Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Veloxion System is intended 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)
  • o Footswitch
• Veloxion Resecting Device Kit: ●
  • o Veloxion Resecting Device
  • o Sheath
  • 0 Continuous Flow Optical Obturator
• Veloxion Fluid Control Set ●
• Veloxion Saline Pole ●

The Controller provides bipolar radiofrequency outputs (cut and coagulation) and fluid control through the use of two integrated peristaltic pumps. The Resecting Device is a disposable, hand held bipolar radiofrequency device configured for the resection and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps, in conjunction with the disposable Fluid Control Set, which provides continuous inflow and aspiration during the procedure.

The provided text is a 510(k) premarket notification from the FDA, and it describes a medical device called the "Veloxion System" for endoscopically controlled tissue chip resection and coagulation, specifically for prostate adenomas.

However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, number of experts, ground truth, or MRMC studies) related to the clinical performance or efficacy of the device.

The "Performance Data" section (VII) lists various types of engineering and safety tests (e.g., Sterility, Biocompatibility, Software, EMC, Mechanical Integrity, Functional Testing, Dimensional Testing, Simulated Use, Thermal effect, Usability). These are primarily focused on the device's technical specifications, safety, and manufacturing quality, rather than its clinical efficacy or diagnostic accuracy.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document does not contain this type of information.

Ask a specific question about this device