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The IOGYN System is intended to distend the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed-loop recirculation of filtered distension fluid. It is also intended for cutting and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device.

The IOGYN System is comprised of the following:

• IOGYN Controller with Integrated Fluid Management .
  • Footswitch O
  • Fluid Management Accessories o
• IOGYN Resecting Device ●

The IOGYN System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the IOGYN Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories; these components form a closed-loop recirculating system. These integrated peristaltic pumps are operated by a software pressure control algorithm that measures and controls intra-uterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection using the Resecting Device. The IOGYN Controller Graphical User Interface (GUI) has fluid control settings which allow the user to toggle infusion ON/OFF and to set the cavity pressure from 30-125mmHg.

The IOGYN System uses a closed-loop fluid management system with a single 3liter saline bag that continuously recirculates filtered distension fluid throughout the procedure. The fluid absorption is limited by the volume within the 3-liter saline bag minus the dead volume within the system, which limits the deliverable volume to less than 2.5L. The 2.5L of recirculated fluid is passed through two levels of filtration - the first level of filtration removes resected tissue and bulk particles; the second level of filtration removes cellular materials, hemoglobin, plasma proteins, cytokines, coagulation factors, bacteria and viruses. These two levels of filtration generate optically clear, sterile, filtered distension fluid which is returned to the 3 liter saline bag and recirculated.

The provided text is a 510(k) summary for a medical device called the IOGYN System. It focuses on demonstrating substantial equivalence to a predicate device after minor material changes and does not provide detailed information about acceptance criteria and comprehensive study results in the format requested.

Therefore, much of the requested information cannot be extracted from this document.

However, I can extract what is available:

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

The document mentions "Performance Testing" which includes:

• Simulated Use
• Durability Testing
• Hi Pot Testing
• Tensile Strength
• Flow Rate
• Pressure Testing
• System undeliverable volume (dead volume)

It states "All device bench test results were acceptable. Data demonstrate that the Resecting Device and the Fluid Management Accessories meet design specifications and are suitable for the intended use and labeled shelf-life."

Without the specific design specifications or quantitative acceptance criteria, a table cannot be fully constructed. The document only provides a qualitative statement that results were "acceptable" and met "design specifications."

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

The document does not specify the sample sizes for any of the performance tests. There is no information regarding the provenance of the data (e.g., country of origin) or whether it was retrospective or prospective. The testing described appears to be bench/laboratory testing rather than clinical study data.

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 entire section is not applicable. The document describes bench testing for material changes in a medical device (IOGYN System), not a study involving human subjects or image interpretation that would require expert-established ground truth.

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

Not applicable. This is not a study assessing diagnostic performance or 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

Not applicable. This is not an AI/software device and no MRMC study was conducted.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. Ground truth as typically defined in diagnostic studies is not relevant here. The "ground truth" for the performance tests would be the established engineering specifications and validated test methods for mechanical, electrical, and fluid dynamics properties.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a training set.

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

Not applicable.

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The IOGYN System is intended to distend the uterus by filling it with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and provide fluid management through the closed loop recirculation of filtered distension fluid. It is also intended for cutting and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device.

The IOGYN System is comprised of the following: IOGYN Controller with Integrated Fluid Management, Footswitch, Fluid Management Accessories, IOGYN Resecting Device. The IOGYN System provides an integrated control system with bipolar radiofrequency outputs (cut and coagulation) and fluid management through the use of two integrated peristaltic pumps. The Resecting Device is a bipolar radiofrequency device configured for the resection and aspiration of uterine pathology. Fluid infusion and aspiration of the uterine cavity are controlled by the IOGYN Controller's peristaltic pumps, in conjunction with the Fluid Management Accessories; these components form a closed loop recirculating system. These integrated peristaltic pumps are operated by a software pressure control algorithm that measures and controls intrauterine cavity pressure by varying saline infusion and aspiration rates in response to pressure changes during aspiration and tissue resection using the Resecting Device. The IOGYN Controller Graphical User Interface (GUI) has fluid control settings which allow the user to toggle infusion ON/OFF and to set the cavity pressure from 30-125mmHg. The IOGYN System uses a closed loop fluid management system with a single 3-liter saline bag that continuously recirculates filtered distension fluid throughout the procedure. The fluid absorption is limited by the volume within the 3-liter saline bag minus the dead volume within the system, which limits the deliverable volume to less than 2.5L. The 2.5L of recirculated fluid is passed through a tissue catch and then a molecular filter to generate optically clear, sterile, filtered distension fluid which is returned to the 3 liter saline bag and recirculated.

