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The Affirm 800 is used in viewing intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral vessel branch occlusion, as well as intraoperative blood flow and vessel patency in bypass surgical procedures in neurosurgery.

The Affirm 800 module is designed to work in conjunction with the Class I Digital Surgical Microscope (DSM) RE3. The Affirm 800 module, a Class II device, comprises hardware and software components that enable the Digital Surgical Microscope to emit excitation light in specific wavelengths to activate the fluorescence properties of Indocyanine Green (ICG). The fluorescence signal emitted by the patient represents the distribution of the infrared dye in the patient's blood vessels during surgery. The emitted light is then captured by the optics of the digital microscope, passed through filters to remove unwanted wavelengths of light, and finally detected by the image sensors. This detected signal is then projected on a 3D monitor, which is part of the microscope system, enabling the surgeon to view the magnified image.

The integrated Affirm 800 fluorescence module is used to visualize infrared fluorescent areas in the surgical field and includes features to record and play back a video clip of the area of focus where fluorescent light is emitted. The module has been designed for excitation in the wavelength range from 740 nm to 800 nm and for fluorescence visualization in the wavelength range from 820 nm to 900 nm. The fluorescence feature generates an image in the infrared spectrum, which means it cannot be seen by the naked eye.

Here's a breakdown of the acceptance criteria and the study details for the Affirm 800 device, based on the provided FDA 510(k) Clearance Letter:

Note: The provided document is an FDA 510(k) Clearance Letter and a 510(k) Summary. These documents summarize the manufacturer's performance testing and justification for substantial equivalence. They don't typically include granular details about every aspect of the study design (like specific expert qualifications, adjudication methods, or sample sizes for specific training sets) that might be found in a full study report or a more comprehensive submission. Therefore, some information requested may not be explicitly available in this type of document and will be noted as "Not explicitly stated."

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size (Clinical/Animal Study): 5 porcine models.
   • Data Provenance: Not explicitly stated, but likely conducted by the manufacturer or a contracted research organization in a controlled setting, given it's an animal study. It is a prospective study by nature of being a "conducted" animal study.

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

   • Number of Experts: Not explicitly stated. The document mentions "Surgeons evaluated image quality." The exact number of surgeons is not provided.
   • Qualifications of Experts: Only "Surgeons" are mentioned. No specific experience levels (e.g., "radiologist with 10 years of experience") are provided.

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

   • Adjudication Method: Not explicitly stated. The document only says "Surgeons evaluated image quality." It doesn't specify if this was an individual assessment, a consensus, or involved an adjudication process for discrepancies.

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

   • MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not explicitly mentioned or described. The performance testing focused on device characteristics and an animal study for image quality evaluation, not on human reader performance with or without AI assistance. The Affirm 800 as described is an imaging module, not an AI-assisted diagnostic tool.

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

   • Standalone Performance: Not applicable in the context of an "algorithm only" device. The Affirm 800 is an imaging system designed for intra-operative visualization with a human surgeon-in-the-loop. Its performance is evaluated on its ability to acquire and display clear fluorescent images, not on an algorithm making a diagnostic decision by itself. However, the technical aspects of image quality (e.g., sensitivity, SNR, depth penetration) could be considered standalone measurements of the imaging capability.

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

   • Ground Truth: For the animal study, the "ground truth" for image quality was based on the subjective evaluation by surgeons on a defined scale (1 to 5). For the technical image quality tests, the "acceptance criteria" likely served as the ground truth, comparing measured values (e.g., Weber contrast, SNR) against pre-defined thresholds or performance of the predicate device. There is no mention of pathology or outcomes data as ground truth for this device's performance.

7. The sample size for the training set:

   • Training Set Sample Size: Not explicitly stated. The document describes verification and validation testing, but it does not detail a separate "training set" for a machine learning model, as the device is specified as an angiographic X-ray system module, not an AI algorithm for diagnosis.

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

   • Ground Truth for Training Set: Not explicitly stated or applicable, as a discrete "training set" for an AI model (with associated ground truth) is not described in the context of this device's submission summary. The device's validation focuses on engineering specifications and direct performance measures rather than training an AI.

