(57 days)
The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.
The primary function of HDi System is to collect reflected ultrasonic (sound) waves from the Kodama catheter and render an intravascular image on the console touchscreen. The catheter emits sound energy from a transducer at the tip; sound waves reflected from the inner vascular tissues are received from the transducer and sent to the console where a high resolution, cross-sectional image is displayed on the touchscreen in real-time.
The main devices are the Console, Patient Interface Module (PIM), Linear Translation System (LTS) (optional), and Kodama Catheter.
The console houses hardware and software required to generate the energy used to excite the transducer in the Kodama catheter; it is the center of control and system architecture for how signals are acquired, processed, images constructed and presented, and overall power management and control of the PIM and LTS. The system digitally records case images, provides a review of recorded cases, and provides for the archival of recorded cases onto removable media.
The handheld PIM provides the electromechanical interface between the catheter and the console. It also provides the mechanical interface to secure the catheter, as well as the mechanical energy to rotate the catheter's imaging assembly. The LTS device provides automated, controlled linear translation of the catheter by providing mechanical coupling to the PIM and to the catheter's telescoping anchor as the PIM is pulled back along the longitudinal axis. The coupling between the LTS and PIM and LTS to catheter is strictly mechanical. The LTS device allows the user to perform automatic pullbacks and can be controlled via touchscreen buttons on the console or the buttons on the LTS. Manual pullbacks may be performed with or without the LTS, making the use of the LTS optional to the user.
The Kodama Catheter emits sound energy from its transducer at the distal tip, which is guided into the coronary and peripheral vasculature. The catheter can be operated at two different frequencies, 40MHz and/or 60MHz, depending on user preference. The catheter design includes an imaging assembly (with transducer, drive cable, coaxial cable, and rotor), sheath assembly (which includes the femoral marker and hydrophilic coating), telescope assembly, and catheter hub assembly. The electrical energy from the catheter is transmitted, via the transmission line embedded in the drive cable, back to the HDi console for signal processing and image reconstruction.
The provided text describes the ACIST Kodama Intravascular Ultrasound Catheter and ACIST HDi System, and cites a 510(k) submission for substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or a dedicated study proving the device meets quantitative acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader improvement.
Instead, the submission focuses on demonstrating substantial equivalence through:
- Bench Testing: Evaluating physical and electrical performance characteristics.
- Animal Study: Confirming imaging capabilities and usability in a peripheral vessel model.
- Comparison to Predicate Devices: Highlighting similar indications for use, fundamental scientific technology, safety, and performance.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's an attempt to answer the questions based on the available information:
1. A table of acceptance criteria and the reported device performance
No explicit quantitative acceptance criteria (e.g., specific accuracy thresholds, sensitivity/specificity targets) or corresponding reported performance values are provided in the document for the new device as compared to a predefined standard. The performance is assessed against specifications and compared to predicate devices qualitatively.
| Acceptance Criteria (Type of Test) | Reported Device Performance (as described) |
|---|---|
| Bench Testing: | |
| Trackability and Deliverability (insertion/retraction force, cross/re-cross force, kink resistance, torque strength) | "meet specifications and perform as intended." |
| Runtime | "meet specifications and perform as intended." |
| Non-Uniform Rotational Distortion (NURD) | "meet specifications and perform as intended." |
| Buckling force | "meet specifications and perform as intended." |
| Animal Study: | |
| Imaging capabilities (in peripheral vessels) | "confirm the HDi System and Kodama Catheter imaging capabilities in the peripheral vessels." |
| Usability (catheter set-up, delivery, retraction) | "provided evaluation on the usability of Kodama catheter... device meets specification and performs as intended." |
2. Sample size used for the test set and the data provenance
- Bench Testing Test Set Sample Size: Not specified.
- Animal Study Test Set Sample Size: "a porcine model" - the exact number of animals is not specified.
- Data Provenance:
- Bench testing data provenance is implied to be from ACIST Medical Systems' internal testing.
- Animal study data provenance is "conducted by ACIST Medical Systems in a laboratory environment."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Bench Testing: Ground truth is established by engineering specifications and direct measurements against those specifications. No external experts are mentioned for ground truth.
- Animal Study: "The physician also provided evaluation on the usability of Kodama catheter." - This suggests at least one physician. Specific qualifications (e.g., years of experience, specialty) are not mentioned. The ground truth here appears to be the visual assessment of imaging capabilities and clinical usability by the physician.
4. Adjudication method for the test set
- No specific adjudication method (like 2+1 or 3+1 consensus) is described for either the bench testing or the animal study. The animal study mentions a "physician also provided evaluation," implying a single observer or their primary findings rather than a multi-reader consensus process for ground truth.
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 multi-reader multi-case (MRMC) comparative effectiveness study is mentioned, nor is there any mention of AI assistance in the context of this device. The device is an intravascular ultrasound system, not an AI-powered diagnostic tool in the sense of assisting human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is an imaging system (hardware and software) that produces images for human interpretation, not an algorithm providing a standalone diagnostic output.
7. The type of ground truth used
- Bench Testing: Engineering specifications and direct physical/electrical measurements.
- Animal Study: Visual assessment of imaging by a physician and their subjective evaluation of usability.
8. The sample size for the training set
- No training set is mentioned as this is not an AI/machine learning device that requires a distinct training and test set for algorithm development in the traditional sense. The device is a medical imaging system.
9. How the ground truth for the training set was established
- Not applicable, as no training set is mentioned.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).