(77 days)
The IVUS modality of the iLab™ Polaris Multi-Modality Guidance 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.
FFR and DFR™ are intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.
FFR and DFR are indicated to provide hemodynamic information for use in the diagnosis and treatment of patients that undergo measurement of physiological parameters.
The Imaging Catheters generate ultrasound images and are intended for ultrasound examination of vascular and cardiac pathology. Boston Scientific manufactures a wide variety of catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of the catheter. Please refer to the Imaging Catheter Directions for Use, packaged with each catheter.
Indications for Auto Pullback Use (IVUS Only)
Automatic Pullback is indicated when the following occurs:
· The physician/operator wants to standardize the method in which intravascular ultrasound images are obtained and documented: procedure-to-procedure, operator-to-operator.
· The physician/operator wants to make linear distance determinations post-procedurally, which requires the imaging core of a catheter to be pulled back at a known uniform speed.
· Two-dimensional, longitudinal reconstruction of the anatomy is desired.
iLab™ Polaris Multi-Modality Guidance System consists of hardware and software components which aid in supporting Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR) and Diastolic hyperemia-Free Ratio™ (DFR™) functionalities.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the DFR™ (Diastolic hyperemia-Free Ratio) feature of the iLab™ Polaris Multi-Modality Guidance System:
1. Table of Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for the DFR™ feature is its equivalence to the iFR® (Instantaneous Wave-Free Ratio) modality, with both being compared against Fractional Flow Reserve (FFR) as a reference standard. The study aimed to demonstrate that DFR™ has comparable diagnostic performance to iFR® when assessing coronary lesion severity without hyperemia.
| Acceptance Criteria / Metric | Target / Predicate Performance (iFR®) | Reported Device Performance (DFR™) |
|---|---|---|
| Equivalence to iFR® when compared to FFR | No statistically significant difference between iFR and FFR as a reference standard, with highly overlapping 95% confidence intervals. | No statistically significant difference between DFR and iFR when compared to FFR as a reference standard, with highly overlapping 95% confidence intervals; all parameters passed pre-defined test criteria. |
| Agreement with iFR® (using iFR® 0.89 cutoff) | N/A (DFR™ is compared to iFR®) | 97.6% Accuracy (99.2% Specificity and 95.8% Sensitivity) in agreement with iFR® using the 0.89 cutoff for assessing hemodynamic severity of coronary lesions. |
| Waveform performance equivalency to predicate/reference pressure wires | Demonstrated equivalency of bench FFR, iFR, and DFR measurements to original values from VERIFY2 dataset. | Demonstrated waveform performance equivalency of the Comet pressure wire to Volcano and St Jude pressure wires. The agreement between measurements was evaluated using linear regression with confidence intervals and Bland-Altman plot, showing no statistical difference. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The test set for DFR™ and Smart Minimum validation consisted of pre-recorded patient level data.
- Data Provenance: The data was acquired from two clinical trials:
- VERIFY2
- CONTRAST
- Geographic Origin (implied): Not explicitly stated, but clinical trials like VERIFY2 and CONTRAST are typically multi-center studies that can involve patients from various countries. The document does not specify the countries of origin.
- Retrospective/Prospective: The data appears to be retrospective as it is described as "pre-recorded patient level data acquired from VERIFY2 and CONTRAST clinical trials" for the purpose of validating the new software features.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth for the test set (i.e., FFR values). However, given that FFR is considered the "reference standard" and typically relies on highly trained cardiologists/interventionalists, it can be inferred that these values were established by qualified medical professionals during the original clinical trials (VERIFY2 and CONTRAST).
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1). The FFR values used as the reference standard were presumably established as part of the original clinical trials' protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported here. The study focuses on the algorithmic performance of DFR™ in comparison to iFR® and FFR, rather than evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone (algorithm only) performance study was conducted. The document describes:
- "Smart Minimum and DFR were validated with non-clinical test methods"
- "iFR data from the CONTRAST dataset was re-generated using a bench iFR setup with a commercially available Volcano FFR system."
- "BSC also demonstrated the waveform performance equivalency of the Comet pressure wire to the Volcano pressure wires... and St Jude pressure wires..."
- The primary comparison is between DFR™ and iFR® (both algorithms) against FFR (the reference standard).
The data presented (97.6% Accuracy, 99.2% Specificity, 95.8% Sensitivity) reflects the algorithmic performance of DFR™ in classifying lesions.
7. Type of Ground Truth Used
The primary ground truth used for evaluating DFR™ and iFR® was Fractional Flow Reserve (FFR).
Additionally, the "original iFR values" from the VERIFY2 dataset served as a reference for validating the bench iFR setup.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size of a training set for the DFR™ algorithm. The validation was performed using pre-recorded patient data from existing clinical trials (VERIFY2 and CONTRAST). It's common for such algorithms to be developed and potentially trained on various datasets prior to this validation, but those details are not included in this submission summary.
9. How the Ground Truth for the Training Set Was Established
Since information on a specific training set or its sample size is not provided, how its ground truth was established is also not described in the document.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).