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The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and selfexpanding stents in the peripheral vasculature.

The Sterling Balloon Dilatation Catheter is a Monorail brand rapid exchange catheter with a semicompliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in to facilitate advancement of the catheter to and through the stenosis to be dilated. The product's catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. The effective length of the balloon catheter is 200 cm; catheter markers indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm).

This document is a 510(k) summary for a medical device called the Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter. It seeks to demonstrate substantial equivalence to a predicate device.

The provided text does not contain information related to an AI/ML device or its performance criteria. Therefore, I cannot furnish the requested details regarding acceptance criteria, study methodologies for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document focuses on the bench testing performed to demonstrate substantial equivalence for this physical medical device (a balloon catheter), not a software or AI/ML product. The performance data section explicitly lists:

• Sterilization Testing
• Bench Testing (Dimensional Verification, Simulated Use, Balloon Inflation & Deflation Time, Catheter Bond Strength, Flexibility & Kink test, Torque Strength, Shaft & Bond Burst, Catheter Extension & Deflation, Packaging Testing, Design Validation Testing)

These are typical tests for a physical medical device to ensure its mechanical properties, function, and safety, not for evaluating an AI algorithm's diagnostic or predictive capabilities.

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The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥70% stenosis).

The Emerge Over-The-Wire (balloon models 1.50-4.00 mm) and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-5.00 mm) are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Emerge Over-The-Wire (balloon models 2.00-4.00 mm) and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-5.00 mm) are also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting).

The Emerge™ Monorail™ (MR) PTCA Dilatation Catheter is a sterile, single-use, intravascular medical devices used to widen coronary artery blockages and/or dilate coronary artery stents upon stent placement. The catheter consists of a shaft with a Pebax balloon near the distal tip and is available in a range of balloon sizes.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Emerge Monorail PTCA Dilatation Catheter." This type of submission is for physical medical devices that are substantially equivalent to previously cleared devices. It does not involve Artificial Intelligence (AI) or machine learning algorithms that would require an evaluation of algorithm performance against ground truth and expert consensus.

Therefore, the specific information requested in the prompt, such as "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML, "sample sizes used for the test set and data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," "type of ground truth," "training set sample size," and "how ground truth for training set was established," is not applicable to this document.

The document describes the submission of a physical device and leverages bench testing and comparisons to a predicate device to demonstrate substantial equivalence. The "Non-clinical Performance Data" section lists various engineering and material tests performed on the catheter (e.g., Effective Length, Crossing Profile, Balloon Fatigue, etc.) to ensure its physical performance and safety. These are not AI/ML-related performance metrics.

In summary, this document does not contain the information requested because it pertains to a traditional physical medical device, not an AI/ML-driven device.

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The Maverick XL balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion. The Maverick XL balloon catheter is also indicated for the post delivery expansion of balloon expandable stents.

The Maverick XL Percutaneous Transluminal Coronary Angioplasty PTCA (Maverick XL) dilatation catheter is a Monorail catheter with a balloon near the distal tip. The distal catheter segment is dual lumen and coaxial, characteristic of all monorail style catheters. The balloon is located at the distal end of the catheter and is designed to provide an inflatable segment of known diameter and length at recommended pressures.

This document is a 510(k) premarket notification for a medical device called the "Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter." It is a regulatory filing with the FDA, not a clinical study report. Therefore, it does not contain information about acceptance criteria for device performance based on a study, nor does it provide details about patient data, expert ground truth, or multi-reader multi-case studies.

The document is primarily focused on demonstrating "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already legally marketed. This is typically achieved through bench testing and, if applicable, comparison to existing clinical data for the predicate device, rather than new clinical trials specifically designed to set and meet acceptance criteria for a novel AI algorithm.

However, I can extract the information that is present in the document related to testing for regulatory purposes:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical sense of a clinical study (e.g., sensitivity, specificity thresholds). Instead, it states that "Bench testing and first article testing were performed to support a determination of substantial equivalence." The acceptance criteria would be for the physical and functional aspects of the catheter to meet pre-defined engineering and design specifications for safety and performance, which are not explicitly detailed here.