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Modus IR used with the Synaptive Surgical Exoscope is indicated for fluorescence imaging in conjunction with indocyanine green to aid in the visualization of vessels (micro- and macro-vasculature) and blood flow in the cerebrovasculature before, during, and after neurosurgery, plastic, and reconstructive surgeries.

Modus IR is an accessory of the Synaptive surgical exoscope. Modus IR provides surgical staff with a means to visualize vessels and blood flow during surgical procedures that may not be visible under white light conditions. When used with the appropriate imaging agent, light output at a specific wavelength excites the imaging agent, which emits light at a specific wavelength that is detected by the optical system, thereby allowing the user to differentiate the structure that the imaging agent has concentrated in. The imaging agent is not packaged or sold as part of Modus IR. It is the responsibility of the user to source and administer the applicable imaging agent according to the excitation and observation wavelengths of Modus IR. Modus IR is selectively enabled by authorized personnel using software configuration management.

Here's a breakdown of the acceptance criteria and study information for the Modus IR device based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 4 comparative video sets, resulting in 40 comparative evaluations (4 video sets * 10 neurosurgeons).
• Data Provenance: Prospective, in vivo animal study using two healthy porcine models. The specific country of origin is not mentioned, but the sponsor is based in Canada.

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

• Number of Experts: 10 neurosurgeons.
• Qualifications of Experts: The document explicitly states "neurosurgeons," implying they are medical professionals specialized in neurosurgery, making them qualified to assess the visualization of cerebrovasculature. Their specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

• The study used an assessment by 10 neurosurgeons who were blinded to which system they were evaluating. The video sets were presented in a randomized order.
• The results state "In all evaluations... was found to be functionally equivalent... (100% confirmation)." This implies a consensus or unanimous agreement among the neurosurgeons regarding the functional equivalence and suitability. It doesn't explicitly state a 2+1 or 3+1 method, but the 100% confirmation suggests that all 10 neurosurgeons agreed on the equivalence.

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

• Yes, an MRMC-like study was done. The in vivo animal study involved multiple readers (10 neurosurgeons) assessing multiple cases (4 comparative video sets) for comparative effectiveness between the subject device and the predicate.
• Effect Size of Human Readers Improve with AI vs. without AI assistance: This information is not provided in the document. The study aimed to demonstrate functional equivalence between the new device (Modus IR) and a predicate device (INFRARED 800 with FLOW 800 option) for aiding human visualization, not to quantify the improvement of human readers with AI assistance compared to without. Modus IR is an imaging accessory, not an AI-powered diagnostic tool in the sense of AI-driven image analysis or decision support for the clinician.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone algorithm-only performance study was not explicitly mentioned or performed. The Modus IR is an imaging accessory that aids human visualization, not an algorithm that performs a task without human interpretation. Its performance is assessed in the context of aiding a human surgeon.

7. Type of Ground Truth Used

• For the in vivo animal study, the ground truth was expert consensus (10 neurosurgeons' unanimous agreement on functional equivalence and suitability of visualization).
• For the bench tests, the ground truth was based on objective measurements and comparisons against the predicate device using established metrics (e.g., limit of detection, spatial resolution measurements, qualitative assessment for image integrity).

8. Sample Size for the Training Set

• The document does not refer to or describe a training set for the Modus IR in the context of an AI/ML algorithm. Modus IR is described as an optical imaging accessory, not a software algorithm that performs diagnostic or analytical functions requiring a training set for machine learning. The software verification and validation mentioned are typically for ensuring software functions as intended, not for training a model.

9. How Ground Truth for the Training Set Was Established

• As no training set is described for an AI/ML algorithm, this information is not applicable.

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Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older.

Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley.

EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.

The EXPLORER AIR® II must be used with EXPLORER AIR® Sterile Drape for use under sterile conditions.

The provided text is a 510(k) premarket notification for the EXPLORER AIR® II device. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K222240) rather than presenting a de novo clinical study with detailed acceptance criteria and performance data for a novel AI/software component.

Therefore, the information required to fully answer your request (acceptance criteria, study details like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided document.

The document states:

• "No clinical tests were conducted to support this submission."
• The primary argument for clearance is that the device is "substantially equivalent" to its predicate due to "minor differences for HW design 2.2 (due to manufacturability and EOL of certain components), Packaging 2.0 (same materials, improvements for repacking in case of service), and SW 2.2 (OTS updates, image visualization improvements, and removal of alignment step by the user prior to every procedure)."
• It mentions "Software verification and validation testing were updated and conducted" to meet FDA guidance, but it does not provide the specific acceptance criteria or the results of these tests in a detailed manner.

