(25 days)
ScanNav Anatomy Peripheral Nerve Block is indicated to assist qualified healthcare professionals to identify and label the below mentioned anatomy in live ultrasound images in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older.
The highlighting of structures in the following anatomical regions is supported:
- · Axillary level brachial plexus
- · Erector spinae plane
- · Interscalene level brachial plexus
- · Popliteal level sciatic nerve
- · Rectus sheath plane
- · Sub-sartorial femoral triangle / Adductor canal
- · Superior trunk of brachial plexus
- · Supraclavicular level brachial plexus
- · Longitudinal suprainguinal fascia iliaca plane
- Femoral block
ScanNav Anatomy Peripheral Nerve Block is an accessory to compatible general-purpose diagnostic ultrasound systems.
ScanNav Anatomy Peripheral Nerve Block is a software (SaMD) which assists qualified healthcare professionals to identify and label relevant anatomical structures in preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years of age or older.
The device receives ultrasound images in real-time from a compatible general-purpose ultrasound machine. It processes these images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures. The ultrasound machine display remains unaffected, and the highlighting is only displayed on a general-purpose panel PC provided with the device.
Here's a breakdown of the acceptance criteria and the study details for the ScanNav Anatomy Peripheral Nerve Block device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance (Femoral Block) |
|---|---|
| FP rate: Mis-identification rate of safety critical anatomical structures in the indicated procedures is less than 5%. | 1.1% (2 out of 183 scans) |
| Accuracy (TP+TN) rate: Correct highlighting of safety critical anatomical structures in the indicated procedures at least 80% of the time. | 96.7% (177 out of 183 scans) |
| FN rate: Non-identification rate of safety critical anatomical structures in the indicated procedures is less than 15%. | 2.2% (4 out of 183 scans) |
Note: The software tests also had acceptance criteria (e.g., successful completion of unit test, integration test, etc.) but specific quantitative performance metrics were not provided in the summary, only that "all software tests have been successfully completed without any anomalies."
Study Details
1. Sample Size for the Test Set and Data Provenance:
- Sample Size: 183 scans were used for the safety and accuracy validation of the Femoral Nerve Block.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only states that the tests used "established protocol and acceptance criteria same as that used for the predicate device."
2. Number of Experts Used to Establish Ground Truth and Qualifications:
- This information is not provided in the given 510(k) summary.
3. Adjudication Method for the Test Set:
- This information is not provided in the given 510(k) summary.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- A MRMC comparative effectiveness study was not explicitly mentioned in this summary. The study described focuses on the device's standalone performance against defined criteria, rather than comparing human readers with and without AI assistance.
5. Standalone (Algorithm Only) Performance:
- Yes, the provided performance metrics (FP rate, Accuracy, FN rate) directly reflect the standalone performance of the algorithm for the Femoral Nerve Block. The device processes ultrasound images using AI algorithms and highlights structures, and the reported rates indicate how well the algorithm performs this task independently.
6. Type of Ground Truth Used:
- The summary states that the validation involved "safety and Accuracy validation" through "established test protocols." While not explicitly named (e.g., "expert consensus" or "pathology"), given the context of identifying anatomical structures in ultrasound images, it is highly probable that the ground truth was established by expert consensus (e.g., skilled sonographers or regional anesthetists manually identifying and labeling the structures) or well-defined anatomical landmarks.
7. Sample Size for the Training Set:
- This information is not provided in the given 510(k) summary.
8. How the Ground Truth for the Training Set Was Established:
- This information is not provided in the given 510(k) summary.
N/A