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

The iLab Ultrasound Imaging System is 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 Permanent Pullback Sled is a device which is used with the iLab Ultrasound Imaging System. The permanent sled is a mechanized device to assist with the acquisition of two-dimensional images obtained from compatible Boston Scientific intravascular ultrasound imaging catheters. This device is designed to be used with Boston Scientific IVUS catheters that have telescoping capability where the catheter anchor housing can engage in the anchor post of the sled.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical sense of a clinical or performance study with detailed metrics like sensitivity, specificity, or accuracy.

Instead, this document is a 510(k) premarket notification for the iLab™ Ultrasound Imaging System, specifically regarding a modification to a "Permanent Pullback Sled." The focus is on demonstrating substantial equivalence to a previously cleared predicate device.

Here's an analysis of the available information based on your requested points:

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

   The document describes design verification testing for the modified "Permanent Pullback Sled." The acceptance criteria were primarily "Pass/Fail" for each test. The reported performance is that "All predetermined acceptance criteria were met."

   Test Category	Acceptance Criteria	Reported Performance
   Design Verification Tests	Pass/Fail	Met
   Motordrive Pullback	Pass/Fail	Met
   Force to Open Latch	Pass/Fail	Met
   Motordrive/Pullback Sled Connection	Pass/Fail	Met
   Linear Velocity	Pass/Fail	Met
   Cleaning Materials Exposure	Pass/Fail	Met
   Acoustic Noise	Pass/Fail	Met
   Holding Force of Nose Section to Anchor Seal	Pass/Fail	Met
   Sled Travel Distance	Pass/Fail	Met
   Nose Clip Insertions	Pass/Fail	Met
   Sled Pullbacks	Pass/Fail	Met
   Environmental Requirements	Pass/Fail	Met
   Packaging Validation	Pass/Fail	Met
   Visual Inspection	Pass/Fail	Met
   Functional Testing	Pass/Fail	Met

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

   The document doesn't specify sample sizes for each design verification test. It refers to "fully packaged units" for packaging validation but doesn't give a number.
   The data provenance is from "Design verification testing" and "packaging testing" performed on the "permanent sled," implying in-house bench testing by Boston Scientific Corporation, likely in the USA (where Boston Scientific is headquartered and the submission was made). This would be considered prospective bench testing rather than using retrospective clinical data.

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)

   This type of information is not applicable and not present in the document. The "ground truth" for bench testing typically refers to engineering specifications and measurements, not expert clinical interpretation.

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

   This is not applicable as the testing described is engineering design verification, not a clinical study involving human readers and adjudicated outcomes.

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 MRMC study was done. This document describes a modification to an ultrasound imaging system component, not an AI-powered diagnostic tool requiring such a study.

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

   No standalone algorithm performance study was done. The device is an ultrasound imaging system and a mechanical sled component, not an AI algorithm.

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

   For the "Design verification testing" and "Packaging validation," the ground truth implicitly refers to the engineering specifications and requirements for the device. Each test had a pre-defined "Pass/Fail" criterion based on these specifications.

8. The sample size for the training set

   This is not applicable. There is no mention of an algorithm or a training set for machine learning in this submission for an ultrasound system component.

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

   This is not applicable, as there is no training set mentioned.

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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 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 provided document states that no clinical studies were required for the modified iLab™ Ultrasound Imaging System to support substantial equivalence. Therefore, the device's acceptance criteria and performance are not discussed in the context of clinical studies.

The document explicitly states:

• "Summary of Clinical Tests: The modified iLab Ultrasound Imaging System did not require clinical studies to support substantial equivalence."

Instead, the determination of substantial equivalence was based on non-clinical data, including:

• Functional/performance testing
• Interoperability testing
• Electrical Safety testing

The document notes that:

• "Design verification testing demonstrates that the modified device meets the acceptance criteria."

However, the specific acceptance criteria and the reported device performance from these non-clinical tests are not detailed in the provided text.

Given this, I cannot provide the information requested in your numbered list, as the study details, sample sizes, expert involvement, and ground truth information are not present for clinical performance.

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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 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™ Ultrasound Imaging System submission (K123535) is for a modification to an existing device, not a new device. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device, rather than comprehensive new acceptance criteria and studies.

Here's a breakdown of the available information regarding acceptance criteria and supporting studies for the modified iLab™ Ultrasound Imaging System (version 2.7.1), acknowledging the limitations of this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a modification and not a new device requiring extensive clinical trials, the acceptance criteria are primarily focused on software verification and validation relative to the predicate device.

