(96 days)
The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Venue is intended to be used in a hospital or medical clinic. Venue clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatic), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harnonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/ PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD.
The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging. measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinics and hospitals. The Venue is a mobile system with a small footprint that easily fits into tight spaces and positioned to accommodate the sometimes-awkward work settings of the point of care user. The Venue has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The single surface screen provides easy cleanability. Articulated monitor arm enables flexible display positions in order to be accessible and clearly visible in both user-standing and sitting positions. The system is capable of displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal which is used as an input for gating during scanning. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis. A barcode reader and RFID scanner are available as additional input devices. A roller bag will also be available for the customer to use when transporting the system. The Venue has a battery that allows for scanning without the need to plug in to an electrical outlet. The system is capable of wireless communication. System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. The Venue utilizes a variety of linear, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes. Compatible biopsy kits can be used for needle-guidance procedures.
The provided document describes the FDA 510(k) premarket notification for the GE Medical Systems Venue diagnostic ultrasound system. While the primary focus of the document is on establishing substantial equivalence to a predicate device, it also includes an "AI Summary of Testing" specifically for a feature called "cNerve." This summary provides some details about the cNerve feature's acceptance criteria and performance evaluation.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, focusing on the cNerve feature.
Acceptance Criteria and Study for cNerve Feature
The cNerve feature is designed to "detect and track nerves during the scouting stage of a nerve block procedure, prior to inserting the needle to inject the anesthetic material."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (cNerve) | Reported Device Performance (cNerve) |
|---|---|
| Success Criteria: Based on conformance of cNerve detections to ground truth annotations of nerve bundles in individual frames. These criteria were derived from a preliminary survey to identify appropriate thresholds for pixel accuracy in frames and frame accuracy in sequences, considering the intended use of nerve tracking during scouting rather than nerve segmentation. | Achievement: Implied that the device met these criteria, as the overall sequence accuracy requirement was met. The specific pixel accuracy and frame accuracy thresholds from the survey are not detailed, but the derived "cNerve performance requirements" were met. |
| Sequence Accuracy Requirement: At least 70% of the sequences are meaningfully detected. | Achievement: The study implicitly found this criterion to be met, as it states "cNerve performance requirements" were satisfied. Specific percentages are not provided in the summary. |
| Sequence Accuracy Requirement: At least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria). | Achievement: The study implicitly found this criterion to be met, as it states "cNerve performance requirements" were satisfied. Specific percentages are not provided in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Individuals: A total of 44 individuals.
- Sequences: 124 sequences. Each individual contributed up to 2 sequences per view location, often from both laterals (left and right).
- Frames: 3776 frames.
- Data Provenance: Retrospective, collected from "USA, Japan, Israel."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: A single clinical expert.
- Qualifications: "A single clinical expert" - specific qualifications (e.g., years of experience, specialty) are not detailed in the provided text.
4. Adjudication Method for the Test Set
- Adjudication Method: "None" explicitly mentioned. Ground truth annotations were "obtained as follows: Frames from scouting sequences were annotated by a single clinical expert, where the anatomical area of the nerves was marked in each frame." This indicates a single-expert annotation without a specified adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed for the cNerve feature in this summary. The AI testing described focuses on standalone algorithm performance against a single expert's ground truth.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes. The "AI Summary of Testing" describes the evaluation of the cNerve feature's "accuracy" based on its detections conforming to ground truth annotations. The acceptance criteria heavily focus on the algorithm's ability to meaningfully and successfully detect nerves in sequences and frames, suggesting a standalone performance evaluation.
7. The Type of Ground Truth Used
- Type of Ground Truth: Expert consensus (from a single expert). The ground truth was established by "a single clinical expert, where the anatomical area of the nerves was marked in each frame."
8. The Sample Size for the Training Set
- Training Set Sample Size: Not specified in the provided document. The summary only mentions that the "data used for verification is completely distinct from that used during training process and there is no overlap between the two."
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not specified in the provided document. The summary only states that the training data and verification data are distinct.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.