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Flexiva Pulse and Flexiva Pulse TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse and Flexiva Pulse TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.

Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use

Flexiva Pulse, Flexiva Pulse TracTip, Flexiva Pulse ID and Flexiva Pulse ID TracTip Single Use Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA connector (Black Hole design), and an ETFE jacketed silica core fiber. Flexiva Pulse and Flexiva Pulse ID fibers are equipped with a polished, flat output tip (242µm, 365µm, 550µm and 910µm size) and the Flexiva Pulse TracTip and Flexiva Pulse ID TracTip fibers are equipped with a polished and reinforced ball-shaped output tip (242µm size).

These fibers may be used in a variety of laser-based surgical cases. For Flexiva Pulse ID laser fibers, an RFID (Radio-frequency identification) tag enables read/write data storage for compatible RFID-equipped laser systems (closed systems).

The provided FDA 510(k) clearance letter and summary for the Flexiva Pulse Laser Fibers does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and study particulars for a medical device. This document is a premarket notification for laser fibers, which are physical components and not typically subject to the same kind of performance studies as, for example, an AI diagnostic algorithm.

Specifically, it lacks information about:

• Acceptance Criteria for a diagnostic output: As the device is a laser fiber for surgical use, its "performance" is about its physical properties and ability to transmit laser energy, not diagnostic accuracy.
• Study proving device meets acceptance criteria in the context of diagnostic accuracy.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test and training sets, and training set sample size and ground truth establishment for AI-based devices. These are all concepts related to clinical performance evaluation, particularly for AI/Machine Learning devices, which is not the nature of the Flexiva Pulse Laser Fibers.

The document does describe performance testing related to the physical and functional attributes of the laser fiber. I will present the information contained in the document that most closely aligns with the spirit of your request, interpreting "acceptance criteria" and "reported device performance" in the context of a physical medical device.

Overview of Device Performance and Testing (Flexiva Pulse Laser Fibers)

The document describes a Special 510(k) submission for the Flexiva Pulse Laser Fibers, indicating that it is a modification to a previously cleared device (predicate device K210925). The core of the submission is to demonstrate substantial equivalence to the predicate device, primarily due to a "secondary coating resin material change." Therefore, the "study" described is focused on validating that this material change does not negatively impact the critical performance characteristics of the laser fiber.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (laser fiber), the "acceptance criteria" and "reported device performance" are related to its functional integrity and safety. These are not performance metrics like sensitivity, specificity, or accuracy, which would be relevant for a diagnostic AI device.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of fibers tested) for the performance tests (Bent Transmission, Fiber Durability, etc.). It generally states that a "Design Verification was executed." The data provenance is internal testing performed by Boston Scientific Corporation. The studies are by nature prospective in the sense that they are performed on newly manufactured devices with the changed coating resin material to verify their performance. There is no mention of country of origin for test data, but it would typically be conducted at the manufacturer's R&D facilities.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is not a diagnostic device where expert ground truth is established for clinical outcomes or interpretations. The "ground truth" for the performance tests mentioned above would be engineering and physical measurement standards.

4. Adjudication Method

Not applicable. This is not a diagnostic device requiring adjudication of clinical interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating human performance (e.g., diagnostic accuracy) with and without AI assistance, which is irrelevant for a laser fiber.

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

No. This refers to the performance of a diagnostic algorithm without human intervention, which is not applicable to a laser fiber.

7. The Type of Ground Truth Used

For the physical performance tests:

• Engineering Specifications/Standards: The "ground truth" is adherence to predefined engineering specifications for power transmission, temperature limits, durability, etc. These would be established based on industry standards, the predicate device's performance, and safety requirements.
• Biocompatibility Standards: For biocompatibility, the ground truth is compliance with recognized biological evaluation standards (e.g., ISO 10993 series), ensuring the materials are safe for human contact.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of what the document indicates about the "study":

The study was a "Design Verification" executed by Boston Scientific Corporation to support the "safe and effective use" of the proposed laser fibers after a "secondary coating resin material change." The purpose was to demonstrate that the modified device remains "substantially equivalent" to its predicate device (K210925). The tests involved evaluating the fiber's ability to transmit laser energy (Bent Transmission), its resilience during use (Fiber Durability while Firing), and safety (Fiber Connector Temperature, Laser System Output Accuracy, Biocompatibility). The document implies that all these tests were successfully completed, confirming that the material change did not compromise the device's performance or safety.

