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1. The Makoto Intravascular Imaging SystemTM is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
   a. The System is intended for the detection of lipid-core-containing plaques of interest.
   b. The System is intended for the assessment of coronary artery lipid core burden.
   c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
2. The System is intended for ultrasound examination of coronary and peripheral intravascular pathology.
   a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.

The Makoto Intravascular Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid corecontaining plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.

This FDA 510(k) summary describes the acceptance criteria and study results for the Makoto Intravascular Imaging System's new Automatic Border Contouring (ABC) and Guide Catheter Detection (GCD) software features.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
   a. The System is intended for the detection of lipid-core-containing plaques of interest.
   b. The System is intended for the assessment of coronary artery lipid core burden.
   c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
2. The System is intended for ultrasound examination of coronary and peripheral intravascular pathology.
   a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.

The Makoto Intravascular Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.

The Makoto Intravascular Imaging System™ is composed of three main components: the Catheter, the Controller (Pullback and Rotation Device (PBR)), and the Console. These three interconnected components work together to produce dual images of NIRS and IVUS in a single scan of the vessel.

The provided document is a 510(k) premarket notification summary for the Makoto Intravascular Imaging System™. It details the device's characteristics and compares it to a predicate device, primarily justifying substantial equivalence based on minimal design changes and previous testing. However, it explicitly states: "No prospective clinical trials were conducted in support of this Traditional 510(k)." This means the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them through clinical performance.

Therefore, I cannot provide the requested table and study details. The document focuses on demonstrating substantial equivalence to a previously cleared device through bench and animal testing, and by asserting that the minor changes (like adding peripheral IVUS indication) do not significantly affect safety or effectiveness.

Based on the provided text, the device was NOT proven to meet acceptance criteria through a clinical study as described in your request. The submission relies on demonstrating equivalence to a predicate device, which implies that the predicate device previously met certain criteria, and the new device is sufficiently similar.

The document does mention:

• Performance Testing (Bench): There are no changes that significantly affect safety or effectiveness. Minor modifications were documented, reviewed, and tested according to verification and validation protocols (which are typically internal and not detailed here).
• Performance Testing (Animal): No new animal testing was conducted. The justification is that the predicate device's animal testing (K163345 on swine for coronary arteries) applies, and the proposed TVC-E195-42 peripheral catheter is identical in form, fit, and function, considering the animal studies as a worst-case (coronary) model for safety and performance.
• Performance Testing (Clinical): "No prospective clinical trials were conducted in support of this Traditional 510(k)."

In summary, the document does not contain the information required to answer your prompt because it did not involve a new clinical study to prove the device met acceptance criteria.

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1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
   a. The System is intended for the detection of lipid-core-containing plaques of interest.
   b. The System is intended for the assessment of coronary artery lipid core burden.
   c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
2. The System is intended for ultrasound examination of coronary intravascular pathology.
   a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The Makoto Intravascular Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.

The provided text discusses the Makoto Intravascular Imaging System™ (Dualpro IVUS + NIRS Imaging Catheter™). It's a 510(k) summary for a re-branded device that is substantially equivalent to a previously cleared predicate device (K163345), with an expanded indication for use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The device's substantial equivalence and the expanded indication are primarily supported by existing data from the predicate device and a single prospective, multi-center clinical study (the Lipid-Rich Plaque (LRP) Study). The study's focus was on the NIRS component of the device and its ability to identify lipid-core-containing plaques associated with adverse cardiac events, rather than AI-driven performance. Therefore, many standard AI/ML study components (like expert ground truth for training/testing, adjudication methods for ground truth, MRMC studies, or standalone algorithm performance) are not directly addressed or applicable in the provided context as the device itself is not an AI/ML product. The "acceptance criteria" here relate to the clinical performance of the NIRS technology for its new indication.

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this submission are implicitly tied to demonstrating the clinical validity of the expanded indication for use, specifically "...the identification of patients and plaques at increased risk of major adverse cardiac events." The performance is measured by the study's ability to show a statistically significant association between NIRS-identified lipid cores and the occurrence of adverse cardiovascular events.