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

• Sample Size for Test Set: Not applicable. This document refers to bench testing and first article testing, not a clinical test set with patient data. The "sample" would be the number of catheters tested in various bench tests (e.g., burst pressure, fatigue, trackability), but these numbers are not specified.
• Data Provenance: Not applicable, as no patient data is mentioned. The testing is described as "bench testing and first article testing," implying laboratory-based testing of the physical device.

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

• Not applicable. There is no mention of expert-established ground truth because this is not a study involving diagnostic accuracy with human interpretation.

4. Adjudication Method:

• Not applicable. There is no adjudication method mentioned.

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

• No. An MRMC study was not done. This submission is for a physical medical device (catheter), not an AI algorithm for image interpretation or diagnosis.

6. Standalone (Algorithm Only) Performance Study:

• No. This is not an AI algorithm.

7. Type of Ground Truth Used:

• Not applicable. The "ground truth" for a physical device like a catheter would be its adherence to engineering specifications and performance standards through physical and functional testing, not a diagnostic pathology or outcome.

8. Sample Size for the Training Set:

• Not applicable. This device does not involve a training set as it's not an AI model.

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

• Not applicable. There is no training set for this device.

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The Coyote MONORAIL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Sterling SL Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Ultra-soft SV Balloon Dilatation Catheter is recommended for the Percutaneous Transluminal Angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Coyote™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheters (Coyote MR) are high performance balloon catheters for peripheral vascular indications. The devices feature an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with 0.014 in (0.36 mm) guidewires.

The Sterling™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (Sterling MR) is a Monorail brand rapid exchange catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in (.36 mm / .46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.

The Sterling™ SL Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (Sterling SL) is high performance balloon catheter for peripheral vascular indications featuring a low profile, semi-compliant balloon combined with a low profile tip. They are a line extension to the existing Sterling catheters and include smaller diameter and longer length balloons. The catheters have a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014" (0.36 mm) or 0.018" (0.46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated.

The Ultra-Soft SV™ Monorail™ Balloon Dilatation Catheter 0.018 is a sterile, single use, Monorail catheter with a semi-compliant balloon near the distal tip which inflates to a known diameter and length at a specific pressure. The catheter consists of a double lumen at the distal end and a single lumen catheter at the proximal end. The 0.018 in. guide wire compatible balloon catheter is available in diameters of 4.0 - 7.0 mm in 1.5 and 2.0 cm balloon lengths.

The provided text describes several medical devices, all Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters from Boston Scientific Corporation. The submission K162350 seeks to declare these devices substantially equivalent to already cleared predicate devices.

Acceptance Criteria and Device Performance (Summary for all listed devices):

The core of the acceptance criteria and device performance evaluation for all listed devices is based on demonstrating substantial equivalence to their respective predicate devices. This is achieved through non-clinical bench and first-article testing.

Study Details:

1. Sample sizes used for the test set and the data provenance:
   The document explicitly states that "Bench and first article testing were performed". This indicates that physical samples of the devices were manufactured and subjected to various tests. However, the exact sample sizes (e.g., number of catheters tested for burst pressure, number of inflation/deflation cycles) are not provided in this summary. The data provenance is internal to Boston Scientific Corporation ("Made in USA" is implied by manufacturing and sterilization facilities in the US, but not explicitly stated for the testing data itself). The studies were retrospective in the sense that they were conducted on produced devices to demonstrate equivalence prior to broader market release with the modification.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This submission is for a medical device (catheter) and relies on non-clinical bench testing and first article testing. It is not a clinical study involving human patients or the interpretation of medical images. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense (e.g., radiologists interpreting images) is not applicable. The "ground truth" for these tests would be established by engineering specifications, regulatory standards, and performance characteristics of the predicate device. The experts involved would be engineers, QA/QC personnel, and regulatory affairs specialists who designed, executed, and reviewed these non-clinical tests. Their specific numbers and detailed qualifications are not provided in this summary.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   As this is non-clinical bench and first-article testing, the concept of an adjudication method used in clinical trials or diagnostic accuracy studies (e.g., for resolving discrepancies in expert interpretations) is not applicable. Test results are typically compared against pre-defined engineering specifications and performance data of the predicate device. Review and approval of the test results would involve internal quality and regulatory processes, but not "adjudication" in the clinical sense.

