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The LipiScan Coronary Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden.

The LipiScan Coronary Imaging System is comprised of the catheter, catheter accessories, pull-back and rotation device and laser console with accessories.

The provided text describes a 510(k) summary for the LipiScan Coronary Imaging System. However, it does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria. The document focuses on establishing substantial equivalence to a predicate device, highlighting similar intended use, operating principles, catheter design, shelf life, packaging, and compliance with general safety and performance standards.

Here's an analysis based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document. The 510(k) summary states, "Further preclinical testing has shown that the product can function as intended and meets all internal design specifications," but it does not list these specifications or acceptance criteria. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy for detecting lipid-core-containing plaques) presented as acceptance criteria or reported device performance.

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

Not explicitly provided for any specific performance study. The document mentions "Ex vivo and in vivo data is presented to support expanded indications for use," but no details about the sample size, type of test set, or data provenance (e.g., country of origin, retrospective/prospective) are given for these studies.

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

Not explicitly provided. Since no specific performance study with a test set is detailed, information about experts, their number, or their qualifications for establishing ground truth is absent.

4. Adjudication Method for the Test Set

Not explicitly provided. As no specific performance study is detailed, there is no information about any adjudication methods (e.g., 2+1, 3+1).

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

Not mentioned and likely not performed or reported in this summary. The document focuses on demonstrating substantial equivalence, not on comparative effectiveness with or without AI assistance. The device is for imaging, and there's no mention of AI assistance for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable/not described. The LipiScan Coronary Imaging System is presented as an imaging system that provides an image of the artery wall. It's a diagnostic tool intended for use by clinicians, not an autonomous AI algorithm. Therefore, a "standalone algorithm only" performance study is not relevant in the context described.

7. Type of Ground Truth Used

Not explicitly stated for specific performance evaluations. The summary does not detail the nature of the ground truth for any studies supporting "expanded indications for use." For such devices, ground truth might involve histology, pathology, or correlative imaging modalities, but this is not specified here.

8. Sample Size for the Training Set

Not applicable/not provided. The device is an imaging system, not explicitly an AI/machine learning algorithm that requires a training set in the conventional sense. The "preclinical testing" and "ex vivo and in vivo data" likely refer to validation and verification testing for safety and performance, not training data for a learning model.

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

Not applicable/not provided. As explained in point 8, there's no mention of a training set or an AI algorithm that would necessitate establishing ground truth for training.

In summary, the provided 510(k) summary serves to demonstrate substantial equivalence to predicate devices and adherence to general safety and performance standards. It mentions "preclinical testing" and "ex vivo and in vivo data" to support its expanded indications, but it lacks the detailed information about specific acceptance criteria and the comprehensive study methodology asked for in the prompt. This level of detail is often found in the full 510(k) submission, not typically in the public summary.

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The Atlantis™ 018 Peripheral Imaging Catheter is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The Atlantis™ 018 Peripheral Imaging Catheter is a sterile, single patient use 40MHz transducer imaging catheter, intended for intravascular ultrasound examination of peripheral vessels. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound (IVUS) Systems: iLab™ (K072517), Galaxy2/Galaxy (K980851), and Clearview™M Ultra (K921750). The Atlantis™ 018 Peripheral Imaging Catheter consists of two main assemblies: Imaging core and Catheter body. The catheter body comprises three sections: Distal lumen, Proximal single lumen, and Telescoping section. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 40 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end makes the connection to the BSC IVUS System Motor Drive Unit (MDU).

The Atlantis™ 018 Peripheral Imaging Catheter is an intravascular ultrasound catheter intended for examination of peripheral vessels. The submission does not detail specific quantitative acceptance criteria with numerical targets. Instead, it relies on demonstrating that the device "meets or exceeds" performance requirements through various tests.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the bench, acoustic output, or animal testing.

• Bench Testing: "Bench testing was conducted to evaluate the physical integrity and functionality of the catheter sheath and imaging core." No specific sample size provided.
• Acoustic Output: "Acoustic output testing was conducted..." No specific sample size provided.
• Animal Testing: "The Atlantis™ 018 Peripheral Imaging Catheter was evaluated through animal testing..." No specific sample size provided.
• Data Provenance: The document does not specify the country of origin for any test data or whether it was retrospective or prospective. It implies these were studies specifically conducted for this submission (prospective, in-house testing).

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish a "ground truth" in the context of human interpretation for diagnostic performance. The evaluation is focused on the physical device's performance through bench, acoustic, animal, and biocompatibility tests.

