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Recommended for balloon atrioseptostomy, an accepted technique in most pediatric cardiology centers for the palliation of several congenital cardiac defects. Balloon atrioseptostomy is performed in conjunction with diagnostic cardiac catheterization and has been carried out after the diagnosis of several congenital cardiac defects: transposition of the great arteries, total anomalous pulmonary venous drainout pulmonary obstruction, tricuspid atresia, mitral stenosis, mitral atresia, and pulmonary atresia with intact ventricular septum.

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There is no information in the provided text regarding acceptance criteria or a study that proves a device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the Z-6 Atrioseptostomy Catheter, confirming its substantial equivalence to a predicate device. It defines the indications for use but does not contain details about a performance study, acceptance criteria, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot provide the requested information in a table or fulfill the other points as the necessary data is not present in the provided text.

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Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The NuMED D'VILL Introducer is recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The introducer consists of a dilator and sheath with hemostasis valve and side port on the proximal end of the sheath assembly. There is a single image band embedded in the distal end of the sheath tubing for imaging purposes. The sheath is Pebax braided with stainless steel and a PTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE. The D'VILL is available in 10, 12 and 14F sizes in both 30 and 85cm lengths, as well as, 12 and 14F in a 65 cm length.

The provided text describes a 510(k) premarket notification for a medical device called the "D'Vill Introducer." This submission is a "Special 510(k)" to obtain marketing clearance for an additional size (65cm length) of an already cleared device, the D'VILL Introducer – K171206.

The crucial information to understand here is that a Special 510(k) is typically used for modifications to a manufacturer's own legally marketed device where the modification does not alter the fundamental scientific technology of the device and does not raise new questions of safety and effectiveness. This often means that the performance testing is focused on demonstrating that the new modification performs equivalently to the existing device within the established parameters, rather than proving the overall safety and effectiveness of a completely new device from scratch.

Therefore, the "acceptance criteria" and "study" described in this document are not a clinical study with human patients, but rather bench testing to demonstrate that the new size performs similarly to the predicate device.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for the D'Vill Introducer (New 65cm Length)

The device in question is an additional size (65cm length) of an already cleared product. The performance testing focused on demonstrating substantial equivalence to the predicate device rather than establishing entirely new safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the precise number of units tested for each performance test. It only states, "A complete list of tests performed are provided below. All tests met their acceptance criteria and specifications."
• Data Provenance: This is bench testing of a medical device, not a human study. The data is prospective, generated from testing newly manufactured devices. The country of origin for the testing is not explicitly stated, but given the FDA submission, it would typically be conducted in a controlled environment, often by the manufacturer or a contracted lab.

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

• This information is not applicable as the ground truth for this type of device modification (addition of a new size) is established through engineering and materials testing standards, not clinical expert consensus. The "ground truth" is adherence to established physical and mechanical performance specifications.

4. Adjudication Method for the Test Set

• Not applicable. Bench testing results are typically measured against predetermined specifications, not adjudicated by experts in the context of diagnostic interpretation.

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

• No. An MRMC study is relevant for diagnostic devices that involve human interpretation of images or other data. This device is a catheter introducer, a physical medical device, and its performance is evaluated through engineering and materials testing, not diagnostic accuracy by human readers.

6. Standalone (Algorithm Only) Performance

• Not applicable. This is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

• The ground truth used for this type of device is based on engineering specifications, material properties, and established industry standards for the performance of introducer catheters. This includes measurements of physical dimensions, force tolerance, leak resistance, and biocompatibility (by equivalence to predicate materials).

8. Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm or a diagnostic tool that requires a "training set" in the machine learning sense. The "training" for the device's development involves engineering design, material selection, and manufacturing processes honed over time, implicitly incorporating knowledge from previous designs and testing.

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

• Not applicable. See point 8. The "ground truth" (or design principles) for manufacturing such a device is established through biomedical engineering principles, regulatory standards (like ISO standards for medical devices), and a history of manufacturing similar devices.

