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The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.

The Veloxion System consists of the following components:

• Veloxion Controller (with Integrated Fluid Control)
  • Footswitch
• Veloxion Resectoscope
• Veloxion Fluid Control Set
• Veloxion Video Control Unit
• Veloxion Roll Stand

The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:

• Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
• Tissue Catch: For collection of gross resected tissue pieces for pathology.
• Waste Management Bags: To provide bags for final collection of outflow.

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 the integrated hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit. The components of Veloxion System perform the following functions:

• The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
• The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
• The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
• The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
• The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag and facilitates the fluid deficit function.

This document, a 510(k) Premarket Notification for the Veloxion System, details the device's characteristics and its equivalence to previously cleared predicate devices, allowing it to be marketed. However, it explicitly states, "No new performance testing was required to establish substantially equivalence. Results of tests in reviewed as part of clearance of K190099 and K162979 with comparison testing to the predicates (predicate Veloxion System and Richard Wolf Resectoscope) support substantial equivalence to the identified predicates."

This crucial statement means the provided text does not contain the acceptance criteria or a study that proves the device meets the acceptance criteria directly within this submission. It relies on previous clearances (K190099 and K162979) and their associated testing.

Therefore, many of the requested details about acceptance criteria, specific performance data, sample sizes, ground truth establishment, and expert involvement are not present in this document.

Despite this, I will extract what information is available and clearly indicate where details are missing based on the document's content.

Based on the provided document, specific details regarding the acceptance criteria and a standalone study proving the device meets these criteria are NOT presented. The submission relies on demonstrating substantial equivalence to predicate devices, referencing prior clearances (K190099 and K162979) for performance data.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is absent:

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

• Not provided in this document. The document states "No new performance testing was required" for this submission, indicating that performance data relies on previous clearances of the Veloxion System (K190099, K162979) and comparative testing against other predicates. This document does not present a table of acceptance criteria or new reported performance data.

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

• Not provided in this document. No new test set is described.

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/Not provided in this document. As no new test set or ground truth establishment is described for this submission, this information is not available. This would typically be relevant for studies involving diagnostic or image-based AI, which this device is not.

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

• Not applicable/Not provided in this document. No test set or human adjudication process is described for this submission.

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/Not provided in this document. This device is a surgical system, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant in this context, and no such study is mentioned.

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

• Not applicable/Not provided in this document. The Veloxion System is a physical medical device (resectoscope system), not a standalone algorithm or AI. Its performance is tied to its mechanical and electronic functions.

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

• Not applicable/Not provided in this document. For a physical device like the Veloxion System, "ground truth" would typically relate to engineering specifications, performance parameters (e.g., fluid flow rates, power output, pressure control accuracy), and safety standards, rather than clinical diagnostic "ground truth" established by experts or pathology. This document does not detail the specific performance testing or the "ground truth" metrics used in prior clearances.

8. The sample size for the training set

• Not applicable/Not provided in this document. The Veloxion System is a hardware device with integrated software for control and monitoring. While software verification testing is mentioned (point below), there's no indication of a "training set" in the context of machine learning.

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

• Not applicable/Not provided in this document. As above, no "training set" in the machine learning sense is described. The document mentions "Software Verification Testing was performed using the same protocol reviewed as part of K 190099 for all steps affected by the change and documentation updated per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This indicates adherence to software validation best practices, but not a machine learning training paradigm.

Summary of what the document does provide:

• Device Name: Veloxion System
• Predicate Devices: K190099, K162979 (both Corinth MedTech, Inc. Veloxion System), K062720, K042523 (Richard Wolf Medical Instruments Corporation systems).
• Indications for Use: The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.
• Technological Characteristics Comparison: A detailed table comparing the subject device's energy type, RF functions, cavity pressure monitoring, irrigation fluid, outer sheath dimensions, electrode extension, and electrode movement to its predicates. Minor differences are noted.
• Performance Data Statement: "No new performance testing was required to establish substantially equivalence. Results of tests in reviewed as part of clearance of K190099 and K162979 with comparison testing to the predicates (predicate Veloxion System and Richard Wolf Resectoscope) support substantial equivalence to the identified predicates."
• Software Verification: Mentions software verification testing was performed using the same protocol as K190099, updated per FDA guidance for software in medical devices.

In essence, this 510(k) submission is a "Special 510(k)" which often means a modification to an already cleared device, and thus relies on demonstration of substantial equivalence rather than entirely new performance studies. The detailed studies proving acceptance criteria were conducted for the original clearances (K190099 and K162979).

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The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

The Veloxion System consists of the following components: Veloxion Controller (with Integrated Fluid Control) with Footswitch, Veloxion Resectoscope, Veloxion Fluid Control Set, Veloxion Video Control Unit, and Veloxion Roll Stand. The system also includes Class I accessories for handling waste: Waste Management Tubing and Tissue Catch. The system provides bipolar resection and coagulation of prostate adenomas, distends the cavity by filling with saline, and provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.

This 510(k) summary for the Veloxion System (K190099) does not include a detailed study with acceptance criteria and reported device performance in the format of a table, nor does it provide a multi-reader multi-case comparative effectiveness study or details on standalone algorithm performance.

However, based on the provided text, here's an attempt to outline the acceptance criteria and study information where available, focusing on what can be inferred or directly stated.

Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance. Instead, it lists various non-clinical tests performed to demonstrate safety and effectiveness and substantial equivalence to a predicate device. The general acceptance criterion implied across all these tests is that the subject device performs as safely and effectively as the predicate device, or meets relevant industry standards.

Here's a summary of the performance claims based on the non-clinical testing data:

Here's the additional information requested, based on the provided text:

2. Sample size 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 sample sizes for any of the non-clinical tests.
• The data provenance (country of origin, retrospective/prospective) is not provided. All tests listed are non-clinical, implying laboratory or simulated environments, rather than patient 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 information is not provided. No clinical studies are described, therefore "ground truth" in the clinical sense (e.g., from expert diagnoses) is not applicable here. The "ground truth" for the non-clinical tests would be the established engineering and medical standards and functional specifications that the device is tested against.

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

• This information is not provided and is not applicable to the non-clinical testing described. Adjudication methods are typically associated with clinical studies involving human observers or diagnoses.

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 multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This device is an active medical device (resectoscope system) for prostate adenoma resection, not an AI-powered diagnostic or assistive tool for image interpretation by human radiologists/clinicians in the sense that MRMC studies typically evaluate. The "visualization testing in a simulated model" is the closest mentioned, but it's not an MRMC study.

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

• This device is not an algorithm or AI system in the typical standalone sense. It's a surgical system with integrated software and controls. While software verification and validation were performed (per IEC 62304), this refers to the performance of the integrated software controlling the device's functions, not a standalone AI algorithm producing diagnostic or predictive outputs.

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

• For the non-clinical tests, the "ground truth" would be objective measurements against established technical specifications, engineering principles, and relevant international and national standards (e.g., ISO, IEC, ASTM standards mentioned in the text). For fluid flow, pressure control, temperature, electrical safety, durability, and biocompatibility, the ground truth is the scientific and engineering benchmarks and standards themselves. For "simulated use" and "comparative visualization," the "ground truth" would involve demonstrating the device's ability to achieve its intended function effectively within the simulated environment, comparable to the predicate.

8. The sample size for the training set

• This information is not applicable. The Veloxion System is a physical medical device with integrated software for control, not a machine learning or AI model that requires a "training set" to learn from data.

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

• This information is not applicable for the reasons stated in point 8.

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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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