4. Adjudication Method

Not applicable, as this is a device performance evaluation, not a study involving human interpretation with a need for adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for an imaging catheter, not an AI software or a device that directly aids human readers in interpretation.

6. Standalone Performance Study

Yes, the studies described are essentially standalone performance evaluations of the device itself (bench, acoustic, animal, and biocompatibility testing). The "algorithm" here is the physical catheter's ability to produce images and operate safely and effectively.

7. Type of Ground Truth Used

The ground truth for the performance evaluations was based on:

• Bench Testing: Engineering specifications and design requirements (e.g., dimensional accuracy, functional performance).
• Acoustic Output: FDA guidance document limits for diagnostic ultrasound systems and transducers.
• Animal Testing: Clinical acceptability for deliverability and imaging characteristics, as assessed by the animal study.
• Biocompatibility: International Standard ISO-10993 and Blue Book Memo, G95-1.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a "training set." The device is a physical imaging catheter.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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The Atlantis™ PV Imaging Catheter is intended for ultrasound examination of peripheral pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

The Atlantis™ PV imaging catheter (H749364560) is a sterile, single use, over-the-wire (OTW) imaging catheter with a 8F distal crossing profile and a transducer capable of producing a frequency of 15MHz and a 8F distal crossing profile. This imaging catheter is designed to be operated with Boston Scientific Corporation (BSC) Intravascular Ultrasound Imaging Systems: iLab™ (K072517), Galaxy2/Galaxy™ (K980851), and Clearview™ Ultra (K921750). The Atlantis™ PV catheter consists of two main assemblies: Catheter body and Imaging Core. The catheter body is comprised of two sections: Dual lumen and Telescoping section (shaft). The dual lumen section is the "working length" of the catheter. The dual lumen is an over-the-wire (OTW) design containing an imaging core lumen and a guidewire lumen. The telescoping section remains outside of the introducer sheath. The telescoping shaft allows the imaging core to be advanced and retracted for 25 cm of linear movement. The corresponding movement of the transducer occurs inside the imaging core lumen. The catheter body is attached to the telescope shaft via a y-manifold with male/female luer connection. The straight leg of the y-manifold is the guidewire exit port with a female luer thread. The luer thread allows flushing of the guidewire lumen. The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking ultrasonic transducer at the distal tip. The distal ends of the imaging core and the catheter body are radiopaque for visualization of the imaging plane and the catheter tip. An electro-mechanical connector interface at the proximal end makes the connection to the Motor Drive Unit (MDU) / Instrument. The MDU-catheter interface consists of an integrated mechanical drive hub and electrical connection.

This 510(k) premarket notification for the Boston Scientific Atlantis™ PV Imaging Catheter (K080272) is a submission for a modified device, referencing a previously cleared predicate device (Atlantis™ PV Imaging Catheter, K050684). As such, the submission focuses on demonstrating substantial equivalence to the predicate device, rather than presenting new clinical study data to establish performance against acceptance criteria for a novel device.

Therefore, many of the requested sections regarding acceptance criteria and a dedicated study to prove these are not applicable or cannot be extracted directly from this document. The document confirms that the device meets performance requirements through non-clinical testing for bench, biocompatibility, and sterility, implying that the acceptance criteria are related to these technical and safety aspects, which are deemed consistent with the predicate device.

Here's the information that can be extracted or reasonably inferred based on the provided text, with explanations for the unavailable sections:

Acceptance Criteria and Device Performance Study for K080272

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states, "The performance test results for bench, biocompatibility and sterility testing of the Atlantis™ PV Imaging Catheter demonstrate that the device meets or exceeds the performance requirements for the specified intended use." It does not provide specific quantitative acceptance criteria or detailed numerical results for these tests. The primary acceptance criterion for this 510(k) is demonstrating substantial equivalence to the predicate device, K050684, for "performance requirements."

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

This information is not provided in the document. The submission references "non-clinical test results" for bench, biocompatibility, and sterility, but it does not specify sample sizes for these tests or the origin of any data (e.g., retrospective or prospective, country of origin), as these are typically part of detailed test reports that are not included in the summary.

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

This information is not applicable/not provided because this submission primarily relies on non-clinical testing and substantial equivalence to a predicate device. There is no mention of a clinical "test set" requiring expert ground truth establishment in the context of this 510(k) summary.

4. Adjudication Method for the Test Set

This information is not applicable/not provided for the same reasons as in point 3.