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:
   No MRMC comparative effectiveness study was done. This submission is for a physical medical device (a catheter), not an AI-powered diagnostic tool, and therefore does not involve human readers interpreting cases or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No standalone algorithm performance study was done. This submission is for a physical medical device (a catheter), not an algorithm or software.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for this submission is based on:

   • Engineering specifications and design requirements for the device.
   • Performance data and characteristics of the predicate devices, which have already demonstrated safety and effectiveness.
   • Relevant industry standards and regulatory guidance for similar medical devices.
   • The absence of new safety or performance issues during the "bench and first article testing."

7. The sample size for the training set:
   Not applicable. This submission is for a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not involved here.

8. How the ground truth for the training set was established:
   Not applicable. As a "training set" is not relevant for this device, how its ground truth would be established is also not applicable.

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The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

The Express® SD Biliary Monorail® Premounted Stent System (Express SD Biliary) is a traditional Monorail catheter with a balloon near the distal tip. Express SD Biliary consists of a delivery system and a stent that is balloon expandable intended to maintain patency of biliary strictures produced by malignant neoplasms.

This document is a 510(k) summary for the Express® SD Biliary Monorail® Premounted Stent System. It's a premarket notification to the FDA to demonstrate substantial equivalence to an already marketed device, not a study proving the device meets acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is not applicable to this type of document.

This 510(k) pertains to a medical device (a stent system), not an AI/ML powered device. The "study" mentioned here refers to non-clinical tests (first article, shaft, and bond burst testing) to ensure the physical properties of the device (specifically a modified corewire) are equivalent to the predicate device, not clinical performance studies against specific acceptance criteria for a diagnostic or prognostic claim.

Here's why some of the requested information cannot be found:

• Acceptance Criteria & Device Performance Table: This document discusses substantial equivalence to a predicate device based on similar design, materials, and non-clinical testing. It does not provide specific performance metrics or acceptance criteria in the way an AI/ML device submission would (e.g., sensitivity, specificity thresholds).
• Sample Size (Test Set) & Data Provenance: Non-clinical testing of physical components doesn't typically involve "test sets" of patient data or data provenance in the context of clinical AI/ML studies.
• Number of Experts & Qualifications / Adjudication: This is relevant for establishing ground truth in clinical studies, particularly for imaging or diagnostic AI. It's not part of a non-clinical device equivalence assessment.
• MRMC Study / Standalone Performance: These are specific to AI/ML powered diagnostic or screening devices to assess their impact on human readers or their performance without human intervention. This device is a physical stent system.
• Type of Ground Truth: Ground truth (e.g., pathology, clinical outcomes) is established in clinical studies for diagnostic or prognostic purposes. The "ground truth" for this device is its physical integrity and performance as determined by engineering tests (e.g., burst pressure, stiffness).
• Sample Size (Training Set) & Ground Truth for Training Set: These concepts are specific to the development and validation of AI/ML models. This document describes a physical medical device.

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The Express SD Biliary Monorail Premounted Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

Not Found

The provided text describes the 510(k) premarket notification for the Express® SD Biliary Monorail® Premounted Stent System. This document does not describe an AI/ML-driven medical device, but rather a traditional medical device (biliary stent). Therefore, much of the information typically requested for AI/ML device evaluations (such as acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) is not applicable or present in this document.

However, I can extract the relevant information regarding the device's acceptance, testing, and comparison to a predicate device.

Device Name: Express® SD Biliary Monorail® Premounted Stent System
Intended Use/Indications for Use: Palliation of malignant neoplasms in the biliary tree.

Acceptance Criteria and Device Performance

The document functions as a 510(k) summary, which establishes substantial equivalence to a predicate device rather than setting specific performance acceptance criteria like sensitivity/specificity for an AI model.