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

• Sample Size: The text states the study was a "prospective, multi-center Lipid Rich Plaque (LRP) clinical study." However, the exact sample size (number of patients or plaques) for this study is not specified in the provided text.
• Data Provenance: The study was "prospective" and "multi-center," indicating real-world data collection. The geographic origin (e.g., country) of the data is not specified.

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

This information is not applicable in the context of the provided text. The device itself (the Makoto Intravascular Imaging System) is an imaging system (NIRS + IVUS) that provides data and detects lipid cores. There is no mention of "AI" or "machine learning algorithm" within this summary that would require establishing ground truth via expert consensus for performance evaluation. The "ground truth" for the LRP study appears to be the occurrence of actual major adverse cardiovascular events in patients, not a subjective interpretation of images by experts.

4. Adjudication Method for the Test Set

Since the ground truth is based on the occurrence of clinical events, an "adjudication method" in the sense of resolving conflicting expert opinions on image interpretation is not applicable. Clinical events (e.g., major adverse cardiac events) are typically adjudicated by an independent clinical events committee in prospective trials, but the specifics of this adjudication are not detailed in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance. No MRMC comparative effectiveness study was mentioned or conducted as per the provided text because the device itself is not an AI/ML assistant to human readers. It's a diagnostic imaging tool.

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

This question is typically for AI/ML algorithms. The Makoto system is an imaging device that measures and displays information (NIRS chemogram). The "detection of lipid-core-containing plaques" is an output of the system's NIRS technology, not a result of a separate AI algorithm being evaluated for standalone performance. Therefore, a "standalone algorithm performance" evaluation as commonly understood for AI/ML is not applicable here. The LRP study assessed the clinical utility of the device's output (NIRS findings) in predicting events.

7. The Type of Ground Truth Used

The primary ground truth for the expanded indication based on the LRP study was outcomes data, specifically the "occurrence of patient and plaque level major adverse cardiovascular events." The NIRS detection of lipid-rich plaques served as the predictor, and the clinical events were the outcome used as ground truth to validate the prediction.

8. The Sample Size for the Training Set

This information is not applicable. The device's NIRS technology is based on spectroscopy and its physical principles, not a machine learning model that requires a "training set" in the conventional AI/ML sense. The LRP study focused on validating the clinical utility of the device's output, not on training an underlying algorithm.

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

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm for this device.

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1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
   a. The System is intended for the detection of lipid-core-containing plaques of interest.
   b. The System is intended for the assessment of coronary artery lipid core burden.
2. The System is intended for ultrasound examination of coronary intravascular pathology.
   a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

The TVC Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.

This document describes the acceptance criteria and the studies performed for the TVC Imaging System (K163345).

Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria with corresponding performance metrics for the TVC Imaging System related to its imaging capabilities (like detection sensitivity or specificity for lipid-core plaques). Instead, the performance testing section indicates that the device "met all design specifications" and "passed all tests conducted and met specification." The focus of the 510(k) summary is on demonstrating substantial equivalence to a predicate device, not on presenting detailed performance metrics against specific quantitative acceptance criteria for the imaging function itself.

However, based on the performance testing descriptions, the implicit acceptance criteria would be that the device:

• Meets biocompatibility standards for external communicating devices in circulating blood with limited contact duration (≤ 24 hrs).
• Achieves sterility and maintains a 6-month shelf life.
• Performs its designated functions (NIRS and IVUS imaging) without safety concerns in an in-vivo model.
• Produces imaging results (e.g., apposition and malapposition of stents) equivalent to the predicate product in an in-vivo model.

Study Information

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

   • Test Set Sample Size:
     • Biocompatibility, Sterilization, Shelf Life, Bench Performance: Not explicitly stated, but assumed to be sufficient for GLP and ISO standard compliance. These are typically lab-based tests, not human data.
     • In-vivo Swine Studies: One study involved multiple coronary arteries per animal (3 per animal) in an unspecified number of swine. Another study involved stented coronary arteries in swine, also an unspecified number of animals. These are prospective animal studies.
   • Data Provenance: The animal studies were conducted in swine (country not specified but likely conducted by or for Infraredx, Inc. in the USA as it's a US company). These are prospective animal data. No human clinical data was provided.

