on the video monitor. When used with the VIS-only laparoscopes, the System is only capable of the conventional mode of visualization described herein.

To provide NIR fluorescence imaging, PINPOINT is used with the imaging agent, indocyanine green (ICG). The patient is injected with ICG imaging agent. The ICG fluoresces when illuminated through the laparoscope with NIR excitation light from the VPI, and the fluorescence response is then imaged with the camera, processed and displayed on an HD video monitor.

When used with a VIS/NIR laparoscope, PINPOINT can operate to provide illumination and imaging of both visible light and ICG fluorescence images simultaneously.

The provided text includes a 510(k) summary for the PINPOINT Endoscopic Fluorescence Imaging System, which describes performance data. However, it does not include specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

Here's what can be extracted and what information is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices and conformance to general safety and performance standards.
• Reported Device Performance:
  • Non-Clinical Performance:
    • Conforms to IEC 60601-1:2012 (Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance).
    • Conforms to IEC 60601-1-2:2007 (Electromagnetic compatibility).
    • Conforms to IEC 60601-2-18:2009 (Particular requirements for the basic safety and essential performance of endoscopic equipment).
    • Assessed as a Class 3R laser device with internal maximum Class 4 laser radiation according to IEC 60825:2007.
    • Animal testing (porcine model) validated in vivo fluorescence imaging capability.
  • Clinical Performance:
    • Clinical evaluation based on literature search and post-market surveillance adverse event information found continued clinical safety and performance.
    • Clinical study and case reports (Journal of Gastrointestinal Surgery, Surgical Innovation, Int! J Sur Case Reports) using the PINPOINT System support expanded Indications for Use.
    • No new concerns related to safety and effectiveness were introduced.

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

• Sample Size for Test Set: Not specified for clinical studies in this document. Animal testing used a "porcine model" (singular, but likely implying multiple animals or instances).
• Data Provenance:
  • Non-Clinical: Novadaq Technologies Inc. and accredited third-party laboratories.
  • Clinical: Clinical literature search, post-market surveillance (adverse event information), a clinical study, and case reports published in medical journals. The country of origin for the clinical data is not specified. It is likely retrospective for the literature review and post-market surveillance, and potentially prospective for the mentioned "clinical study," but this is not explicitly stated.

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

• Not specified. The document refers to clinical studies and case reports, which would typically involve medical experts, but details about ground truth establishment and expert qualifications are absent.

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

• Not specified.

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 MRMC study mentioned. This device appears to be an imaging system intended for direct visualization by surgeons, not an AI-assisted diagnostic tool for interpretation by readers. The document highlights its use "to provide real time endoscopic visible and near-infrared fluorescence imaging" and "enables surgeons to perform minimally invasive surgery" and "visual assessment."

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

• Not applicable. This is an imaging system for direct surgeon use, not an algorithm. The "device is not intended for standalone use for biliary duct visualization" refers to its use in conjunction with white light and cholangiography, not to an algorithm's standalone performance.

7. The type of ground truth used

• Animal Testing: "In vivo fluorescence imaging capability" validated in a porcine model. This implies comparison against expected fluorescence patterns.
• Clinical Evaluation: Clinical literature and adverse event information. For the clinical study and case reports, the ground truth would typically be surgical outcomes, direct visualization during surgery, or other clinical assessments, but this is not explicitly detailed.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device with a distinct training set. The device was "designed and developed."

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

• Not applicable (see above).

Summary of Missing Information:

The provided text is a 510(k) summary demonstrating substantial equivalence to predicate devices and conformance to general safety and performance standards. It lacks the detailed specifications of acceptance criteria, specific clinical study designs (e.g., sample sizes, ground truth establishment methods, expert qualifications, adjudication, MRMC studies) that would be present for a novel AI/algorithm-based diagnostic device. The performance data presented focuses on regulatory compliance, technological characteristics, and general safety/performance based on existing literature and animal models, rather than detailed quantitative performance metrics from controlled clinical trials against specific acceptance criteria.

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The Pinpoint™ GT Safety Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Safety Introducer Needle may be used in any appropriate patient population.

