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The Aqua Medical RF Vapor System is indicated for use in the coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.

The Aqua RF Vapor Ablation System is a catheter-based device that uses radiofrequency (RF) energy to produce heated water vapor for the coagulating and ablating tissue. The RF energy heats liquid as it flows through the catheter, creating steam that is directed to the target tissue. The system includes the following components:

• Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. The catheter connects, fluidically and electrically, to the generator. A foot pedal is used to control the RF energy and vapor delivery.
• Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7F (2.3 mm) with an outer catheter sheath that is 10.5F and a length between 145 cm and 210 cm. Catheters are designed to be used through an endoscope working channel diameter of 3.7mm. This submission included only the modified circumferential catheter.
• Cassette (Syringe and Tubing): Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.

This 510(k) clearance letter pertains to the Aqua Medical RF Vapor Ablation System. However, the provided document does not include acceptance criteria or the study details that prove the device meets such criteria.

The document states that "The proposed modifications do not introduce new safety and effectiveness concerns and support the company's substantial equivalency claim" and mentions "supporting non-clinical data" and "bench testing and scientific rationales." It lists various performance tests conducted for the Generator, Catheter, and Cassette components, but it does not provide any quantitative acceptance criteria or performance results from any clinical or even pre-clinical study testing the device's efficacy against specific metrics.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.

The information given is limited to:

• Device Name: Aqua Medical RF Vapor Ablation System
• Indications for Use: Coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract (e.g., Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE), Radiation Proctitis (RP)) in adults.
• Modifications: To the generator, Cassette (syringe and tubing), and circumferential catheter.
• Tests Performed (Non-Clinical):
  • Generator: EMC & Electrical Safety, Software validation, Generator Hardware Verification
  • Catheter: Hardware Verification Testing, Simulated-use tissue validation (Lean Beef Testing)
  • Cassette: Biocompatibility, Shelf-Life assessment, Sterilization Validation
• Conclusion: The device is substantially equivalent to the predicate device, and modifications do not raise new safety or effectiveness concerns.

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The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia(BPH). It is indicated for men ≥ 50 years of age with a prostate volume 30 cm³ ≤ 150 cm³. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate "wet" thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.

The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure.

Following thermal therapy for BPH, small pieces of coagulated tissue may slough off and be expelled via urination. This sloughing process may continue for a few months post-procedure depending on the rate of healing.

The Rezūm System consists of the following:
• Rezūm Generator – reusable, non-sterile capital equipment, provided with one power cord
• Rezūm Delivery Device Kit – sterile, single-use kit containing the following disposable components:

• One sterile Delivery Device with cable and tubing
• One sterile syringe
• One sterile spike adaptor
• One sterile water vial

The provided FDA 510(k) clearance letter and summary for the Rezūm System (K250584) focuses on an expanded indication for use, specifically for larger prostate volumes, rather than establishing acceptance criteria for a new device's performance. The information provided describes studies demonstrating the comparable safety and effectiveness of the device for this expanded range, rather than defining specific performance metrics against pre-defined acceptance criteria for a novel device.

Since the document is for an expanded indication and not a de novo clearance, the acceptance criteria are implicitly that the device performs similarly in safety and effectiveness in the expanded patient population as it did in the previously cleared population. The study's goal was to demonstrate this similarity.

Here's an analysis based on the provided text, outlining what can and cannot be extracted regarding acceptance criteria and performance data:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this context is less about a numerical threshold for a novel device's performance (e.g., sensitivity > X%, accuracy > Y%) and more about demonstrating that the device's safety and efficacy profile remains acceptable and comparable within the expanded patient population.

Implicit Acceptance Criteria:

• Safety: No new or unexpected adverse events in patients with prostate volumes >80 cm³ and ≤150 cm³. The rates of adverse events, including serious complications, should be generally similar to those observed in patients with prostate volumes ≤80 cm³.
• Effectiveness: Significant and similar improvements in functional and quality of life outcomes in patients with prostate volumes >80 cm³ and ≤150 cm³ compared to patients with prostate volumes ≤80 cm³. No negative impact on sexual function.