In summary, this document describes a submission based on substantial equivalence and non-clinical testing (software verification and validation), not a performance study of an AI algorithm with specific acceptance criteria and detailed clinical study results as you've requested.

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· INFRARED 800 with FLOW 800 Option is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. Likewise, INFRARED 800 with FLOW 800 Option used during fluorescence guided surgery aids in the visual assessment of intra-operative blood flow as well as vessel patency in bypass surgical procedures in neurosurgery, plastics and reconstructive procedures and coronary artery bypass graft surgery.

· YELLOW 560 is a surgical microscope accessory intended to be used with a compatible surgical microscope in viewing and visual assessment of intraoperative blood flow in cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency of very small perforating vessels. It also aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery.

Fluorescence accessories (YELLOW 560 and INFRARED 800 with FLOW 800 option) are an accessory to surgical microscope and are intended for viewing and visual assessment of intra-operative blood flow as well as aids in the real-time visualization of blood flow and visual assessment of vessel types before and after Arteriovenous Malformation (AVM) surgery. The functionality of these filters is derived from their ability to hight fluorescence emitted from tissue that has been treated with a fluorescence agent by applying appropriate wavelengths of light and utilizing selected filters. This helps a surgeon to visualize different structural body elements (such as vessels, tissue, blood flow, occlusions, aneurysms, etc.) during various intraoperative procedures. The fluorescence accessory can be activated by the user via the Graphical User Interface (GUI), foot control panel or the handgrips, for example.

For these accessories to be used with a qualified surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of YELLOW 560 and INFRARED 800 with FLOW 800 Option.

The fluorescence accessories are embedded into the surgical microscope. The emission filter wheels are present within the head of the microscope. For filter installation into the surgical microscope, two emissions filters (one for each eyepiece) are placed into each of these filter wheel is present in front of the light source, which is installed along with the excitation filter

The provided text is a 510(k) summary for the Carl Zeiss Meditec Inc. "Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary primarily addresses:

• Indications for Use: The device is a surgical microscope accessory for viewing and visual assessment of intraoperative blood flow in the cerebral vascular area (e.g., assessing cerebral aneurysm, vessel branch occlusion, patency of small perforating vessels, and vessel types before/after Arteriovenous Malformation (AVM) surgery). It also aids in real-time visualization of blood flow and vessel patency in bypass surgical procedures in neurosurgery, plastics, reconstructive procedures, and coronary artery bypass graft surgery.
• Technological Characteristics: Comparison to predicate devices (YELLOW 560 (K162991) and INFRARED 800 with FLOW 800 Option (K100468)) is presented, showing substantial equivalence in application, patient population, device description, fluorescent agents used, visualization of real-time images, display, physical method, fluorescence excitation/detection, white light application, camera adaption, zoom, autofocus, autogain, control system, storage, and upgrade options. Minor differences are noted and deemed not to affect substantial equivalence.
• Non-Clinical Testing: A list of performance testing parameters for the system is provided, confirming that the "functional and system level testing showed that the system met the defined specifications."

Therefore, based on the provided text, a detailed table of acceptance criteria and a study proving the device meets those criteria (with specific performance metrics) cannot be fully constructed as requested. The document attests that the device met internal specifications through software verification and non-clinical system testing, but does not provide the specific numerical acceptance criteria or the study results themselves.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be fully provided as specific numerical acceptance criteria and reported device performance are not detailed in the provided document. The document states that "functional and system level testing showed that the system met the defined specifications" and lists the parameters tested. However, the values for these specifications and the results of the testing are not included.

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

• Sample Size: Not specified. The document mentions "non-clinical system testing" and "software verification testing" but does not provide details on the number of samples, test cases, or images used.
• Data Provenance: Not specified. This appears to be internal company testing (bench testing) rather than a study involving patient data.

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

• Not applicable/Not specified. This was a non-clinical bench and software performance testing; it does not involve expert ground truth for clinical assessment.

4. Adjudication method for the test set

• Not applicable/Not specified. As noted above, this was non-clinical bench and software performance testing.