The "acceptance criteria" here are implicitly related to demonstrating that the new device is as safe and effective as the predicate device, especially regarding its Magnetic Resonance (MR) compatibility, which was the focus of the non-clinical testing.

Study Details (as inferable from the document):

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

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

   • Sample Size: Not explicitly stated. The document mentions "Bench testing was performed" but does not detail the number of stents or test configurations used.
   • Data Provenance: The testing was "non-clinical bench testing" performed by Boston Scientific Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device, and the testing described is non-clinical (bench testing) for MR compatibility, not expert-adjudicated clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as it's not a clinical study requiring expert adjudication of results.

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-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI models. For MR compatibility, the "ground truth" would be established by validated test methods and standards for assessing electromagnetic compatibility and material safety in MR environments.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The NC Emerge Over-The-Wire (OTW) and NC Emerge Monorail (MR) PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis.
NC Emerge Over-The-Wire and NC Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-5.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents (bare metal and drug-eluting).

The NC Emerge PTCA Dilatation Catheters are sterile, single-use, intravascular medical devices. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The NC Emerge PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There are two (2) radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.

The provided text describes a 510(k) premarket notification for the NC Emerge™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to existing predicate devices through bench testing and biocompatibility testing. The document explicitly states "No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."

However, the provided text does not contain the specific acceptance criteria, reported performance values, or detailed study results (like sample sizes, ground truth establishment, or expert information) that would typically be found in a comprehensive study report. The "Performance Data" section lists the types of tests performed but does not provide quantitative results or explicit acceptance criteria for those tests.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be provided based on the input:

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

• Cannot be provided definitively from the text. The document lists the types of performance tests conducted (e.g., Effective Length, Rated Burst Pressure, Balloon Fatigue), but it does not specify the acceptance criteria or quantitative reported performance values for these tests. For example, it doesn't state what the accepted range for "Effective Length" is or what the measured effective length was. It only concludes that the tests supported substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided from the text. The document mentions "bench testing and biocompatibility testing were performed" but does not specify the sample sizes used for these tests. It also does not provide information on data provenance (country of origin, retrospective/prospective). This is common for 510(k) summaries, which often abstract away detailed test reports.

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 / Cannot be provided from the text. This type of information is relevant for studies involving human physiological data or image interpretation where expert consensus forms the ground truth. The tests described are "bench testing" and "biocompatibility testing," which are laboratory tests performed on the device itself, not human subjects. Therefore, the concept of "experts establishing ground truth" in the way described does not apply here.

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

• Not applicable / Cannot be provided from the text. Similar to point 3, adjudication methods are typically used for expert review of subjective data (like medical images or clinical outcomes). The described tests are objective laboratory measurements, so adjudication by experts is not relevant.

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. This device is a PTCA Dilatation Catheter, a physical medical device used in interventional cardiology. It is not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

• No. This device is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study is not relevant.

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

• Not applicable / Cannot be provided directly as "ground truth" in the requested sense. For the bench and biocompatibility tests, the "ground truth" would be established by physical measurement standards, internationally recognized test methods (e.g., ISO standards), and internal Boston Scientific specifications for device performance. It's not "expert consensus" on an image, for example, but rather adherence to predefined engineering specifications and biological safety standards.

8. The sample size for the training set

• Not applicable / Cannot be provided from the text. Training sets are relevant for machine learning or AI models. This device is a physical medical device, not an AI system. Therefore, there is no "training set" in this context.

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

• Not applicable / Cannot be provided from the text. As explained in point 8, there is no training set for this type of device.

Summary of available information from the text regarding acceptance criteria and study:

The document outlines that the device was subjected to:

• "bench testing"
• "biocompatibility testing"

These tests were performed "according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, 08 September 2010."