Reported Device Performance (as demonstrated by the supporting studies):

• Safety: "Patients with prostate volumes >80 cm³ had generally similar rates of adverse events, including serious complications. No unexpected adverse events were reported, and all adverse events were consistent with those reported in the Rezūm System pivotal clinical study."
• Effectiveness: "Significant and similar improvements in functional and quality of life outcomes were demonstrated in both patient populations, with no negative impact to sexual function."

Table of (Implicit) Acceptance Criteria and Reported Device Performance:

Study Details:

The document describes two types of clinical evidence used to support the expanded indication:

1. Systematic review and meta-analysis of clinical studies: This reviewed existing data on the Rezūm System for patients with prostate volumes >80 cm³ and compared outcomes to patients with prostate volumes ≤80 cm³.
2. Manufacturer-sponsored prospective, non-randomized, single-arm study: This study specifically evaluated the safety and effectiveness of the Rezūm System in patients with prostate volumes >80 cm³ and ≤150 cm³. The results were compared to data from the Rezūm System's original "pivotal clinical study."

Based on the provided text, here's what can be answered for each point:

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

   • Systematic Review/Meta-analysis: The text does not specify the exact sample size. It states it was a "systematic review and meta-analysis of clinical studies," implying a pooling of data from multiple studies. The data provenance (country of origin, retrospective/prospective) is not specified for the individual studies included in the meta-analysis, but they are existing clinical studies.
   • Manufacturer-sponsored study: The text does not specify the exact sample size. It describes the study as "prospective, non-randomized, single-arm." It evaluates patients with prostate volumes >80 cm³ and ≤150 cm³. Data provenance is primarily domestic, as it's a manufacturer-sponsored study submitted to the FDA. It is prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The Rezūm System is a therapeutic device (for relieving symptoms and reducing prostate tissue), not a diagnostic algorithm. Therefore, "ground truth" in the typical sense of expert label annotations for images or diagnostic classifications is not directly applicable here. The outcomes (symptom relief, prostate tissue reduction, adverse events, quality of life, sexual function) are assessed directly from patient reports, objective measurements (e.g., prostate volume changes), and clinical evaluations by treating physicians. The text does not mention a specific "ground truth" panel of experts, nor would it typically be required for a therapeutic device study focused on clinical outcomes.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable (N/A). As a therapeutic device focusing on direct clinical outcomes, adjudication methods like those used for diagnostic algorithms (e.g., for image interpretation) are not described or typically relevant in this context. Clinical events and outcomes are recorded based on predefined criteria, and adverse events are typically reported and classified by investigators and reviewed by safety committees.

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:
   Not applicable (N/A). This is a therapeutic device, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case study comparing human readers with and without AI assistance is not relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable (N/A). This is a therapeutic medical device, not an algorithm. The Rezūm System is a physical device used in a procedure performed by a human clinician.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
   As explained in point 3, the concept of "ground truth" for a therapeutic device is different. For this submission, the "ground truth" and evidence of effectiveness and safety comes from:

   • Clinical Outcomes Data: Patient-reported symptoms, quality of life scores, measures of sexual function, and potentially objective measures like post-treatment prostate volume.
   • Adverse Event Reporting: Documentation and classification of adverse events.
   • Comparison to a Pivotal Clinical Study: The study for the expanded indication compared its outcomes to those established in the device's original pivotal clinical study.

7. The sample size for the training set:
   Not applicable (N/A). This is a therapeutic medical device; there is no "training set" in the context of machine learning or AI algorithms. The development of the device itself would have involved engineering, preclinical, and early human studies, but these are not referred to as a "training set."

8. How the ground truth for the training set was established:
   Not applicable (N/A), as there is no "training set" in the AI/ML context for this device.

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The SpydrBlade Flex Instrument is indicated for use in the cutting (incision, dissection, avulsion) of soft tissue using radiofrequency energy and the coagulation (hemostasis, cauterization, arrest of bleeding) of soft tissue using microwave energy in the gastrointestinal tract as required or encountered in endoscopic procedures.

The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.
The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.

The Creo Medical electrosurgical system comprises of the CROMA electrosurgical generator, an interface cable accessory and a footswitch accessory, and a compatible electrosurgical instrument.

