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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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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 Dilation Catheters are also indicated for the post-delivery 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 2.00 mm to 4.00 mm and balloon lengths 8 mm to 30 mm.

The provided document is a 510(k) summary for the Boston Scientific Emerge™ Monorail (MR) and Over-The-Wire (OTW) PTCA Dilatation Catheter. It outlines the device description, intended use, comparison to predicate devices, and performance data to demonstrate substantial equivalence.

This document does not contain information typically found in a study proving a device meets acceptance criteria related to AI/ML software performance. Instead, it focuses on the physical and biological performance of a medical device (a PTCA dilatation catheter), demonstrating its safety and effectiveness through bench testing and biocompatibility. Therefore, most of the questions you've asked, which are relevant to AI/ML software evaluation, cannot be answered from this document.

However, I can extract the information that is present and indicate where requested information is not applicable or not provided.

Device Acceptance Criteria and Performance (Physical Device)

The acceptance criteria for this medical device (a PTCA Dilatation Catheter) are derived from the "Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010." The reported device performance is based on successful completion of the listed tests, demonstrating conformance to these requirements.

The document states: "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."

Inapplicable/Not Provided Information for AI/ML Software Evaluation

Given that this is a submission for a physical medical device (a balloon catheter) and not an AI/ML software, the following requested information is not applicable or not provided in the document:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as testing was primarily bench testing and biocompatibility, not data-driven AI/ML performance evaluation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device refers to its physical and biological properties.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This device does not involve human readers interpreting data enhanced by AI.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, "ground truth" would refer to the validated physical and chemical properties and biological responses, measured through standardized tests.
7. The sample size for the training set: Not applicable. There is no training set for an AI/ML model for this device.
8. How the ground truth for the training set was established: Not applicable.

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