The types of tests completed are listed under "Performance Data":

Biocompatibility and Chemical Characterization Tests:

• Cytotoxicity
• Sensitization
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Materials Mediated Pyrogenicity
• USP Physicochemical
• Hemolysis (Direct Contact)
• Hemolysis (Extract Method)
• Complement Activation
• Coagulation
• In Vitro Hemocompatibility

In-vitro Performance Tests:

• Effective Length
• Shaft Inner and Outer Diameter
• Crossing Profile
• Balloon Preparation, Deployment, and Retraction
• Withdrawal into a Guide Catheter
• Rated Burst Pressure
• Balloon Fatigue (Repeat Inflations)
• Balloon Compliance
• Balloon Inflation/Deflation Time
• Catheter Bond Strength Tensile
• Tip Pull Test
• Flexibility and Kink
• Torque Strength
• Radiopacity
• Coating Integrity
• Particulate Evaluation
• Rated Burst Pressure in a Stent
• Balloon Fatigue (in Stent)
• Kissing Balloon Compatibility

Conclusion: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."

In essence, the "study" is a series of laboratory tests demonstrating that the NC Emerge PTCA Dilatation Catheter performs comparably to its predicate devices in accordance with regulatory guidance and relevant standards, ensuring its safety and effectiveness. The specific quantitative acceptance criteria and detailed performance values are not disclosed in this summary document.

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The Threader Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis) for the purpose of improving myocardial perfusion.

The Threader Micro-Dilatation Catheters are intended to provide support to facilitate the placement of quidewires in the coronary vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another.

The Threader Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary vasculature.

The Boston Scientific Threader ™ Micro-Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a semi-compliant balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter (1.2 mm) and length (12 mm) at recommended pressures. The Threader™ Micro-Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There is a single radiopaque marker band located in the center of the balloon body to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.

Here's a breakdown of the acceptance criteria and the study information for the Threader™ Micro-Dilatation Catheter, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify the sample sizes used for the biocompatibility or in-vitro performance tests. It only states that these tests were "completed."

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin. Given the nature of these tests (bench testing and biocompatibility), they are typically conducted in a controlled laboratory environment.

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

This information is not applicable and therefore not provided in the 510(k) summary. The ground truth for device performance in this context is established through objective physical and chemical testing against engineering specifications and regulatory guidance, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of data (e.g., medical images) requires consensus. The tests described are objective, physical, and chemical measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI with human readers, which is not relevant for this device.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device (catheter), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Threader™ Micro-Dilatation Catheter is based on:

• Engineering Specifications: The device's design parameters (e.g., balloon diameter, length, bond strength) are inherent to its design and manufacturing.
• Regulatory Guidance: The "Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010" provides the established benchmarks and acceptance criteria for these types of devices.
• Predicate Device Performance: The device is compared to legally marketed predicate devices, implying that their established performance serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. "Training set" refers to data used to train AI algorithms, which is not relevant for this physical medical device.

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

This information is not applicable for the same reasons as above.

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The Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) is intended for dilatation of stenosis in coronary arteries or bypass grafts.

The Emerge™ Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis).

The Boston Scientific Emerge™ PTCA Dilatation Catheter (1.20 mm) is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The Emerge™ PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There is a single radiopaque marker band located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.

The Emerge™ PTCA Dilatation Catheter (1.20 mm diameter) will be available in balloon lengths from 8 mm to 20 mm.

The provided text describes the 510(k) summary for the Boston Scientific Emerge™ PTCA Dilatation Catheter (1.20 mm). This is a medical device, and the "acceptance criteria" and "study" refer to the performance goals and the clinical trial conducted to demonstrate the device's safety and effectiveness for its intended use. There is no mention of "AI" in this document.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

• Successful delivery, inflation, deflation, and withdrawal of the study balloon.
• No evidence of vessel perforation, flow limiting dissection (grade C or higher), or reduction in TIMI flow from baseline related to the study balloon.
• Final TIMI flow grade of 3 at the conclusion of the PCI procedure. | Subjects: 98.3% (59/60)
  Lesions: 98.5% (66/67)

Specifically:

