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The ActivSight Intraoperative Imaging System (ActivSight) is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery.

Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.

The ActivSight Intraoperative Imaging System (ActivSight) is an accessory to existing commercial surgical laparoscope systems, including cameras and video processor units. ActivSight provides real-time endoscopic fluorescence and nearinfrared imaging. These imaging features allow surgeons to visually assess vessels, blood flow, and tissue perfusion (using fluorescence and near-infrared imaging), and to visually assess at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence. Fluorescence imaging is enabled through use of any commercially available Indocyanine Green (ICG). These visualization features are available for surgeons to use during minimally invasive surgery. ActivSight is intended to be used in a surgical environment.

This report confirms that the ActivSight Intraoperative Imaging System (K231344) has been found substantially equivalent to its predicate device (K203550) by the FDA. This determination is primarily based on non-clinical testing related to a new sterilization method, as the device itself is identical in intended use and technology to the predicate. Therefore, detailed information regarding acceptance criteria and performance of an AI/human-in-the-loop system, as typically required for novel AI-powered medical devices, is largely not applicable to this specific submission.

However, based on the limited information provided, we can infer some aspects and highlight what is not present given the nature of the submission. Since the provided text is a 510(k) clearance letter and summary for a modification (specifically, a new sterilization method) to an existing device, it does not contain the detailed clinical study data typically found in original submissions for AI-powered devices.

Here's an analysis based on the context:

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

The provided documentation does not specify acceptance criteria and reported device performance related to diagnostic accuracy or clinical effectiveness, as this was a 510(k) submission for a modification (sterilization) rather than a de novo AI device.

The non-clinical testing performed focused on:

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

For the sterilization efficacy testing:

• Sample Size: Not explicitly stated, but typically involves a sufficient number of test articles (e.g., medical devices or biological indicators) to statistically validate a SAL of 10^-6.
• Data Provenance: Not specified, but likely laboratory testing conducted under controlled conditions. This is not clinical data from patients.

For functional testing after reprocessing:

• Sample Size: Not explicitly stated, but usually involves testing multiple units through a predefined number of reprocessing cycles.
• Data Provenance: Not specified, but likely laboratory testing.

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

This is not applicable to this type of submission. Ground truth, in the context of diagnostic accuracy, would involve expert radiologists or pathologists interpreting images or samples. The testing here is for sterility and functional reliability, not diagnostic performance.

4. Adjudication method for the test set

This is not applicable as there are no expert interpretations requiring adjudication.

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

No MRMC study was performed or required for this 510(k) submission, as it relates to a modification of an existing imaging system's sterilization method, not its diagnostic or assistive AI capabilities. The device is an intraoperative imaging system that provides fluorescence and near-infrared imaging for surgeons, not an AI-powered diagnostic tool for human readers.

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

Not applicable. The ActivSight system is described as an "accessory to existing commercial surgical laparoscope systems" and "enables surgeons to visually assess," indicating it's a visualization tool used by surgeons, not a standalone AI algorithm producing interpretations.

7. The type of ground truth used

For sterilization testing, the ground truth is established by microbiological methods (e.g., culturing biological indicators after sterilization to confirm kill rates). For functional testing, the ground truth is the device's operational specifications and performance metrics (e.g., image quality, light output, mechanical integrity).

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set. Even if the original predicate device (K203550) involved some form of image processing or enhancement, the provided document does not indicate that it is an AI/ML-based device that would undergo a training phase.

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

Not applicable for the same reason as point 8.

In summary:

This 510(k) clearance is for a change to an already cleared medical device (specifically, its sterilization method). Therefore, the detailed performance data, acceptance criteria, and study designs typically associated with new AI/ML-driven diagnostic or treatment devices are not present in this document. The "study" mentioned here refers to the non-clinical validation of the new sterilization processes and confirmation of the device's continued functional reliability after these processes.

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The ActivSight Intraoperative Imaging System (ActivSight) is intended to provide real-time endoscopic fluorescence and near infrared imaging. ActivSight enables surgeons to visually assess vessels, blood flow, and related tissue perfusion using fluorescence and near infrared imaging, and at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence, all during minimally invasive surgery.

Fluorescence imaging of biliary ducts with ActivSight is intended for use with standard of care white light, and when indicated, intraoperative cholangiography. The device is not intended for stand-alone use for biliary duct visualization.