The CROMA electrosurgical generator comprises two distinct energy sources for the independent generation of bipolar radiofrequency (RF) current at 400 kHz and microwave (MW) current at 5.8 GHz.
Both energy sources are delivered through the same output coaxial connector. These generator outputs are controlled in terms of voltage, power, current, duty cycle, and duration by means of widely used and long-established design and engineering techniques. Via these controls and system design, only one energy source can be delivered to the output coaxial connector at any one time.

The compatible electrosurgical instrument that is subject of this submission is SpydrBlade Flex. The subject and predicate devices use the same electrosurgical generator, footswitch, and interface cable.

SpydrBlade Flex is a single-use, sterile endoscopic electrosurgical instrument used for procedures in the gastrointestinal (GI) tract. The product is sterilized using Ethylene Oxide.
SpydrBlade Flex is intended for use in endoscopes with a minimum working channel of 3.2 mm and maximum working length of 1.35 m.

SpydrBlade Flex incorporates a distal tip, a shaft, and a handle. The distal tip includes a jaws assembly that consists of two gold-plated ceramic bipolar antennas, each soldered to a stainless-steel base. The stainless-steel bases are joined in a manner to provide a mechanical opening and closing function. The bipolar antennas deliver RF energy for cutting and MW energy for coagulation, in the same manner as the predicate Speedboat SB1. The cutting and coagulation functions are performed regardless of the jaw mechanism and can be provided with the jaws open or closed. The jaw mechanism provides a grasping function for easier tissue manipulation between and during energy applications.

The subject and predicate devices are composed of the same technological components with the same principles of operation related to the energy function:

• Cutting of mucosa, sub-mucosa, muscle using bipolar RF energy,
• Thermal coagulation of mucosa and/or sub-mucosa, muscle, vascular and arterial structures using MW energy.

The provided FDA 510(k) clearance letter pertains to the SpydrBlade Flex Instrument (PRD-RG1-001), an endoscopic electrosurgical unit and accessories. However, the document does not contain information related to software-based AI performance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth by expert consensus for diagnostic purposes.

The information requested in the prompt, such as acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets, number and qualifications of experts for ground truth, adjudication methods, and training set details, are typically associated with the clearance of AI-powered diagnostic devices.

The SpydrBlade Flex Instrument, as described in this 510(k) summary, is a surgical instrument that uses RF and MW energy for cutting and coagulation of soft tissue. The "Software Verification and Validation" section likely refers to the embedded software controlling the electrosurgical generator and instrument functions, ensuring its proper operation and safety, rather than an AI analyzing medical images or data for diagnostic purposes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance for AI, nor can I elaborate on sample sizes, ground truth establishment, or human-in-the-loop performance studies, as this information is not present in the provided document for this specific device.

The document primarily focuses on:

• Substantial Equivalence: Comparing the SpydrBlade Flex Instrument to a predicate device (Speedboat Flush SB1 Instrument) based on indications for use, technological characteristics (design, materials, principles of operation), and safety/performance testing.
• Non-Clinical Testing: Sterilization, biocompatibility, electrical safety, microwave safety, electromagnetic compatibility, and software verification/validation.
• Bench Tests: Confirming that the device meets design verification and validation criteria and performs equivalently to the predicate device.

Key takeaway for your request: This document describes the clearance of a medical device (an electrosurgical instrument) that does not appear to involve AI for diagnostic purposes, hence the absence of the detailed AI-related study information you are seeking.

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The SB Knife Jr2 is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47702, MD-47702L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current.

SB Knife Jr2 under application (Hereinafter "the Subject Device" is a single-patient use EtOsterilized hand-held device that connects to an external high frequency (HF) generator and is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker's diverticulum within the digestive tract using high-frequency current. Varying generator power, cycle and duration results in a control of these surgical capabilities. The Subject Device is designed to connect with Olympus and ERBE connectors and uses the disposable or reusable Olympus or ERBE grounding plates and connecting cables intended for the generators.

The Subject Device is not life supporting or life sustaining. It is designed as a short-term limited contact device (less than 24 hours), has no software, and has been certified to comply with IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1-6 and IEC 60601 2-18 by ISO 17025 accredited laboratory.

The Subject Device consists of two models as follows:

MD-47702 Working Length: 1970 mm
MD-47702L Working Length: 2320 mm

The provided text is a 510(k) summary for the SB Knife Jr2, a medical device. It does not contain the information typically found in a study proving a device meets specific acceptance criteria based on performance.