2. 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)

   • For the in-vivo animal studies, the "ground truth" for evaluating imaging performance (e.g., stent apposition, safety) would typically be established by veterinary cardiologists, interventionalists, or pathologists experienced in animal models. The document does not specify the number or qualifications of experts involved in establishing this "ground truth" or interpreting the animal study results.

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

   • The document does not describe any specific adjudication method for the in-vivo animal studies. Evaluations are generally described as "determined to meet the objectives" or "found to be equivalent," implying a direct assessment by the study investigators rather than an adjudicated consensus process.

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 described. The device is for imaging, and the studies focused on its technical performance and equivalence to a predicate device, not on how human readers' interpretation might improve with or without AI (which is not explicitly defined as part of this device in the given text). The device descriptions focus on displaying a "Chemogram" for lipid core plaques and IVUS images, which are direct outputs for interpretation.

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

   • The document describes performance testing of the "TVC Imaging System™ with the TVC Catheter and Controller" and "Commercial UI Software and Controller Software." This implies testing the integrated system, which can be considered standalone performance in the sense of the algorithm and hardware producing outputs, but it's not explicitly framed as an "algorithm-only" performance evaluation separate from the full device operation. The NIRS component involves algorithms for detecting lipid core-containing plaques and displaying them in a Chemogram, representing a standalone algorithmic output.

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

   • For the in-vivo animal studies, the ground truth for safety would be assessed through pathological examination post-procedure (e.g., histological analysis of coronary arteries for tissue damage). For assessing stent apposition, the predicate device's output was used as a comparative "ground truth" for the new device's findings. No human pathology or outcomes data were used, as no clinical study was performed.

7. The sample size for the training set

   • No training set is mentioned as this 510(k) summary focuses on demonstrating substantial equivalence through non-clinical performance and a limited animal study, not on the development or training of an AI algorithm within the device. While the device does have "Commercial UI Software and Controller Software" and outputs like a "Chemogram" (which implies underlying algorithms), details about any machine learning models or their training data are not provided.

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

   • Not applicable, as no training set or machine learning model training details were provided.

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• 1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
  • a. The System is intended for the detection of lipid-core-containing plaques of interest.
  • b. The System is intended for the assessment of coronary artery lipid core burden.
• 2. The System is intended for ultrasound examination of coronary intravascular pathology.
  • a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Not Found

The provided document, a 510(k) premarket notification letter for the Infraredx, Inc. TVC Imaging System™, does not contain the acceptance criteria or a study proving its performance. The letter is an FDA response stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Key information missing from this document includes:

• Acceptance criteria the manufacturer set for the device's performance.
• The actual study results that demonstrate the device meets those criteria.
• Details about the test set, training set, ground truth establishment, or expert involvement.

To answer your request thoroughly, the corresponding 510(k) summary or the full 510(k) submission would be required. The provided text only confirms the device's regulatory clearance.

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1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
   a. The System is intended for the detection of lipid-core-containing plaques of interest.
   b. The System is intended for the assessment of coronary artery lipid core burden.
2. The System is intended for ultrasound examination of coronary intravascular pathology.
   a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Not Found

The provided text is a 510(k) summary from the FDA for a medical device called the TVC Imaging System. It states the indications for use but does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval, not a clinical study report or a detailed technical specification about performance benchmarks. To find the information you're looking for, you would typically need to consult the device's clinical study reports, scientific publications, or its design verification and validation documentation, which are not included in this FDA letter.

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• 1. The TVC™ Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
  • a. The System is intended for the detection of lipid-core-containing plaques of interest.
  • b. The System is intended for the assessment of coronary artery lipid core burden.
• 2. The System is intended for ultrasound examination of coronary intravascular pathology.
  • a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Not Found

The provided text is a 510(k) premarket notification decision letter from the FDA for the Infraredx TVC Imaging System. It does not contain the detailed information necessary to answer all the questions about acceptance criteria and study particulars. The letter primarily focuses on regulatory approval based on substantial equivalence to predicate devices and outlines general regulatory obligations.