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The VIKING Fixed Curve Diagnostic Catheter is indicated for use to diagnose cardiac arrhythmias.

The Viking Fixed Curve Diagnostic Catheters (also referred to as Viking Catheters) are intended for use in electrophysiology procedures to record, stimulate and pace in the diagnosis of cardiac arrhythmias.

The Viking Catheters receive electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter into the vasculature percutaneously. To reach the right side of the heart, either the internal jugular vein, the subclavian veins, or the femoral veins can be accessed. To reach the left ventricle, the retrograde approach via the femoral artery can be used. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism, as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.

Viking Catheters are radiopaque, flexible, insulated catheters. The catheters have a polymer shaft that houses the electrical wiring that connects the electrodes to a connector at the proximal end of the catheter; each electrode wire is soldered into this connector. When the catheter is used, the connector is attached to a sterile cable that connects to the hospital recording and pacing equipment.

The Viking Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

The provided FDA 510(k) clearance letter and summary for the VIKING™ Fixed Curve Diagnostic Catheter do not contain any information regarding acceptance criteria and studies demonstrating device performance in the context of an AI/algorithm-based diagnostic device.

The document describes a medical device, specifically a diagnostic catheter, and the FDA's determination of substantial equivalence to a predicate device. The performance data discussed relates to:

• Bioburden Testing: To confirm bioburden levels were not adversely affected.
• Design Verification Testing: To demonstrate adherence to product specifications at baseline and after accelerated aging (25 months/761 days).
• Packaging Verification Testing: To ensure packaging meets design input and maintains sterility.

These tests are standard for physical medical devices to ensure safety, sterility, functionality, and shelf-life, not for evaluating the diagnostic accuracy or effectiveness of an AI algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to an AI diagnostic device because the provided text is for a physical diagnostic catheter and does not involve AI or algorithmic performance evaluation.

To directly answer your numbered points based only on the provided text, without making assumptions:

1. A table of acceptance criteria and the reported device performance: Not applicable for AI performance from this document. The document presents performance data for physical device characteristics (bioburden, design verification, packaging verification) to support substantial equivalence, but no specific acceptance criteria or reported values are detailed in the summary itself.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for AI performance from this document. The document refers to "Design Verification Testing" and "Packaging Design Verification testing" but does not specify sample sizes or data provenance in the context of diagnostic accuracy.
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 for AI performance from this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for AI performance from this document.
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, as this is a physical diagnostic catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for AI performance from this document. The "ground truth" for the catheter's physical performance would be its adherence to engineering specifications and international standards.
8. The sample size for the training set: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is a physical diagnostic catheter, not an AI algorithm.

In summary, the provided FDA document pertains to the clearance of a physical medical device (a catheter) and does not involve the evaluation of an AI algorithm or its diagnostic performance.

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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 OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The OptiMap™ System is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology.

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an Amplifier, Cart, Monitor, and Workstation that contains proprietary mapping software. Signals from a 64-electrode mapping basket catheter are transmitted to the Workstation by the Amplifier, processed by the mapping software, and the results are displayed on the Monitor.

The OptiMap System utilizes proprietary algorithms to process intra-cardiac electrogram (EGM) signals from a 64-electrode unipolar mapping basket catheter. The software transforms the time domain waveform information from the electrodes into space domain information which calculates the Electrographic Flow™ (EGF™) vectors for Atrial Fibrillation. The system also has algorithms that display action potential wavefront propagation or Activation Cycle Path (ACP). The ACP maps are a reconstruction of the activation wavefront propagation and may be used to visualize organized atrial arrhythmias.