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

• Software Verification: The document states "Software unit and system level verification testing." The specific sample sizes for test cases or environments are not explicitly provided in this summary.
• Software Validation: The summary mentions "Validation was performed by testers with clinical experience evaluating IVUS images." The specific number of cases or images used for validation is not explicitly provided.
• Data Provenance: The document does not specify the country of origin of the data used for testing or validation. It is implied to be laboratory/internal testing performed by the manufacturer. The studies are retrospective in the sense that they are conducted on pre-existing software and images (or simulated scenarios), rather than a prospective clinical trial.

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

• For software validation, the document states, "Validation was performed by testers with clinical experience evaluating IVUS images." The number of experts is not specified, nor are their detailed qualifications (e.g., specific clinical roles, years of experience).

4. Adjudication Method for the Test Set

• The document does not specify an adjudication method. Given the nature of a software verification and validation report for a modification, a formal adjudication process between independent experts as seen in clinical trials is unlikely to have been documented in this summary.

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

• No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "The modified iLab Ultrasound Imaging System did not require clinical studies to support substantial equivalence."

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

• The software verification and validation activities described are inherently a form of standalone testing, as they focus on the software's performance against its requirements and its image quality relative to a predicate device. However, the term "standalone" in the context of an AI-powered diagnostic device often implies a specific evaluation against a ground truth without human intervention during diagnosis. While the software generates images, its ultimate interpretation in a clinical setting still involves a human reader. The described "validation" focuses on image quality equivalence for human interpretation.

7. The Type of Ground Truth Used

• For Software Verification: The "ground truth" for software verification is adherence to the Software Requirements Specifications. The 'truth' is whether the software performs as designed.
• For Software Validation: The "ground truth" for image quality validation was based on the performance of the predicate device. The goal was to demonstrate that the image quality of the modified iLab 2.7.1 was "equivalent or better" than the predicate device, as evaluated by testers with clinical experience. This is a comparative ground truth rather than an absolute truth (e.g., pathology).

8. The Sample Size for the Training Set

• This information is not provided. This being a software update, the underlying core algorithms for image processing and display would have been developed and trained using data not described in this document, which focuses only on the modifications. If the update involved new machine learning components, details about their training set would typically be required, but this summary doesn't suggest that kind of fundamental change.

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

• This information is not provided, as details about a "training set" for the underlying algorithms are outside the scope of this particular submission for a software modification. If new machine learning models were introduced as part of the update, this information would be critical. However, the description suggests an update to existing software functionalities.

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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 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 consists of two compact PC units (one for Image Processing and one for Data Acquisition), up to two displays (one primary and an optional secondary). The iLab System imaging and processing PC are used during an intravascular procedure, at the end of the IVUS procedure, the processing PC supports the archiving of the images obtained during the procedure. The iLab System processing PC converts the native iLab images into DICOM format images prior to archiving to removal media such as a CD, DVD or removable hard disk cartridge. Images can also be archived to a DICOM network server. The iLab™ System is available in two configurations: a Cart-based Configuration and an Installed Configuration.

The document provided is a 510(k) Summary for the Boston Scientific iLab™ Ultrasound Imaging System. It describes the device, its intended use, and comparison to a predicate device. The document details various non-clinical testing performed, including software and hardware verification and validation efforts. However, it does not contain any information about clinical studies with human participants, expert review of data, or establishment of ground truth in the way typically expected for AI/ML device evaluations.

The testing described is primarily focused on engineering verification and validation of the system's components and software against predefined requirements, rather than a performance study involving a test set with established ground truth.

Therefore, many of the requested elements for acceptance criteria and study details cannot be extracted from this document, as they are not relevant to the type of submission provided.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:

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

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

• Sample Size for Test Set: Not applicable. The document describes software verification and validation, and hardware testing, not a clinical performance study with a "test set" in the context of patient data.
• Data Provenance: Not applicable for a clinical test set. The verification and validation involved "multiple configurations of PC systems" and "production equivalent" systems. On-site validation was planned for "3 or more customer sites."

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)

• Number of Experts: Not applicable. No clinical expert review process is described for establishing ground truth for a test set.
• Qualifications of Experts: Not applicable. The "software validation effort will be performed by testers with iLab clinical experience," but these are testers for engineering validation, not clinical experts establishing ground truth for a performance study.