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 was mentioned. The device is an accessory to a surgical microscope providing visualization, not an AI diagnostic tool that assists human readers in interpreting images.

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

• Not applicable. The device provides "real-time visualization" and "visual assessment," which implies human interpretation of the images/data it presents. It's an accessory, not a standalone automated diagnostic algorithm. The testing described is for the functional and system performance of the accessory.

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

• Not applicable for the non-clinical and software testing described. The "ground truth" for the performance testing would be the predefined specifications that the system components were designed to meet.

8. The sample size for the training set

• Not applicable. The description does not suggest this device uses machine learning or AI that would require a "training set" in the conventional sense for image analysis. It's a fluorescence visualization system.

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

• Not applicable, as there is no mention of a training set.

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Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the SPY-PH System is used with SPY AGENT GREEN to perform intraoperative fluorescence angiography. The SPY-PHI System is indicated for use in adult and pediatric patients one month of age and older.

The SPY-PHI System is indicated for fluorescence imaging of blood flow and tissue perfusion before, and after. vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.

Upon interstitial administration of SPY AGENT GREEN, the SPY-PHI System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon intradermal administration of SPY AGENT GREEN, the SPY-PHI System is indicated for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast cancer for which this procedure is a component of intraoperative management.

The SPY-PHI System is a real-time white-light and near-infrared illumination/ fluorescence imaging system used during open-field surgical procedures. Near-infrared illumination is used for fluorescence imaging using SPY AGENT® GREEN for the visual assessment of blood flow, tissue perfusion and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. It consists of the SPY Portable Handheld Imager/ imaging head with an integrated light guide and camera cable and the Video Processor/ Illuminator. Additionally, SPY-QP Fluorescence Assessment Software is provided as an optional upgrade to the SPY-PHI System that enables relative quantification of NIR fluorescence.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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AccuFFRangio Plus is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of coronary vessels in X-ray angiographic images, for use on individual patients with coronary artery disease.

When the quantified results provided by AccuFFRangio Plus are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.

AccuFFRangio Plus is a system that is used to perform calculations in X-ray angiographic images of the coronary arteries. It includes hardware and software (AccuFFRangio) and the hardware of the device which mainly has a display function and provide the software an operation environment. AccuFFRangio Plus is changed from our own legally marketed predicate device AccuFFRangio that is a stand-alone software package. Therefore, the significant change lies in equipping a computer system to the software on a particular mobile cart.

The provided text is a 510(k) summary for the device AccuFFRangio Plus. It primarily focuses on demonstrating substantial equivalence to a predicate device (AccuFFRangio) by highlighting that the core software is unchanged and the modifications are primarily hardware-related. As such, the document does not detail specific acceptance criteria or performance studies for the AI/algorithm itself for several reasons:

• The 510(k) is for a hardware modification of an already cleared device. The "significant change" lies in integrating the existing software into a new hardware system (a mobile cart with computer, monitor, etc.). Therefore, the performance data presented primarily addresses the new hardware aspects (electrical safety, EMC, etc.) and leverages the software's previous clearance.
• The software (AccuFFRangio) was likely cleared previously. The document states, "The software installed in the subject device is the same as the predicate device." This suggests that the clinical performance and acceptance criteria for the software were established and validated during the predicate device's (AccuFFRangio, K210093) original 510(k) clearance process. This document is not resubmitting that, but relies on it.
• The device calculates "quantified results" and "quantification of the pressure drop," not necessarily an AI-driven diagnosis or classification. While the term "AI" or "deep learning" is not explicitly used, the description of "quantified results" and "pressure drop" calculations suggests an analytical tool rather than a traditional diagnostic AI that might have sensitivity/specificity metrics.

Therefore, based solely on the provided text, I cannot provide a detailed response to your request regarding AI acceptance criteria and study proving the device meets them because this information is not present in this specific 510(k) summary. The summary explicitly states: "No clinical testing was necessary to support the device modifications described in this Special 510(k)." and "The following testing was leveraged from the predicate device. The results from the predicate were used to support the subject device the software contained in the AccuFFRangio Plus is the same as the predicate device."

To answer your request, one would need to refer to the original 510(k) submission for the predicate device, AccuFFRangio (K210093), as that is where the software's performance and validation data would have been submitted. This document focuses on the safety and efficacy of the hardware integration and the overall system's continued substantial equivalence.

