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INDICATIONS FOR USE AS A RESECTION ELECTRODE:

The Dornier Bi Polar Electrode is designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation, or removal of soft tissue and where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedure for which the devices can be used are: Transurethral resection in saline (TURis), Transurethral prostatectomy, transurethral resection of the prostate (TURP), for benign prostatic hyperplasia, Transurethral incision of the prostate (TUIP) or bladder neck, Transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

The following electrodes are intended to be used as resection electrodes:

• BIP12CLL: BIPOLAR 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use
• BIP12CLM: BIPOLAR 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use
• BIP30CLL: BIPOLAR 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use
• BIP30CLM: BIPOLAR 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use
• BIPMBLA: BIPOLAR Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use
• BIPNEEL: BIPOLAR Needle 24 Fr Electrode-Sterile, Single-Use

INDICATIONS FOR USE AS A VAPORIZATION ELECTRODE:

The Dornier Bi Polar Electrode is designed and intended for use in urological surgical procedures involving vaporization, ablation, coagulation, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indication include: Use in the prostate, bladder, and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH), bladder cancer, tumors, lesions and neoplasms. The specific urological indications include Transurethal Electro vaporization (TUVP), (TVP), (TUEVP) also known as Transurethal Vapor Resection of the prostate (TUVRP), Transurethal Vaporization in Saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.

The following electrode is intended to be used for plasma vaporization:

• BIPDDSC: BIPOLAR Dornier Disc™ 24 Fr Electrode-Sterile, Single-Use

The Dornier Bipolar electrodes are sterile packaged, bipolar electrodes designed to deliver high frequency electrosurgical energy at the treatment area of the patient. Dornier bipolar electrodes are intended for single-use only.

The electrodes are designed to be connected through a compatible resectoscope to the electrosurgical unit for the delivery of electrosurgical energy at the treatment area of the patient. It is suitable for surgical cutting, coagulation and removal of soft tissues by controlled heating effect.

The Dornier Bipolar Electrode shall be used in conjunction with compatible resectoscopes such as Olympus Bipolar 12° and Olympus Bipolar 30° to the compatible bipolar electrosurgical generator such as Gyrus PlasmaKinetic™ SuperPulse Generator and Olympus ESG 400.

Electrical energy is supplied by the generator. A cable is connected from the generator to the working element of the Resectoscope. The Positive lead attaches to the bottom of the working element and the negative to the top of the working element. Electrical current flows from the generator into the Connector, down the Inner Tube and into the tip of the probe, creating a plasma field. The current returns via the saline, through Forks and Scope, into the negative lead and back to the generator. The strength of the plasma field can be adjusted by increasing or lowering the power setting on the generator. A foot switch is used to turn the electrode on and off.

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The Vanquish Water Vapor Ablation System is indicated for the thermal ablation of targeted prostate tissue via a transurethral approach.

The Vanquish Water Vapor Ablation System provides a method of focal thermal ablation that utilizes the high energy stored in water vapor to target prostate tissue. In a minimally invasive transurethral outpatient procedure performed under transrectal ultrasound (TRUS) guidance, sterile water is heated within the system and converted into vapor. This vapor is then delivered through small emitter holes at the distal end of a transurethral needle into the prostate tissue.

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The Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC631Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope. The preloaded guidewire is used for guiding and exchanging endoscopic accessories for biliary duct, including but not limited to the common bile, cystic, pancreatic and right and left hepatic ducts.

The Single Use Sphincterotome V (Distal Wireguided) KD-VC411Q/VC431Q/VC433Q Series are intended to be used for papillotomy using high-frequency current in combination with an endoscope.

The Single Use 3-Lumen Sphincterotome V KD-V411M/V431M Series is intended to be used for papillotomy using high-frequency current in combination with an endoscope and guidewire.

The DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME KD-411Q/431Q Series is intended to be used for papillotomy using high-frequency current in combination with an endoscope.

The Single Use Sphincterotome KD-VC, KD-V, and KD Series consists of the following devices:

• Single Use Preloaded Sphincterotome V (Distal Wireguided) KD-VC600 Series (aka CleverCut3V)
• Single Use Sphincterotome V (Distal Wireguided) KD-VC400 Series (aka CleverCut3V)
• Single Use 3-Lumen Sphincterotome V KD-V Series (aka CleverCut3V)
• DISPOSABLE TRIPLE Lumen SPHINCTEROTOME KD Series (aka FlowCut)

The subject devices have separate lumens for guidewire, cutting wire and injection of contrast medium for papillotomy. The knives are pre-curved and have a tapered tip to facilitate insertion into the papilla of Vater. The insertion portion of the KD-V, and KD-VC Series have a V-marking, which the relative insertion length into the endoscope can be confirmed by the positional relationship between the V-marking and the biopsy valve of the endoscope and feature an integrated C-Hook to attach to the endoscope. The distal end of the sphincterotome is coated with CleverCut coating ("Olympus' PFA (perfluoroalkoxy) coating designed to prevent thermal injury to non-target tissue while cutting the papilla of Vater. The KD-VC600 Series offers models that are preloaded with VISIGLIDE guidewires.