Summary of the Study:

The "study" was a series of in-vitro (bench) performance tests designed to demonstrate that the new 65cm length of the D'Vill Introducer performs equivalently to the existing, predicate D'Vill Introducer (K171206). The tests covered physical dimensions, mechanical strength, and functional integrity (e.g., leakage, kink resistance). All tested parameters met the prespecified acceptance criteria, leading to the conclusion of substantial equivalence for the new size. Biocompatibility was addressed by stating that the materials and manufacturing processes are identical to the predicate device.

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Recommended for introduction of balloons, catheters and other diagnostic and interventional devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The NuMED D'VILL Introducer is recommended for introduction of balloons, catheters and other diagnostic and interventional devices. The introducer consists of a dilator, and sheath with hemostasis valve and side port on the proximal end of the sheath assembly. There is a single image band embedded in the distal end of the sheath tubing for imaging purposes. The sheath is Pebax braided with stainless steel and a PTFE liner and will accommodate a 0.035" guidewire. The dilator is LDPE. The D'VILL is available in 10, 12 and 14F sizes and 30 and 85cm lengths.

The document provided is a 510(k) summary for the D'Vill Introducer, a medical device. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about a study proving the device meets specific acceptance criteria based on performance data.

The "Performance Testing" section on page 4 lists several tests performed:

• Surface Inspection
• Size Designation – Sheath and Dilator
• Freedom from Leakage – Sheath and Hemostasis Valve
• Peak Tensile Force - 3 locations
• Strength of Union Between Hub and Dilator
• Dimensional Requirements – Sheath, Stopcock, and Dilator
• Luer Hub Testing
• Kink/Flexibility Testing – Sheath and Dilator
• Sterilization Testing
• Biocompatibility Evaluation – Short duration contact with circulating blood (< 24 hours)
• Shelf Life Testing

The document states, "All tests met their acceptance criteria and specifications." However, it does not provide the specific acceptance criteria for each test or the reported results.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I answer questions related to sample size, ground truth, experts, or comparative effectiveness studies, as this information is not present in the provided text.

The information requested, such as specific performance metrics (e.g., leakage rate, tensile strength values, specific dimensions) and their acceptance thresholds, as well as the actual test results, would typically be found in a more detailed test report or design verification document, which is not included in this 510(k) summary. These summaries focus on demonstrating substantial equivalence rather than providing detailed raw performance data.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for the NuMED, Inc. BIB Stent Placement Catheter. It indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed, but does not include performance data or details of a study.

The sections you've highlighted regarding "Indications for Use" and what appears to be garbled text or non-English characters do not provide the requested information. Therefore, I cannot complete the table or answer the specific questions about acceptance criteria or a study based on the provided input.

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Recommended for temporary occlusion of the aorta.

The REBOA Balloon Occlusion Catheter is a coaxial catheter recommended for temporary occlusion of the aorta. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi-layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter, and will accept the passage of the appropriate guidewire. All catheter sizes will have radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. There are also markings on the catheter shaft to aid in placement. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches.

This document describes testing and acceptance criteria for the REBOA Catheter, a device intended for temporary occlusion of the aorta.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each in-vitro test. It mentions "All catheters" or "All samples" met the criteria, suggesting that a representative sample was tested for each evaluation.

The data provenance is from in-vitro testing, meaning the tests were conducted in a laboratory setting, not on human subjects. There is no information regarding country of origin, retrospective or prospective data.

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

This information is not applicable as the "ground truth" for the in-vitro tests conducted on the REBOA Catheter is based on objective, measurable physical and mechanical properties, not expert interpretation of diagnostic data.

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are objective physical measurements, not requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance:

This information is not applicable as the REBOA Catheter is a medical device, not an AI diagnostic tool that would involve human readers.

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

This information is not applicable for the same reason as point 5.

