(239 days)
The InVision System is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.
The InVision System is an accessory to ultrasound systems that provides guidance for the placement of needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters).
The InVision System consists of four (4) principal components:
- a passive infrared position tracking system; (1)
- (2) tracking mounts for the ultrasound transducer and the needle;
- custom guidance software installed on a computer; and (3)
- (4) a stereoscopic monitor with passive glasses for viewing the monitor.
Acceptance Criteria and Study for the InVision System
Based on the provided K083728 510(k) Premarket Application for the InVision System, the following information can be extracted regarding its acceptance criteria and the study conducted to demonstrate compliance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes bench tests that were conducted. However, it does not explicitly state specific quantifiable acceptance criteria with corresponding reported performance metrics. Instead, it offers a general statement about the study's outcome.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (as stated in the document) |
|---|---|
| Capable of safely performing the stated intended use | "The results of these studies demonstrate that the InVision System is capable of safely and accurately performing the stated intended use." |
| Capable of accurately performing the stated intended use | "The results of these studies demonstrate that the InVision System is capable of safely and accurately performing the stated intended use." |
| Similar effectiveness to the Ultraguide 1000 predicate device (K974432) | "The results also show similar effectiveness to the Ultraguide 1000 predicate device (K974432)." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Bench tests were conducted." This implies an artificial or controlled environment rather than a clinical trial with human subjects.
- Sample Size: The specific sample size for the "bench tests" is not provided.
- Data Provenance: The data provenance is laboratory/bench testing, not human subjects. Therefore, there is no country of origin or retrospective/prospective designation in the traditional clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that the testing involved "bench tests" and not clinical data requiring expert interpretation, there is no mention of experts used to establish ground truth for a test set in the traditional sense linked to medical imaging diagnosis or intervention. The ground truth for bench tests would typically be established through precise measurements and known physical parameters.
4. Adjudication Method for the Test Set
As the testing was "bench tests" and did not involve human expert interpretation of medical images for ground truth, an adjudication method (like 2+1, 3+1) is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted according to the provided text. The study focused on bench testing and comparison to a predicate device's effectiveness, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document refers to "bench tests" to evaluate the "performance characteristics of the InVision System." Since the InVision System is an accessory that enhances the ultrasonic image and predicts the needle path for physician guidance, the "standalone" performance in this context would likely refer to the accuracy of its tracking system, prediction algorithms, and display overlay in a controlled environment. The results of these bench tests are the closest indication of standalone performance, demonstrating its capability of "safely and accurately performing the stated intended use."
7. Type of Ground Truth Used
The "bench tests" would likely use known physical parameters and precise measurements as the ground truth. For instance, the ground truth for needle position and predicted path would be established by physical measurements in a phantom or controlled setup, and the system's output would be compared against these known values. No mention of expert consensus, pathology, or outcomes data as ground truth is made, which aligns with bench testing rather than clinical study.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This suggests that either:
- The system was not developed using machine learning that requires a distinct training set in the modern sense.
- The details of any internal development/training data were not deemed necessary to include in the 510(k) summary for this type of device and submission.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided (as per point 8), there is no information on how ground truth for a training set was established.
§ 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.