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

This information is not applicable/not provided. The Atlantis™ PV Imaging Catheter is an intravascular ultrasound catheter, a diagnostic imaging device which (based on this document) does not incorporate Artificial Intelligence (AI) to assist human readers. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

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

This information is not applicable/not provided. This device is a hardware imaging catheter, not an algorithm. Standalone algorithm performance studies are not relevant here.

7. The Type of Ground Truth Used

This information is not applicable/not provided in the context of clinical performance data for this 510(k) submission. The "ground truth" for the non-clinical tests would be the established scientific and engineering standards and methods for assessing bench performance, biocompatibility, and sterility, rather than expert consensus, pathology, or outcomes data typically associated with clinical studies of diagnostic accuracy.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is an imaging catheter and not an AI/machine learning algorithm, so there is no concept of a "training set" in this submission.

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

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

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The iLab™ Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

The iLab™ Ultrasound Imaging System is a combination of proprietary hardware and software that has been designed for real-time viewing of intravascular anatomies and is intended to be a basic diagnostic tool for imaging and evaluation of patients who are candidates for transluminal procedures. The iLab™ System is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging intravascular anatomies with transducer ranges of 9 to 40 MHz. The iLab™ System is also designed to be compatible with multiple Ultrasound Imaging Catheters manufactured by BSC used in different anatomies throughout the body. The system is also supported by a MotorDrive Unit that is compatible with all existing BSC Intravascular Ultrasound (IVUS) catheter products. The iLab™ System consists of two compact PC units (one for Image Processing and one for Data Acquisition), up to two displays, control devices, media storage devices, and a printer. The Data Acquisition PC (front-end PC) digitizes the RF Ultrasound echo, performs digital signal processing, and stores IVUS frames in a vector-based format. Once saved, the vectorbased frame of data is packetized and sent over a private Local Area Network (LAN) connection onto the Image Processing PC (back-end PC) subsystem. The real-time vector data is unpacked and the frame data is converted from vector-based to raster-based frame, which can then be displayed on the primary and secondary (optional) displays. The iLab™ System is available in two configurations: a Cart-based Configuration and an Installed Configuration. There is no functional or electrical difference between the Cart-Based and Installed Configurations; differences are limited to cable lengths and the location of the modules of the system.

Here's a summary of the acceptance criteria and study information for the iLab™ Ultrasound Imaging System based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to a predicate device (Galaxy® Intravascular Ultrasound System) for market clearance. The acceptance criteria are therefore implicitly tied to meeting similar safety and performance standards as the predicate, rather than specific numerical thresholds presented as acceptance criteria for the iLab™ System's performance in isolation.

Here's the additional information requested, based on the provided text:

• 1. Table of Acceptance Criteria and Reported Device Performance: See table above.

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

  • Sample Size: The document does not specify a distinct "test set" sample size in terms of patient data or case numbers. The testing described is primarily focused on bench testing of the system's electrical, acoustic, and functional components.
  • Data Provenance: The provenance of data for these tests is implicitly from the Boston Scientific Corporation's internal testing labs ("Bench testing was performed... This testing included hardware unit-level tests, software unit-level test, and system-level tests.") and independent test facilities for electrical safety. It is not based on clinical patient data or a clinical study.

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

  • This information is not provided in the document as the testing described is primarily technical and bench-based, not involving expert interpretation of clinical images for ground truth establishment.

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

  • This information is not applicable as the evaluation did not involve human interpretation of images requiring adjudication. The assessment was against technical specifications and predicate device equivalence.

• 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, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission focused on demonstrating substantial equivalence through technical and bench testing, not a clinical study comparing human reader performance with or without AI assistance. The device itself is an imaging system, not explicitly described as having AI assistance for interpretation.

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

  • The document describes the iLab™ Ultrasound Imaging System as a complete hardware and software system for real-time imaging, intended as a basic diagnostic tool. The performance evaluations discussed (electrical, acoustic, functional) are for the system itself in a standalone manner, but not as an "algorithm only" in the context of automated interpretation or decision support. It's a fundamental imaging device, not an AI-driven interpretive algorithm.

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

  • Internal specifications and predicate device characteristics served as the "ground truth" for the technical and functional tests. For example, electrical safety was validated against EN standards, and acoustic output was deemed equivalent to the predicate device due to identical components and signal generation. There is no mention of pathology, expert consensus on clinical images, or outcomes data being used as ground truth for this submission.

• 8. The sample size for the training set:

  • Not applicable. The document describes a medical device clearance based on substantial equivalence, primarily through bench testing comparing it to a predicate device. It does not mention any "training set" in the context of machine learning or AI development.

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

  • Not applicable. As no training set is mentioned, the method for establishing its ground truth is not provided.

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