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The VS3-Iridium System is intended to provide real-time visible and near infrared fluorescence imaging in both open and minimally invasive procedures.

Upon intravenous administration and use of an ICG consistent with its approved labeling, the VS3-Iridium System is used to perform fluorescence imaging visualization of vessels, blood flow and tissue perfusion before during and after general minimally invasive surgical procedures and plastic, micro-, reconstructive surgeries.

Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-Iridium System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved labeling, the VS3-Iridium 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The VS3-Iridium System is an advanced stereoscopic visualization system made up of a combination of hardware and software to provide high definition visible and near infrared (IR) fluorescent imaging. The visualization system can incorporate an endoscope for minimally invasive surgical procedures and a microscope positioned above the patient during open surgical procedures.

The VS3-Iridium System including the endoscope and the microscope is designed to work with an approved infrared dye (Indocyanine green (ICG) or pafolacianine sodium injection or pafolacianine). ICG may be excited at excitation at either 785 or 805 nm, and pafolacianine is excited only by the 785 nm wavelength. The principle of operation is the same for both infrared dyes. That is, the VS3-Iridium System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera, enabling qualitative and quantitative measurement of the IR intensity. Near IR fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow.

The VS3-Iridium System allows the capture of normal (white) light image in parallel with the fluorescence IR image and displays both to the surgeon to provide a view of the anatomy. In addition, the VS3-Iridium System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

This document describes a 510(k) premarket notification for the VS3-Iridium System (VS3-IR), an advanced stereoscopic visualization system. The filing seeks to re-frame the indications for use statement to align with the specific indications of legally marketed Indocyanine green (ICG) products and pafolacianine, and to eliminate the need for the VS3-Iridium Fluorescence ICG Kit.

Here's an analysis of the provided information about acceptance criteria and supporting studies:

1. Table of acceptance criteria and reported device performance:

   The document explicitly states: "No performance data are needed to support the modified indications for use. As noted above, there are no technological changes associated with the proposed labeling changes. Additionally, no new surgical procedures or tissue types are being referenced in the modified indications for use."

   Therefore, there is no table of acceptance criteria or reported device performance for this specific 510(k) submission, as the changes are purely administrative regarding the Indications for Use statement and the removal of an accessory, not a modification to the device's technological characteristics or its core performance. The FDA granted substantial equivalence based on the device being "the same or similar" to previously cleared versions.

2. Sample size used for the test set and the data provenance: Not applicable. No new performance data was required for this 510(k) submission as there were no technological changes to the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance data was required for this 510(k) submission.

4. Adjudication method for the test set: Not applicable. No new performance data was required for this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The VS3-Iridium System is described as a visualization system for real-time visible and near infrared fluorescence imaging, not an AI-assisted diagnostic or interpretative tool that would involve human readers improving with AI assistance. This submission specifically deals with changes to the Indications for Use, not a new AI component or performance evaluation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The VS3-Iridium System is a visualization system used by a surgeon, implying human-in-the-loop operation. This submission does not introduce or evaluate any new standalone algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No new performance data was required for this 510(k) submission.

8. The sample size for the training set: Not applicable. This submission concerns re-framing indications for use and removing an accessory, not a new algorithm development or training.

9. How the ground truth for the training set was established: Not applicable. As above, this submission concerns re-framing indications for use and removing an accessory, not a new algorithm development or training.

Summary of the Study and Rationale for No New Performance Data:

The core of this 510(k) submission (K223020) is a "special 510(k) premarket notification to re-frame the indications for use statement to be consistent with specific indications of legally marketed ICG products, eliminating the need for the VS3-Iridium Fluorescence ICG Kit."

The manufacturer, Visionsense, Ltd., argues that:

• There are no changes in the technological characteristics of the visualization system hardware, software, or accessories.
• The only change in the system configuration is to obsolete the VS3-IR ICG Kit.
• The proposed changes in the indications for use statement are to reflect the previous discontinuation of a 3D module and associated endoscopes, streamline ICG-related indications, and reflect that these indications are derived from approved ICG drug labeling.
• These changes are considered a "simple statement of product functionality that has always been present and does not represent any new use for the system."
• There are "no questions related to safety or effectiveness of the device when used as labeled," and the change is "not considered a critical change to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device."