However, I can extract information related to the general "performance data" presented for the current 510(k), which focuses on the hardware and usability aspects:*

Acceptance Criteria and Study for AccuFFRangio Plus (Hardware-Focused)

As established above, this 510(k) focuses on the hardware modifications. The "acceptance criteria" and "performance" are therefore related to the safety and functionality of the integrated system, not the clinical performance of the underlying software's calculations, as that was established during the predicate device's clearance (K210093).

1. Table of Acceptance Criteria and Reported Device Performance (Hardware & Usability)

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Human Factors Testing: 15 qualified participants.
  • For other tests (Electrical Safety, EMC, Hardware Verification, Transportation, Accelerated Aging, Labeling), the sample size typically refers to the number of units tested, which isn't explicitly stated but is implicitly "sufficient" to meet the standard requirements.
• Data Provenance: Retrospective (leveraging data and conclusions from the predicate device's software clearance). No new clinical data was generated for this specific 510(k). Country of origin is not specified for the original data, but the submitter is from Hangzhou, China.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable to the hardware/usability tests described in this document.
• For the Human Factors testing, "15 qualified participants" were used. Their specific qualifications (e.g., medical professionals, years of experience) are not detailed here, but they would be representative of the intended users.
• For the original software's ground truth establishment (from the predicate device's 510(k)), this information would be detailed in K210093.

4. Adjudication Method for the Test Set

• Not applicable for the hardware/usability tests.
• For the Human Factors testing, success was determined by the absence of "use errors" during "critical tasks," rather than a formal adjudication process.

5. MRMC Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this 510(k). The document explicitly states "No clinical testing was necessary to support the device modifications described in this Special 510(k)."

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

• The software aspect of the device ("AccuFFRangio") is described as a "stand-alone software package" in the predicate description. Therefore, standalone software performance was likely evaluated during the predicate device's (K210093) clearance. This 510(k) document does not provide those details, but leverages that previous data. The "AccuFFRangio Plus" is now an integrated hardware/software system.

7. Type of Ground Truth Used

• For the hardware studies, ground truth is based on engineering standards (e.g., IEC, ASTM) and internal quality control specifications.
• For the software's calculations (leveraged from the predicate), the type of ground truth (e.g., another device, invasive measurements, expert consensus on imaging) would have been established during K210093. This document describes the device as providing "quantified results of coronary vessel segments based on a 3D reconstructed model" and "Quantification of the pressure drop in coronary vessels," implying quantitative ground truth rather than subjective diagnostic labels.

8. Sample Size for the Training Set

• Not applicable to this 510(k) which covers hardware modifications and re-uses existing software.
• For the original software development (from the predicate device's 510(k)), this information would be detailed in K210093.

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

• Not applicable to this 510(k).
• For the original software (from the predicate device's 510(k)), this information would be detailed in K210093.

In summary, this 510(k) submission is a "special 510(k)" for a hardware modification, explicitly relying on the prior clearance of its predicate software. Therefore, the detailed AI/algorithm specific performance data and acceptance criteria you requested are not contained within this document but would be found in the original submission for the predicate device, AccuFFRangio (K210093).

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Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older.

Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley.

EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) or pafolacianine has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760mm) and emitted in the band around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.

The provided text describes a 510(k) premarket notification for the EXPLORER AIR® II device. The submission is to expand the device's indications for use to include the infrared dye, pafolacianine. The document focuses on demonstrating substantial equivalence to predicate devices, particularly concerning the new imaging agent.

Here's an analysis of the acceptance criteria and the study proving the device meets them based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with specific pass/fail values. Instead, it describes performance verification related to its capability with the new imaging agent, pafolacianine, and comparison to predicate devices. The implicit acceptance criterion is that the device can effectively detect pafolacianine and perform comparably or better than existing cleared devices.

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

The document refers to "testing... in two devices" for pafolacianine detection. This suggests the sample size for the core performance test was limited to these two devices (likely two units of the EXPLORER AIR® II). The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified, but it implies a controlled laboratory setting. The comparison testing with the secondary predicate device also falls under this testing.

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

No information is provided regarding the use of experts to establish ground truth for the test set. The performance data presented seems to be based on objective measurements like image contrast (CNR) and visualization of known concentrations, rather than expert interpretation of a diagnostic task.

