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510(k) Data Aggregation
(122 days)
The SonoAir Series Digital Color Doppler Ultrasound System is intended for diagnostic ultrasound imaging in B(2D),B/M,M,B+CFM,B+CPA (PD),B+DPD,B+PW,B+CFM + D (PW),B+CPA(PD) + D (PW), Fusion Harmonic Imaging modes. The device is a general-purpose ultrasonic intended for use by an appropriatelytrained qualified clinician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid, testes ), Adult Cephalic, Cardiac Adult. Musculo-skeletal(Conventional, Superficial).Peripheral Vascular, Trans-vaginal and Urology,which is intended to be used in a hospital or medical clinic.
The SonoAir Series Digital Doppler Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array.This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (2D), Fusion Harmonic Imaging, M-Mode, Pulsed Doppler (PW) Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode or a combination of these mode.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SonoAir Series Digital Color Doppler Ultrasound System, structured to answer your questions:
Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission generally relies on demonstrating that the new device is as safe and effective as existing devices, often without requiring new large-scale clinical trials measuring specific performance metrics against pre-defined acceptance criteria in the way a novel AI algorithm might.
1. A table of acceptance criteria and the reported device performance
The document does not provide explicit acceptance criteria and corresponding performance metrics for the SonoAir Series Digital Color Doppler Ultrasound System in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications, safety standards, and intended uses.
The "acceptance criteria" in this context are broadly related to meeting established medical device safety and performance standards, and having comparable features and indications for use as the predicate device. The "reported device performance" is essentially that it complies with these standards and operates similarly to the predicate.
Here's a table based on the provided information, focusing on the comparisons made for substantial equivalence, rather than specific performance metrics against diagnostic acceptance criteria:
| Acceptance Criterion (Implicit) | Reported Device Performance (SonoAir Series) |
|---|---|
| Indications for Use (Substantially Equivalent to Predicate) | Comparable to predicate devices (EBit 90 & XBit 90) with minor differences. Differences analyzed and deemed not to raise new safety/effectiveness concerns. |
| Design | Same autocorrelation for color processing, FFT for pulse/CW Doppler, supporting linear, curve, phase array probes, Cine playback, image archive. |
| Operational Controls | Same design as predicate. Minor differences in setting ranges (e.g., depth range, color wall filter, color baseline, PW sweeping speed, PW sample volume, PW angle correction, baseline) exist but comply with standards and meet clinical requirements. |
| Safety Compliance | Complies with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993 (various parts). |
| Operational Modes | Comparable operational modes (B mode, M mode, CFM, PW, CPA(PD), DPD, Triplex, HPRF, FHI, etc.) to predicate devices. |
| Measurements | Similar 2D, M-mode, and Doppler measurements to predicate devices. |
| Transducer Types & Connectors | Convex Array, Phased Array, Linear Array, 4 ports. Considered similar to predicate (differing slightly in volume probe and number of ports). |
| Users / Sites | Hospitals, clinics usage (same as predicate). |
| Acoustic Output | Track 3; MI, TIS, TIC, TIB (Derated Ispta: 720mW/cm² max, TIS/TIB/TIC: 0.1-4.0 Range, Mechanical Index: 1.9 Max, Derated Isppa: 190 W/cm² max) - same as predicate. |
| Power Requirements | Power requirements: AC: 100V-240V, Freq: 50-60Hz; Operating temp: 10-38°C; relative humidity 30-75%; Barometric pressure: 700 to 1060hPa. Operating temperature is within the scope of the predicate. |
| Software Documentation (Moderate Level of Concern) | Included and reviewed per FDA guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical testing was required." This means there was no specific clinical test set used to evaluate the device against diagnostic performance metrics. The evaluation was based on non-clinical tests demonstrating compliance with recognized standards and a comparison of technical specifications with predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical testing was required, there were no "experts" in the context of establishing ground truth for a diagnostic test set. The evaluation relied on regulatory compliance and engineering comparisons.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
5. 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
Not applicable. This is a general diagnostic ultrasound system, not an AI-assisted diagnostic device, and no clinical studies of this nature were conducted or required for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a general diagnostic ultrasound system, not an AI-driven algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this 510(k), the "ground truth" for demonstrating substantial equivalence was adherence to recognized medical device standards and the technical specifications and operational characteristics of the legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a general diagnostic ultrasound system; there is no mention of an AI component or a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as no training set was identified.
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