Based on these justifications, the FDA determined that "No performance data are needed to support the modified indications for use." The device was deemed substantially equivalent to its own previously cleared versions (K150018, K152204, K183453, K191851, K210265) because the modifications were administrative and did not alter the technological characteristics or intended use in a way that would raise new questions of safety or effectiveness.

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The VS3 Iridium System is intended for viewing anatomical structures during invasive surgery and for viewing fluorescent images for the visual assessment of blood flow and lymphatic flow. The unit is indicated for viewing internal surgical sites during general surgical procedures. It provides an adjunctive method for the evaluation of tissue perfusion and related tissue transfer circulation in tissue and free flaps used in general, plastic, micro-and reconstructive surgical procedures. It also enables the identification of functional lymphatic vessel, and/or lymph nodes. The VS3 Iridium System is also intended to visualize tissues that have taken up the pafolacianine during procedures that are consistent with the approved labeling of that dye.

Upon intravenous administration and use of an ICG consistent with its approved labeling, the Iridium Module of the VS3-IR System is used to perform intraoperative fluorescence angiography.

Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-IR System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine in accordance with its approved labeling, the VS3-IR 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The VS3 Iridium System is an advanced stereoscopic visualization system made up of a combination of hardware and software to provide high definition visible and near infrared (IR) fluorescent imaging. The visualization system can incorporate an endoscope for minimally invasive surgical procedures and a microscope positioned above the patient during open surgical procedures.

The VS3 Iridium System including the endoscope and the microscope is designed to work with an approved infrared dye (Indocyanine green (ICG) or pafolacianine sodium injection or pafolacianine). ICG may be excited at excitation at either 785 or 805 nm, and pafolacianine is excited only by the 785 nm wavelength. The principle of operation is the same for both infrared dyes. That is, the VS3 Iridium System provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera, enabling qualitative and quantitative measurement of the IR intensity. Near IR fluorescence imaging with ICG permits the system to visualize blood flow and related tissue circulation, of lymphatic flow.

The VS3 Iridium System allows the capture of normal (white) light image in parallel with the fluorescence IR image and displays both to the surgeon to provide a view of the anatomy. In addition, the VS3 Iridium System permits recording surgical procedures, storing them on removable storage devices, and replaying the procedures.

This Traditional 510(k) premarket notification is to expand the indication for use statement to include the additional cleared infrared dye, pafolacianine sodium injection, for use with infrared imaging.

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

Acceptance Criteria and Device Performance

The provided text focuses on expanding the indications for use of the VS3 Iridium System to include pafolacianine. The acceptance criteria are implicitly tied to demonstrating the safety and efficacy of the device when used with this new fluorescent dye, specifically its ability to detect target lesions.

Table of Acceptance Criteria and Reported Device Performance:

The study aimed to demonstrate the benefit of using the VS3 Iridium System with pafolacianine (OTL38) for detecting folate receptor positive (FR+) ovarian cancer that would otherwise be missed.

Study Details:

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

   • Sample Size: The imaging subgroup (those using the VS3 Iridium System) had a sample size of n=127.
   • Data Provenance: The study was a "phase 3, randomized, single dose, open-label study." While the specific country of origin is not explicitly stated for the data, the clinicaltrials.gov identifier (NCT03180307) indicates it was a registered clinical trial, which typically involves prospective data collection.

2. 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 text. The text mentions "confirmed FR+ ovarian cancer evaluable lesion," but it doesn't detail how this confirmation (ground truth) was established or who established it.

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

   • This information is not provided in the text.

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:

   • This was not a MRMC comparative effectiveness study in the typical sense of evaluating human readers with and without AI assistance for interpretation.
   • It was a study evaluating a device (VS3 Iridium System) used with a fluorescent dye (pafolacianine) to detect lesions not visible with normal light or palpation. The "effect size" is the proportion of patients where these additional lesions were found (33%).

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

   • No, this was not a standalone (algorithm only) study. The device is a "visualization system" used by surgeons/clinicians for intraoperative imaging. The detection of lesions relies on the combination of the OTL38 (pafolacianine) and NIR fluorescent light observed by humans.

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

   • The text frequently mentions "confirmed FR+ ovarian cancer evaluable lesion." This strongly implies that the ground truth for the presence of these lesions was based on pathology or other definitive clinical confirmation methods (e.g., biopsy). However, the exact method and who confirmed it are not detailed.

