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The MAMBA and MAMBA Flex Microcatheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature, and can be used to exchange one guidewire for another. The microcatheters are also intended to assist in the delivery of contrast media into the coronary vasculature.

The MAMBA™ and MAMBA™ Flex devices (referred to as the "MAMBA Microcatheters") are designed to provide a platform for the user to exchange quidewires without losing their position in the vasculature.

The MAMBA device is available in a 135cm length, while MAMBA Flex is available in 135cm and 150cm lengths.

The MAMBA Flex models have a smaller outer diameter and a more flexible distal portion than the MAMBA device.

Marks on the proximal portion of the catheter shaft and a radiopaque marker at the distal tip facilitate placement of the device.

The device's inner lumen permits the use of 0.014 in./0.36 mm or smaller quidewires. The shaft consists of a coil which allows the device to be torqued to assist in advancement. The distal portion of the shaft is coated hydrophilic coating to assist in advancement.

The proximal end has a single luer hub for flushing or injecting through the inner lumen and is for guide wire lumen access during a guidewire exchange.

The MAMBA Microcatheters are to be used in patients where vessel conditions require additional wire support to reach the lesion and will deliver radiopaque media and therapeutic agents to selected sites in coronary vasculature.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Boston Scientific MAMBA and MAMBA Flex Microcatheters. This document specifically focuses on the substantial equivalence of these microcatheters to a legally marketed predicate device (MAMBA Microcatheters, K171452).

The information provided does not describe a study proving the device meets acceptance criteria in the context of an AI/ML medical device, particularly one involving ground truth derived from expert consensus, pathology, or outcomes data. It also does not involve human readers, multi-reader multi-case (MRMC) studies, or standalone algorithm performance. This document is for a physical medical device (microcatheter), not a software or AI-driven diagnostic tool.

Therefore, many of the requested categories are not applicable to the content provided. I will fill in the relevant information based on the document's content, and specify "Not Applicable" or explain why the information isn't present for the other categories.

Acceptance Criteria and Device Performance for MAMBA and MAMBA Flex Microcatheters

The FDA 510(k) summary for the Boston Scientific MAMBA and MAMBA Flex Microcatheters describes non-clinical performance data to establish substantial equivalence to a predicate device. The "acceptance criteria" here refer to the performance benchmarks that the new device had to meet during bench testing to demonstrate that it is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: 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" and "No new safety or performance issues were raised during the testing." While specific numerical performance values are not provided in this summary, the implication is that the new device met the pre-defined acceptance thresholds for each test.

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

• Sample Size: The document does not specify the exact number of units or tests performed for each bench test. It generically states "Bench testing was performed."
• Data Provenance: The data is from non-clinical bench testing conducted by Boston Scientific Corporation. The country of origin for the testing is not specified, but the company is U.S.-based. This is retrospective data in the sense that it was conducted prior to the 510(k) submission.

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

• Not Applicable. This is a physical medical device. The "ground truth" and "performance" are established through engineering specifications, material science, and mechanical bench testing, not through expert human review of diagnostic images or clinical outcomes in the same way an AI/ML device would be evaluated. The "experts" involved would be engineers, QA personnel, and potentially biomaterials scientists.

4. Adjudication Method for the Test Set

• Not Applicable. As described above, this is about physical device performance rather than interpretation or classification that would require adjudication among multiple human reviewers. Test results are likely objectively measured (e.g., burst pressure, force to kink).

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

• No. This type of study (MRMC) is relevant for diagnostic imaging AI/ML devices where the AI assists human readers. This document describes a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Not Applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering specifications, material properties, and pre-defined performance thresholds for physical and mechanical characteristics (e.g., dimensional accuracy, burst strength, flexibility, torqueability, guidewire exchange efficiency). It is based on objective, quantifiable measures of the device's physical attributes and functional capabilities as designed and manufactured.

8. The Sample Size for the Training Set

• Not Applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such a device largely refers to its design, material selection, and manufacturing processes, which are informed by engineering principles and previous device experience.

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

• Not Applicable. As per point 8, there is no "training set" in the context of an AI/ML algorithm for this physical device. The design and development of the microcatheters are based on established engineering principles, industry standards for medical devices, and performance requirements derived from extensive experience with similar predicate devices. The "ground truth" in this context would be the successful performance of existing, legally marketed devices that serve as benchmarks.

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The MAMBA™ and MAMBA™ Flex Microcatheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature, and can be used to exchange one guidewire for another.

The microcatheters are also intended to assist in the delivery of contrast media into the coronary vasculature.

