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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 and video)
  • Footswitch
• Veloxion Resectoscope
• Veloxion Fluid Control Set
• 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.

The Veloxion System provides bipolar resection and coagulation of prostate adenomas, it distends the cavity by filling with saline and it provides pressure control of the cavity to facilitate viewing with the integrated Resectoscope.

The provided text describes a 510(k) premarket notification for the Veloxion System, a medical device used for prostate adenoma resection. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria based on a clinical study of its diagnostic or therapeutic efficacy.

Therefore, many of the requested details regarding acceptance criteria for device performance (e.g., sensitivity, specificity, or effect size of human reader improvement with AI) and a study proving the device meets these criteria are not present in this regulatory submission document. This document is instead a technical comparison and non-clinical testing summary to assert device safety and effectiveness.

However, I can extract information related to the technical specifications and performance testing conducted to demonstrate substantial equivalence, which serves as the "acceptance criteria" for this type of regulatory submission.

Here's the closest interpretation of your request based on the provided text:

Acceptance Criteria and Device Performance (Based on Technical Specifications and Non-Clinical Testing for Substantial Equivalence)

Study Proving the Device Meets the Acceptance Criteria:

The document describes non-clinical testing rather than a traditional clinical study with patient outcomes or reader performance data. The "study" here refers to a battery of engineering and bench tests designed to demonstrate that the small changes in the new Veloxion System (subject device) do not alter its safety or effectiveness compared to the previously cleared Veloxion System (predicate device).

Here's a breakdown of details relevant to your questions, adapted to the context of this 510(k) submission:

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify sample sizes for individual non-clinical tests (e.g., number of units tested for durability, or number of simulated uses). This information is typically detailed in the full test reports, not summarized in the 510(k) summary letter.
   • Data Provenance: The data is generated from non-clinical performance testing conducted by the manufacturer, Corinth MedTech, Inc. The location of the testing is not specified, but it would typically be conducted at the manufacturer's facilities or a qualified testing lab. The nature is retrospective in the sense that these tests were completed before the 510(k) submission, and reported as final results. There is no mention of data from human subjects or real-world clinical use.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in the context of this 510(k) submission. The "ground truth" for this device's regulatory pathway is established through engineering specifications, validated test methods, and comparison to a predicate device's known performance. There were no human readers or expert consensus required to establish a "ground truth" for diagnostic or analytical performance, as this is not a diagnostic AI device. The tests, like functional testing, biocompatibility, electrical safety, etc., have well-defined pass/fail criteria based on standards and engineering principles.

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

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging or AI devices, where human expert disagreement needs a resolution mechanism for ground truth. In non-clinical performance testing, the results are typically quantitative measurements against predefined specifications, or qualitative observations per a test protocol, which do not usually require a human "adjudication" process like a clinical reading study.

4. 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 is not applicable. The Veloxion System is an electrosurgical device for tissue resection, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was conducted or is relevant for this type of device.

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

   • This is not applicable. This device is a surgical instrument system, not an AI algorithm. Its function relies on mechanical, electrical, and fluidic principles controlled by the user, not a standalone AI algorithm.

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

   • For this device, the "ground truth" for meeting regulatory requirements is primarily based on:
     • Engineering specifications and standards: e.g., electrical safety standards (IEC 60601 series), biocompatibility standards (ISO 10993), sterility standards (ISO 11135), etc.
     • Defined functional performance criteria: for aspects like flow rates, pressure control, temperature limits, tissue cutting/coagulation performance (demonstrated in simulated use), and durability.
     • Comparison to Predicate Device: The ultimate "ground truth" for a 510(k) relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of safety and effectiveness, based on similar technological characteristics and comparable performance. Any differences (like the cut mode flow rate) must be shown not to raise new questions of safety or effectiveness, which was addressed via performance testing.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" in the context of this device, as it is not an AI/machine learning product.

8. How the ground truth for the training set was established:

   • This is not applicable for the same reason as above. There is no training set mentioned in this context.

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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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