7. The sample size for the training set:

   • The provided text describes a Phase 3 clinical study designed to test the performance of the device, not to train it. The VS3 Iridium System is primarily an imaging and visualization system, not an AI-driven diagnostic algorithm that would typically require a separate "training set" in the context of machine learning. Therefore, information about a training set is not applicable/provided for this type of device and study.

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

   • As mentioned above, information about a training set is not applicable/provided for this device and study.

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Intended to facilitate passage of a laparoscope through the anus allowing visual examination of the rectum and distal portions of the colon. Use of device is limited to non-sterile procedures where non-sterile laparoscopes are used.

Not Found

The provided document is an FDA 510(k) clearance letter for a medical device called "Trans-anal Introducer." It states that the device is "substantially equivalent" to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance testing, study design (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment.

The letter is a regulatory document confirming clearance based on substantial equivalence, and it references the device's indications for use. It does not provide the detailed technical and clinical study data that would demonstrate how the device meets specific performance acceptance criteria.

Therefore, I cannot fulfill your request using the provided text. The information you are asking for (acceptance criteria table, study details, expert qualifications, etc.) would be found in the manufacturer's 510(k) submission, specifically the sections detailing the performance testing and clinical evaluations, which are not part of this public clearance letter.

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The system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and large joint arthroscopic procedures.

The VS3 ETV endoscope is the same endoscope as the predicate VS3 with the addition of 3 working channels. The endoscope is designed and manufactured the same way. The endoscope is a rigid metal shaft that uses a proximal sensor module which is mounted onto a camera block on the proximal side of the endoscope (the handle). The endoscope uses stereoscopic images which are transmitted from the visual field at the distal end of the scope through an optical transmission (for left and right channels). The endoscope camera sensor module picks up the left and right images of the scene inside the body and delivers them to the external display. The endoscope incorporates fiber optic threads that transfer the light from the illumination unit to the surgical scene. The VS3 ETV endoscope contains 3 working channels. The endoscope utilizes the same principle of operation, software, system architecture, camera and visual viewing technologies, illumination sources, display monitors, carts, CCU and couplers as the predicate VS3.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VS3-ETV device:

The provided text is a 510(k) summary for the VS3-ETV, which is a modified version of the predicate device, the VS3 Stereoscopic High Definition Vision System (K141002). This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics for clinical outcomes.

Therefore, many of the requested details about a study proving the device meets acceptance criteria are not available in this type of document because the submission strategy is based on comparing technological characteristics and non-clinical performance to a cleared predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially derived from the technological characteristics of the predicate device and the established recognized standards the device conforms to. The "reported device performance" are the stated characteristics of the proposed device, which are shown to be equivalent to the predicate.

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission showing substantial equivalence, the "acceptance criteria" are not typically clinical performance metrics with target values (e.g., sensitivity, specificity). Instead, they are the demonstration that the modified device's technological characteristics and non-clinical performance (e.g., safety, sterilization) are either identical or equivalent to the predicate device, or that any differences do not raise new questions of safety or effectiveness.

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

• Sample Size: The document does not describe a clinical "test set" in terms of patient data. The "performance testing" mentioned refers to non-clinical tests like reuse validation, cleaning, disinfection, and sterilization. The sample size for these non-clinical tests (e.g., number of instruments tested for sterilization cycles) is not provided.
• Data Provenance: Not applicable as it's not a clinical study on patient data. The non-clinical tests were likely conducted by the manufacturer, Visionsense Ltd., in Israel or a contract testing lab.

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

• Number of Experts/Qualifications: Not applicable. There is no mention of a human-read clinical test set or ground truth established by experts in this 510(k) summary. The performance data presented are physical/technical specifications and results from non-clinical validation tests.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

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

• MRMC Study / Effect Size: Not applicable. This device is an endoscope/vision system, not an AI diagnostic algorithm for image interpretation. There is no mention of AI assistance for human readers or an MRMC study.

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

• Standalone Performance: Not applicable. This is a hardware device (endoscope system), not a standalone algorithm.

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

• Ground Truth: Not applicable in the traditional sense of a diagnostic device. For the technical performance characteristics, the "ground truth" would be established by direct measurement with calibrated instruments (e.g., optical resolution charts for horizontal/vertical resolution, rulers for working distance). For the non-clinical tests like sterilization, the ground truth is established by validated laboratory methods (e.g., biological indicators for sterility assurance).

