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This system is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.

The NeedleView CH is a rigid Fiberoptic scope with a working channel designed for single use. The product consists of a 17,000 pixel coherent silica fiber bundle, 30um diameter light fibers and a stainless steel channel encased in a stainless steel shaft. The effective field of view is 80° in air and 62° in water. The direction of view is 0°. The scope has retaining groves to incorporate a drape that will cover the camera and cord that connects to the Surg View System. The NeedleView CH Scope Kit consists of a fiber-optic based micro-endoscope (3.4mm Outer Diameter, 1.85mm Working Channel, 160mm Working Length), 12F Cannula (4mm Inner Diameter), 12F Dilator(4mm Diameter), 14Gx127mm Tuohy Needle, 18Gx152mm Tuohy Needle, #11 Scalpel, Guidewire (70cm Length), Hemostasis Valve Adapter (HVA), and a sterile drape. All of these items are disposable and for single-use only. The micro-endoscope is made to couple with a non-disposable system hand piece that contains a light source and camera, which is available separately.

This document is a 510(k) summary for the NeedleView CH™ Scope Kits, a medical device for arthroscopic and endoscopic procedures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, thereby eliminating the need for extensive clinical trials.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on non-clinical performance and biocompatibility testing to demonstrate substantial equivalence. It does not provide specific numerical "acceptance criteria" or "reported device performance" in the format of a clinical trial outcome with metrics like sensitivity, specificity, or accuracy. Instead, it lists the types of performance tests conducted for various components of the NeedleView CH™ Scope Kit and states that these tests were "completed" or "utilized" specific standards. This implies that the device met the requirements of these standards for each test.

Since no specific numerical performance criteria or results are detailed in the provided text, a table like the one requested cannot be fully constructed with explicit numerical values. However, we can infer the categories of acceptance based on the tests conducted.

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

The document does not specify the sample sizes used for any of the performance tests. The data provenance is also not explicitly stated beyond the fact that these tests were performed by BioVision Technologies, LLC, for their device. This is typical for 510(k) submissions focusing on substantial equivalence through non-clinical bench testing, where detailed sample sizes for each specific test component are often included in the full test reports, not generally in the summary document.

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

Not applicable. This submission relies on performance testing against established engineering and biocompatibility standards, not on expert-adjudicated "ground truth" for diagnostic or clinical outcomes. There were no human experts evaluating the performance in a clinical context for the purpose of establishing ground truth for a test set in the way one would for an AI diagnostic device.

4. Adjudication Method for the Test Set:

Not applicable. As the tests described are physical, mechanical, and biological evaluations against standards, there is no "adjudication method" involving human reviewers in the context of clinical interpretation or diagnosis. The results of the tests would be pass/fail based on the specified standard's criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

No. A MRMC comparative effectiveness study was not performed. This device is a physical medical instrument (an arthroscope/endoscope), not an AI-assisted diagnostic or interpretative system. The submission explicitly states: "Clinical testing was not used to prove substantial equivalence."

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

No. This device is a physical instrument for visualization, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used:

For the performance and biocompatibility testing, the "ground truth" used is implicitly the established scientific and engineering standards (e.g., ISO 10993-1, ASTM F2096, ISO 11607-2, etc.). The device's components had to meet the performance specifications outlined in these standards. There is no pathology, outcomes data, or expert consensus serving as "ground truth" in the clinical sense for this type of submission.

8. The Sample Size for the Training Set:

Not applicable. Since this is not an AI/machine learning device, there is no "training set."

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

Not applicable. No training set was used.

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The IOGYN Endoscope is intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. It is indicated for use in diagnostic examination and therapeutic surgical procedures of, but not limited to, urology and gynecology.

The IOGYN Endoscope is a rigid multi-channel endoscope provided with a rod lens system to transmit light and images, a working channel, and two fluid channels. The body consists of an outer and an inner tube of surgical steel. The light fibers, rod-lens optical system, and two fluid channels are sandwiched between these tubes. The inner tube serves as a working channel to provide access for resection/coagulation instruments. The fluid channels are intended to move fluid. At the proximal end, the endoscope is provided with a light post that is compatible with standard endoscopic light sources, and with an eyepiece intended for visualization. The IOGYN Endoscope is dimensionally compatible with the IOGYN System.

The provided text describes the 510(k) submission for the IOGYN Endoscope. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, especially in the context of AI performance. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a performance study with quantitative metrics for AI or human performance.

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

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is missing:

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

The document does not provide a table of acceptance criteria with specific quantitative targets and corresponding reported device performance for an AI-powered device. Instead, it indicates that "Thermal testing and simulated use testing were performed to support safety and effectiveness and substantial equivalence to the predicate device. The IOGYN Endoscope met all specified design and performance requirements."

This statement is very general and does not provide specific metrics or acceptance criteria as would be expected for an AI device.

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

This information is not provided in the document. The testing mentioned (thermal and simulated use) does not appear to involve a "test set" of patient data in the context of an AI study.

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)

This information is not provided in the document. The document describes a medical device (endoscope), not an AI system that would require expert-established ground truth on a test set.

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

This information is not provided in the document.

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

This information is not provided in the document. The document describes an endoscope, not an AI-assisted diagnostic tool.

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

This information is not provided in the document. The device is a physical endoscope, not a standalone algorithm.

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

This information is not provided in the document. The "ground truth" for the device's performance would likely relate to its mechanical and optical functionality, not diagnostic accuracy based on medical imaging.

8. The sample size for the training set

This information is not provided in the document. AI training sets are not relevant to the approval of this physical endoscope.

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

This information is not provided in the document.

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