Specifically, the text describes:

• The device and its intended use.
• A comparison to a predicate device (SB Knife®).
• Differences between the subject device and the predicate device, particularly regarding type, shape, structure, presence of a rotating operation portion, and materials.
• Non-clinical testing performed (transportation, shelf-life, packaging, sterilization, electromagnetic compatibility, electrical safety, biocompatibility).
• A statement that clinical testing was not performed.

Therefore, I cannot extract the requested information about acceptance criteria and a study proving the device meets them from the provided text. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through technological comparison and non-clinical performance, rather than providing a detailed study of the device's performance against pre-defined acceptance criteria for a new clinical claim or feature that requires such a study.

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The Disposable Sphincterotome is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This device can also be used to cannulate and inject contrast medium.

The subject device Disposable Sphincterotome is a sterile, single-use endoscopic device, intended to be used with flexible endoscopes for intubation of the pancreaticobiliary system and for sphincterotome. The disposable sphincterotome consists of cutting wire, sheath, quide wire connector, injection connector, conductive column, finger ring, handle, and imaging ring. The subject device has 72 specifications. The differences among these models are the Cutting Length, Tip Length, Working Length and Type of guide wire lumen channel. The subject device is EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years. The main materials used for construction of Disposable Sphincterotome include PTFE, ABS, SUS304.

The provided document is a 510(k) Summary for a Disposable Sphincterotome. This type of device is a medical instrument and not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML is not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Boston Scientific Corporation's Autotome™ RX). The "study" referenced in the document is a series of non-clinical, bench tests, and material conformity assessments rather than a clinical trial or AI/ML performance study.

Here's a breakdown based on the provided text, indicating why AI/ML specific questions are not relevant:

1. AI/ML Device Type: Not an AI/ML powered device. It is a physical medical instrument.

2. Acceptance Criteria and Reported Device Performance (as per the document):

   Acceptance Criteria / Test Performed	Reported Device Performance (Summary)	Relevance to AI/ML
   Sterilization and Shelf Life	Successfully tested per ISO 11135 and ASTM 1980; 3-year shelf life.	Not Applicable
   Biocompatibility	Successfully tested per ISO 10993 (cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity, material medicated pyrogenicity); non-toxic and biocompatible.	Not Applicable
   Performance Testing (Bench)	All tests verified (Appearance, Dimension, Operational Performance, Tensile Performance, Hydraulic Leak Resistance, Injection Connector performance, Conduction resistance, Contrast Agent Injection Function, Cutting Line Function, Radiopacity, Compatible endoscopes tests, Thermal effect test).	Not Applicable
   Electromagnetic Compatibility & Electrical Safety	Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-2.	Not Applicable

3. Sample Size for Test Set and Data Provenance:

   • Sample Size: Not specified for individual bench tests, but generally refers to a set of devices tested in a lab setting.
   • Data Provenance: The tests are "bench tests" performed by the manufacturer, Beijing ZKSK Technology Co., Ltd. Origin would be China (where the manufacturer is located). These are not patient data.

4. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications: Not applicable. Ground truth for a physical medical device's performance in bench testing is established by engineering specifications and direct physical measurement/observation, not expert consensus on medical imaging or clinical interpretation.

5. Adjudication Method: Not applicable.

6. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No. The device is a physical instrument, not an AI assistance tool for human readers.

7. Standalone (Algorithm Only) Performance: Not applicable as it's not an algorithm.

8. Type of Ground Truth Used: Engineering specifications, physical measurements, and conformity to international standards (e.g., ISO, IEC). This is about device function and safety, not diagnostic accuracy.

9. Sample Size for the Training Set: Not applicable. There is no AI model or training set.

10. How the Ground Truth for the Training Set Was Established: Not applicable.

In summary, the provided document describes a traditional medical device (Disposable Sphincterotome) submission to the FDA. The listed "studies" are bench tests and compliance assessments to demonstrate the device's physical and material properties, safety, and functionality, and to establish substantial equivalence to a predicate device. It does not involve any AI/ML components or associated performance testing.

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This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. Also indicated for sphincterotome-aided, wire-quided selective cannulation of the biliary ducts.