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. (See #8)

Summary of Device and Study Focus:

The VS3-ETV is an endoscope system. The 510(k) submission focuses on demonstrating that the modified device (VS3-ETV, with added working channels) is substantially equivalent to a previously cleared predicate device (VS3, K141002). This means the primary "study" involved comparing the technical specifications and conducting non-clinical performance tests (reuse, cleaning, disinfection, sterilization) to show that the addition of working channels does not introduce new safety or effectiveness concerns compared to the predicate. The reference device K983365 (Aesculap Minop System) was used to establish precedence for the irrigation and working channels concept itself. There is no mention of clinical trials or studies involving patient data to establish new clinical performance criteria for this modification.

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The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.

The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic. micro- and reconstructive surgical procedures.

The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.

The VS3-IR System is made up of the following components:

• VS3 3D Endoscope (K123467, K141002, K131434)
• VS3-IR-MMS & ICG Kit (K150018)
• VS3-IR-Endoscope & ICG Kit (not yet assigned).

The VS3 3D endoscopes (cleared in K123467, K131434, and K141002) are based on the proximal camera concept with a stereoscopic camera block on the proximal side of the endoscope (the handle). The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block through an optical transmission system to PC workstations or external display monitors for enhanced viewing or capturing. VS3 includes reusable endoscopes which are cleaned and sterilized using the same methods and are indicated for the same lifecycle.

In addition to traditional endoscopic procedures, VS3-IR system includes support for Infrared (IR) Fluorescence visualization (hereafter referred to as Iridium utilizes the VS3 system with scopes that support IR fluorescence visualization. VS3 Iridium Miniature Microscope (VS3-IR-MMS) which was cleared in K150018 is positioned 20cm to 45cm above the patient during an open procedure. The proposed Iridium Endoscopes (VS3-R-Endoscope) is used during laparoscopic minimally invasive procedures. VS3 Iridium MMS and Endoscopes are designed to work with an approved IR fluorescence dve (Indocvanine Green or ICG), which has excitation at 805nm and emission band between 825nm and 850nm. VS3 Iridium (VS3-IR) provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera.

Both the Iridium MMS and Iridium Endoscope utilize the left channel of the VS3 imaging system (camera and image processor) for IR fluorescence imaging and the right channel for visible light imaging. This structure allows fluorescence imaging to use the same acquisition and processing pathways as the approved 3D endoscopes (cleared in K123467, K131434, and K141002).

The provided document describes the acceptance criteria and study for the Visionsense VS3-IR System, specifically focusing on the VS3-IR-Endoscope component.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative metrics alongside "reported device performance" in a separate column. Instead, it states that the device "met all performance acceptance criteria" during bench testing. The closest we can get to structured criteria are the functional requirements and the successful detection and visualization described.

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

The document describes bench testing, which typically does not involve a "test set" in the sense of clinical cases or data. The testing involved simulating a surgical field.

• Sample Size: Not applicable in the context of clinical data. The testing was conducted on the device itself and its ability to perform certain functions in a simulated environment.
• Data Provenance: Not applicable as it's bench testing, not clinical data. The testing was performed by Visionsense Ltd.

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

• Number of Experts: Not mentioned. Bench testing usually relies on engineering and scientific personnel to verify device function against specifications.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Bench testing for functional verification does not typically involve an adjudication process by human experts in the same way clinical data evaluation would.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document describes bench testing of the device's functional performance, not a study of human reader improvement with or without AI assistance. The device is for visualization, not an AI diagnostic tool that assists human readers.

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

• Standalone Performance: The study focuses on the standalone performance of the device's imaging capabilities. It verified that the device, without human interpretation for evaluation of its own core function, could detect and visualize fluorescence. However, the device itself is a "human-in-the-loop" tool, as it's an endoscope for surgeons to use for visualization. The bench testing verified the device's ability to produce the images that a human user would then interpret.

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

• Type of Ground Truth: For the bench testing, the "ground truth" was established by the physical and chemical principles of fluorescence (ICG excitation and emission) and the known properties of the simulated surgical field. The expectation was that the device would accurately capture and display this known phenomenon. It's a functional ground truth, verified by the correct operation of the system (laser excitation triggering fluorescence, detection by IR camera, and appropriate image fusion).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes the functional testing of a medical device (endoscope), not the development or training of an AI algorithm from a dataset.