However, based on the limited information provided in the "Indications for Use" section (Section 8 of the original submission, which is referenced in the letter), we can infer the primary performance goals for the device. The "Indications for Use" state:

• The TVC™ Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
  • a. The System is intended for the detection of lipid-core-containing plaques of interest.
  • b. The System is intended for the assessment of coronary artery lipid core burden.
• The System is intended for ultrasound examination of coronary intravascular pathology.
  • Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Given this, the acceptance criteria would revolve around the ability of the device to accurately detect lipid-core-containing plaques and assess coronary artery lipid core burden using near-infrared, and to perform ultrasound examination of coronary intravascular pathology.

Based on the provided document, I cannot complete most of the requested information because the 510(k) decision letter does not include the detailed study design and results. The information below reflects what could be inferred as acceptance criteria and explicitly states where the document is insufficient to answer the question.

Inferred Acceptance Criteria and Reported Device Performance

Detailed Study Information

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

   • Not available in this document. The 510(k) decision letter does not include details on the test set, its size, or provenance.

2. 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 available in this document.

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

   • Not available in this document.

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 based on available information. The device described (TVC Imaging System) is an imaging system (hardware and associated software for image acquisition and analysis), not explicitly stated to be an AI-assisted diagnostic tool for human readers in the context of an MRMC study. While it provides "assessment of coronary artery lipid core burden" and "detection of lipid-core-containing plaques," the document does not describe its interaction with human readers for improved diagnostic accuracy in an MRMC setting.

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

   • Not available in this document. The document does not specify if a standalone performance study was conducted.

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

   • Not available in this document.

7. The sample size for the training set

   • Not available in this document. The 510(k) decision letter does not provide details about training data, as it primarily focuses on the regulatory decision rather than detailed technical study methodologies.

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

   • Not available in this document.

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1. The TVC™ Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
   a. The System is intended for the detection of lipid-core-containing plaques of interest.
   b. The System is intended for the assessment of coronary artery lipid core burden.
2. The System is intended for ultrasound examination of coronary intravascular pathology.
   a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Not Found

This FDA letter is a 510(k) clearance for the TVC Imaging System, meaning it has been determined to be substantially equivalent to a legally marketed predicate device. While it indicates the device can be legally marketed, it does not typically contain the detailed study information needed to fully answer your questions about acceptance criteria and study proving device performance. Such information is usually found in the 510(k) submission itself (which includes the scientific data and clinical studies), rather than in the clearance letter.

Therefore, based solely on the provided text, I can only provide limited information. Many of your questions, particularly those about specific performance metrics, sample sizes, ground truth establishment, and expert qualifications, cannot be answered from this document.

Here's what can be extracted:

• Device Name: TVC™ Imaging System
• Intended Use (Indications for Use):
  • Near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography for:
    • Detection of lipid-core-containing plaques.
    • Assessment of coronary artery lipid core burden.
  • Ultrasound examination of coronary intravascular pathology in patients who are candidates for transluminal coronary interventional procedures.

Regarding your specific questions and what can/cannot be answered from the provided text:

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

   • Cannot be provided. The clearance letter does not include specific performance metrics or acceptance criteria from the underlying studies. This information would be in the 510(k) submission.

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. The clearance letter does not detail the clinical studies, including sample sizes, data provenance, or study design (retrospective/prospective). This would be in the 510(k) submission.

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):

   • Cannot be provided. The clearance letter does not describe how ground truth was established or the details of expert involvement. This would be in the 510(k) submission.

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

   • Cannot be provided. The clearance letter does not describe adjudication methods. This would be in the 510(k) submission.

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:

   • Cannot be provided. The clearance letter does not mention if an MRMC study was performed or any human-AI comparative effectiveness. The device's primary function as described (NIRS and IVUS imaging) doesn't inherently suggest an AI-assisted interpretation component for human readers in the way an AI diagnostic algorithm might.

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

   • Likely applicable, but details not provided. The description focuses on the system intended for examination and assessment. For a diagnostic imaging system, the "standalone" performance would typically refer to its ability to generate images and measurements for the intended use, which would have been demonstrated in the submission. However, specific standalone performance metrics or the nature of an "algorithm only" test are not detailed in this letter.

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

   • Cannot be provided. The clearance letter does not specify the type of ground truth used in the studies. This would be in the 510(k) submission.

