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The HyperVue™ Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The Starlight™ Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.

The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

The NIRS capability of the HyperVue Imaging System is intended for the detection of lipid core containing plaques of interest.

The NIRS capability of the HyperVue Imaging System is intended for the assessment of coronary artery lipid core burden.

The NIRS capability of the HyperVue Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

The HyperVue™ Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system.

The HyperVue™ Imaging System consists of the following components:

• Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface.
• Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data.
• Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.
• Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.

The provided text is a 510(k) Summary for the HyperVue™ Imaging System, focusing on a software update. It is important to note that this document does not contain the detailed performance testing results, acceptance criteria, or the study design (e.g., sample size, ground truth establishment, expert qualifications, MRMC study details) that would prove the device meets specific acceptance criteria for clinical performance.

The document states:

• "Design verification and validation (V&V) of the HyperVue™ Imaging System with the updated software were performed in compliance with external standards and internal design control procedures. V&V testing comprised of system/software verification and summative usability testing to confirm device performance."
• "Software verification and validation were conducted to FDA regulations, standards, and guidance document requirements. The results of this testing conclude the software has met these requirements."
• "Benchtop testing of the entire device was conducted to evaluate certain system-level features, such as measurements, that require both hardware and software to evaluate. The results of this testing conclude the system has met these requirements."
• "Usability evaluation was conducted to establish that the updated software for the HyperVue™ Imaging System meets the needs of the intended users to perform OCT-NIRS imaging safely and effectively according to ANSI/AAMI/IEC 62366-1."
• "No clinical testing is provided in this pre-market notification."

The FDA's 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device. For software updates like this, the focus is often on verifying that the changes do not introduce new safety or effectiveness concerns and that the device continues to perform as intended. Detailed clinical performance studies (like MRMC studies) with specific acceptance criteria are often reserved for novel devices or significant changes that introduce new claims or potential risks not addressed by the predicate.

Therefore,Based on the provided text, I cannot complete the requested information regarding specific acceptance criteria and the study that clinically proves the device meets them because the document explicitly states "No clinical testing is provided in this pre-market notification." The performance testing described is primarily focused on software verification, bench testing of system-level features, and usability, demonstrating that the software update does not adversely affect the known performance characteristics of the predicate device.

Here's what I can extract and what remains unknown based on the provided text:

Acceptance Criteria and Reported Device Performance

Since no specific clinical performance metrics or thresholds are provided in this regulatory document for the software update, a table for clinical acceptance criteria and reported device performance cannot be generated from the given text. The "acceptance" by the FDA in this context is based on demonstrating substantial equivalence and ensuring the software update does not negatively impact existing validated performance.

Study Details (as much as can be inferred from the document)

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

   • Acceptance Criteria: Not explicitly stated in terms of quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy for disease detection). The criteria are implicitly related to software verification, usability, and system-level functional performance (e.g., measurements, image display) as demonstrated by bench testing.
   • Reported Device Performance:
     • "The results of this testing conclude the software has met these requirements." (Referring to FDA regulations, standards, and guidance document requirements for software V&V).
     • "The results of this testing conclude the system has met these requirements." (Referring to benchtop testing of system-level features).
     • "The updated software for the HyperVue™ Imaging System has been found to be safe and effective for the intended users, uses, and use environments." (From Usability Study).

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

   • Test Set Sample Size: Not specified for any performance testing.
   • Data Provenance: Not specified. The testing seems to be internal verification and validation, possibly using simulated data, phantom data, or existing (de-identified) data for bench testing. The document states "No clinical testing is provided in this pre-market notification," meaning patient data for new clinical performance claims was not used for this submission.

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

   • Not applicable / Not specified. Given that no clinical testing was performed for this submission, there's no mention of expert-established ground truth for a clinical test set. Usability testing would involve users, but they are evaluating the software interface, not providing ground truth for diagnostic accuracy.

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

   • Not applicable / Not specified. No clinical test set requiring ground truth adjudication 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:

   • No, an MRMC study was NOT done. The document explicitly states: "No clinical testing is provided in this pre-market notification." Therefore, no effect size of human reader improvement can be reported from this document.

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

   • The document implies that "software verification and validation" and "benchtop testing" evaluate the software's functional performance. However, specific standalone performance metrics (e.g., for automated detection of features) are not provided in this summary. The software "orchestrates the control, acquisition, processing, and display of the OCT-NIRS data" and provides "computer-aided measurement tools." Whether these tools have undergone standalone performance validation (and what those metrics are) is not detailed here.

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

   • Not applicable / Not specified for clinical performance. For software verification and bench testing, ground truth would likely be established through engineering specifications, known correct behaviors, or physical measurements on phantoms, but this is not a clinical ground truth.

8. The sample size for the training set:

   • Not applicable / Not specified. This document describes a software update and its verification, not the original development and training of a machine learning model. If any ML components were part of the predicate device, their training details are not provided here, and no new training due to this software update is indicated.

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

   • Not applicable / Not specified. See point 8.

Conclusion from the document's perspective:

The submission for the HyperVue™ Imaging System (K230691) is for a software update to an existing cleared device. The manufacturer demonstrated substantial equivalence to its predicate (SpectraWAVE Imaging System and Catheter, K221257) by showing that the software modifications do not introduce new questions of safety or effectiveness. This was supported by:

• Software verification and validation in compliance with IEC 62304 and FDA requirements.
• Benchtop testing to confirm system-level features and measurements.
• Human factors engineering (HFE) usability testing to ensure safe and effective use.