The request is about acceptance criteria and study information for a specific medical device, IOGYN System. However, the provided text describes the device, its regulatory information, warnings, precautions, and a summary of nonclinical/bench studies, and clinical information without explicitly stating detailed acceptance criteria for each test or a comprehensive study proving specific quantitative acceptance criteria.

The document outlines various performance tests and their results (all reported as "Pass"), but it often refers to "device specification" or "target specification" without detailing the specific numerical or qualitative targets that constitute acceptance. For example, in the "Performance Testing - Fluid Management" section, it says "Specification for flow rate was met" but doesn't state what that flow rate specification was. Similarly, for "Pressure Control," it states "Actual pressure should not exceed set pressure by (b)(4) Trade Secret/CCI for more than (b)(4) Trade Secret/CCI" but the numerical values are redacted.

Therefore, a table of acceptance criteria and reported performance with quantitative metrics for each test cannot be fully constructed from the provided text due to the lack of explicit, unredacted numerical acceptance criteria for most tests.

However, I can extract the available information regarding the studies and performance as much as possible.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit numerical acceptance criteria are largely redacted or not provided in the document. The table below summarizes the tests performed and the reported results (all "Pass"), indicating that the device met its internal specifications, even if those specifications are not detailed in this public document.

2. Sample Sizes and Data Provenance for Test Sets

• Nonclinical/Bench Studies:
  • Shelf Life Testing: Resection device (n=30) and fluid management accessories (n=30) were tested at baseline and after 7 months of real-time aging. Packaging integrity (peel strength, dye penetration) involved n=10 samples each. Device functionality tests involved n=10 samples.
  • Mechanical Testing: 10 samples following simulated use and corrosion exposure.
  • Performance Testing (Fluid Management): 10 samples of FMA and RDs.
  • Durability Testing: Devices operated for over (b)(4) Trade Secret/CCI (number redacted) hours.
  • Simulated Use Testing: Used (b)(4) Trade Secret/CCI (description redacted).
  • Data Provenance: Bench testing, ex-vivo testing (for Temperature and Coagulation Testing) in a lab setting.
• Clinical Testing:
  • Sample Size: 36 subjects (age 25 to 65 years with endometrial polyps and/or submucosal myomas) enrolled. 34 subjects were treated.
  • Data Provenance: Prospective (implied by "clinical studies were conducted...between October 2012 and May 2013" with follow-up), multi-country (Mexico, Hungary, Canada).

3. Number of Experts and Qualifications for Establishing Ground Truth (Clinical Test Set)

The provided text does not specify the number of experts used to establish ground truth for the clinical test set, nor their specific qualifications (e.g., radiologist with X years of experience). The clinical study focused on the "ability to resect tissue" and observed "histopathology examination of the removed tissue," which implies a pathologist would be involved in ground truth, but no details are given. The report states "The sponsor concluded that a large intramural myoma migrated into the visual field secondary to incision of the myoma capsule," suggesting clinical observation and potentially a surgeon's assessment.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical test set or any other test set. Clinical outcomes appear to be reported as observed within the study.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as described in the provided text. The clinical study evaluated the device's performance directly, not human readers' improvement with or without AI assistance. The IOGYN System is a medical device for hysteroscopic procedures, not an AI diagnostic tool that assists human readers.

6. Standalone (Algorithm Only) Performance Study

As the IOGYN System is a closed-loop hysteroscopic insufflator with cutter-coagulator, it is a physical device that performs surgical functions and fluid management. It is not an "algorithm only" device in the sense of a diagnostic AI. Its "performance" is inherently linked to its physical operation, and thus, a "standalone algorithm only" study is not applicable in the typical AI context. However, the software components underwent standalone verification and validation testing as part of the overall software safety and performance assessment for a 'MAJOR' level of concern device.

7. Type of Ground Truth Used

• Nonclinical/Bench Studies: Ground truth was established by engineering specifications, physical measurements, and defined performance criteria (e.g., flow rates, pressure ranges, mechanical strength limits, bacterial/viral removal percentages, durability hours).
• Clinical Testing: Ground truth for the primary endpoint (tissue resection) was based on observed surgical outcomes (percentage of myoma/polyp resected) and histopathology results of the removed tissue. Safety ground truth included clinical observation of adverse events and fluid deficit measurements.

8. Sample Size for the Training Set

The document does not specify a "training set" in the context of an AI/machine learning algorithm, as the IOGYN System is a physical device with integrated software for control, not a learning algorithm that requires a traditional training set. The software itself underwent hazard analysis, verification, and validation, but this is distinct from training an AI model.

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

This question is not applicable as there is no mention of a "training set" for an AI/machine learning algorithm in the provided document. The software's "ground truth" or correct functionality was established through software requirements specifications, design documents, and subsequent verification and validation testing against those specifications.

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