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The Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas via suction channel under continuous flow conditions following resection using a bipolar resecting device. It is also intended to distend the uterus by filling with saline to facilitate viewing with a hysteroscope and to monitor the volume differential between into and out of the uterus.

The Veloxion System consists of the following components:

• Veloxion Controller (with Integrated Fluid Control)
  • Footswitch
• Veloxion Resecting Device Kit:
  • Veloxion Resecting Device
  • Sheath
  • Continuous Flow Optical Obturator
• Veloxion Fluid Control Set
• Veloxion Saline Pole
  The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items apply no aspiration to the patient, they only handle waste after it is already outside the patient), which includes:
• Waste Accessory Bag for collection of waste aspirated form the patient and from under patient's buttocks,
• Waste Accessory Tubing for collection of waste from under the patient's buttocks
• Waste Management Pump for moving the waste to the Waste Bag.
  The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with a hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit.

The provided text describes a 510(k) premarket notification for the Veloxion System, a hysteroscopy device, and compares it to predicate devices. However, the document does not contain information related to acceptance criteria or a study proving the device meets specific performance metrics in the format requested, particularly for an AI/algorithm-based device.

The "Performance Data" section (Page 8 of the original document) lists various tests performed, but these are general engineering and functional validation tests for the hardware components of the hysteroscope system (e.g., software V&V, integrity, functional testing of aspiration/irrigation, dimensional inspection, simulated use, durability, electrical safety, usability). These tests are typical for a medical device's safety and effectiveness but do not detail specific acceptance criteria for device performance in a clinical context (e.g., sensitivity, specificity, accuracy for a diagnostic task), nor do they describe a study comparing the device's diagnostic or assistive capabilities against a specific ground truth, as would be expected for an AI/algorithm.

Therefore, many of the requested data points cannot be extracted from this document as they are not present. The document focuses on establishing substantial equivalence based on technological characteristics and general performance testing of the physical system, not on the performance of a specific algorithm or AI component in a diagnostic or interpretive task.

If the "Veloxion System" refers to a device with an AI component for interpretation, that information is not detailed within this 510(k) summary. The summary describes fluid control, tissue resection, and coagulation functions.

Based on the information provided in the document:

1. A table of acceptance criteria and the reported device performance: Not available in a format detailing clinical performance metrics (e.g., sensitivity, specificity, accuracy) for an AI or algorithm. The document lists general performance data for the physical device, such as "Software Verification and Validation Testing," "Integrity: System withstands operating pressures," "Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control," etc. These are not quantifiable metrics that can be presented in a table against acceptance criteria for an AI's diagnostic or interpretive performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or not provided. The testing described is for the hardware system's functionality and safety, not for an algorithm's diagnostic performance on a dataset.

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): Not applicable or not provided, as there is no mention of a diagnostic performance study with ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not provided.

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 or not provided. The document describes a medical device for hysteroscopy, not an AI-assisted diagnostic tool for interpretation by human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable or not provided. The device described performs physical actions (resection, coagulation, fluid control) and monitoring, not standalone image analysis or diagnostic tasks.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or not provided, as there is no diagnostic performance study described.

8. The sample size for the training set: Not applicable or not provided. This would be relevant for an AI/machine learning model, which is not the focus of this 510(k) summary.

9. How the ground truth for the training set was established: Not applicable or not provided.

Summary of available performance data (from section VII "Performance Data") related to the device's functional performance:

The document indicates that the following performance data were provided in support of substantial equivalence:

• Software Verification and Validation Testing performed per IEC 62304 and FDA guidance.
• Integrity testing (system withstands operating pressures).
• Functional Testing (Cut and coagulation, aspiration, irrigation, pressure control).
• Dimensional Inspection and Testing.
• Simulated Use (Tissue resection and spot coagulation, regulation of cavity pressure).
• Durability Testing (Electrode durability for tissue resection and coagulation).
• Fluid deficit testing.
• Comparative testing to predicate for electrode durability, pressure control, and fluid control.
• Electrical Safety & EMC per IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009, and IEC 60601-2-2:2009.
• Usability Testing (Use related risk evaluation).

Conclusion from the document:
Based on these performance tests, the Veloxion System is considered substantially equivalent, safe, and effective as the predicate systems. The document confirms that the differences between the Veloxion System and predicate devices (e.g., dual pump system, programmed flow rates, single-use patient-contacting components) were evaluated through performance testing to demonstrate safety and effectiveness.

In essence, the document confirms the device meets acceptance criteria related to its mechanical, electrical, software, and functional performance, but not for AI/algorithm-based diagnostic or interpretive capabilities, as those are not described as functions of this device.

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