The ActivSight Intraoperative Imaging System (ActivSight) is an accessory to existing commercial surgical laparoscope systems, including cameras and video processor units. ActivSight provides real-time endoscopic fluorescence and near-infrared imaging. These imaging features allow surgeons to visually assess vessels, blood flow, and tissue perfusion (using fluorescence and near-infrared imaging), and to visually assess at least one of the major bile ducts (cystic duct, common bile duct, or common hepatic duct) using fluorescence. Fluorescence imaging is enabled through use of any commercially available Indocyanine Green (ICG). These visualization features are available for surgeons to use during minimally invasive surgery. ActivSight is intended to be used in a surgical environment.

ActivSight consists of the following reusable components:

• ActivSight Imaging Module, consisting of optics and sensing electronics. The imaging module attaches physically between the third-party laparoscope and the third-party imaging system camera. Reprocessing of this component requires cleaning and disinfection between uses.
• ActivSight Light Engine, equipment consisting of system electronics that provide laser fluorescence and near-infrared illumination, processing of video input from both the third-party Camera Control Unit (CCI) and the ActivSight lmaging Module, and outputs video to the surgical monitor. This component does not require reprocessing between uses.
• ActivSight Light Cable, component consisting of a Y-shaped bifurcated light a cable that connects to the third party white-light source, the ActivSight Light Engine, and the third party laparoscope light post (providing white-light illumination of the surgical site through the laparoscope). Reprocessing of this component requires cleaning and steam sterilization.
• ActivSight Sterilization Tray, stainless-steel sterilization tray designed to a properly secure the ActivSight Light Cable for disinfection and sterilization. Reprocessing of this component is accomplished in its use- cleaning and steam sterilization.

ActivSight consists of the following disposable components:

• ActivSight Sterile Drape, a sterilized plastic drape that is provided for each use = to provide a sterile barrier between the imaging module and the patient.
• -ActivSight Calibration Target, a sterilized paper imaging target containing a checkerboard pattern for calibration of the ActivSight imaging module prior to each use of the device.

The provided text describes the ActivSight Intraoperative Imaging System, its indications for use, and a comparison to predicate devices, but it does not contain explicit acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical trial reports or validation studies.

The document primarily focuses on regulatory approval (510(k) submission) by demonstrating substantial equivalence to a legally marketed predicate device. While "Performance Data" is mentioned, it refers to compliance with general safety and performance standards (e.g., IEC standards for electrical safety, software lifecycle) and an animal study for comparative visualization, not a clinical study to establish quantitative performance against defined acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide the available information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document. The document focuses on demonstrating compliance with general safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62366-1, ANSI AAMI IEC 62304, IEC 60825-1, IEC 60601-2-18) and a "design validation in an animal study." However, specific quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, or other clinical efficacy metrics are not provided, nor are the detailed results of such performance against these criteria.

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

• Test Set Sample Size: Not specified for any clinical performance or validation study against specific acceptance criteria. The document mentions an "animal study" for design validation, but details like the number of animals or specific data points are omitted.
• Data Provenance: The "design validation" was conducted as an "animal study." No information on a human test set or its provenance (e.g., country of origin, retrospective/prospective) is provided.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study Done: No, an MRMC comparative effectiveness study is not mentioned in the provided text. The document refers to an "animal study" for comparative visualization against a predicate's ICG mode, but this is not a human MRMC study to assess reader improvement with AI assistance.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was mentioned.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Done: The document describes the device (ActivSight) and its capabilities, including "real-time endoscopic fluorescence and near-infrared imaging" and enabling surgeons to "visually assess vessels, blood flow, and related tissue perfusion." The "animal study" compared ActivSight Perfusion (speckle laser) and ActivSight ICG (fluorescence) modes against the predicate's ICG mode in terms of "comparatively visualizing blood flow and perfusion." This suggests evaluating the device's imaging capabilities (algorithm included), but it is not framed as a formal "standalone performance study" with defined metrics like sensitivity/specificity for disease detection, or an "algorithm only" evaluation completely separated from the hardware and human interpretation, as typically meant by standalone performance in AI/ML medical devices. The primary focus is on the device as a whole system providing real-time visualization.

7. Type of Ground Truth Used

• Ground Truth Type: For the "animal study," the ground truth for "comparatively visualizing blood flow and perfusion" is implied to be direct visual assessment by the comparing technologies (ActivSight's modes vs. predicate's ICG mode). The document does not specify an independent, objective ground truth established by pathology, outcomes data, or expert consensus beyond the visual comparison of the imaging techniques themselves.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified. The document does not mention details about algorithm training or associated datasets.

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

• Ground Truth Establishment for Training Set: Not specified, as training set details are not provided.

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