8. The sample size for the training set:

   • Cannot be provided. As this is a 510(k) clearance for an imaging system (NIRS and IVUS), the concept of a "training set" in the context of machine learning (like an AI algorithm) may not be directly applicable in the same way, unless the device incorporates such algorithms. Even if it does, the sample size would not be in this clearance letter.

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

   • Cannot be provided. (See point 8).

In summary: The provided document is an FDA clearance letter confirming substantial equivalence. It does not contain the detailed technical and clinical study results that would typically include acceptance criteria, performance metrics, sample sizes, ground truth methodologies, or expert qualifications. To obtain this information, you would need to access the full 510(k) submission (K123108) itself, which is often available through the FDA's public database.

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1. The LipiScan™ IVUS Imaging System is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
   a. The System is intended for the detection of lipid-core-containing plaques of interest.
   b. The System is intended for the assessment of coronary artery lipid core burden.
2. The System is intended for ultrasound examination of coronary intravascular pathology.
   a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

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

The InfraReDx LipiScan™ IVUS Imaging System is designed for near-infrared examination of coronary arteries to detect lipid-core containing plaques and assess lipid core burden, as well as for ultrasound examination of coronary intravascular pathology.

The provided document, K093993, does not contain specific acceptance criteria or an evaluation study with quantitative performance metrics for the InfraReDx LipiScan™ IVUS Imaging System. The information focuses on demonstrating substantial equivalence to predicate devices based on design, intended use, operating principle, and safety testing.

Here's a breakdown of the information available and the aspects that are not available in the provided text:

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

This information is not provided in the document. The submission details bench, electrical safety, and acoustic output testing, stating that the device "meet[s] or exceed[s] performance requirements" and that "the device satisfies all performance and functional requirements," but it does not specify what those quantitative requirements or acceptance criteria were, nor does it present specific performance values (e.g., sensitivity, specificity for lipid core detection, or quantitative accuracy metrics for IVUS measurements).

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 mentions "Ex vivo and in vivo data is presented to support expanded indications for use." However, it does not provide any details regarding the sample size, data provenance (country of origin), or whether the data was retrospective or prospective for these studies.

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 information is not provided in the document.

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

This information is not provided in the document.

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:

This type of study is not mentioned in the document. The device is described as an imaging system, not an AI-assisted diagnostic tool in the context of comparative effectiveness with human readers.

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

This information is not explicitly provided in the document, as the submission does not detail specific algorithm performance studies. The focus is on the integrated system's safety and functionality rather than standalone algorithmic performance metrics.

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

The document states "Ex vivo and in vivo data is presented to support expanded indications for use." While it implies comparison to some form of ground truth, the specific type of ground truth (e.g., histological analysis for lipid cores, or a gold standard for IVUS measurements) is not detailed.

8. The sample size for the training set:

This information is not provided. The document describes software verification and validation, but not a "training set" in the context of machine learning or AI, which is a common use of the term.

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

This information is not provided as there is no mention of a training set or ground truth establishment for such a set.

Summary of available information related to performance and testing:

• Non-clinical Test Results: Bench, electrical safety, and acoustic output safety testing were performed.
• Bench Testing: Evaluated performance and functionality, including hardware and software unit-level tests and system-level tests. Results "demonstrate that the device satisfies all performance and functional requirements." (No specific criteria or performance values are given).
• Electrical Safety Testing: Complies with EN 60601-1 and EN 60601-1-2 standards, verified by independent test facilities.
• Software Verification and Validation: Performed in accordance with applicable FDA guidance documents.
• Acoustic Output Testing: Performed in accordance with FDA Guidance, "Information for Manufactures Seeking Market Clearance of Diagnostic Ultrasound Systems and Transducers", issued September 30, 1997.
• Ex vivo and in vivo data: Presented to support expanded indications for use. (No further details on these studies are provided).

In conclusion, while the document confirms various tests were conducted to ensure safety and functionality, it lacks the specific quantitative acceptance criteria, detailed study designs, sample sizes, and expert qualifications that would typically describe the device's performance against defined criteria. The submission focuses on substantial equivalence based on overall functionality and safety testing rather than a detailed performance study with quantifiable metrics against specific acceptance thresholds.

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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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