Tesla BiCord Active Cord:

This device is used to connect the Teslatome Bipolar Sphincterotome to compatible electrosurgical generators.

ln a sphincterotomy, access to the biliary tract is gained by passing a sphincterotome through a duodenoscope and positioning the distal tip adjacent to the major papilla is cannulated using the tip of the sphincterotome. The papilla is then incised using an electrosurgical current applied to the cutting wire by an electrosurgical generator that is connected to the sphincterotome by an active cord.

The Teslatome consists of a three-ring handle, tri-lumen catheter, and cutting wire with a connection to an electrosurgical generator via the Tesla BiCord active cord. The connection delivers a current to the cutting wire that is exposed at the device. A multilumen catheter allows for the injection of contrast and/or the passage over a prepositioned wire guide using the proximal end of the device.

The provided text is a 510(k) summary for the Teslatome Bipolar Sphincterotome and Tesla BiCord Active Cord. It details the device, its intended use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria, a detailed study proving the device meets these criteria, or any clinical study details.

The document explicitly states: "The non-clinical tests for seal strength, functional testing after simulated distribution, current carrying capacity, device burnout, neutral electrode thermal performance, and force of device pushability demonstrate adherence to the quality design and risk management systems of the manufacturer. The Teslatome and BiCord active cord are substantially equivalent to the currently cleared predicate devices."

This indicates that while non-clinical tests were performed, the 510(k) relies on the substantial equivalence to a predicate device (K192339) rather than a de novo clinical study with specific acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered, along with the reasons why other information cannot be provided based on the input:

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

• Cannot be provided. The document broadly mentions "non-clinical tests for seal strength, functional testing after simulated distribution, current carrying capacity, device burnout, neutral electrode thermal performance, and force of device pushability." However, it does not list specific quantitative acceptance criteria for these tests or the reported performance values against those criteria. It only states that the tests "demonstrate adherence to the quality design and risk management systems of the manufacturer" and that the devices are "substantially equivalent."

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

• Cannot be provided. The document does not detail sample sizes for the non-clinical tests. It also does not discuss any test set in the context of clinical data or data provenance (country of origin, retrospective/prospective), as it relies on non-clinical testing and substantial equivalence.

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

• Cannot be provided. This information is relevant for studies involving human interpretation or clinical data with ground truth establishment. The provided text only discusses non-clinical device testing for substantial equivalence, not studies requiring expert ground truth.

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

• Cannot be provided. This is relevant for clinical studies involving multiple readers and ground truth adjudication. Not applicable to the non-clinical testing mentioned.

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

• Cannot be provided. The device described (Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord) is an endoscopic electrosurgical unit and accessories, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study or AI-related effectiveness is not applicable and not mentioned.

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

• Cannot be provided. As noted above, this is not an AI algorithm. The device is a physical medical instrument.

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

• Cannot be provided. For the non-clinical tests mentioned, the "ground truth" would be established engineering specifications, performance standards, or comparison to the predicate device's known characteristics, not clinical ground truths like pathology or expert consensus. Specific details are not included.

8. The sample size for the training set

• Cannot be provided. This information is related to machine learning models. The device discussed is a physical medical instrument, not an AI model requiring a training set.

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

• Cannot be provided. This information is related to machine learning models. Not applicable for this device.

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The Aqua Medical RF Vapor System is indicated for use in the coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.

Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.

The Aqua RF Vapor Ablation System uses a catheter to deliver heated water vapor to the tissue surface undergoing treatment. The Aqua RF Vapor Ablation System is a catheter-based system for heating and coagulating tissue. The heat is delivered to the target tissue in the form of water vapor that is generated within the catheter tip using radiofrequency (RF) energy. Application of heat to the tissue results in coagulation and ablation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue. The Aqua Medical RF VaporAblation System consists of the following components:

• Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter.
• Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7F -(2.3 mm) with an outer catheter sheath that is 10.5F and a length between 145 cm and 210 cm. There are 3 types of RF Vapor catheters available. Catheters are designed to be used through an endoscope working channel diameter of 3.7mm.
• Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.

The provided text is a 510(k) summary for the Aqua Medical RF Vapor Ablation System. It details the device's indications for use, its description, and the testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results typically found in reports for AI/software devices, particularly those relating to clinical performance metrics based on a test set, human expert involvement, or comparative effectiveness studies.