7. The Type of Ground Truth Used:

The ground truth for the in-vitro tests is based on objective, measurable physical and mechanical properties (e.g., diameter, pressure resistance, burst strength, inflation/deflation times, pull strength).

8. The Sample Size for the Training Set:

This information is not applicable as there is no mention of a "training set" in the context of this device. The testing described is for performance verification of the final device, not for training a model or algorithm.

9. How the Ground Truth for the Training Set was Established:

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

Summary of the Study:

The study detailed in the 510(k) Summary is an in-vitro performance verification study of the REBOA Catheter. It compares the performance of the REBOA Catheter against pre-defined acceptance criteria and, in some cases, against a predicate device (PTS-X PTV Catheter and Fogarty Occlusion Catheter). The study aims to demonstrate that the REBOA Catheter meets the necessary physical and mechanical specifications for its intended use, establishing substantial equivalence to legally marketed predicate devices. The "study" here refers to a series of laboratory tests, not a clinical trial or an AI algorithm validation.

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Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.

The NuMED BIB® Stent Placement Catheter Model 420 is indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter. The catheter is triaxial in construction with two lumens being used to inflate the balloons while one lumen is being used for tracking over a guidewire. The purpose of the double balloon catheter is to apply an incremental inflation for the purpose of dilating a stent. The inner balloon provides initial expansion of the stent and also acts as a tool to hold the stent on the catheter prior to the outer balloon being inflated. The outer balloon is then inflated providing the remainder of the expansion. There are radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The balloon material is clear. The catheter balloon diameters are stamped onto the inflation extensions and are labeled with balloon diameter x balloon length and the catheter lot number.

The provided text describes a medical device, the NuMED BIB® Stent Placement Catheter, and its substantial equivalence to a predicate device. It includes performance data from in vitro testing and a clinical trial. However, the document does not explicitly state acceptance criteria in a quantitative format, nor does it present the study results specifically framed as meeting such criteria. Instead, it leverages prior testing and a clinical trial to demonstrate substantial equivalence.

Based on the provided text, here's an attempt to extract and infer the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, this table will present the key performance indicators from the leveraged studies, which implicitly served as the basis for performance evaluation for substantial equivalence.

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

• Test Set Description: The clinical study is referred to as the COAST trial.
• Sample Size: 112 patients were enrolled.
• Data Provenance: The COAST trial was a "prospective, multi-center, single arm study." While the specific country of origin is not explicitly stated, "multi-center" implies data from several locations, typically within a regulatory region (e.g., USA for FDA approval).

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

The provided text only refers to clinical trial data (COAST study) for safety and effectiveness. It does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic performance or image interpretation often associated with AI/ML devices. Therefore, this question is not applicable to the submitted document. The clinical outcomes served as the definitive measure of device performance.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set, as no "ground truth" establishment by multiple experts is discussed for diagnostic purposes. Clinical trial outcomes are typically assessed by study investigators and monitored, but not through an adjudication process in the sense of resolving discrepancies between expert opinions on a data point.

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 such MRMC comparative effectiveness study is mentioned. The device is a physical medical device (stent placement catheter), not an AI-powered diagnostic or assistive tool for human readers.

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

This question is not applicable. The device is a physical medical device; it does not have a standalone algorithm or AI component.

7. The type of ground truth used

For the clinical study (COAST trial), the "ground truth" for evaluating the device's performance was:

• Clinical Outcomes/Events:
  • Rates of serious adverse events within 30 days.
  • Rates of post-procedure paradoxical hypertension.
  • Reduction in arm-leg systolic blood pressure gradient from baseline to 12 months.
  • Length of hospital stay.
• Successful implantation: The text states, "The results demonstrated that the CP Stent could be successfully mounted and implanted using the BiB Stent Placement Catheter..."

For the bench and biocompatibility testing, the "ground truth" was established based on pre-defined engineering specifications, material standards, and biological safety guidelines, which the device components were expected to meet.