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

• Ground Truth for Training Set: Not applicable as no training set for an AI algorithm is mentioned or implied.

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The Endoscope Module of the VS3-IR-MMS System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The Iridium Module of the VS3-IR-MMS System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

The VS3-IR-MMS System consists of the cleared base system and the Iridium Module that is the subject of this submission. The currently marketed VS3 system with endoscope functionality was cleared under the following product codes: GCJ (General Surgery Endoscope), GWG (Neurological Endoscope), and HRX (Orthopedic Arthroscope). The cleared base system consists of the following components and accessories: High Definition 3D Endoscope, High Definition 3D Camera with 3 control buttons and a focus adjustment knob, 2D Coupler, CCU, Light Source, and Display Monitor. The VS3-IR-MMS System that is the subject of this submission contains the previously cleared components of the cleared base system listed above, as well as a High Definition IR Fluorescence Scope (MMS), a Laser Light Source (LLS), associated software and VS, Iridium IR Fluorescence Kit. The new Iridium Module, which uses the newly added High Definition IR Fluorescence Scope (MMS) and a Laser Light Source (LLS), as well as the cleared High Definition 3D Camera, Camera Control Unit (CCU), and Display Monitor, is used to generate florescence excitation illumination for external use in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.

The document describes the VS3-IR-MMS System and its Iridium Module, which is intended for capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method. The submission focuses on demonstrating substantial equivalence to a predicate device, the Novadaq Technologies SPY Imaging System (K063345), rather than setting specific performance acceptance criteria for the new module.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the Iridium Module's performance in terms of metrics like sensitivity, specificity, or accuracy. Instead, it relies on demonstrating that the device "functions as intended" and "met all performance acceptance criteria" based on bench testing and limited human subject evaluations. The primary "acceptance criteria" presented are related to regulatory standards compliance and functional equivalence to the predicate.

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

• Bench Testing:
  • ICG in sterile water: A single sample of 10mg ICG diluted to 2 ug/ml.
  • ICG through chicken skin: A single sample of ICG in sterile water covered with chicken skin.
• Human Simulation: A human hand was used. (Sample size: 1)
• Human Subjects: "Several human subjects" were evaluated in free flaps. (Exact sample size not specified, but implied to be small).
• Data Provenance: The human hand simulation and human subject evaluations were conducted "outside of the United States." The context suggests these were prospective evaluations, albeit limited.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test sets. The interpretations of "good quality imaging" during bench testing and "functions as intended" or "no adverse events" during human evaluations were likely made by the researchers or clinical personnel involved in the studies, but their specific expert qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not mention any formal adjudication method (e.g., 2+1, 3+1) for evaluating the test results. The assessment appears to be based on direct observation and qualitative judgment by the study personnel.

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 was done. This device is not described as an AI-powered diagnostic or assistive tool for human readers in the traditional sense. It's an imaging system for visualizing blood flow.

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

The device is an imaging system; it captures and displays images for human interpretation. The concept of "standalone algorithm only" performance, as it applies to AI/ML diagnostic tools, is not relevant here. The system's function is to provide the visual information.

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

• Bench Testing: The ground truth was the known presence and concentration of ICG and the physical setup (ICG solution, ICG under chicken skin). Visual assessment of "good quality imaging" was the outcome.
• Human Simulation (Hand): The ground truth was the expected blood flow in a human hand after ICG administration. Visual assessment of corresponding dye fluorescence was the outcome.
• Human Subjects (Free Flaps): The ground truth was the actual tissue perfusion and related tissue-transfer circulation in free flaps. The assessment was that the device visualized blood flow and "functions as intended with no adverse events reported." This implies clinical observation of actual perfusion.

8. The Sample Size for the Training Set

No information is provided about a "training set" for the Iridium Module. The document describes a system with specific optical and imaging characteristics, not a machine learning model that requires a training set. The software modifications mentioned are likely for instrument control and image processing, not for AI model training.

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

As no training set is mentioned in the context of machine learning, this question is not applicable.

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The VS3-OT system is intended for viewing internal surgical sites during general surgical procedures, visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.

