(280 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Display of slow blood flows by displaying the Doppler backscatter amplitude of the fluid.
The Power Doppler (a.k.a. Angio Doppler) is a new feature of a previously cleared Combison 530D Diagnostic Ultrasound scanner. The Power Doppler is an enhanced Doppler data processing feature that uses previously cleared Color Doppler hardware, but displays only a color encoded signal corresponding to the amplitude of the Doppler signal. It enables visualization of slow blood flows. The data received by the doppler is processed the same way as that for the color Doppler mode. The Power Doppler is used with previously cleared electronic probes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Combison 530D Power Doppler Mode:
Important Note: The provided document is a 510(k) Premarket Notification summary from 1997-1998 for an ultrasound device. It focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive "study" in the modern AI/machine learning sense. As such, many of the requested categories (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance for AI, etc.) are not applicable or not explicitly detailed in this type of regulatory submission for a traditional medical device prior to the widespread use of sophisticated AI algorithms. The "acceptance criteria" here primarily refer to meeting the performance characteristics of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device, the Toshiba SSA380 Color Angio Mode. The primary performance characteristic highlighted for the Power Doppler mode is the visualization of slow blood flows.
| Acceptance Criteria (based on Predicate) | Reported Device Performance (Combison 530D Power Doppler) |
|---|---|
| Display of slow blood flows | Display of slow blood flows (1 to 8 cm/sec) |
| Color encoded display of slow blood flows | Color encoded display of slow blood flows |
| Signal to be displayed: Mean power of Doppler backscatter | Signal to be displayed: Mean power of Doppler backscatter |
| Wall motion filter: Digital | Wall motion filter: Digital |
| Bits used for P-signal display: 5 | Bits used for P-signal display: 8 |
| Filter for inline signals: Moving Average Filter | Filter for inline signals: Inline filter |
| Acoustic output within safe limits (MI or TI greater than 1.0 reported for specific transducer/mode combinations) | Acoustic output within safe limits (MI or TI greater than 1.0 reported for specific transducer/mode combinations) |
| Intended Use: Diagnostic ultrasound imaging or fluid flow analysis for various clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, Peripheral Vascular, Transrectal, Transvaginal, Muscular-Skeletal Conventional, Intra-Operative) | Extended Intended Use: "N" (new) for Amplitude Doppler across all applicable clinical applications for various transducers. "E" (added under Appendix E) for B, M, PWD, CWD, Color Doppler modes and "Combined (B-M)" for some transducers. |
Explanation of "Acceptance Criteria" in this context: The device is demonstrating "substantial equivalence" to a legally marketed predicate device (Toshiba SSA380). Therefore, the "acceptance criteria" are effectively that the new device's technological characteristics and intended use are as safe and effective as the predicate device, or that any differences do not raise new questions of safety or effectiveness. The table reflects a direct comparison of features to support this claim.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. This type of 510(k) submission generally relies on a comparison of device specifications and, if necessary, limited verification and validation testing, not typically patient-based "test sets" in the clinical trial sense for AI.
- Data Provenance: Not specified. The submission focuses on device design and comparison to the predicate, not clinical data from a specific country or retrospective/prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/not specified. For an ultrasound device, "ground truth" often refers to the physical parameters and performance measurable on phantoms or through technical specifications, not expert interpretation of images in a blinded reader study which would be more common for AI-driven diagnostic tools.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. This would typically apply to reader studies where disagreements among expert interpretations are resolved, which is not described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC study was not done for this submission.
- Effect Size of Human Readers with/without AI: Not applicable, as this is a new ultrasound imaging mode (Power Doppler) in a traditional diagnostic device, not an AI-assisted diagnostic tool.
6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance Study: Not applicable in the context of an AI algorithm. The device's performance as a standalone tool (the ultrasound system itself) is implied by the comparison to the predicate device's technical specifications and safety data (e.g., acoustic output).
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance relies on engineering specifications, technical measurements (e.g., acoustic output), and functional equivalence to the predicate device's features. For example, the ability to display slow flow (1-8 cm/sec) is a functional specification, not a diagnostic finding confirmed by pathology or outcomes data in this submission. The "Intended Use" statements for various clinical applications are based on the cleared predicate device's applications and the inherent capabilities of ultrasound.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is an ultrasound system with a new processing mode, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no machine learning "training set" for this device.
§ 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.