The software output includes static and dynamic EGF maps that graphically depict the temporal activity and location of sources of EGF with respect to the catheter electrodes. The software displays active sources of flow and passive flow phenomena, detects spatial and temporal stability of sources of flow and detects the prevalence of sources of flow. In addition, the software output includes ACP maps displaying isochrones and a wavefront animation for each cycle.

The provided text is a 510(k) Clearance Letter and a 510(k) Summary for the OptiMap™ System. While it details the device, its intended use, and substantial equivalence to a predicate, it does not contain the specific performance study results, acceptance criteria, or details regarding the methodologies of testing (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).

The relevant section, "VII. Summary of Non-Clinical Performance Testing," states:

"Software verification and validation testing was completed on the subject device demonstrating that the OptiMap System with Version 1.3 Software (including ACP functionality) successfully performed at the unit, integration and system levels. All open issues from the verification and validation activities have been resolved or documented as unresolved anomalies. The OptiMap System met the acceptance criteria listed in the test protocols, performs as designed, and is suitable for its intended use."

This statement confirms that testing was performed and acceptance criteria were met, but it does not provide the specific criteria or the quantitative results of these tests. Therefore, I cannot populate the requested tables and information based solely on the provided text.

To answer your request, the necessary information (specific performance metrics, acceptance thresholds, sample sizes, ground truth details, etc.) would typically be found in the actual validation study report, which is not part of this 510(k) clearance letter or summary.

If such a document were available, the information would likely be organized as follows:

Acceptance Criteria and Device Performance Study

Since the provided text does not contain the specific performance study details, the following tables and sections are illustrative, showing what information would be required to fulfill the request. This information was not found in the provided 510(k) document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: (Not provided in the document. Would typically specify number of patient cases, EGM recordings, or arrhythmias analyzed.)
• Data Provenance: (Not provided in the document. Would specify country of origin, if retrospective or prospective data collection, and if multi-center.)

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: (Not provided in the document. Would specify the count of experts.)
• Qualifications of Experts: (Not provided in the document. Would specify their medical specialization, board certifications, and years of experience, e.g., "3 Board-Certified Electrophysiologists, each with >10 years of experience in cardiac arrhythmia diagnosis and treatment.")

4. Adjudication Method for the Test Set

• Adjudication Method: (Not provided in the document. Common methods include:
  • 2+1: Two experts review independently, and a third adjudicates disagreements.
  • 3+1: Three experts review independently, and a fourth adjudicates if necessary, or majority agreement is used.
  • Consensus: All experts discuss and reach a consensus.
  • None: A single expert's reading is considered ground truth, or adjudicated by a pre-defined process.)

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Conducted?: (Not provided in the document. Typically stated if human-in-the-loop performance with and without AI assistance was evaluated.)
• Effect Size (if applicable): (Not provided in the document. Would quantify the improvement in human reader performance, e.g., "Radiologists' diagnostic accuracy improved by X% (from Y% to Z%) when using OptiMap™ System assistance compared to without assistance.")

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Conducted?: Yes, the summary for "Software verification and validation" implies that the system's performance was evaluated independently, as it describes the system successfully performing at unit, integration, and system levels. However, the specific metrics and results are not detailed.

7. Type of Ground Truth Used

• Type of Ground Truth: (Not provided in the document. For cardiac arrhythmia diagnosis, this could be:
  • Expert Consensus: Agreement among multiple expert electrophysiologists based on clinical data.
  • Electrogram Analysis: Detailed analysis of raw EGM signals by experts, potentially correlated with clinical outcomes.
  • Clinical Outcomes Data: Correlation with patient outcomes (e.g., successful ablation, recurrence of arrhythmia).
  • Pathology/Histology: Less common for electrophysiology mapping, but relevant for some cardiac conditions.)

8. Sample Size for the Training Set

• Training Set Sample Size: (Not provided in the document. This is distinct from the test set and crucial for machine learning model development.)

9. How Ground Truth for the Training Set Was Established

• Training Set Ground Truth Establishment: (Not provided in the document. Similar methods to the test set ground truth would apply, but often with a larger scale and potentially more automated or semi-automated labeling steps initially, followed by expert review.)

