(77 days)
The UltraGuide 1000 system is indicated for enhancing the ultrasonic image of an interventional needle or needlelike rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a 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 clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.
The UltraGuide 1000 provides visual enhancement of the interventional needle by overlaying the image of insertion device and its predicted future path on the insertion action and of the internal organs, all displayed on the monitor of a personal computer. The device uses magnetic transmitters and receivers, sold under the trade name "MiniBirds," to determine the location and orientation of the ultrasound scan head and the interventional needle. The positions and orientations of the interventional device, and the video of the ultrasound image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.
The provided text offers limited information regarding specific, quantifiable acceptance criteria and detailed study results that explicitly "prove" the device meets such criteria. However, I can extract and infer some information based on the content provided.
Here's an attempt to structure the answer based on the given information:
Acceptance Criteria and Device Performance
The submission focuses on establishing substantial equivalence to predicate devices in terms of safety and efficacy, rather than meeting specific quantifiable performance metrics. The implicit acceptance criterion is that the UltraGuide 1000 performs at least as well as or better than the predicate devices without introducing new safety concerns.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety: No adverse events introduced by the device. | "Neither procedure [UltraGuide 1000 or EchoTip needles] had any adverse events." This indicates the UltraGuide 1000 did not cause new safety issues compared to the predicate device in the clinical test. |
| Efficacy/Performance: Comparable or improved performance in needle placement and procedure time. | "The UltraGuide 1000 permitted more rapid abd safer placement of the needles and a more rapid procedure." This suggests improved efficacy over one of the predicate devices (EchoTip needles) in the context of amniocentesis. |
| Technological Equivalence: Use of established technology (magnetic transmitters/receivers). | "The device uses magnetic transmitters and receivers, sold under the trade name 'MiniBirds,' to determine the location and orientation... These devices have been used on medial devices cleared by the FDA." This addresses the technological equivalence to already cleared devices. |
| Bench Test Performance: Comparable physical tests to predicate. | "Physical tests were comparable to that of the ColorMark, which uses a technology which is closer to that of the UltraGuide." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: "over 50 patients"
- Data Provenance: Not explicitly stated, but the context of a clinical test implies prospective data collection for the specific study. No country of origin is specified for the patient data itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text.
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Adjudication method for the test set:
- This information is not provided in the given text.
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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:
- A formal MRMC study as it's typically understood for AI evaluation (with multiple human readers evaluating cases with and without AI assistance to measure improvement) is not described.
- The clinical test involved a comparison between UltraGuide 1000 and EchoTip needles in amniocentesis. While it's a comparative effectiveness study, it's not structured as an MRMC study with explicit "human readers with/without AI assistance" effect size reporting. The reported effect is "more rapid and safer placement of the needles and a more rapid procedure" when using the UltraGuide 1000, implicitly indicating improvement over the predicate.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm-only performance study is not described. The device is described as a "Visualization Enhancement System" and is used "by overlaying the image of insertion device and its predicted future path" to assist a human operator. Its performance is implicitly tied to human interaction.
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The type of ground truth used:
- For the clinical test, the "ground truth" seems to be based on observed clinical outcomes and performance metrics during the amniocentesis procedure (e.g., speed of placement, safety, occurrence of adverse events). It does not appear to rely on an external "ground truth" like pathology for diagnostic accuracy.
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The sample size for the training set:
- This information is not provided. The "UltraGuide 1000" is described as a "Visualization Enhancement System" that uses magnetic tracking and calculations. There is no mention of a machine learning or AI component requiring a "training set" in the traditional sense, although it would have undergone internal engineering and calibration.
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How the ground truth for the training set was established:
- As there is no explicit mention of a machine learning or AI "training set," this information is not applicable/provided.
§ 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.