The application explicitly states that no clinical testing was provided as part of this pre-market notification, indicating that the clearance is based on the equivalence and rigorous non-clinical verification of the software update.

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The Spectra WAVE Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The SpectraWAVE Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.

The SpectraWAVE Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

The NIRS capability of the SpectraWAVE Imaging System is intended for the detection of lipid core containing plaques of interest.

The NIRS capability of the SpectraWAVE Imaging System is intended for the assessment of coronary artery lipid core burden.

The NIRS capability of the SpectraWAVE Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system.

The SpectraWAVE Imaging System consists of the following components:

• Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface.
• Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data.
• Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.
• Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.

This document describes the SpectraWAVE Imaging System, an intravascular imaging device combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS). It aims to demonstrate substantial equivalence to predicate devices, K192019 Dragonfly OpStar™ Imaging Catheter and K183599 Makoto Intravascular Imaging System™.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table detailing quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for NIRS detection of lipid-core plaques) and corresponding reported performance values for each criterion. Instead, it broadly states that "All testing passed the acceptance criteria" for bench testing and that the animal study met acceptance criteria for acute performance and safety.

The Indications for Use (page 3) serve as a high-level set of intended performance characteristics for the NIRS capability:

• Detection of lipid core containing plaques of interest.
• Assessment of coronary artery lipid core burden.
• Identification of patients and plaques at increased risk of major adverse cardiac events.

However, specific numerical acceptance criteria for these indications (e.g., a minimum sensitivity or specificity for lipid core detection) are not provided in this document. The Device Comparison Tables (Table 1 and Table 2, pages 5-6) compare various technical specifications (e.g., catheter diameter, image collection time, rotational rate) to predicate devices, indicating that the SpectraWAVE device's specifications are "Substantially equivalent," which implies they meet comparable functional performance as the predicates.

For instance, a comparison point that serves as an implicit performance and acceptance criterion for the OCT portion is the "SpectraWAVE Imaging System allows imaging of vessels up to 5.2mm in diameter, which covers the expected range of left main coronary arteries" as stated in the "Discussion of Equivalence & Differences" column (page 6) when comparing to the primary predicate which is limited to 3.5mm. This implies the SpectraWAVE device meets or exceeds the imaging range of its predicate for OCT.

Similarly, under "NIRS Verification & Validation summarizes the NIRS performance of the SpectraWAVE system, with the predicate device as a reference" in Table 2, it indicates that the NIRS performance was evaluated against the predicate, implying an acceptance criterion of comparable performance. However, the specific quantitative comparison is not detailed here.

Given the absence of a detailed quantitative table in the provided text, a summary is provided below based on the implicit and some explicit performance claims.

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

• Test Set Sample Size: The document does not specify exact sample sizes for test sets in a numerical sense (e.g., number of cases or images) for performance studies related to lipid core detection or OCT imaging metrics. It mentions "a series of bench tests" (page 17) and "a GLP animal study" (page 17).
• Data Provenance:
  • Bench Testing: In vitro, conducted internally by SpectraWAVE.
  • Animal Testing: In vivo, conducted in a porcine coronary artery model, GLP (Good Laboratory Practice) study (page 17).
  • Clinical Testing: "No clinical testing is provided in this pre-market notification." (page 17)

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

This information is not provided in the document. Since no clinical testing was performed and detailed performance metrics for NIRS/OCT interpretation by experts are not discussed, there's no mention of experts establishing ground truth for a test set. Ground truth for the animal study would typically be established through pathological examination by veterinary pathologists, but details are not provided.

4. Adjudication Method for the Test Set

This information is not provided in the document. Without details on expert review or ground truth establishment by multiple parties, an adjudication method cannot be inferred.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers' improvement with or without AI assistance was not explicitly described or provided in this pre-market notification. The document states, "No clinical testing is provided in this pre-market notification." (page 17).

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

The document broadly mentions "Software verification and validation were conducted to FDA regulations, standards, and guidance document requirements. The results of this testing conclude the software has met these requirements." (page 16). While this confirms the software's functional correctness and validation, it does not specifically describe a standalone performance study of the algorithm's diagnostic capabilities (e.g., NIRS lipid core detection accuracy) without human intervention. The NIRS capability is intended for detection and assessment, implying an algorithmic component, but its standalone performance against a ground truth is not detailed in terms of metrics.

7. The Type of Ground Truth Used

• Bench Testing: Ground truth would be derived from known physical properties and measurements of phantoms or test objects.
• Animal Testing: Ground truth for acute performance and safety in the porcine model would typically involve direct observation, physiological measurements, and subsequent histopathological analysis of the vessel tissue. The document refers to "vascular injury" assessment, which implies pathological ground truth (page 17).
• NIRS Performance (implicit): The NIRS capabilities are compared against a predicate device, suggesting the predicate's established performance serves as a comparative reference, rather than explicitly an independent "ground truth" like pathology for novel claims. However, the predicate device (Makoto Intravascular Imaging System) itself utilizes NIRS for lipid core detection, which would have been validated against pathology in its original submission.

8. The Sample Size for the Training Set

This information is not provided. The document does not describe the development or training of any AI/ML models that would typically require a training set. Given that it's a 510(k) submission, the focus is on substantial equivalence rather than novel AI algorithm validation with separate training/test sets. Performance is demonstrated through equivalency to predicates and standard engineering verification and validation activities.

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

This information is not provided as no training set or AI/ML model training is described.

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