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The SurroundScope System is designed to be used with documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including the female reproductive organs.

The SurroundScope System (SS) is an endoscopic platform for visualization during surgery. The SS System is a modification of the previously cleared WV1 Endoscope (K190190) developed by 270Surgical. The SS System is designed to be used with documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment. The SS System features two viewing capabilities: standard and extended. The standard view uses one lens and displays a 90 degree field of view while the extended view uses two additional lenses on the side of the tip and displays a 270 degree field of view. Each lens has its own set of LEDs for illumination.

The SS System is comprised of two main components:

• SS endoscope (Video endoscope)
• Camera Controller Unit (CCU) (Video Processor)

The SS endoscope is a reusable, rigid video endoscope. It is a reusable (autoclavable) endoscope and is intended to be used in a sterile environment. It is initially supplied non-sterile to the user and requires the user to process (i.e., clean and sterilize) the device for initial use, as well as to reprocess the device after each use. The SS endoscope main components are the video and illumination system, the endoscope body, and the endoscope main connector. The endoscope consists of a camera head at the distal tip, insertion tube, control handle, umbilical cable, and main connector. The insertion tube and distal tip are made of gold coated stainless steel. The distal tip contains sapphire for the optical components. The required illumination for the endoscope is supplied by integrated LEDs, located on the endoscope's distal tip. The endoscope video system is controlled by the video processor which collects the video signal produced by the image sensors (CMOS).

The SurroundScope Camera Control Unit (CCU) processes and manages the images/video signal from the endoscope and transfers them to the monitor. The CCU video center also powers and controls the CMOS located in the SS endoscope.

The SurroundScope System is a rigid video endoscope designed for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs. It supports both standard (90-degree field of view) and extended (270-degree field of view) viewing capabilities. The system comprises an SS endoscope (reusable, rigid video endoscope) and a Camera Controller Unit (CCU).

Here's an analysis of the acceptance criteria and the studies performed to demonstrate the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding performance results in a consolidated format. However, it states that "All tests met the predefined acceptance criteria" for various bench tests. The performance data section describes the tests performed and their successful outcomes. For the purpose of this response, I will synthesize the information regarding "acceptance criteria" from the fact that studies were conducted to industry standards and FDA guidance, and "reported device performance" from the statement that the devices met these criteria.

2. Sample Size for the Test Set and Data Provenance

The document describes various bench tests, but it does not specify the sample sizes used for these tests. For cleaning, drying, and sterilization, it mentions "multiple reprocessing cycles." For biocompatibility, it refers to standard ISO test methods, which have their own sample size requirements, but these are not enumerated here.

The data provenance is from bench testing and conducted by an independent lab (Wuxi AppTec) for specified tests (cleaning, drying, sterilization). There is no indication of human subject data, country of origin is not specified for the test set, and it is entirely retrospective as it's a pre-market submission for a device.

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

Since the studies described are primarily bench testing (physical, electrical, optical, and chemical properties, as well as software validation), the concept of "ground truth" derived from human experts in a clinical context (e.g., radiologists, pathologists) does not directly apply here.

The "ground truth" for these performance tests is established by the relevant industry standards (ISO, IEC, AAMI, USP) and FDA guidance documents, which define the expected performance metrics and acceptable thresholds. The "experts" involved would be the testing engineers and scientists at the independent labs or internally, who are qualified to conduct these specific technical tests according to the standards. No specific number or qualifications of these technical experts are provided in the document.

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective, quantitative bench tests against established engineering and scientific standards, not subjective interpretations requiring adjudication by human experts.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through bench testing, safety, and performance against a predicate device and established standards. This type of study would typically be performed for AI-driven diagnostic or interpretative devices to assess human performance with and without AI assistance, which is outside the scope of this endoscope system's pre-market submission description.

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

Yes, standalone performance (in the context of a medical device's technical capabilities without human interaction) was assessed for various parameters of the SurroundScope System. For example:

• Optical Performance: Field of view, depth of field, signal-noise ratio, non-uniformity, distortion were measured objectively.
• Color Accuracy: Tested against colorimetry standards.
• System Functionality and Latency: Assessed as objective system performance.
• Electrical Safety and Electromagnetic Compatibility: Tested to ensure compliance with standards regardless of human interaction during use.
• Software Validation: The software itself was validated.

These are all measures of the device's inherent technical performance without considering how a human user might interact with or interpret the output in a clinical scenario.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Industry and International Standards: Such as ISO 8600 series for endoscopes, IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility, AAMI TIRs for reprocessing, and various CIE ISO standards for colorimetry. These standards define the acceptable range and methodology for measuring performance.
• FDA Guidance Documents: For reprocessing and software validation, these documents outline the expected validation methods and content for pre-market submissions.
• Specifications: Predefined acceptance criteria for the device itself, derived from these standards and the manufacturer's own design specifications (e.g., 90°/270° field of view, 17-200mm depth of field).

8. The Sample Size for the Training Set

Not applicable. The SurroundScope System is a hardware endoscope with integrated software for image processing and control. It is not an AI/ML device that requires a "training set" of data in the sense of machine learning. The term "software validation" refers to verifying that the software performs its intended functions correctly and reliably, not to training an algorithm.

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

Not applicable, as there is no "training set" for this device. The software validation is based on requirements and specifications defined by the developer and adherence to FDA guidance.

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