The "Performance Data" section (Page 6-7) describes non-clinical testing for the device's hardware and a "Lean Beef Testing" experiment. This suggests that the device's performance relies primarily on its physical and functional attributes, rather than an AI component requiring a complex clinical validation study with extensively adjudicated ground truth, as would be typical for an AI-powered diagnostic or predictive device.

Therefore, many of the requested details about acceptance criteria and study proving performance (specifically for an AI/software component, human-in-the-loop, etc.) are not present in this document.

Based on the available information, here's what can be extracted and what cannot:

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

The document does not provide a table of acceptance criteria or specific quantitative performance metrics in the way one would expect for an AI device (e.g., sensitivity, specificity, AUC). Instead, it mentions:

• Hardware Verification Testing:
  • Acceptance Criteria (Implied): Catheter joint forces and sliding forces "passed the specification requirements." Fatigue cycle testing was completed to "validate the physical integrity and durability of the subject device."
  • Reported Performance: "The catheter joint forces and sliding forces passed the specification requirements for the testing. The fatigue cycle testing was completed to validate the physical integrity and durability of the subject device under simulated-use conditions including extreme tortuosity, mechanical cycling, high-vapor output and temperature exposure." (No specific numbers provided).
• Lean Beef Testing:
  • Acceptance Criteria (Implied): "Equivalent results between the previous time-based treatment when compared to the modified energy level-based treatment." And "Equally desired ablation depths (penetration of heat) will be produced by both systems." (Based on the conclusion below).
  • Reported Performance: "The Lean Beef testing demonstrated equivalent results between the previous time-based treatment when compared to the modified energy level-based treatment. The test also demonstrated that the ablation depths for the modified Circumferential Delivery Catheters are substantially equivalent to those produced by the Predicate Circumferential Delivery Catheters through the dose ranges evaluated in the test. Equivalent ablation depths (penetration of heat) were produced by both systems supporting our substantial equivalency claim." (No specific quantitative values like mm or power settings are provided).

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

• Sample Size: Not specified for any of the tests.
• Data Provenance: The "Lean Beef Testing" implies a laboratory, non-clinical setting (animal tissue model - "Lean Beef"). It is not clinical data from patients.

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

• Not applicable/Not mentioned. The testing described (hardware, lean beef) does not involve human expert interpretation of clinical data to establish ground truth.

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

• Not applicable/Not mentioned. Adjudication methods are typically used for clinical image or data interpretation studies, which are not described here.

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, not performed. This device is an ablation system, not a diagnostic AI tool that assists human readers.

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

• Not applicable. This device generates vapor for ablation; its performance is not measured as an "algorithm only" in the context of diagnostic or predictive AI. The software controls the generator, but its performance is tied to the physical delivery system.

7. The type of ground truth used:

• For hardware testing: Mechanical and physical specifications.
• For Lean Beef Testing: Ablation depth and characteristics measured directly in the beef tissue. This is a physical/material measurement rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set:

• Not applicable. This document describes a physical medical device, not an AI model that undergoes a "training" phase with a dataset. The software mentioned is for control of the generator, not for learning from vast datasets.

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

• Not applicable. As above, there is no "training set" in the context of an AI model for this device.

In summary, the provided FDA 510(k) summary focuses on the substantial equivalence of modifications to an existing physical medical device (RF vapor ablation system) through engineering and bench testing, rather than a clinical study evaluating an AI component's performance. The "performance data" section primarily refers to non-clinical tests demonstrating the device's physical and functional equivalency.

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The Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation of gastrointestinal tissue.

The Reusable Interface Cable comprises a flexible, low-loss coaxial cable intended for high-power microwave operation and has latching connectors at each end for connection to the CROMA Electrosurgical Generator and compatible Creo Medical Instruments (Surgical Accessories). The established lifetime of the Reusable Interface Cable is for 20 uses in total.

The provided text is related to a 510(k) premarket notification for a medical device (Reusable Interface Cable 1.5 m), which is an electrosurgical accessory. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide detailed acceptance criteria and study results for clinical efficacy or sophisticated AI performance.