The subject devices are provided to the user sterilized by ethylene oxide and intended for single use only.

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The Single Use Electrosurgical Knife KD-612 Series is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.

The Single Use Electrosurgical Knife KD-620UR is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.

The Single Use Electrosurgical Knife KD-650 Series is intended to be used to cut tissue using high-frequency current within the digestive tract in combination with an endoscope and electrosurgical units.

The Single Use Electrosurgical Knife was designed to be used with compatible Olympus endoscopes, A-Cord (power cable), and electrosurgical units to cut tissue using high-frequency current within the digestive tract. The subject device is inserted endoscopically into the body cavity and tissue is cut by applying a high frequency current. The subject device is a sterile (EO) single use electrosurgical knife comprised of a handle and an insertion portion. The handle portion consists of the body and the slider. The insertion portion consists of the distal end with one lumen for the stainless-steel cutting knife and the sheath portion. The slider extends the cutting knife from the distal end of the sheath/tube when pushed and retracts the cutting knife into the sheath/tube when the slider is pulled.

The Single Use Electrosurgical Knife is available in three different models: KD-612, KD-620UR, and KD-650. The primary difference between the models is the tip shape of the distal end.

The subject device has the same technological characteristics and similar design as the applicable predicate device.

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The DISPOSABLE HOT BIOPSY FORCEPS FD-210U/FD-230U are intended to be used to collect tissue samples within the digestive tract using high-frequency current under endoscopic observation in combination with an endoscope.

The Disposable Hot Biopsy Forceps have been designed to collect tissue endoscopically within the digestive tract using high-frequency current under endoscopic observation. The Disposable Hot Biopsy Forceps consists of a handle section and insertion portion. The cups in the distal end of insertion portion are activated in the open and closed position by maneuvering the slider in the handle. The cup shapes are provided in either alligator jaw-step (FD-210U) or oval type (FD-230U).

The subject device is connected to a compatible electrosurgical device by an A-cord. The A-cord jack is connected to the plug on the handle of the subject device. The target tissue is held by the cups. The tissue is subjected to high frequency electric current transmitted from the plug which allows for collecting tissue.

The subject device has the same technological characteristics and similar design as the applicable predicate device.

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This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

The SureTome™ SW Sphincterotome with DomeTip ® are sterile, single use devices compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing high frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.

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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 Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures.

The Multi4 System is an electrosurgical system used during urethral resection procedures of adult patients. The system, intended to remove and collect tissue from the bladder, includes a single-use electrosurgical instrument, known as the Multi4 B, as well as the reuseable Multi4 Pump. The Multi4 Pump administers energy from an external electrosurgical unit to the handheld Multi4 B instrument, which has electrosurgical functions and allows for fluid transport and tissue sample collection. The Multi4 B instrument accesses the bladder through the working channel of a commercially available cystoscope. The Multi4 System is a prescription device intended for use in professional healthcare facilities by healthcare professionals (HCPs).

The Multi4 System consists of the following components:
• Multi4 Pump (with Integrated Fluid Control)
o Footswitch
• Multi4 B
o Resectoscope & Needle
o Simple4tainer (For collection of gross resected tissue pieces for pathology)

The provided FDA 510(k) clearance letter and summary for the Multi4 System primarily focuses on demonstrating substantial equivalence to predicate devices through design similarity, material composition, intended use, and technological characteristics. The document details extensive non-clinical testing performed to ensure safety and effectiveness.

However, the provided text does not contain details about acceptance criteria, the study design, or performance metrics in a way that allows for the construction of a table comparing acceptance criteria with reported data, nor does it provide information on sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The document does mention:

• Non-Clinical Testing: Software Verification and Validation Testing, Sterility Testing, Packaging Testing, Shelf-life Testing, Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity), Electrical Safety & EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-2), Integrity Testing, Functional Testing (Cut and coagulation, aspiration, irrigation, injection), Dimensional Inspection and Testing, Simulated Use Testing.
• Lack of Clinical Study: The "SUMMARY OF NON-CLINICAL TESTING" section and the overall context strongly suggest that the clearance was based on non-clinical data demonstrating equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against acceptance criteria for a new AI/algorithm. There is no mention of "ground truth" as it would apply to an AI study (e.g., expert consensus, pathology, outcomes data).

Therefore, I must state that the requested information regarding acceptance criteria, study data for AI performance, sample sizes for AI test/training sets, expert roles, adjudication, and MRMC studies is not present in the provided text. The document focuses on demonstrating substantial equivalence via engineering and bench testing, not clinical performance or AI/algorithm validation with a test set and ground truth in the manner typically required for AI-driven devices.

Without this specific information from the provided text, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-driven device with performance metrics.

If this were an AI device, the missing information would be crucial for understanding its validation. For this specific device and the information provided, the "acceptance criteria" were met by demonstrating that the Multi4 System performs as safely and effectively as its predicate devices through rigorous non-clinical testing.

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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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