8. The sample size for the training set

The document does not describe a "training set" in the context of AI/ML. The device is a physical medical device. The "leveraged" data from K050857 and P150028 could be considered as prior performance data used for development and comparison, but not a "training set" in the AI sense.

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

As there is no "training set" for an AI/ML algorithm described, this question is not applicable. The prior performance data from K050857 and P150028 were established through engineering tests, biocompatibility assessments, and clinical evaluation as per regulatory requirements for medical devices.

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Balloon Aortic Valvuloplasty

The NuMED Z-MED™ catheter is a coaxial catheter recommended for Balloon Aortic Valvuloplasty. The catheter's inner and outer shafts are constructed of polyamide tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. This balloon is of the non-compliant variety. Both the shaft size and the guidewire size vary according to balloon diameter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. The lumen has radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with the catheter specifications and lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches. The NuMED Z-MED II™ catheter is a coaxial catheter recommended for Balloon Aortic Valvuloplasty. The catheter's inner and outer shafts are constructed of polyamide tubing. The catheter features a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. This balloon is of the non-compliant variety. Both the shaft size and the guidewire size vary according to balloon diameter. The distal lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. The lumen has radiopaque platinum marker band(s), centered or under the balloon shoulders, for placement using fluoroscopy. The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with the catheter specifications and lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study

The K122012 submission for the Z-MED and Z-MED II Catheters primarily relies on in-vitro (bench) testing and a review of existing clinical data for safety and effectiveness. No specific algorithms or human-in-the-loop performance studies are described as this is a medical device (catheter), not an AI/software device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details in-vitro test results for the Z-MED and Z-MED II catheters, as well as two predicate devices (NuCLEUS-X and NuCLEUS). The table below focuses on the Z-MED and Z-MED II results as the subject devices.

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

• Sample Size for In-Vitro Testing: The document does not explicitly state the numerical sample size for each in-vitro test (e.g., how many catheters were visually inspected or burst tested). It refers to "All catheters" or "All samples" meeting criteria, indicating that a sufficient number were tested.
• Data Provenance (Clinical):
  • Country of Origin: The clinical evaluation report was prepared to meet the requirements of the Medical Device Directive MOD 93/42/EEC (European Union standard). The clinical use of the Z-MED and Z-MED II catheters for BAV and BMV is mentioned in "those countries where they are used," and for BPV in "the United States."
  • Retrospective/Prospective: The clinical information gathered appears to be a retrospective review of existing clinical literature, device history, previous sales, and reported complaints. It references "Numerous clinical studies reported in literature" and "200 patients" without incidents from BAV prior to TAVI.

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

This information is not applicable and not provided in the context of this submission. The tests described are in-vitro bench tests for a physical medical device (catheter), which do not typically involve experts establishing ground truth in the way it's done for diagnostic AI/software. The ground truth for in-vitro tests is based on objective physical measurements and engineering specifications.

For the clinical context, the "ground truth" refers to observations from actual patient use, as reported in clinical literature and through device monitoring. No specific number or qualification of experts reviewing patient outcomes is provided beyond the implicit understanding that medical professionals conducted the procedures and reported outcomes.

4. Adjudication Method for the Test Set

This is not applicable for the in-vitro bench testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in cases where there's variability in interpretation (e.g., image analysis by multiple radiologists). The in-vitro tests are objective physical measurements.

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

An MRMC study is not applicable and not mentioned. This type of study is relevant for diagnostic devices, especially those involving human interpretation of data, often comparing human performance with and without AI assistance. The Z-MED and Z-MED II are interventional catheters, not diagnostic devices or AI software. There's no AI component mentioned to compare human readers with or without.

6. Standalone (Algorithm Only) Performance Study

This is not applicable and not mentioned. The devices are physical catheters, not algorithms or software. Therefore, there is no standalone (algorithm only) performance to evaluate.

