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510(k) Data Aggregation
(107 days)
ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER
The Ultrasonix Ergosonix 500 is intended for use in obstetrics/gynecology, general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies. The specific intended uses of this system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), cephalic, small organ (breast, thyroid, testicle), transvaginal, trans-rectal, pediatric and fetal imaging, cardiac (adult) and cardiac (pediatric).
The Ultrasonix Ergosonix 500 Ultrasound Diagnostic Scanner is highly mobile, software-controlled, diagnostic ultrasound system capable of the following operating modes: 2D B-mode, M, Pulsed Doppler, Color Flow (including amplitude Doppler). The system can generate real-time compound images and harmonic images. The system is designed for use in linear and convex scanning modes, and supports linear, convex, and microconvex probes.
This document is a 510(k) Pre-market Notification for the Ultrasonix Ergosonix 500 Ultrasound Scanner. It seeks to demonstrate substantial equivalence to previously cleared predicate devices (ATL HDI 5000 System (K002003) and Acuson Sequoia (K973767)).
The document does not describe "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the typical sense of a clinical performance study with defined metrics for a novel AI device. Instead, it focuses on demonstrating safety and substantial equivalence to predicate ultrasound devices for various clinical applications and imaging modes.
Here's an analysis based on the provided text, addressing the requested information where applicable:
1. A table of acceptance criteria and the reported device performance
The document does not define specific performance acceptance criteria in terms of sensitivity, specificity, accuracy, or other statistical measures typically associated with AI/CADe devices. The "acceptance criteria" for this conventional ultrasound device are implicitly its compliance with recognized safety and performance standards and its substantial equivalence to predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Compliance with EN 60601-1, UL 2601-1, C22-2 No 601-1, EN 60601-1-2, IEC 60601-2-37, AIUM "Acoustic Output Labeling Standard", AIUM "Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices" | The Ultrasonix Ergosonix 500 is "designed to comply" with all listed standards. |
| Acoustic output limits compliance with NEMA UD-3 and 510(k) Diagnostic Ultrasound Guidance (September 30, 1997 revision) | Acoustic output limits reported as: |
| ISPTA: 720mW/cm2 | |
| TIS/TIB/TIC: 0.1 - 4.0 (Range) | |
| Mechanical Index (MI): 1.9 (Maximum) | |
| ISPPA: 0-700 W/cm2 (Range) | |
| These limits are stated to be "the same as predicate Track 3 devices." | |
| Substantial equivalence in intended use, principles of operation, and technological characteristics to predicate devices. | Stated to be "substantially similar" and "operates identically" in principle, with similar hardware and parameters for image quality. Differences noted in "more innovative" programmable system made of 2 building blocks. |
| Intended Use approval for specified clinical applications (Obstetrics/Gynecology, General Radiology, Abdominal, Small parts, Peripheral Vascular, Musculo-skeletal (conventional & superficial), Cephalic (pediatric & adult), Small organ (breast, thyroid, testicle), Transvaginal, Trans-rectal, Pediatric, Fetal imaging, Cardiac (adult & pediatric)) across various modes (B, M, PWD, CD, AD, CVI, Combined, other). | The "Diagnostic Ultrasound Indications for Use Form" (pages 6-9) indicates the system and its transducers (4C1, L7, EC6.5/128) are cleared for a broad range of clinical applications and imaging modes, largely marked with "P" (previously cleared by FDA) or left blank where it implies standard capability. The specific mode availability varies slightly per transducer as detailed in the forms. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not involve a "test set" in the context of clinical data for algorithmic performance evaluation. It's for a conventional ultrasound device, where equivalence is primarily demonstrated through engineering specifications, compliance with standards, and comparison of technical characteristics and intended uses to predicate devices. Therefore, the concept of sample size and data provenance for a test set is not applicable here.
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)
Not applicable, as there is no "test set" requiring ground truth establishment by experts for algorithmic performance evaluation. The review process by the FDA involves their own experts assessing the submitted documentation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" or adjudication of diagnostic outputs from an algorithm.
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 submission for a standalone ultrasound imaging system, not an AI-assisted diagnostic or CADe device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone diagnostic ultrasound imaging system. It produces images and physiological data that are interpreted by a qualified physician. There is no AI algorithm being submitted for standalone performance evaluation in the context of this 510(k).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As this is a conventional ultrasound system, performance is established through technical validation against standards and comparison to predicate devices, rather than through clinical studies requiring a ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm or system that requires a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as above.
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