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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.

Ask a specific question about this device

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).

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 and benign conditions requiring endometrial ablation via suction channel under continious flow conditions following resection using a bipolar resectoscope. It is also intended to distend the uterus by filling with saline to facilitate viewing and to monitor the volume differential between fluid flowing into and out of the uterus.

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.

This document describes the FDA clearance for the Veloxion System, a device used in gynecological procedures. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and study design for performance.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

This document does not provide specific acceptance criteria or reported device performance metrics in a quantifiable way. It states: "Results of tests provided for the predicate were adequate to support the new indication." This implies that the device met certain performance standards, but those standards and the actual performance are not detailed here.

Missing Information: Specific numerical acceptance criteria (e.g., accuracy thresholds, failure rates, precision limits) and the measured performance of the device against these criteria.

2. Sample size used for the test set and the data provenance:

This document does not specify a sample size for a test set or data provenance (country of origin, retrospective/prospective). It refers to "tests provided for the predicate" but does not detail them.

Missing Information: The specific sample size of the test set, the country of origin of the data, and whether the data was retrospective or prospective.

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

This document does not mention the use of experts to establish a ground truth or their qualifications. Given the nature of the device (a hysteroscopic system for tissue resection/coagulation and fluid management), the "ground truth" would likely be related to the device's functional integrity, safety, and effectiveness in performing its intended tasks, rather than image interpretation.

Missing Information: Information on experts used for ground truth establishment and their qualifications.

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

This document does not describe any adjudication method.

Missing Information: The adjudication method used for the test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This document does not refer to a multi-reader multi-case comparative effectiveness study or AI assistance. The Veloxion System appears to be a surgical device with fluid management and visualization capabilities, not an AI-powered diagnostic tool for human readers.

Missing Information: Information on MRMC studies or AI assistance.

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

This document does not describe a standalone algorithm performance study. The device is a system with human-in-the-loop operation (trained gynecologists).

Missing Information: Information on standalone algorithm performance.

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

This document does not explicitly state the type of ground truth used. For a device like the Veloxion System, the "ground truth" for proving effectiveness and safety would likely involve a combination of:

• Pre-clinical testing: Bench testing for mechanical, electrical, fluid management, and energy delivery performance.
• Biocompatibility testing: To ensure materials are safe for human contact.
• Sterilization validation: To confirm the device can be properly sterilized.
• Clinical validation (if applicable and part of the predicate device's data): Observing the device's performance in surgical settings, potentially using outcomes data for the predicate.

The primary predicate (K190113) was cleared previously, and the current submission (K191335) largely relies on the predicate's testing. The specific new indication mentioned is "endometrial ablation," which suggests that the testing would focus on the device's ability to safely and effectively perform ablation, possibly verified through histopathology or visual confirmation of ablation efficacy.

Missing Information: Explicit statement of the type of ground truth used.

8. The sample size for the training set:

This document does not mention a training set sample size. This is because the Veloxion System is a physical medical device, not an algorithm that requires a "training set" in the machine learning sense.

Missing Information: A training set sample size.

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

This document does not mention a training set or how its ground truth was established, for the same reasons as point 8.

Missing Information: How ground truth for a training set was established.

Summary of what the document does provide:

• Device Name: Veloxion System
• Indications for Use: Intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, removal of intrauterine polyps and myomas, and benign conditions requiring endometrial ablation via suction channel under continuous flow conditions following resection using a bipolar resectoscope. It also distends the uterus with saline for viewing and monitors fluid volume differential.
• Predicate Device: Veloxion System (K190113) from Corinth MedTech, Inc.
• Basis for Clearance: Substantial equivalence to the predicate device, with an added indication for endometrial ablation. The submission states, "Results of tests provided for the predicate were adequate to support the new indication." This implies that the validation work done for the predicate device, plus any additional testing for the new indication, was sufficient.

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 resectoscope. It is also intended to distend the uterus by filling with saline to facilitate viewing and to monitor the volume differential between fluid flowing into and out of the uterus.

The Veloxion System consists of the Veloxion Controller (with Integrated Fluid Control), Footswitch, Veloxion Resectoscope, Veloxion Fluid Control Set, Veloxion Video Control Unit, and Veloxion Roll Stand. It also includes Class I accessories for waste handling: Waste Management Tubing, Tissue Catch, and Waste Management Bags. The system provides bipolar resection and coagulation, distends the uterus with saline, controls intrauterine pressure, and monitors fluid deficit.

Based on the provided text, here's a detailed breakdown of the acceptance criteria and the study conducted for the Veloxion System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a pass/fail format for specific performance metrics. Instead, it describes performance characteristics that were tested and compared to the predicate device. For the purpose of this request, I will extract the performance characteristics that were "tested" and the reported "performance" from the "Technological Characteristics" table (Table 1) and the "Performance Data" section.

2. Sample Size for the Test Set and Data Provenance

The document lists various performance tests and comparative testing to the predicate, but it does not specify the sample sizes (n) used for each test set.

The data provenance is not explicitly stated regarding country of origin or whether the studies were retrospective or prospective. The studies appear to be benchtop performance and engineering tests conducted in-house by the manufacturer rather than clinical trials involving patient data. This is implied by tests such as "Comparative visualization testing in a simulated model" and "Simulated Use: Tissue resection and spot coagulation of cavity pressure, O imaging."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not mention the use of experts or their qualifications for establishing ground truth for any of the performance tests described. The "performance data" section primarily describes engineering and benchtop tests, not clinical evaluations requiring expert interpretation.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

As the document does not describe studies involving human readers or interpretation of results that would require adjudication (e.g., image reading), no adjudication method is mentioned or implied.

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

There is no mention of an MRMC comparative effectiveness study, nor any evaluation of AI assistance or human reader improvement. The device described is a medical instrument (hysteroscope system), not an AI-powered diagnostic or interpretive tool that would typically involve such studies.

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

This question is not applicable as the device is a physical medical instrument, not a standalone algorithm. Its performance is inherent to its mechanical, electrical, and optical functions.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the engineering and performance tests:

• Physical/Engineering Standards: Measurements against known physical properties or engineering specifications (e.g., pressure, flow rates, dimensions, temperature, electrical safety).
• Predicate Device Performance: Direct comparison to the performance of the legally marketed predicate device (K180752), establishing its performance as a de facto "ground truth" for equivalence.
• Simulated Models: For visualization and tissue interaction tests ("Comparative visualization testing in a simulated model," "Simulated Use: Tissue resection and spot coagulation").

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the technical performance data provided.

8. The Sample Size for the Training Set

This question is not applicable as the document describes a medical device, not a machine learning model that would require a "training set."

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

This question is not applicable for the same reason as point 8.

Ask a specific question about this device

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.

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.

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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