The MAMBA™ and MAMBA™ Flex devices (referred to as the "MAMBA Microcatheters") are designed to provide a platform for the user to exchange guidewires without losing their position in the vasculature.

The MAMBA device is available in a 135cm length, while MAMBA Flex is available in 135cm and 150cm lengths.

The MAMBA Flex models have a smaller outer diameter and a more flexible distal portion than the MAMBA device.

Marks on the proximal portion of the catheter shaft and a radiopaque marker at the distal tip facilitate placement of the device.

The device's inner lumen permits the use of 0.014 in./0.36 mm or smaller quidewires. The shaft consists of a coil which allows the device to be torqued to assist in advancement. The distal portion of the shaft is coated hydrophilic coating to assist in advancement.

The proximal end has a single luer hub for flushing or injecting through the inner lumen and is for guide wire lumen access during a guidewire exchange.

The MAMBA Microcatheters are to be used in patients where vessel conditions require additional wire support to reach the lesion and will deliver radiopaque media and therapeutic agents to selected sites in coronary vasculature.

This document describes a 510(k) premarket notification for the MAMBA™ and MAMBA™ Flex Microcatheters. It asserts substantial equivalence to a predicate device, the ASAHI Corsair Microcatheter. The provided text primarily focuses on device description, indications for use, and a general statement about performance data, but does not contain the specific details required to answer many of the questions.

Here's an analysis of what can and cannot be answered based on the provided text:

Key Takeaway: The provided 510(k) summary is for a medical device (microcatheter), not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "acceptance criteria" as applied to AI performance, "test sets," "ground truth establishment," "MRMC studies," or "standalone algorithm performance" (questions 1, 2, 3, 4, 5, 6, 7, 8, 9) does not directly apply in the context of this document.

The "Performance Data" section refers to bench, animal, and biocompatibility testing typical for a physical medical device. It states that "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." However, it does not provide the specific numerical acceptance criteria or reported device performance in a table format that would be expected for an AI device.

Detailed Breakdown of Questions and Answers based on the provided text:

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

   • Cannot be provided. The document states that "Bench, animal and biocompatibility testing in accordance with ISO 10993 were performed to support a determination of substantial equivalence." It concludes that "No new safety or performance issues were raised during the testing; therefore, this device may be considered substantially equivalent to the predicate device." However, it does not present specific quantitative acceptance criteria or numerical reported performance data in a table format for a medical device like a microcatheter. The "acceptance criteria" for a physical device would relate to things like burst pressure, flow rate, tensile strength, kink resistance, etc., which are not detailed here.

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

   • Cannot be provided. This question is relevant to AI/SaMD. For a physical device, "sample size" would refer to the number of devices tested in bench or animal studies. While it states "Bench, animal and biocompatibility testing," it does not specify the sample sizes used for these tests or the "provenance" of such data (e.g., animal study location, if applicable).

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. This question is specific to AI/SaMD development, where expert consensus often establishes ground truth for image labeling or diagnosis. This document pertains to a physical medical device.

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

   • Not applicable. This question is specific to establishing ground truth with multiple readers for AI/SaMD development.

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. MRMC studies are used to evaluate the impact of AI assistance on human reader performance, typically in diagnostic imaging. This is a physical medical device.

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

   • Not applicable. This question refers to the performance of an AI algorithm on its own. This document is about a physical device.

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

   • Not applicable in the AI sense. For a physical device, "ground truth" would relate to objective measurements from bench testing (e.g., a force gauge measurement compared to a specification) or observations in animal studies (e.g., successful navigation, absence of vessel damage). The document only generally states that "Bench, animal and biocompatibility testing" were performed.

8. The sample size for the training set

   • Not applicable. "Training set" refers to data used to train an AI algorithm. This is a physical medical device.

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

   • Not applicable. Same reasoning as above.

Summary of what the document does provide:

• Device identification: MAMBA™ and MAMBA™ Flex Microcatheters.
• Classification: Class II, Percutaneous Catheter (DQY).
• Intended Use: Provide support for guidewire placement, facilitate guidewire exchange, assist in delivery of contrast media, and therapeutic agents in coronary vasculature.
• Predicate Device: ASAHI Corsair Microcatheter (K151103, K083127).
• Performance Data Overview: Mentions "Bench, animal and biocompatibility testing in accordance with ISO 10993" were performed. Concludes that no new safety or performance issues were raised and the device is substantially equivalent.
• Regulatory Outcome: FDA issued a substantial equivalence letter.

In conclusion, the provided text is a standard 510(k) summary for a physical medical device, not an AI/SaMD. As such, the detailed performance and validation data typically required for AI device assessment (as reflected in most of your questions) are not present or applicable.

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