The VS3 Stereoscopic High Definition Vision System, Model VS3-OT consists of the following components:

• Endoscope
• Light source
• Camera Control Unit (CCU)
• Camera
• Display monitors
• 2D Endoscope coupler

The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-0T is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System. Model VS3-OT allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-OT also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-OT to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the way a typical performance study for AI/ML devices might. Instead, it focuses on general performance standards, substantial equivalence to predicate devices, and regulatory compliance.

However, based on the information provided, we can infer some "acceptance criteria" through the lens of comparison to predicate devices, particularly regarding technical specifications. The study described is a comparison of the subject device (VS3-OT) with legally marketed predicate devices, focusing on demonstrating substantial equivalence rather than a standalone performance study with a test set, ground truth, and human readers in the traditional sense.

Here's an attempt to structure the information according to your request, highlighting what is present and what is absent:

Acceptance Criteria and Study for Visionsense Ltd VS3 Stereoscopic High Definition Vision System, Model VS3-OT

The provided document describes the regulatory submission for the VS3 Stereoscopic High Definition Vision System, Model VS3-OT, focusing on demonstrating substantial equivalence to predicate devices rather than a standalone performance study with explicit acceptance criteria and corresponding performance metrics for a novel AI/ML algorithm.

The "acceptance criteria" can be inferred from the technical specifications of the predicate devices which the subject device aims to match or exceed to demonstrate substantial equivalence. The "study" refers to the comparison table provided in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like the VS3-OT (an endoscope), performance standards often relate to optical and physical characteristics. Since this is a substantial equivalence submission, the "acceptance criteria" are the performance characteristics of the predicate devices. The "reported device performance" is the VS3-OT's specifications.

Note: "Meets" indicates that the subject device's reported performance is comparable to or better than the predicate devices' specifications, supporting the claim of substantial equivalence for these technical characteristics.

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

This document does not describe a "test set" in the context of an AI/ML algorithm evaluation with a specific sample size of cases or images. The "study" relies on a direct technical comparison against the published specifications of predicate devices. There is no information about data provenance (e.g., country of origin, retrospective/prospective) for a test set, as such a test set is not explicitly detailed.

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

Not applicable. The document does not describe a test set that requires expert-established ground truth for an AI/ML algorithm. The comparison is based on objective technical specifications.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or expert review process described in this context.

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

No, an MRMC comparative effectiveness study involving human readers with or without AI assistance was not performed or described in this submission. The device is an imaging system (endoscope), not an AI diagnostic tool.

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

Not applicable. The device is a surgical vision system; it is not an AI algorithm performing standalone analysis.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the published technical specifications and performance characteristics of the legally marketed predicate devices, which serve as the benchmark for demonstrating substantial equivalence. There is no explicit mention of pathology, outcomes data, or expert consensus being used as ground truth for a novel AI algorithm's performance.

8. The Sample Size for the Training Set

Not applicable. This submission is for a conventional medical device (endoscope), not an AI/ML system developed with a training set of data.

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

Not applicable. As there's no training set for an AI/ML algorithm, the method of establishing its ground truth is not relevant here.

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Intended for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.

The VS3 Stereoscopic High Definition Vision System, Model VS3-NE consists of the following components: Endoscope, Light source, Camera Control Unit (CCU), Camera, Display monitors, 2D Endoscope coupler. The VS3 Stereoscopic High Definition ("3DHD") Vision System, Model VS3-NE is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housing optical relay components and light fibers. The VS3 Stereoscopic High Definition Vision System, Model VS3-NE also includes 2D coupler capability that allows the VS3 Stereoscopic High Definition Vision System, Model VS3-NE to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

This submission describes a Substantial Equivalence (SE) determination for a medical device, meaning the device's acceptable performance is demonstrated by its similarity to already legally marketed predicate devices, rather than through independent studies with specific acceptance criteria. Therefore, most of the requested information (acceptance criteria, study details, ground truth, expert involvement, etc.) is not applicable in the context of this 510(k) summary.

Here's a breakdown of what can be extracted and why other parts are not available:

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

• Not Applicable. In a 510(k) for substantial equivalence, the "acceptance criteria" are effectively that the new device's technological characteristics, indications for use, and principles of operation are sufficiently similar to those of a legally marketed predicate device such that no new questions of safety or effectiveness are raised. The performance is "reported" by showing these similarities, not by meeting specific quantifiable performance metrics in independent studies for this particular submission.