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

• Adjudication Method: Not applicable. No clinical test set or adjudication process is described.

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

• MRMC Study: No. This document describes a traditional 510(k) for an ultrasound imaging system update, not an AI/ML device requiring an MRMC study.

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

• Standalone Performance: Not applicable. This is an ultrasound imaging system, not an algorithm-only device. The testing focuses on the system's functional integrity.

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

• Type of Ground Truth: Not applicable. The "ground truth" in this context refers to the system meeting its engineering specifications and requirements, as outlined in "Software Requirements Specifications" and "Product and Marketing requirements." No clinical "ground truth" (e.g., pathology, outcomes) for diagnostic accuracy is mentioned.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set in that context.

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

• Training Set Ground Truth: Not applicable.

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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 iReview Software accessory does not change the iLab indications for use.

The iLab™ Ultrasound Imaging System with the iReview™ Software accessory, is designed for realtime 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 with the iReview Software accessory consists of two compact PC units (one for lmage Processing and one for Data Acquisition), up to two displays (one primary and an optional secondary) and the iReview Software contained on a separate CD. The iReview Software utility can be installed on any commercial grade PC that meets the minimum hardware and operating system requirements. The iLab System imaging and processing PC are used during an intravascular procedure, at the end of the IVUS procedure, the processing PC supports the archiving of the images obtained during the procedure. The iLab System processing PC converts the native iLab images into DICOM format images prior to archiving to removal media such as a CD, DVD or removable hard disk cartridge. Images can also be archived to a DICOM network server.

The iReview™ Software utility enables the off-line review of the archived iLab System images, including the Longview™ reconstructed images, Dynamic Review™ of the IVUS image runs, area and distance measurements, book marked images, image graphics, bio-signals such as ECG and the broadcast of any audio recording acquired during the IVUS procedure. The iReview Software also supports the creation of new area and distance measurements and the ability to export images to external printers. The iReview Software utility, using the iLab proprietary GUI look and feel, is a simple easy to use, image viewing software for iLab IVUS images.

The provided text describes the iReview™ Software, an accessory to the iLab™ Ultrasound Imaging System. The assessment focuses on the software's verification and validation rather than clinical performance against specific metrics for disease detection or diagnosis.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of clinical performance data used for algorithm evaluation. The testing described is primarily focused on software verification and validation, rather than a clinical study evaluating diagnostic accuracy.

• Test Set Sample Size: Not applicable/not explicitly stated in terms of a clinical image dataset. The testing was performed on "multiple configurations of PC systems." (Page 2)
• Data Provenance: Not applicable. The software reviews archived images from the iLab™ Ultrasound Imaging System, which captures intravascular ultrasound images. The document does not specify the origin (country, etc.) or whether these archived images were retrospective or prospective for the purpose of this software testing.

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

• This information is not provided. The testing described focuses on software functionality and usability, not on diagnostic accuracy requiring expert ground truth for interpretation. Software validation was performed by "testers with iLab clinical experience." (Page 2) However, this refers to their experience in operating the iLab system, not necessarily their role as medical experts establishing ground truth for diagnostic image interpretation.

4. Adjudication Method for the Test Set

• Not applicable. As described, the testing is for software functionality and verification, not for diagnostic performance that would require adjudication for discrepancies.

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

• No, a MRMC comparative effectiveness study was not done. The document does not mention any studies evaluating human reader performance with or without AI assistance. This submission is for an accessory software designed for viewing and reviewing archived images, not for an AI-powered diagnostic tool.

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

• Not applicable. The iReview™ software is an accessory for displaying and reviewing images from an existing ultrasound system. It is not a standalone diagnostic algorithm. Its function is to allow "off-line review of the archived iLab System images." (Page 1)

7. The Type of Ground Truth Used

• For the software verification and validation, the "ground truth" was the predefined Product and Marketing Requirements, and Software Requirements Specifications. The software's ability to correctly display images, perform measurements, and archive data according to these specifications was the "truth" against which its performance was measured. There is no mention of clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

• Not applicable. The iReview™ Software is described as a utility for viewing and reviewing pre-existing images; it is not an AI/machine learning algorithm that requires a training set in the typical sense for image analysis.

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

• Not applicable, as there is no mention of an AI/machine learning algorithm requiring a training set with established ground truth for learning purposes.

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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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