(95 days)
Qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures. The pullback feature of the PIMr withdraws the imaging core within the protective sheath for a maximum of 15cm.
SpinVision is an accessory to the In-Vision Gold Imaging System that enables the Revolution 45MHz Rotational Imaging Catheter to generate intravascular ultrasonic images. The primary components of the SpinVision accessory consist of the Patient Interface Module (PIMr), upgraded Analog/Digital/Sigma board, and the host software. The ability to perform an automatic or manual pullback is integrated into the PIMr. An RFID transmitter within the rotational catheter sends a low frequency signal to the PIMr allowing it to recognize the name and serial number of the catheter.
Here's a breakdown of the acceptance criteria and study information for the In Vision Gold with SpinVision device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary only states that "Applicable testing was performed to evaluate the SpinVision accessory to the In-Vision Imaging System. The test results were found to be acceptable as required by the test plans and protocols." It does not provide specific quantitative acceptance criteria or detailed reported device performance metrics. Therefore, this section cannot be fully completed from the given text.
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "Applicable testing was performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not provide information on the number of experts used to establish the ground truth or their qualifications.
4. Adjudication Method for the Test Set:
The document does not mention an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that an MRMC comparative effectiveness study was performed, nor does it provide any effect size for human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance:
The document does not explicitly state whether a standalone performance study (algorithm only without human-in-the-loop) was done. The description of SpinVision as an "accessory" suggests it integrates with an existing imaging system (In-Vision Gold), implying it's not a standalone diagnostic algorithm in the sense of AI-driven image interpretation.
7. Type of Ground Truth Used:
The document does not specify the type of ground truth used for testing.
8. Sample Size for the Training Set:
The document does not provide any information regarding a training set or its sample size. This is typical for 510(k) submissions of this era for devices that are not primarily AI/ML algorithms requiring extensive training data.
9. How Ground Truth for the Training Set Was Established:
As no training set is mentioned (see point 8), there is no information on how its ground truth was established.
Summary of the Study Information Provided Regarding Device Performance:
The provided 510(k) summary describes the In Vision Gold with SpinVision as an accessory to an existing Intravascular Ultrasound (IVUS) Imaging System. The primary purpose of this submission is to demonstrate its substantial equivalence to predicate devices, not primarily to showcase performance through detailed clinical trials against specific acceptance criteria.
The key statement regarding performance is: "Applicable testing was performed to evaluate the SpinVision accessory to the In-Vision Imaging System. The test results were found to be acceptable as required by the test plans and protocols."
This type of statement is common in 510(k) submissions where the device builds upon established technology and the focus is on safety and effectiveness through equivalency. The document mentions the intended use of the device: "Qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature. As an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures." The "pullback feature" is also highlighted.
However, the 510(k) summary does not provide any specific quantitative (numerical) acceptance criteria or detailed results of the testing beyond the general statement of acceptability. It does not specify sample sizes, ground truth methodologies, expert qualifications, or details about the types of studies typically associated with AI/ML algorithm evaluation (like MRMC or standalone performance).
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.