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The Ureteral Stents are intended to facilitate urinary drainage from the kidney to the bladder via placement endoscopically or fluoroscopically by a trained physician.

The Urinary Diversion Stent Sets are intended to provide external drainage of urine after urinary diversion surgeries.

The Ureteral Stents are sterile, single use, disposable devices that provide a lumen that allows fluids to move from the kidney to the bladder. The Ureteral Stents are provided in multiple French sizes and lengths.

The Urinary Diversion Stent Sets are sterile, single use, disposable devices that allow internal drainage from the kidney to an external collection system.

Based on the provided FDA 510(k) clearance letter for the Boston Scientific Corporation's Ureteral Stents and Urinary Diversion Stent Sets (K250824), it's important to note that no study or specific performance criteria are detailed in this document.

This 510(k) is a "Special 510(k) ", which is used when changes to a legally marketed device do not affect its safety or effectiveness. The key takeaway from Section J (Performance Testing) and Section I (Substantial Equivalence) is:

• Changes are limited to labeling updates. The submission explicitly states: "The changes proposed within this bundled Special 510(k) are to the labeling for the proposed devices. There are no changes in design, performance, operating principle, or fundamental technology being proposed within this premarket notification."
• No new testing was required: "Therefore, existing test information/data remains valid for the proposed devices. No additional Verification or Validation testing was required for the changes to the labeling."
• Substantial Equivalence based on existing data: The conclusion reiterates that "Based on the intended use/indications for use, operating principle and comparison of key technological characteristics presented in this premarket notification, it is concluded that the proposed Ureteral Stents and Urinary Diversion Stent Set are substantially equivalent to the predicate device (cleared under K190603)."

Therefore, the document does not contain the information required to populate the sections you requested regarding acceptance criteria and a study proving the device meets those criteria, because no new performance testing was conducted for this specific 510(k) submission.

Here is a table explaining why each of your requested points cannot be answered from this specific 510(k) submission:

In summary, the provided 510(k) document (K250824) is a regulatory clearance for minor changes (specifically labeling updates) to existing, already cleared medical devices. It explicitly states that these changes do not require new performance testing, and therefore, it does not contain the details of studies, acceptance criteria, or ground truth establishment that would be present in an original 510(k) submission for a novel device or a device with significant design changes or a software/AI component. The "proof" of meeting acceptance criteria for these devices relies on the data submitted and reviewed for the predicate device (K190603).

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The Navigator HD Ureteral Access Sheath is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

Navigator™ HD Ureteral Access Sheath Set consists of a semi-rigid outer sheath and a semi-rigid inner dilator with interlocking hub. The set permits utilization of a guidewire to assist in device placement.

Sheath: The Navigator™ HD Sheath has a sheath hub which is over-molded onto the sheath shaft has three layers: Outer Pebax layer, Reinforced stainless steel coil enhancing torqueability and maneuverability, Inner PTFE liner. The sheath outer layer contains Barium Sulphate as a radiopacifier. In addition to the stainlesssteel coil, a radiopaque marker band is sandwiched between the Pebax and PTFE layers. The radiopaque marker band is located at the sheath tip and, along with the radiopacifier added to the sheath outer layer, enhances fluoroscopic visualization of sheath placement during the procedure. A hydrophilic coating is applied to the entire length of the shaft to reduce friction and facilitate placement of the device.

Dilator: The Navigator™ HD dilator has a hub with a standard luer lock at the proximal end. The tab on the dilator hub allows it to lock into the sheath hub. The dilator shaft is made of extruded tube Pellethane to allow for dimensional stability, low moisture absorption, and chemical resistance. The dilator tip is made of a softer grade of Pellethane to improve tip flexibility to assist in atraumatic placement. Both the dilator shaft and tip contain Barium Sulfate as a radiopacifier, enhancing visualization under fluoroscopy during the procedure. A hydrophilic coating is applied to the entire length of the dilator to reduce friction and facilitate placement of the device, either when assembled with the sheath or when used separately as a dilatation device.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML are not applicable here.