Bard Access Systems, Inc.'s, Pinpoint™ GT Safety Introducer Needle is designed for percutaneous access to introduce a guidewire. The Pinpoint™ GT Safety Introducer Needle contains a magnet which emits a passive magnetic field that can be detected by Ultrasound Systems equipped with Pinpoint™ GT Technology. The Pinpoint™ GT Safety Introducer Needle, when used with the Pinpoint™ GT System creates a virtual image of the needle on the Ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The provided text describes a 510(k) premarket notification for the Pinpoint™ GT Safety Introducer Needle, arguing for its substantial equivalence to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.

The document relates to a physical medical device (introducer needle) and the performance tests described are for the physical properties and safety of this device, not for an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/algorithm.
• Sample size used for the test set and data provenance for AI.
• Number of experts and their qualifications for establishing ground truth for AI.
• Adjudication method for AI.
• MRMC comparative effectiveness study results for AI.
• Standalone performance for an algorithm.
• Type of ground truth used for AI.
• Sample size for the training set for AI.
• How ground truth for the training set was established for AI.

The Pinpoint™ GT Safety Introducer Needle is a physical device, not an AI-powered diagnostic/predictive tool. The "Pinpoint™ GT Technology" mentioned is described as a passive magnet that interacts with an Ultrasound System to create a "virtual image of the needle on the Ultrasound display." This indicates a hardware-software integration for visualization, not an AI algorithm performing diagnostic interpretation or prediction.

What the document does provide regarding acceptance criteria and performance:

The document states that a series of verification and validation tests were performed "in accordance with Design Controls as per 21 CFR §820.30" and various ISO standards and guidance documents.
"The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."

Summary of Performance Tests (Bench, Biocompatibility):

Bench Tests:

• Dimensional Analysis
• Assembly Leak
• Hub to Cannula Bond Strength
• Needle Stiffness
• ISO Luer Compliance
• Guidewire Compatibility
• Safety Mechanism Override
• Visual Inspection
• Corrosion
• Usability and Simulated Use
• Blood Flash
• Echogenicity
• Magnet Testing
• Particulate testing (USP <788>)

Biocompatibility Testing:

• Cytotoxicity
• Sensitization
• Intracutaneous
• Acute Systemic Toxicity
• Pyrogenicity
• Rabbit Blood Hemolysis
• Unactivated partial Thromboplastin Time Assay
• Dog Thrombogenicity

The document asserts that the device met the acceptance criteria for these tests (which would be defined by the referenced standards and internal protocols), thereby demonstrating substantial equivalence to the predicate device. Specific numerical acceptance criteria or detailed results of these tests are not provided in this summary document. It only states that the criteria were met.

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The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology IENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery.

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

• Matrixectomy
• Periungual and subungual warts
• Plantar warts
• Radical nail excision
• Neuromas

The PinPointe™ FootLaser™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Dermatology and Plastic Surgery (ablation, vaporization, excision, and coagulation of soft tissue) including:

• Lesions of skin and subcutaneous tissue
• Telangiectasia
• Port wine lesions
• Spider veins
• Hemangiomas
• Plantar warts
• Periungual and subungual warts
• Removal of tattoos
• Debridement of decubitus ulcer
• Treatment of keloids

Oropharangeal/ Dental Surgery Indicated for:

• Abscess incision and drainage
• Aphthous ulcers treatment
• Biopsies, excisional and incisional
• Crown lengthening
• Exposure of unerupted I partially erupted teeth
• Fibroma removal
• Frenectomy
• Frenotomy
• Gingival incision and excision
• Gingivectomy
• Gingivoplasty
• Hemostasis
• Implant removal
• Lesion (tumor) removal
• Leukoplakia
• Operculectomy
• Oral papillectomy
• Pulpotomy
• Pulpotomy as adjunct to root canal therapy
• Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
• Selective ablation of enamel (first degree) caries removal
• Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility
• Tissue retraction for impressions
• Vestibuloplasty

General Surgery Indicated for:
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:

• Cholecystectomy
• Lymphadenectomy
• Mastectomy
• Partial nephrectomy
• Hepatectomy
• Pilonidal cystectomy
• Pancreatectomy
• Resection of lipoma Splenectomy
• Pelvic adhesiolysis
• Hemorrhoidectomy
• Removal of lesions
• Thyroidectomy
• Removal of polyps
• Parathyroidectomy
• Removal of tumors
• Herniorrhaphy
• Tumor biopsy
• Tonsillectomy
• Debridement of decubitus ulcers
• Appendectomy

Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:

• Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues
• Tonsillectomy
• Adenoidectomy

The PinPointe™ FootLaser™ is comprised of the following main components:

• Main console containing the major electrical components, including:
  • Control/ Display Panel with the:
  • Keyswitch (that controls authorized access to the laser system);
  • emergency Laser Stop button;
  • Displays (laser emission indicator, average power, pulse energy, repetition rate)
  • LCD screen user interface permitting selection of treatment emission when the footswitch is depressed and a fiber optic is properly attached);
• 1064 nm treatment laser (solid state Nd:Y AG laser rod) with flashlamp and associated light regulation components and electronics;
• 630 -680 nm (red) aiming beam diode laser;
• Delivery device fiber-optic connector port;
• Remote interlock connector (External door interlock connector);
• Connector ports for the footswitch and power cord;
• Accessory holder (attached to the rear of the main console);
• Footswitch;
• Medical grade power cord;
• Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue:
  • Guide Tip No Standoff: Reusable, cleanable, tip is provided for noncontactuse to direct and control the placement of the laser beam (free beam) at the treatment location. The Guide tipattaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
  • Guide Tip - With Standoff: Reusable, cleanable, tip is provided for minimal-contact with intact skin/ tissue to direct and control the placement of the laser beam at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
• Delivery Devices for Contact with Breached Surfaces:
  • Optical Fibers - Reusable, cleanable, sterilizable optical fibers (range of 200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
  • Handpieces - Reusable, cleanable, sterilizable handpieces (large and small diameter shafts) provided non-sterile, clean and ready for sterilization (steam autoclave). The optical fiber is threaded through the handpiece and secured and held in place with the handpiece locking cap;
  • Handpiece Tips Disposable single-use tips are provided in straight and curved configurations and are used to direct and control the placement of the optical fiber tip at the treatment location. The handpiece tips attach to the end of the handpiece. The optical fiber is threaded through both the handpiece and the handpiece tip;
• Accessories:
• Safety Glasses
• Tools:
  • Optical Fiber Striper;
  • Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).

The provided text is a 510(k) summary for the PinPointe FootLaser, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device (K093547).

It explicitly states: "No clinical data was needed for these indications. They are identical to those on K093547." and "The technological characteristics of the PinPointe Footlaser are substantially equivalent to those of the predicate device." and "The PinPointe FootLaser was found to be substantially equivalent to the predicate device."

Therefore, this document does not describe a study that proves the device meets specific acceptance criteria in the way requested by the prompt (e.g., using a test set, ground truth, experts, etc.). Instead, its approval is based on a demonstration of equivalence to a previously approved device.

As such, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, or details about training sets, because these types of studies were not conducted or reported for this 510(k) submission.

The tables provided in the document compare the characteristics of the "PinPointe FootLaser" (the new device) to the "PinPointe FootLaser" (the predicate device K093547), highlighting their identical specifications and indications for use. This comparison serves as the basis for the declaration of substantial equivalence, not as a report of a new performance study against defined acceptance criteria for the new device itself.

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This product is used for patients who require external beam stereotactic radiation therapy of the head and neck region or radiosurgery of the cranial region. The system provides cranial and head and neck fixation and stereotactic localization with automatic software fiducial localization. It is intended to be used during both Computed Tomography (acquisition of the imaging series used for the patient's treatment plan) and each of the patient radiation treatments.

The Aktina Pinpoint Head and Neck Stereotactic Localizer, Part Number 50-100, is used for the localization and fixation of patients undergoing stereotactic radiotherapy and radiosurgery of the cranial area, as well as radiotherapy of the head and neck area. Fixation is accomplished via two components: a customized Dental Tray that with the aid of slight vacuum suction fixes to the roof of the patient's mouth, and a customized head and neck support. Localization is accomplished via two components: a hardware component which comprises of a Stereotactic Fiducial Frame that is positioned over the patient's treatment area while being accurately interfaced to the Dental Tray, and a software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame. The Fiducial Frames are used during the patient's initial CT and then as a setup target box for each treatment thereafter.

The K103616 510(k) submission for the "Pinpoint Stereotactic Head and Neck Localizer" does not contain the detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for submissions involving AI/software with performance metrics.