4. Adjudication method for the test set

No information on an adjudication method is provided. Given the nature of the tests (detection of known concentrations and image contrast analysis), an adjudication process by experts is not described or implied.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The performance data focuses on the device's technical capability to detect pafolacianine and a direct comparison of its imaging characteristics against a predicate device, not on human reader performance with or without AI assistance.

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

The performance tests described (pafolacianine detection at different concentrations, CNR analysis, visualization of samples) appear to be standalone assessments of the device's imaging capabilities without explicit human interpretation as part of the primary test endpoint. The software validation is also a standalone assessment of the algorithmic components.

7. The type of ground truth used

The ground truth for the pafolacianine testing appears to be based on:

• Known concentrations of pafolacianine.
• Objective measurements such as Contrast-to-Noise Ratio (CNR).
• Direct observation of the images to confirm visualization of lower concentration samples.

This indicates a quantitative and controlled experimental ground truth, rather than clinical outcomes or expert consensus on patient cases.

8. The sample size for the training set

The document does not mention a training set sample size or the use of machine learning models that would require one. The verification approach described is primarily focused on demonstrating the physical and software performance of the imaging system with the new dye, rather than the development of a predictive algorithm using a training set.

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

As no training set is mentioned for an algorithm, there is no information on how its ground truth was established.

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AcculCAS is software intended to be used for performing calculations in X-ray angiographic images of the intracranial vessels. AcculCAS enables neurointerventionalists to obtain quantifications of one or more lesions in the analyzed intracranial vessel segment. In particular, AccuICAS provides:
Quantitative results of intracranial vessel segments based on a 3D reconstructed model;
Dimensions of the intracranial vessels and lesions;
Quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels.
AccuICAS is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the assessment of intracranial vessels in X-ray angiographic images.
When the quantified results provided by AccuICAS are used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.

ArteryFlow AcculCAS is designed as a stand-alone software package to run on a PC. This software can read traditional x-ray angiographic images with DICOM format from the local file directory.
AcculCAS is composed of the following analysis workflows: Image Loading, Frame Selection, Vessel Reconstruction and Hemodynamics Calculation for visualization of the target intracranial vessel segment, quantification of morphological parameters and pressure drop of the intracranial vessel segment. AcculCAS is only for quantitative imaging output but not for diagnosis.
AcculCAS calculates the pressure gradient (PG) and pressure ratio (PR) value for the intracranial vessel. To obtain these values for a specific lesion in an intracranial vessel, the user needs to start with Frame Selection using the same vessel under different angulation. In each of these images, a classic 2D intracranial vessel contour detection is performed, after which a reconstruction of the intracranial vessel segment is obtained in 3D space. Based on the 3D reconstruction and patients' mean arterial pressure, the corresponding pressure gradient (PG) and pressure ratio (PR) value at each position can be calculated.
AcculCAS enables neurointerventionalists to obtain accurate anatomical quantifications of one or more lesions in the analyzed intracranial vessel segment, and to assess the best viewing angles which can be helpful for optimal visualization of the lesion.
AcculCAS's outputs mainly include quantitative dimension results of intracranial vessel and lesions segments based on a 3D reconstructed model and quantification of the pressure gradient (PG) and pressure ratio (PR) in intracranial vessels. Besides, other information provided to the end user also belongs to the outputs, such as display of reference vessels and lesions, display of target vessel lumen contour, 3D reconstructed model of intracranial vessels, the diameter stenosis distribution and PG/PR distributions.

Here's a breakdown of the acceptance criteria and study details for the AccuICAS device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes a qualitative acceptance: that "All of these tests met the predefined criteria, indicating that the AccuICAS algorithm is accurate, and the device is clinically acceptable." The performance is described by the successful validation of various outputs and calculations.

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

• Sample Size:

  • Morphological parameters: "three brass phantoms and a dozen clinical data." (A dozen typically means 12, so 15 total, 12 clinical data points).
  • Diameter stenosis distribution, PG/PR distributions: "several clinical patients with stenosis lesions." (The exact number is not specified but is less precise than "a dozen").
  • Hemodynamics calculation: "calculated results with the measured results." (Implies the testing involved a dataset that had both device-calculated and independently measured PG/PR values, but the sample size is not stated beyond "results").

• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. Given the submitter's address (Hangzhou, CHINA), it is possible the clinical data originated from China, but this is not confirmed. The nature (retrospective/prospective) is also not specified.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. The ground truth for hemodynamics validation seems to have come from "measured results" rather than expert consensus on images.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The validation seems to rely on comparisons against phantoms, "measured results," and unspecified clinical data outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned or described in the provided text. The device is for "quantitative imaging output but not for diagnosis" and the validation focuses on the accuracy of its calculations.

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

Yes, the performance data presented appears to be a standalone (algorithm only) evaluation. The validation described tests the accuracy of the algorithm's outputs (segmentation, reconstruction, morphological parameters, hemodynamics calculations) against established references (phantoms, measured results), not against human interpretation assisted by the AI.

7. The Type of Ground Truth Used

• Phantoms: For morphological parameters (brass phantoms).
• "Measured Results": For hemodynamics calculations (PG and PR values). This suggests an independent, possibly invasive or highly accurate, method of obtaining these measurements, rather than clinical consensus readings from images.
• Clinical Data/Patient Observations: For diameter stenosis and PG/PR distributions, and implicitly for the "dozen clinical data" for morphological parameters. The exact nature of how this "ground truth" was established for clinical data is not specified (e.g., expert consensus, other imaging modalities, surgical findings, pathology reports, or long-term outcomes). However, the phrasing "compared the calculated results with the measured results" for PG/PR strongly implies an objective, independent measurement was the ground truth for that specific aspect.

8. The Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set.

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

The document does not provide any information about how the ground truth for the training set was established.

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Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR® II is used in capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR® II is indicated for use in adult and pediatric patients one month of age and older.

EXPLORER AIR® II is a fluorescence imaging system, which enables users to visually assess blood flow to evaluate tissue perfusion and tissue-transfer circulation. It can be used on any part of the body during plastic, reconstructive, gastrointestinal, and organ transplant surgeries. EXPLORER AIR® II consists of an imaging system that contains two cameras (one (1) for fluorescence, one (1) for color images) suspended by an articulated arm attached to a trolley. A touch screen and secondary monitor are also mounted on the trolley. EXPLORER AIR® II enhances the surgeon's vision with use of near infrared fluorescence (NIR) imaging. The technology is based on the exposure of the tissue of interest to light after fluorescent dye such as indocyanine green (ICG) has been administered to the patient. The EXPLORER AIR® II visualizes fluorescence excited by infrared light (740-760nm) and emitted in the band centered around 800nm. After image acquisition, the composite image (overlay of fluorescence and color images) is displayed along with the fluorescent and color images. The user can tag and compare images, play the recorded videos, and export the selected files.

The provided text describes the regulatory clearance of the EXPLORER AIR® II device by the FDA. It outlines the device's intended use, technological characteristics, and comparisons to a predicate device (SPY Elite Intraoperative Perfusion Assessment System). However, it does not contain the detailed information required to describe specific acceptance criteria for AI/ML performance, nor a study design with a test set, ground truth experts, or MRMC study results.

The document discusses performance data related to:

• Electrical safety and electromagnetic compatibility (EMC)
• Photobiological safety
• Verification of optical, mechanical and functional requirements (including fluorescent performance, physical properties, environmental conditions, optical requirements, design/ergonomics, usage requirements, power supply, data export, mechanical restrictions)
• ICG (Indocyanine green) testing for detection capability and limit of detection
• Human factors validation
• Software verification and validation testing

While these are performance tests, they are focused on the hardware, general functionality, and safety of the imaging system itself, rather than an AI/ML algorithm's diagnostic or prognostic performance in assessing blood flow and tissue perfusion from the images. The device's function is described as "capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion," indicating that the visual assessment is primarily done by the human user. The software section mentions that a malfunction could lead to a delay in care if the physician were to rely on EXPLORER AIR® II instead of performing a visual assessment, implying the device is an assistive tool for visual assessment, not an automated diagnostic AI.

Therefore, I cannot extract the requested information about AI model acceptance criteria, test sets, expert ground truth, or MRMC studies from this document. The device described appears to be a medical imaging system that facilitates visual assessment by a human, not an AI/ML software as a medical device (SaMD) that performs automated analysis or provides diagnostic output based on AI.