The document discusses the substantial equivalence of the Navigator™ HD Ureteral Access Sheath Set to a previously cleared predicate device.

Here's the relevant information that can be extracted, addressing the spirit of the request as much as possible for a non-AI/ML device:

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

The document doesn't present "acceptance criteria" in the typical AI/ML sense (e.g., specific sensitivity/specificity thresholds). Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The performance is assessed by comparing technological characteristics and performing design verification and usability testing related to a minor change.

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

This is a physical medical device. The "test set" would refer to samples of the device undergoing engineering performance testing. The document does not specify sample sizes for the "Design Verification" or "Summative Usability" testing, nor does it mention data provenance (e.g., country of origin, retrospective/prospective clinical data). These would typically be detailed in internal test reports referenced by the submission but not included in this summary.

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

This is not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for the device's performance relies on engineering specifications and established safety/efficacy profiles of similar devices.

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

Not applicable for a physical medical device. Adjudication methods are relevant for subjective interpretations of data, typically in clinical studies or AI/ML ground truth establishment.

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. This is not an AI/ML device, and no human reader study with or without AI assistance was performed or needed.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for the device's acceptable performance is based on:

• Engineering specifications and standards: Ensuring the device meets its design requirements.
• Performance testing results: Demonstrating functional equivalence and safety (e.g., mechanical performance, biocompatibility).
• Historical performance of predicate device: The K140323 device, which has a proven track record.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The Resolution™ Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking
2. Hemostasis for:

• Mucosal/sub-mucosal defects

The Resolution™ Clip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip.
The delivery system consists of a handle assembly and delivery catheter. The clip delivery system is offered in a 155cm and 235cm working length. The clip consists of a stainless-steel capsule and clip arms, a cobalt chrome yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening and closing may be limited by clinical circumstances and patient anatomy, among other factors. The Resolution™ Clip is designed to be compatible with endoscopes with working channels equal to or greater than 2.8 mm. There are no associated accessories included with this device.

The provided text is a 510(k) summary for a medical device (Resolution Clip) and does not describe acceptance criteria or a study proving the device meets acceptance criteria for an AI/ML-driven medical device.

The document discusses a physical medical device, specifically a hemostatic clip for the GI tract. The 510(k) submission is for a modification to an existing device (removal of an outer sheath component). The "performance data" mentioned refers to non-clinical bench testing to confirm that the modified physical device still meets performance requirements (e.g., proper device removal from endoscope, passability within endoscope, absence of endoscope damage).

Therefore, I cannot extract the requested information about acceptance criteria or a study proving an **AI/ML-**driven device meets acceptance criteria from the provided text. The questions regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for training sets are not applicable to this type of device modification submission.

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The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.

The AdVance XP Male Sling System is provided as a sterile, single-pack kit composed of the following primary components: Male Sling, Needle Passers (2), Retractor Ring, and Stay Hooks. The subject of this premarket notification is around the Male Sling component of the AdVance XP Male Sling System, specifically the implantable portion of the Male Sling assembly, which is the mesh sling and the tissue anchors. There are no modifications to the Needle Passers, or Retractor Ring and Stay Hooks (which form the Retraction System) as a part of this submission. Note that the Retraction System are comprised of purchased, off-the-shelf components cleared through K791665.

The provided text is a 510(k) summary for a medical device (AdVance™ XP Male Sling System) and does not describe a study involving acceptance criteria related to software or AI performance, nor does it include information about a test set, ground truth, expert adjudication, or MRMC studies.

The document discusses the substantial equivalence of a newly proposed medical device to a predicate device, focusing on material composition, manufacturing wash processes, sterilization, and biocompatibility. The "Performance Data" section specifically mentions "bench testing" to evaluate physical attributes of the mesh and the final product assembly.

Therefore, I cannot extract the information required by your request from the provided text, as it pertains to a different type of medical device evaluation.