7. Type of Ground Truth Used

• In-Vitro Testing: The ground truth for the in-vitro tests is established by the predefined engineering specifications and acceptance criteria outlined in the table (e.g., balloon diameter within +/- 10% of labeled, no breaks, inflation/deflation times). These are objective, measurable physical parameters.
• Clinical Evaluation: The "ground truth" for clinical safety and performance is based on real-world patient outcomes and reported incidents/adverse events from existing clinical use and literature reviews.

8. Sample Size for the Training Set

This is not applicable. The Z-MED and Z-MED II are physical medical devices undergoing traditional bench testing and clinical review, not AI models that require training sets.

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

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

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This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve.

• A patient with isolated pulmonary stenosis.
• A patient with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for the NuMED Inc. Tyshak NuCLEUS™ Catheter, which primarily addresses regulatory classification and substantial equivalence to predicate devices, along with indications for use. It does not include details on performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

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The NuMED NuCLEUS and NuCLEUS-X BAV Catheters are indicated for Balloon Aortic Valvuloplasty.

The NuCLEUS BAV and the NuCLEUS-X BAV are both coaxial catheters, with the NuCLEUS-X currently cleared in the United States under K081680 for Balloon Pulmonic Valvuloplasty (BPV). The NuCLEUS BAV is currently only marketed outside of the United States. The outer body of both devices is made of {Redacted as b4} tubing, while the inner shaft (or tubing) material is the only difference between the two devices. In the NuCLEUS-X Catheter, the inner tubing is comprised of {Redacted as b4}while in the NuCLEUS Catheter, the inner tubing is comprised of {Redacted as b4} The sponsor states that the {Redacted as b4}makes it less likely to stretch when force is used. From an engineering perspective, in terms of composition, testing, and intended use, FDA believes there is no significant difference in these technological characteristics between the inner tubing of the two catheters based upon the non-clinical performance testing results. Furthermore, these two devices would be expected to perform in a similar manner in the clinical setting during balloon aortic valvuloplasty procedures. The catheters also feature a molded proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. The balloon is designed with a waist formed into the middle of the balloon to allow accurate balloon placement. Upon reaching a specified pressure, the waist will expand to the rated balloon diameter and dilate the valve to the rated diameter. The distal lumen terminates at the tip of the catheters and will accept the passage of the 0.035" guidewire. This lumen has 3 radiopaque platinum marker bands. One under each of the balloon shoulders and one located at the "waist" or center of the balloon for placement using fluoroscopy. The catheters are packaged in a {Redacted as b4} sheath and double packed in two {Redacted as b4} sealed Tyvek pouches.

This document describes the regulatory evaluation of the NuMED NuCLEUS and NuCLEUS-X BAV Catheters. The assessment includes non-clinical bench studies and the leveraging of extensive clinical experience with similar devices and the BAV procedure in general.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data for the NuMED NuCLEUS-X and NuCLEUS BAV Catheters are primarily derived from non-clinical bench testing:

Note: The document references specific sizes for the Balloon Minimum Burst Strength for each device, which are too extensive to list individually in this summary table, but they are detailed in the provided text.

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

For the formal performance testing (bench studies), samples were taken across various models and sizes of both the NuCLEUS-X and NuCLEUS catheters.

• Visual Inspection, Balloon Preparation, Diameter & Profile, Balloon Distensibility, Balloon Inflation/Deflation, Balloon Inflstability, Bond Strength, Catheter Body Max Pressure: "All catheters" or "Twenty samples of all Diameters" or "Twenty samples of each guidewire size" were tested and met the criteria.
• Repeated Balloon Inflation (Balloon Fatigue Test): 30 samples for both NuCLEUS-X and NuCLEUS.
• Balloon Minimum Burst Strength: 20 samples for different configurations (smallest diameter-shortest length, smallest diameter-longest length, largest diameter-shortest length, largest diameter-longest length, and all diameters in between) for both NuCLEUS-X and NuCLEUS.
• Tip Pull and Torque Test: Twenty random samples of each shaft size for both NuCLEUS-X and NuCLEUS.

