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Upon intravenous administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. During minimally invasive surgery, the FloNavi Endoscopic Fluorescence Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts, using near-infrared imaging.

Upon interstitial administration and use of an ICG consistent with its approved label, the FloNavi Endoscopic Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The proposed system, FloNavi Endoscopic Fluorescence Imaging System (FloNavi System) is comprised of an image processing unit, a camera head, and a light source (including a flexible light guide cable).

There are two models of the proposed system. The primary components of each model are provided in Table 1.

Model 1: Image Processing Unit: OPTO-CAM214K, Camera Head: OPTO-CHD214KE/OPTO-CHD214KH, Light Source: OPTO-LED214K
Model 2: Image Processing Unit: OPTO-CAM2100, Camera Head: OPTO-CHD2100, Light Source: OPTO-LED2100

FloNavi Endoscopic Fluorescence Imaging System is capable of providing real-time endoscopic visible and near-infrared fluorescence imaging.

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

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

The proposed system is designed to be used with rigid endoscopes, monitors and other ancillary equipment.

The requested information about the acceptance criteria and study proving device performance is not available in the provided text. The document is an FDA 510(k) clearance letter and summary, which confirms substantial equivalence to a predicate device based on non-clinical testing, but does not detail acceptance criteria or specific performance study results of the type requested.

The document explicitly states:
"No clinical tests were performed." and "Performance testing was conducted on imaging performance and light source performance to support the marketing claims and to confirm that safety and effectiveness of the FloNavi Endoscopic Fluorescence Imaging System is at least equivalent to the predicate device."

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Effect size of human readers with vs. without AI assistance (as no clinical AI assistance study is mentioned).
6. Standalone performance (algorithm only) was done. (While non-clinical performance was done, it's not described in terms of specific standalone algorithm performance, but rather overall system performance.)
7. Type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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The TELE PACK + is an all-in-one Imaging System, which comprises a light source for illumination, Camera Control Unit (CCU) for use with compatible camera heads or video endoscopes for image processing, as well as a monitor for image display, intended for the visualization of endoscopic and microscopic procedures.

The Telepack + is a portable and compact all-in-one imaging system that includes a 18.5 inch screen display, a camera control unit and internal LED light source, that is intended to be connected to a compatible device (camera head or videoendoscope) for the purpose of visualization and documentation of endoscopic and microscopic procedures as well as stroboscopy. The Telepack + includes a LED illumination light source to illuminate the intended area and a 18.5 inch monitor for display. It also allows the users to redefine the functions that take place when a button is pressed. The Telepack + is a non-patient contacting and require only wipe down as needed.

The provided text is a 510(k) Summary for the Telepack + imaging system. It describes the device, its intended use, and the non-clinical performance data used to demonstrate substantial equivalence to a predicate device. However, it does not contain information about:

• Acceptance criteria in the context of an AI/algorithm-driven device's performance metrics (e.g., sensitivity, specificity, AUC).
• A study proving the device meets these acceptance criteria through a comparison of algorithm performance against a ground truth dataset, or human reader performance.
• Sample sizes for test sets where ground truth is established by experts.
• The number or qualifications of experts used for establishing ground truth.
• Adjudication methods for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Effect sizes of human reader improvement with AI assistance.
• Standalone algorithm performance studies.
• Specific types of ground truth (e.g., pathology, outcomes data for a disease).
• Sample size for training sets.
• How ground truth for training sets was established.

The "Performance Testing" section within the "Non-Clinical Performance Data" discusses basic image quality characteristics like "Minimum Illumination," "Spatial Resolution," "Color Performance," "Latency," "White Balance," and "AE Step Response," along with "Head Button Functionality." These are engineering performance metrics for an imaging system, not performance metrics for an AI/algorithm diagnosing or assisting in diagnosis.

The document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence." This indicates that the Telepack + is a hardware imaging system, and its approval was based on demonstrating that its image quality and functionality are comparable to its predicate, rather than on the diagnostic performance of an embedded AI algorithm.

Therefore, I cannot provide the requested information based on the given text.

In summary, the provided document does not contain the information required to answer your prompt because the device is an imaging system, not an AI/algorithm-driven diagnostic aid.

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The KARL STORZ Flexible Video-Neuro-Endoscope System is indication and access during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection, hydrocephalus treatment, endoscopic third ventriculostomy with choroid plexus cauterization (ETV/CPC), endoscopic third ventriculostomy, cyst fenestration, and aqueduct exploration.

The Flexible Video-Neuro-Endoscope System is a videoscope indicated for viewing and providing access during cranial diagnostic and therapeutic procedures. The system consists of the KARL STORZ Flexible Video-Neuro-Endoscope (Model Number: 11161V) and the IMAGE1 SPIES Camera Control Unit (CCU), which has been cleared in K160044.KARL STORZ Flexible Video- Neuro-Endoscope's working shaft is 350 mm long with 8.5 Fr elliptical shaped distal tip (minor diameter is 2.4 mm and major diameter is 3.2 mm). The shaft has a Pellathane (polyurethane) cover and contains a PTFE working channel with an I.D. of 1.2 mm. The working channel length is 519 mm. Both instrument and irrigation ports have stopcocks, and there are no check valves or other restrictions to prevent the back flow within any point of the fluid path. The Video Neuroscope's direction of view is 0° and the direction of view is 90°. The distal tip houses the CMOS (complementary metal oxide semiconductor) imaging sensor, and the illumination is provided by two glass fiber light bundles, whose LED light source is located in the handpiece. In the handpiece of the KARL STORZ Flexible Neuro-endoscope, the user will find a deflection lever, which allows the distal tip to deflect 270 degrees in the UP/DOWN direction. Next to the deflection lever is three control buttons (“Select", "Left (Up)", and "Right (Down)") that provide a remote means for the user to interact with the IMAGE1 SPIES CCU and can be programmed to initiate specific functions such as white balance, image capture, zoom, and access to CCU setup menu. Once set by user, the control button assignment is retained after the system being switched on and off. LED (Light Emitting Diode) is integrated in the handpiece, and it is used to provide illumination of the anatomy under examination. The light is transmitted from the LED to the distal tip via two glass fiber light bundles. The raw data captured at the distal tip CMOS imaging sensor is converted to a standard NTSC (National Television System Committee) video signal by the printed circuit board (PCB), also housed in the handpiece.

The provided document describes the KARL STORZ Flexible Video-Neuro-Endoscope System. It does not contain information about an AI-powered device or a study involving human readers or AI assistance. The document focuses on the substantial equivalence of the neuro-endoscope system to a predicate device through non-clinical bench testing and biocompatibility assessments. Therefore, I cannot extract information related to AI performance, human reader improvement with AI assistance, or related metrics.

However, I can provide the acceptance criteria and study findings for the non-AI device presented in the document:

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

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

The document does not specify a "test set" in terms of patient data or images. The evaluation was done through non-clinical bench testing and biocompatibility testing on the device itself and its materials. There is no information regarding the country of origin of data or whether it was retrospective or prospective, as it did not involve clinical data.

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

Not applicable. The evaluation was primarily engineering and laboratory-based, focusing on performance specifications and material compatibility, not expert interpretation of clinical data.

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

Not applicable. There was no clinical test set 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. This device is a neuro-endoscope, which is a viewing and access tool, not an AI-assisted diagnostic or interpretive system. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported.

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

Not applicable. There is no algorithm or AI component in this device.

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

The "ground truth" for the non-clinical tests was established by predefined engineering specifications, performance limits, and standardized testing methods (e.g., ISO 10993 standards for biocompatibility, specific sterilization cycle parameters).

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set or associated ground truth was established for this device.

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