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EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

The unidirectional steerable diagnostic catheters acquire electrical signals from the cardiac tissue, which are transmitted via the electrode wiring through the connector and cable to an amplifier, where the signals are displayed on an EP recording system for the physician to view and interpret in diagnosing cardiac arrhythmias. The physician inserts the diagnostic catheter(s) percutaneously via either the anterior approach using the internal jugular vein or the subclavian vein or via the femoral vein or for a retrograde approach, via the femoral artery. In some cases, the radial artery may be used to access the targeted cardiac chamber. Using fluoroscopic guidance, the physician then navigates the diagnostic catheter to the target site using the catheter steering mechanism as confirmed by the intracardiac electrograms and/or pacing threshold, confirming electrode to endocardium interface.

The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The EP+XT Catheter has a white rotating handle mechanism which provides curve actuation of the distal tip. The Dynamic Tip and Dynamic XT Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

The EP•XT, Dynamic Tip, and Dynamic XT Catheters are offered pre-packaged sterile and are a single use product not to be reused, reprocessed, or resterilized. The method of sterilization is ethylene oxide (EO).

This document describes the FDA's decision to clear Boston Scientific's EP.XT, Dynamic Tip, and Dynamic XT Unidirectional Steerable Diagnostic Catheters for marketing based on a determination of substantial equivalence to predicate devices. This clearance is not based on a study proving the device meets specific performance criteria for diagnostic accuracy in the same way an AI/ML diagnostic would be; rather, it relates to the device's physical and functional characteristics and its ability to acquire electrical signals.

Therefore, the requested information (acceptance criteria and study details related to diagnostic performance, human reader improvement with AI, ground truth, expert adjudication, etc.) is not applicable to this 510(k) submission. This is a clearance for a physical medical device (catheter) used to acquire data, not a software-based diagnostic algorithm.

Here's a breakdown based on the provided document, addressing what is relevant and noting what is not:

1. Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are based on the device's physical and functional performance, sterilization, and packaging, demonstrating it is substantially equivalent to a predicate device. There are no diagnostic performance metrics (e.g., sensitivity, specificity, AUC) reported because this is not a diagnostic algorithm.

2. Sample Size Used for the Test Set and Data Provenance

N/A. This 510(k) summary does not describe a clinical study for diagnostic performance with a test set of patient data. The "test set" for this device would refer to units of the manufactured catheters themselves undergoing engineering and bench testing. The document states "Design verification testing was performed on the EP.XT, Dynamic Tip, and Dynamic XT Catheters," implying a sample of the manufactured devices were tested, but specific numbers are not provided in this summary.

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

N/A. This is not a diagnostic algorithm requiring expert-established ground truth on patient data. The ground truth for this device's performance relates to engineering specifications and international standards (e.g., ISO 11607-1 for packaging, ISO 11737-1 for bioburden).

4. Adjudication Method for the Test Set

N/A. Not applicable to a physical device's engineering and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a diagnostic tool that acquires electrical signals, not an AI-powered diagnostic system.

6. If a Standalone Performance Study Was Done

No, not in the context of an algorithm's diagnostic performance. The "performance data" described (Bioburden, Design Verification, Packaging Verification) are standalone tests of the device's physical and functional attributes against engineering specifications and regulatory standards.

7. The Type of Ground Truth Used

The "ground truth" for this device's clearance is based on:

• Engineering Specifications: The design inputs and performance requirements set by Boston Scientific for the catheters.
• International Standards: E.g., ISO 11737-1 for bioburden, ISO 11607-1 for packaging, and likely other ISO standards for biocompatibility and electrical safety (though not explicitly listed in the summary).
• Predicate Device Performance: The primary "ground truth" for 510(k) clearance is that the new device performs "substantially equivalent" to legally marketed predicate devices, meaning it has similar technological characteristics and the same intended use.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device that requires a training set of data.

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

N/A. Not applicable as there is no training set for an AI/ML algorithm.

In summary: The provided document is a 510(k) clearance letter for a medical device (catheter) based on substantial equivalence. It does not contain information about acceptance criteria or studies related to the diagnostic accuracy of an AI/ML algorithm, nor does it describe human-in-the-loop performance studies. The "performance data" refers to the physical and functional characteristics of the catheter itself, not its diagnostic accuracy in interpreting patient data.

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