Data Provenance: The non-clinical (bench) data was generated by the manufacturer, NuMED, Inc. The clinical data is based on existing, published literature and clinical experience from various sources globally. The document does not specify a country of origin for the clinical data in most cases, but some references mentioned (e.g., European Heart Journal, Revista Espanola de Cardiogia) indicate international provenance. The clinical data is retrospective, drawing from previously documented clinical studies and experiences.

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

For the clinical evaluation, the "ground truth" and assessment of the devices and BAV procedure were established by:

• Sponsor-provided literature: NuMED provided "two clinical reports containing extensive published literature" summarizing the clinical use of their devices.
• FDA Reviewers: The FDA specifically states, "The specifically-cited clinical experience using the NuMED NuCLEUS family of catheters for BAV is a scientifically sound approach that was agreed upon by the scientific and clinical reviewers of this de novo." These reviewers are presumably experts in cardiology and medical device evaluation within the FDA, though their specific qualifications (e.g., years of experience as cardiologists) are not detailed in this document.

For the bench testing, the ground truth is based on engineering specifications and direct physical measurements, not expert consensus on qualitative data.

4. Adjudication Method for the Test Set

For the bench testing, no "adjudication method" in the sense of expert review consensus is mentioned. The tests have clear pass/fail acceptance criteria demonstrated by direct measurements.

For the clinical evaluation, the "adjudication" was effectively performed by the FDA's "scientific and clinical reviewers" who assessed the provided literature, including the NuMED NuCLEUS family of catheters, and determined that the body of evidence supported the safety and effectiveness. This is implicit in the FDA's "FDA Comment" sections on each cited paper. No formal N+1 reader adjudication scheme is described regarding the clinical literature review.

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 document describes the evaluation of a physical medical device (balloon catheter) for regulatory approval, not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC comparative effectiveness study involving human readers with or without AI assistance was conducted or is relevant to this submission.

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

Not Applicable. As mentioned above, this is a physical medical device, not an algorithm. The "standalone performance" is represented by the extensive bench testing which evaluates the device's physical properties and functionality.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth for bench studies is based on engineering specifications and measurable physical properties. For example, balloon diameter within +/- 10% of labeled, inflation/deflation times, burst pressure, bond strength, and visual inspection for anomalies. These are objective measures against predefined criteria.
• Clinical Evaluation: The ground truth for the clinical aspect is primarily based on published clinical literature and extensive real-world clinical experience (outcomes data) with similar devices and the BAV procedure, as well as specific mentions of the NuMED NuCLEUS catheters in successful procedures. This includes demonstrating:
  • Well-accepted use of BAV as a palliative treatment for severe aortic stenosis.
  • BAV as a preparatory step for TAVR.
  • Successful outcomes where NuMED NuCLEUS catheters were used.
  • The similarity in design between NuCLEUS and NuCLEUS-X making existing NuCLEUS clinical data applicable to NuCLEUS-X.

8. The Sample Size for the Training Set

Not Applicable in the context of machine learning. For the clinical evaluation, the "training set" equivalent would be the vast body of worldwide clinical experience with BAV, which is described as "extensive," "many years," and involving "numerous BAV clinical studies." This represents a very large, but unquantified, patient population. For the specific NuMED NuCLEUS family, the cited clinical studies involved cohorts of 20, 212, and 50 patients, and various unspecified "patients" in other papers.

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

Not Applicable for machine learning. For the clinical evaluation, the "ground truth" (i.e., the established understanding of the BAV procedure and the performance of these catheters) was established through:

• Accumulated Clinical Data: Decades of clinical practice and research on Balloon Aortic Valvuloplasty (BAV) using various devices.
• Published Studies: Peer-reviewed medical literature documenting the efficacy, safety, and outcomes of BAV procedures, including specific mentions of NuMED NuCLEUS catheters.
• FDA Assessment: The FDA's "scientific and clinical reviewers" critically evaluated this body of literature and experience to form their conclusions regarding the safety and effectiveness of the device and procedure.

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