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Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-380A system in K933743. It is an amplitude based color display subset of color doppler imaging that performs frame addition to accentuate minute vascular structures and signal the presence of blood, rather than the motion of flow. This feature is independent of velocity, angle of incidence and direction of interrogation and reduces the effects of aliasing.
Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and study details.
Based on the provided document (K963705), there is insufficient information to fully answer all aspects of your request. This 510(k) appears to be for a "Color Enhancement Function for the SSA-380A" (Amplitude Doppler), which is a post-processing modification. The submission primarily focuses on establishing substantial equivalence to a previously cleared device (SSA-380A in K933743) rather than presenting a detailed performance study with specific acceptance criteria as one might see for a diagnostic AI algorithm.
However, I can extract and infer information from the text to the best of my ability based on the nature of 510(k) submissions for such modifications:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Expected/Inferred) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|---|
| Safety and Effectiveness | The device performs as intended without introducing new safety risks or compromising the effectiveness of the base device (SSA-380A). | The Color Enhancement Function (Color Angio) is described as a post-processing modification of the already cleared Power Mode display. It "accentuate[s] minute vascular structures and signal[s] the presence of blood, rather than the motion of flow." It is also stated to be "independent of velocity, angle of incidence and direction of interrogation and reduces the effects of aliasing." These descriptions imply it improves or enhances the display of vascular structures without compromising the underlying Doppler principles, thus maintaining or improving effectiveness for its intended use. |
| Technical Performance | The "Color Enhancement Function" should accurately display amplitude-based color information, consistent with the principles of Amplitude Doppler, reducing aliasing effects as claimed. | The device is stated to "perform[s] frame addition to accentuate minute vascular structures and signal the presence of blood..." and that it "reduces the effects of aliasing." This implies that its technical performance in displaying these enhanced features is satisfactory. |
| Substantial Equivalence | The modified device is as safe and effective as a legally marketed predicate device. | The submission directly states "Substantial Equivalence Summary: Color Angio is a post-processing modification to the Power Mode display that was cleared with the SSA-380A system in K933743." This is the primary "performance" being reported – equivalence. |
Important Note: The document does not provide a formal table of acceptance criteria with specific numerical thresholds (e.g., sensitivity, specificity, AUC > X%) or a detailed study demonstrating these criteria being met. The acceptance criteria for such a modification typically revolve around maintaining the safety and effectiveness of the predicate device and demonstrating that the changes do not introduce new risks or alter the fundamental intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This information is not provided in the document.
- Data Provenance: This information is not provided in the document. Given the nature of a 510(k) for a post-processing modification to an existing system, it's possible that internal testing or comparison to existing images was performed, but no details are given. It's likely such a modification would not involve a large, formal clinical trial with a "test set" in the way an AI diagnostic algorithm would.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. For a color display enhancement, "ground truth" might involve expert subjective assessment of image quality, clarity, and visualization of structures, but no details on such a process are given.
4. Adjudication Method for the Test Set
- This information is not provided in the document, and it's unlikely a formal adjudication method was used given the nature of the submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a MRMC comparative effectiveness study is not mentioned or implied. The document focuses solely on the device itself and its substantial equivalence. The concept of "human readers improve with AI vs without AI assistance" is not applicable here as this is a display enhancement for human interpretation, not an AI assisting in a diagnostic task.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This information is not explicitly stated, but the "Color Enhancement Function" (Color Angio) is an algorithm (post-processing modification) that operates independently to generate the enhanced display. Its performance is its standalone generation of this enhanced image. However, its effectiveness is ultimately dependent on human interpretation of that image.
7. The Type of Ground Truth Used
- This information is not explicitly provided. For a display enhancement feature, "ground truth" might implicitly refer to:
- Physics-based validation: Ensuring the algorithm correctly processes amplitude data.
- Subjective expert assessment: Experts reviewing enhanced images and confirming improved visualization of vascular structures compared to non-enhanced images.
- Clinical observation: Demonstrating that the enhanced images aid in clinical assessment (e.g., finding minute vessels).
- Given the brevity, it's most likely that internal technical validation and perhaps a limited expert review were performed, focusing on whether the feature did what it claimed (accentuated structures, reduced aliasing).
8. The Sample Size for the Training Set
- This information is not provided. As this is described as a "post-processing modification" rather than a machine learning model requiring extensive training data, the concept of a "training set" in the context of AI (neural networks, etc.) is likely not applicable in the way you're thinking. It's more likely a traditional image processing algorithm.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided, and as noted above, a "training set" with established ground truth in the AI sense is likely not applicable to this type of device modification.
§ 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.