(78 days)
The Clear Guide ONE is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, and for predicting its future path on a display 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 visualization.
The Clear Guide ONE is a medical device that tracks instrument positioning during ultrasound-guided procedures to provide instrument guidance to the end user. The device attaches directly to the transducer probe, and through optical detection technology, the Clear Guide ONE identifies and tracks any needle or needle-like rigid object entering the field of view. By coupling positioning information with the ultrasound image, the projected instrument pathway is displayed to the user for guiding instrumentation. The Clear Guide ONE is an accessory to an existing ultrasound machine and transducer probe.
The provided text describes the Clear Guide ONE device, its intended use, and a summary of performance data used to support its substantial equivalence to a predicate device. However, it does not explicitly provide a table of acceptance criteria or detailed results of a specific study proving the device meets those criteria in the format requested. Instead, it states that "Bench testing was performed to demonstrate that the Clear Guide ONE device could accurately achieve its intended use."
Based on the provided document, here's what can be extracted and inferred regarding the acceptance criteria and study:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally claims that "the Clear Guide ONE is as safe and as effective as the predicate device" and that "its intended function" was accurately achieved.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accurately track instrument positioning | Achieved |
| Display projected instrument pathway | Achieved |
| Safe and effective as predicate device | As safe and effective as the predicate device (AIM, K121479) |
| Compliance with IEC 60601-1-2 | Complies |
| Compliance with IEC 60601-1 | Complies |
2. Sample size used for the test set and the data provenance
The document does not specify a numerical sample size for the test set. It mentions "Bench testing was performed by physicians to validate the device through end users." The data provenance is implied to be from internal bench testing, but no country of origin is specified. The testing seems to be prospective as it was performed to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that "Bench testing was performed by physicians." It does not specify the number of physicians or their detailed qualifications (e.g., years of experience, specialty).
4. Adjudication method for the test set
The document does not mention any adjudication method for the test set.
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
An MRMC comparative effectiveness study is not mentioned. The device, Clear Guide ONE, is an "accessory to an existing ultrasound machine" for augmenting images and predicting needle paths, implying an assistance role, but a study specifically measuring human reader improvement with and without this assistance is not detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device "overlays instrument positioning data onto an existing ultrasound image through proprietary software algorithms," which suggests a standalone algorithmic component. However, the performance data discussed (bench testing with physicians) implies a human-in-the-loop context for validation. No separate "algorithm-only" performance is detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used for the bench testing is not explicitly defined. Given the nature of tracking and projecting needle paths, it would likely involve direct observation and confirmation of accurate tracking and projection by the performing physicians during the bench tests, compared to the actual physical needle position. This would fall under a form of expert observation/review rather than pathology or outcomes data.
8. The sample size for the training set
The document does not provide information about a training set or its sample size. The focus is on demonstrating performance for substantial equivalence to a predicate device.
9. How the ground truth for the training set was established
Since no training set information is provided, how its ground truth was established is also not discussed.
§ 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.