Instead, the submission presents a comparison table demonstrating the similarities between the subject device (VS3-NE) and its predicate devices (VSII System K081102 and VS3 K123467).

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

• Not Applicable. This 510(k) submission does not include a clinical or performance test set in the conventional sense (i.e., a set of medical images or patient data used to evaluate algorithm performance). The "test" for substantial equivalence is the comparison of the device's specifications and intended use against predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment by experts is described in this submission, as it focuses on substantial equivalence to existing devices.

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

• Not Applicable. There is no test set or adjudication process described as this is a substantial equivalence submission.

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

• Not Applicable. This device is a stereoscopic high definition vision system (an endoscopic camera system), not an AI algorithm designed to assist human readers or perform diagnostic tasks. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

• Not Applicable. This is a hardware vision system, not an algorithm, so standalone algorithm performance is not relevant.

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

• Not Applicable. There is no ground truth, in the sense of medical diagnostic accuracy, required for this substantial equivalence submission. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not Applicable. There is no AI component or training set described in this submission.

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

• Not Applicable. As there is no training set mentioned, this question is not applicable.

Summary of the K131434 Submission:

The K131434 submission is for the VS3 Stereoscopic High Definition Vision System, Model VS3-NE, an endoscope. The device's approval is based on its Substantial Equivalence to two predicate devices:

• Visionsense Ltd VS (K081102)
• Visionsense Ltd VS3 (K123467)

The submission argues for substantial equivalence based on the following:

• Same Intended Use/Indications for Use: Viewing internal surgical sites during general surgical procedures and for visualization of ventricles and structures within the brain during neurological surgical procedures.
• Similar Principles of Operation: Proximal HD camera concept with a stereoscopic camera block, capturing right and left images for a 3D video stream.
• Similar Technological Characteristics: The device shares core components and specifications (e.g., rigid stainless steel endoscope, similar diameter, length, field of view, and direction of view) with the predicate devices.

The submission also notes compliance with several recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-18, ISO 14971, ISO 8600 series). These standards are device-specific performance criteria for safety and manufacturing, not diagnostic acceptance criteria.

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The VS3 is intended for viewing internal surgical sites during general endoscopic and laparoscopic surgical procedures.

The VS3 consists of the following components: Endoscope, Light source, Camera Control Unit (CCU), Camera, Display monitors, 2D Endoscope coupler. The VS3 Stereoscopic High Definition ("3DHD") system is based on the proximal HD camera concept with a stereoscopic camera block located on the proximal side of the endoscope (the handle). This allows high resolution capture of the 3D video stream. The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block containing the HD sensor module. The VS3 system allows for separation of the camera module with image sensor module and electronics from the endoscope shaft housinq optical relay components and light fibers. The VS3 system also includes 2D coupler capability that allows the VS3 system to be used with FDA-cleared, third party 2D scopes at user sites to display monocular video.

The provided text describes a 510(k) submission for the Visionsense VS3 Stereoscopic Vision System, a Class II medical device. However, it does not contain the detailed information required to fill out the table regarding acceptance criteria, study details, and performance metrics as it is primarily focused on establishing substantial equivalence to a predicate device.

Specifically, the document states:

• "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes."
• "However, the VS3 system and its components follow FDA recognized consensus standards for electrical safety, electromagnetic compatibility, and biocompatibility. In addition, cleaning validation, sterilization, and software validation were performed for the subject device. The completed testing listed above demonstrates that the subject device is as safe and effective as the predicate device."

This indicates that the "study" proving the device meets acceptance criteria is primarily a series of verification and validation tests against recognized consensus standards and internal quality controls, rather than a clinical performance study with specific acceptance criteria in terms of diagnostic accuracy or other performance metrics typically associated with AI/software devices. Therefore, many of the requested fields cannot be answered from the provided text.

However, based on the information provided, here's what can be extracted and what cannot be:

1. Table of acceptance criteria and the reported device performance:

Note: The text explicitly states "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") for endoscopes." This implies there are no specific quantitative or clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) provided in this document as would be expected for a diagnostic AI device. The "performance" described focuses on meeting safety, electromagnetic, and material standards, and demonstrating functional equivalence to the predicate device with the added feature of HD.