Therefore, the document does not contain information relevant to:

• A table of acceptance criteria and reported device performance related to a diagnostic or AI-driven outcome.
• Sample size used for a test set in the context of an accuracy study or provenance of data.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes of AI assistance.
• Standalone algorithm performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Device Description: A flexible, low-loss coaxial cable connecting a Creo Medical Instrument to a CROMA Electrosurgical Generator for delivering RF and/or Microwave energy. It specifies a lifetime of 20 uses.
• Intended Use/Indications for Use: Connection of compatible Creo Medical Instrument to the CROMA Electrosurgical Generator to deliver RF/Microwave energy for cutting, coagulation, and ablation of gastrointestinal tissue. This indication is stated to be the same as the predicate device, with reworded readability.
• Technological Comparison: The subject device is a reusable version of the predicate device. The conductor cable was modified for durability while maintaining identical electrical properties. Principles of operation, electrical properties, energy source, materials, dimensions, and cleaning methods are identical to the predicate.
• Non-Clinical Tests:
  • Electrical safety testing: Conducted in compliance with FDA-recognized versions of IEC 60601-2-2 and IEC 60601-2-6 standards.
  • Performance bench testing: Conducted to establish device durability over its established lifetime for:
    • Cleaning between uses (reprocessing)
    • Rotation load
    • Cyclic load
    • Connector connection and disconnection forces.

Conclusion:

This submission is for an accessory device (cable) that facilitates the use of an electrosurgical unit. The "acceptance criteria" and "study" described are primarily related to electrical safety and physical durability/reusability of the cable, ensuring it functions as intended for its specified lifespan and remains substantially equivalent to the predicate device. It does not involve complex performance metrics or clinical studies in the context of diagnostic accuracy or AI-driven decision support.

Since the provided text does not contain the requested information about diagnostic performance, AI, or specific clinical study details as implied by the questions, I cannot populate the table or answer those specific points. The information available is about engineering and regulatory compliance testing for a reusable medical cable.

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Gold Probe Bipolar Electrohemostasis Catheter is indicated for use in transendoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract.

Injection Gold Probe Bipolar Electrohemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. The Injection Gold Probe Catheter also has irrigation capability. Any other use is not recommended.

The Gold Probe is a bipolar electrohemostasis catheter with irrigation capabilities. When passed through an endoscope and activated, it will deliver a bipolar current to cauterize tissue. The Gold Probe is available in 7 Fr and 10 Fr with a working length of 300cm (7 and 10 Fr) and 350cm (7 Fr), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for perpendicular and tangential use, while the HemoGlide Coating on the catheter promotes minimal friction during endoscope passage.

The Injection Gold Probe is an injection therapy and bipolar electrohemostasis catheter with irrigation capabilities. The Injection Gold Probe is available in a working length of 210 cm with outer diameters of 7F (2.3 mm) and 10F (3.3 mm), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for perpendicular and tangential use, while the HemoGlide Coating on the catheter promotes minimal friction during endoscope passage.

This document is a 510(k) premarket notification for a medical device, specifically the Gold Probe Bipolar Electrohemostasis Catheter and the Injection Gold Probe Bipolar Electrohemostasis Catheter.

Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to AI/algorithm performance, human-in-the-loop studies, or detailed ground truth establishment. The document explicitly states:

"The proposed Gold Probe Bipolar Electrohemostasis Catheter and Injection Gold Probe Bipolar Electrohemostasis Cathter technological characteristics remain unchanged from predicate Gold Probe Bipolar Electrohemostasis Catheter (K970278) and Injection Gold Probe Bipolar Electrohemostasis Catheter (K133933) respectively; therefore, no further performance testing was required."

This statement indicates that the submission is based on substantial equivalence to previously cleared predicate devices, claiming that the technological characteristics are unchanged, and thus, no new performance testing was deemed necessary by the manufacturer for this 510(k) submission.

Therefore, I cannot populate the requested table and details because the provided document does not contain information about:

1. A table of acceptance criteria and reported device performance (in the context of an AI/algorithm study).
2. Sample sizes for a test set or data provenance for such a study.
3. Number and qualifications of experts for multi-reader studies or ground truth establishment in this context.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

This 510(k) summary focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and indications for use, rather than presenting a performance study against specific acceptance criteria for a new or AI-enabled device.

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