To answer your request based on the provided text, I must state that the document does not contain the information about an AI/ML component's performance study as described in your prompt.

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The DIR 800 is an accessory for the Aesculap Aeos and is used in viewing intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency in neurosurgery. It also aids in the visual assessment of intraoperative blood flow and vessel patency in bypass surgical procedures in neurosurgery.

The DIR 800 is an accessory to the Aeos Digital Surgical Microscope Class I 510(k) exempt surgical operating microscope. The DIR 800 allows the Aeos to produce excitation light to illuminate the fluorescence properties of the Indocyanine Green (ICG). The generated fluorescence signal depicts the distribution of the infrared dye in the patient's blood vessels during surgery.

The provided text describes a 510(k) premarket notification for the DIR 800 device. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct safety and effectiveness through extensive clinical trials with strict acceptance criteria often seen for novel devices.

Therefore, the information available in this document is primarily related to proving substantial equivalence, not a standalone "performance study" in the sense of a clinical trial with specific diagnostic accuracy metrics. The "performance data" section largely covers verification and validation (V&V) testing to ensure the device performs as intended and is comparable to the predicate.

Here's an attempt to extract the requested information based on the provided text, while acknowledging the limitations of a 510(k) submission in terms of detailed performance criteria and study design:

Device Name: DIR 800
Predicate Device: Carl Zeiss Surgical GmbH, INFRARED 800 with FLOW Option (K100468)
Intended Use: Accessory for viewing intra-operative blood flow in the cerebral vascular area (e.g., assessing cerebral aneurysm, vessel branch occlusion, patency in neurosurgery, bypass procedures).

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence and the device performing as intended through verification and validation. There are no explicit quantitative performance metrics like sensitivity/specificity thresholds mentioned for clinical utility in this document.

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

• Test Set (Animal Study):

  • Sample Size: A porcine model and a rabbit elastase model. The exact number of animals is not specified beyond "a" model for each.
  • Data Provenance: The study was conducted specifically to support this submission. The text doesn't specify country of origin for the animals, but the submission is to the US FDA. It was a prospective animal study.

• Test Set (Bench Testing): Not applicable for "sample size" in the traditional sense of patient data. Bench tests would involve specific units of the device or test setups according to a protocol.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Animal Study Experts: "Neurosurgeons" were used for independent scoring assessments.
  • Number of Experts: Not specified.
  • Qualifications: "Neurosurgeons." No further details on years of experience or board certification are provided in this document.

4. Adjudication Method for the Test Set

The text states that in the animal study, "independent scoring assessments which were predefined in the protocol" were performed. It does not specify a formal adjudication method like 2+1 or 3+1. It implies individual assessments were carried out and then likely compared against pre-established criteria or against the DSA gold standard.

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

No.

• The study described is an animal study comparing the DIR 800 visualization to Digital Subtraction Angiography (DSA), not a human MRMC study to compare human reader performance with and without AI assistance.
• The DIR 800 is an imaging accessory that allows visualization, not an AI algorithm that assists in interpretation or diagnosis. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this device's function as described.

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

Yes, in essence, as much as applicable for an imaging accessory.

• The "performance data" largely describes the standalone technical performance of the imaging system (DIR 800) in visualizing blood flow when ICG is introduced.
• The animal study assessed the device's capability to visualize structures and blood flow independently (compared to DSA) and confirmed it met its pre-established acceptance criteria for visualization, image quality, etc. This is inherently a standalone performance assessment of the device's imaging capabilities.

7. The Type of Ground Truth Used

• Animal Study: Digital Subtraction Angiography (DSA) data was collected and used as a comparative "ground truth" to evaluate the DIR 800's visualization of blood flow, vascular structures, and aneurysms in the animal models. DSA is a widely accepted method for visualizing vasculature.

8. The Sample Size for the Training Set

Not applicable.

• The DIR 800 is described as an optical imaging accessory that enables visualization of fluorescence. There is no indication in the document that it incorporates a machine learning/AI algorithm that would require a separate "training set" of data in the typical sense for an AI-powered diagnostic device.
• The "software" mentioned underwent standard software verification and validation, but not training on a dataset.

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

Not applicable, as there is no mention of a training set or AI model in the provided description of the DIR 800 device.

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