• Failure of delivery, inflation/deflation, and withdrawal: 1.7% (1/60 subjects, 1.5% (1/67) lesions) due to unsuccessful delivery (failure to cross a lesion).
• Vessel perforation, flow limiting dissection, or reduction in TIMI flow: 0.0% (0/60 subjects, 0/67 lesions).
• Failure of final TIMI flow: 0.0% (0/60 subjects, 0/67 lesions). |
  | Secondary Clinical Endpoints (Safety Events):
  In-hospital MACE (cardiac and non-cardiac death, MI and TVR)
  In-hospital stent thrombosis within the target vessel
  Clinically significant arrhythmias requiring intervention | In-hospital MACE: 5.0% (3/60 subjects)
• All Death or MI: 5.0% (3/60)
• All Death: 0.0% (0/60)
• MI: 5.0% (3/60)
• Q-Wave MI: 0.0% (0/60)
• Non-Q-Wave MI: 5.0% (3/60)
• TVR, Overall: 0.0% (0/60)
• In-hospital ARC Stent Thrombosis: 0.0% (0/60)
• In-hospital Clinical Significant Arrhythmias: 0.0% (0/60) |

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

• Test Set (Clinical Study) Sample Size: 60 subjects with 67 target lesions.
• Data Provenance: Prospective, open-label, multi-center, single-arm, observational study (called "EMERGE") conducted at 3 US sites.

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

The document does not explicitly state the "number of experts" or their "qualifications" involved in establishing ground truth in the way one might for an AI model's test set. However, in a clinical trial setting for a medical device:

• The "ground truth" for success/failure, complications, and patient outcomes are typically determined by the treating physicians at the clinical sites based on their observations during the procedure and post-procedure follow-up.
• Adjudication committees (often composed of independent expert clinicians) are commonly used in clinical trials to ensure consistency and impartiality in evaluating clinical endpoints, especially adverse events. The "Secondary Endpoint Outcomes" table indicates "CEC adjudicated data" (Clinical Events Committee), suggesting that expert clinicians were involved in reviewing and determining the final classification of these events. The specific number and qualifications of these CEC members are not provided in this summary.

4. Adjudication Method for the Test Set

• The document states that "Secondary Endpoint Outcomes" are based on "site reported and CEC adjudicated data," indicating that a Clinical Events Committee (CEC) was involved in adjudicating safety endpoints. The specific method (e.g., 2+1, 3+1) is not detailed, but the use of a CEC implies a formal, expert-driven review process for critical events.
• For the primary endpoint, the data appears to be based on site-reported observations of procedural success, with definitions provided in the protocol.

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

• No. This was a single-arm observational study evaluating the performance of the Emerge 1.20 mm PTCA Dilatation Catheter alone. It did not involve comparing human readers (clinicians) with and without AI assistance.

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

• Not applicable. This document is about a physical medical device (a catheter), not an algorithm or AI.

7. The Type of Ground Truth Used

• The ground truth for the clinical study was based on clinical observations, procedural outcomes, and patient follow-up data collected during hospitalization.
• This includes direct measurements and assessments made by interventional cardiologists (e.g., TIMI flow grade, presence of dissection/perforation), as well as clinical event reporting and subsequent adjudication by a Clinical Events Committee (CEC) for safety endpoints (e.g., MI, death, stent thrombosis).

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" in this context. The device was evaluated in a clinical study to assess its performance in real-world use.

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

• Not applicable. (See #8)

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The Emerge™ Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00 - 4.00 mm) are also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting).

The Boston Scientific Emerge™ PTCA Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The Emerge™ PTCA Dilatation Catheter is offered in both Monorail (MR) and Over-the-Wire (OTW) platforms. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance. The Emerge™ PTCA Dilatation Catheter will be available with balloon diameters of 1.50 mm and balloon lengths 8 mm to 20 mm.

The provided 510(k) summary for the Emerge™ Monorail (MR) and Over-The-Wire (OTW) PTCA Dilatation Catheter (K121196) describes the device, its intended use, and a comparison to predicate devices, along with performance data. However, it does not explicitly define specific acceptance criteria with numerical targets for each test, nor does it present the device's reported performance in a quantitative table against such criteria.