Additional Information (where available or noted as unavailable):

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

• Not provided. The document describes engineering and quality assurance validation (e.g., electrical safety, sterilization validation) against consensus standards but does not detail sample sizes or data provenance for a "test set" in the context of clinical performance data or AI model evaluation.

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

• Not applicable/Not provided. This information is relevant for studies validating interpretations or diagnostic outputs, typically in AI/software clinical performance studies. The provided text does not describe such a study.

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

• Not applicable/Not provided. As above, this pertains to expert-led ground truth establishment for performance 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, an MRMC comparative effectiveness study was not done (or at least not described in this submission summary). The device is a stereoscopic vision system (hardware-based 3D visualization), not an AI-assisted diagnostic tool for human readers.

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

• Not applicable/Not provided. The device is an endoscopic system providing visualization, not a standalone algorithm.

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

• Not applicable/Not provided. The device's validation focuses on engineering and safety standards, and functional equivalence to a predicate, rather than validating against a clinical "ground truth" for diagnostic accuracy.

8. The sample size for the training set:

• Not applicable/Not provided. This is not an AI/machine learning device in the context of this submission. "Training set" would not apply in the conventional sense.

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

• Not applicable/Not provided. As above, this is not an AI/machine learning device.

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The VSII System is intended for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, as well as for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.

Visionsense Stereoscopic Vision System (VSn) consists of a proprietary CCD camera, embedded in the distal end of a rigid metal arthroscope. An array of miniature lenses - the Lenticular Arrav (LA) - built onto the CCD surface during the wafer fabrication process, captures the image from slightly different angles, thus mimicking the natural human "stereo vision" obtained when the eyes simultaneously pick up two different images of the same object (right and left). The captured image is subsequently transmitted to a PC workstation, processed and presented on a stereoscopic display panel. Images are recorded and may be later downloaded for further analysis.

The provided text is a 510(k) summary for the Visionsense Stereoscopic Vision System (VSn). It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria or detailed study results demonstrating performance against such criteria.

The section titled "Performance" states: "No performance standards or special controls have been developed under Section 514 of the Federal Food, Drug, and Cosmetic Act ("FDC Act") for arthroscopes. However, the VSn System and its components comply with international standards for electrical safety, electromagnetic compatibility, and biocompatibility."

This indicates that the submission primarily relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with defined acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided document.

Here's a breakdown of what can and cannot be answered:

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

• Acceptance Criteria: Not explicitly stated in the document for product performance. The document mentions compliance with "international standards for electrical safety, electromagnetic compatibility, and biocompatibility," which serve as regulatory acceptance criteria for device components, but not performance criteria related to its imaging capabilities or clinical effectiveness.
• Reported Device Performance: Not detailed in terms of a clinical or technical performance study with specific metrics. The document focuses on the system's ability to provide "stereo vision" by capturing images from slightly different angles and processing them for display.

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

• Not applicable/Not provided. The document does not describe a clinical or technical performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable/Not provided.

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

• Not applicable/Not provided.

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

• Not applicable/Not provided. This device is a vision system, not an AI-assisted diagnostic tool.

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

• Not applicable/Not provided. This device is a vision system for human use, not an automated algorithm.

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

• Not applicable/Not provided.

8. The sample size for the training set:

• Not applicable/Not provided. The document does not describe a machine learning model requiring a training set.

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

• Not applicable/Not provided.

Summary of available information related to performance/equivalence:

• Device: Visionsense Stereoscopic Vision System (VSn)
• Intended Use: Viewing internal surgical sites during anterior and posterior spinal procedures (nucleotomy, discectomy, foraminotomy), general surgical procedures, and visualization of ventricles and structures within the brain during neurological surgical procedures.
• Technological Characteristics: Proprietary CCD camera with a Lenticular Array to capture images from slightly different angles, mimicking natural human stereo vision. Images are processed and presented on a stereoscopic display panel.
• Basis for Clearance: Substantial Equivalence to predicate devices (K081102, K073279, K990635, K051827) and compliance with international standards for electrical safety, electromagnetic compatibility, and biocompatibility. The current submission expands the indications for use based on similarity to previously cleared versions and other endoscopes.
• Performance Standards: No specific performance standards or special controls under Section 514 for arthroscopes.

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