This submission is for a physical medical device (a head and neck fixation system with stereotactic localization hardware and software). The emphasis is on proving substantial equivalence to a predicate device, as opposed to demonstrating specific diagnostic or predictive performance metrics.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

Reasoning for Absence: The submission focuses on proving substantial equivalence to a predicate device, which had previously demonstrated its safety and effectiveness. The modifications to the device (new mouthpiece design with external vacuum port) are described as not altering its fundamental form, fit, or function, thus not requiring new performance studies with specific acceptance criteria in the context of diagnostic accuracy.

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

• Sample Size: Not applicable/not provided. This is a hardware device with localization software, not a diagnostic AI system evaluated on a dataset of patient images.
• Data Provenance: Not applicable/not provided.

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

• Not applicable. Ground truth establishment by experts for a test set of data is not relevant for this type of device submission.

4. Adjudication Method for the Test Set:

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI-assisted diagnostic or interpretation system. The "software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame" is a localization algorithm, not a system for human reader interpretation improvement.

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

• The submission mentions a "software component that reads the patient's Computed Tomography (CT) imaging series and determines the coordinate system of the patient within the fiducial frame." While this is an algorithm, the 510(k) does not describe a standalone performance study with metrics like accuracy, sensitivity, or specificity for this software component. The focus is on the overall system's equivalence. Hardware specification testing is mentioned, which would include verification of the integrated system's function.

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

• Not applicable in the context of evaluating a diagnostic or predictive algorithm. For the localization software, the "ground truth" would likely involve precise physical measurements of the fiducial frame and geometric validation against CT scans, rather than clinical ground truth from patient data.

8. The sample size for the training set:

• Not applicable. There is no mention of a machine learning training set for an AI model in this submission. The software component described is likely based on deterministic algorithms for coordinate system determination, rather than a learned model.

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

• Not applicable.

Summary of the Study per the 510(k):

The "study" presented in this 510(k) is primarily a substantial equivalence comparison to a predicate device, rather than a detailed performance study with quantitative acceptance criteria for a new AI or diagnostic algorithm.

The core of the "study" is outlined in Section 7, "Performance Standards and Data," and Section 9, "Summary of Substantial Equivalence":

• Performance Data: "Hardware specification testing has been performed to show that the verification, validation and safety requirements have been met." This suggests internal testing against engineering specifications, but specific metrics are not disclosed in this summary.
• Biocompatibility: The new mouthpiece components were evaluated against ISO-10993-1, demonstrating biocompatibility for surface contact of less than 24 hours.

The FDA's decision to clear the device K103616 relies on its similarity in design and intended use to the predicate device (K081935), with the conclusion that "No new issues of safety or effectiveness are introduced by using this device." This implies that the predicate device's established safety and performance profile is leveraged for the current device due to their high degree of similarity and the minor nature of the changes.

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The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery.

Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

• Matrixectomy
• Periungual and subungual warts
• Plantar warts
• Radical nail excision
• Neuromas

The PinPointe™ FootLaser™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

• Lesions of skin and subcutaneous tissue
• Telangiectasia
• Port wine lesions
• Spider veins
• Hemangiomas
• Plantar warts
• Periungual and subungual warts
• Removal of tattoos
• Debridement of decubitus ulcer
• Treatment of keloids

Oropharangeal / Dental Surgery
Indicated for:

• Abscess incision and drainage
• Aphthous ulcers treatment
• Biopsies, excisional and incisional
• Crown lengthening
• Exposure of unerupted / partially erupted teeth
• Fibroma removal
• Frenectomy
• Frenotomy
• Gingival incision and excision
• Gingivectomy
• Gingivoplasty
• Hemostasis
• Implant recovery
• Lesion (tumor) removal
• Leukoplakia
• Operculectomy
• Oral papillectomy
• Pulpotomy
• Pulpotomy as adjunct to root canal therapy
• Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
• Selective ablation of enamel (first degree) caries removal
• Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility
• Tissue retraction for impressions
• Vestibuloplasty

General Surgery
Indicated for:

• Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
• Cholecystectomy
• Lymphadenectomy
• Mastectomy
• Partial nephrectomy
• Hepatectomy
• Pilonidal cystectomy
• Pancreatectomy
• Resection of lipoma
• Splenectomy
• Pelvic adhesiolysis
• Hemorrhoidectomy
• Removal of lesions
• Thyroidectomy
• Removal of polyps
• Parathyroidectomy
• Removal of tumors
• Herniorrhaphy
• Tumor biopsy
• Tonsillectomy
• Debridement of decubitus ulcers
• Appendectomy

Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including:

• Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues
• Tonsillectomy
• Adenoidectomy

The PinPointe™ FootLaser™ is comprised of the following main components:

• Main console containing the major electrical components, including:
• Control/ Display Panel with the:
• Keyswitch (that controls authorized access to the laser system);
• emergency Laser Stop button;
• Displays (laser emission indicator, average power, pulse energy, repetition rate)
• Standby button (default mode when laser system turned on - places system into the Standby mode preventing laser emission).
• Ready button (places system into the Ready mode allowing laser emission when the footswitch is depressed and a fiber optic is properly attached);
• A 1064 nm treatment laser (solid state Nd: YAG laser rod) with flashlamp and associated light regulation components and electronics;
• A 630 -680 nm (red) aiming beam diode laser;
• Delivery device fiber-optic connector port;
• Remote interlock connector (External door interlock connector);
• Connector ports for the footswitch and power cord;
• Accessory holder (attached to the rear of the main console);
• Footswitch:
• Medical grade power cord:
• Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue:
• Guide Tip -No Standoff: Reusable, cleanable, tip is provided for noncontact use to direct and control the placement of the laser beam (free beam) at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
• Guide Tip -With Standoff: Reusable, cleanable, tip is provided for minimal-contact with intact skin/ tissue to direct and control the placement of the laser beam at the treatment location. The Guide tip attaches to the end of the handpiece. The optical fiber is threaded through the handpiece and fits securely into the bore of the Guide tip;
• Delivery Devices for Contact with Breached Surfaces:
• A Reusable, cleanable, sterilizable optical fibers (range of Optical Fibers -200 - 1000 um diameter) provided non-sterile, clean and ready for sterilization (steam autoclave).
• Reusable, cleanable, sterilizable handpieces (large and small diameter shafts) provided non-sterile, clean and ready for sterilization (steam autoclave). The optical fiber is threaded through the handpiece and secured and held in place with the handpiece locking cap;
• Handpiece Tips Disposable single-use tips are provided in straight and curved configurations and are used to direct and control the placement of the optical fiber tip at the treatment location. The handpiece tips attach to the end of the handpiece. The optical fiber is threaded through both the handpiece and the handpiece tip:
• Accessories:
• Safety Glasses
• Tools:
• Optical Fiber Striper;
• Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).

The provided document, a 510(k) summary for the PinPointe™ FootLaser™, discusses the device's indications for use and substantial equivalence to predicate devices. It states that the "safety and effectiveness... was demonstrated in clinical studies" for the temporary increase of clear nail in patients with onychomycosis, but it does not provide detailed acceptance criteria or present the results of those studies in a structured format as requested. Therefore, I cannot fully answer the request based solely on the provided text.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance for test sets.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes of AI assistance.
• Standalone (algorithm-only) performance.
• Type of ground truth used (beyond implying clinical outcomes related to "clear nail").
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and a general statement about clinical studies for one specific indication.

Therefore, for the relevant section (onychomycosis), here is what can be extracted, and what cannot be provided:

Device Indication of Interest: Temporary increase of clear nail in patients with onychomycosis.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the document.
• Data Provenance: The document only states that "clinical studies" were conducted. No information about country of origin or whether they were retrospective/prospective is provided.

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

• Not specified in the document.

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

• Not specified in the document.

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

• This device is a laser system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device and is not mentioned in the document.

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

• This device is a laser system for treatment, not a standalone diagnostic algorithm. This metric is not applicable and is not mentioned in the document.

7. The type of ground truth used:

• Based on the indication, the ground truth would likely be clinical assessment of clear nail growth at 6 and 12 months post-treatment, presumably by a clinician. However, the document does not explicitly state the methodology for establishing this ground truth (e.g., objective measurements, subjective ratings by clinicians, etc.).

8. The sample size for the training set:

• Not applicable as this is a medical device, not a machine learning algorithm that requires a training set in the conventional sense. The "clinical studies" mentioned would be analogous to a clinical trial, but details are not provided.

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

• Not applicable for the reasons stated in point 8.

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