Instead, the document states: "The Emerge™ PTCA Dilatation Catheter was subjected to testing according to the requirements of Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices."

This indicates that the acceptance criteria are implicitly defined by the relevant FDA guidance document and the performance of the predicate devices. The "reported device performance" is summarized as having met these requirements without raising new safety or performance issues.

Given the information provided, it's not possible to create a table with quantitative acceptance criteria and reported device performance because these specific details are not outlined in the 510(k) summary. The summary refers to the types of tests performed and the overall conclusion that the device performed acceptably, rather than specifying numerical thresholds and results.

Below is an attempted reconstruction based on the available information, highlighting what is implicitly assumed from the text versus what is explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria and reported device performance values are not provided in the 510(k) summary, the table below reflects what is implied by the document's general statements regarding testing and substantial equivalence. The acceptance criteria are implicitly those established by the FDA Guidance Document and the performance of predicate devices. The reported performance is a qualitative statement of compliance.

Detailed Study Information:

The 510(k) summary provides limited details regarding the specifics of each test (e.g., sample sizes for individual tests, specific numerical thresholds, raw data). The description focuses on the types of tests performed and the overarching conclusion of substantial equivalence.

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

The document mentions "Bench testing and biocompatibility testing were performed." However, it does not specify the sample sizes (n) used for each of the listed performance and biocompatibility tests.

• Sample Size: Not specified for individual bench or biocompatibility tests.
• Data Provenance: Implied to be laboratory bench testing and in vitro biocompatibility testing, likely conducted by the manufacturer (Boston Scientific Corporation) or its contracted labs. The country of origin for the data is not specified but is typically within the country of manufacture or a region with certified testing facilities for medical devices. Given Boston Scientific's location in Minnesota, USA, the testing was likely performed in the USA or by labs adhering to US standards. The studies were likely prospective in the sense that they were designed and executed specifically to evaluate the new device for this premarket notification.

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

This device is a physical medical device (catheter) and the testing described is primarily mechanical/functional bench testing and laboratory-based biocompatibility testing. These types of studies do not typically involve "experts" establishing a clinical ground truth in the way image analysis or diagnostic AI algorithms do.

• Number of Experts: Not applicable in the context of clinical ground truth establishment. The "ground truth" for these tests relates to engineering specifications, material properties, and biological safety standards.
• Qualifications of Experts: The "experts" would be the engineers, scientists, and technicians who designed the tests, conducted the experiments, and analyzed the results according to recognized standards (e.g., ISO, ASTM, FDA guidance). Their qualifications would include relevant scientific and engineering degrees and experience in medical device testing.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective measurements (e.g., burst pressure, dimensions, chemical analysis, cell viability) against pre-defined engineering and safety specifications, not subjective assessments requiring adjudication.

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

No. This is a physical medical device, not a diagnostic imaging or AI-driven system that would involve human readers interpreting cases with and without AI assistance. Therefore, an MRMC comparative effectiveness study is not relevant to this device.

6. Standalone (Algorithm only without human-in-the-loop performance) Study:

Not applicable. This device is a physical product, not a software algorithm. The "standalone performance" refers to the device's functionality as tested on the bench and in biocompatibility labs, without a human user directly influencing the measurement of that performance during the specified tests. The tests themselves inherently assess the device's intrinsic mechanical and material properties.

7. Type of Ground Truth Used:

The "ground truth" for this medical device's evaluation is based on a combination of:

• Engineering Specifications: Defined by the manufacturer and aligned with industry standards (e.g., for dimensions, pressures, fatigue).
• Regulatory Standards/Guidance: Adherence to FDA's "Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010" and relevant ISO/ASTM standards for medical device materials and performance.
• Predicate Device Performance: The performance of the predicate devices (Emerge™ PTCA Dilatation Catheter K113220 and Apex™ PTCA Dilatation Catheter P860019/S208) serves as the benchmark for substantial equivalence.
• Biocompatibility Standards: Established limits for various biological responses (e.g., cytotoxicity, hemolysis) as defined by ISO 10993 series and other relevant standards.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set" of data.

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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