(139 days)
The modified U-2000 is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3 dimensional image processing.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Small Organ (breast, thyroid, testes), Peripheral Vascular, Musculo-skeletal Conventional.
The modified U-2000 software provides the capability for the acquisition, analysis, storage and retrieval of digital 3D ultrasound image data sets and multiplaner reformatting capabilities.
The U-Systems Inc. 510(k) Notification for the U-2000 Ultrasound System with modified software (K013848) does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, the Echotech 3D Freescan, and adherence to internal software quality assurance procedures.
Therefore, many of the requested fields cannot be directly extracted from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
No specific, measurable acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity values) or numerical performance metrics for the modified software are provided in the document. The document primarily attests to functional capabilities and intended use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance
No information is provided regarding a specific "test set" for performance evaluation, its sample size, or data provenance (e.g., country of origin, retrospective or prospective). The validation mentioned is related to software quality assurance procedures.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
No information is provided regarding experts, ground truth establishment, or their qualifications, as no specific performance study with a test set is detailed.
4. Adjudication method for the test set
Not applicable, as no specific test set or adjudication process is described.
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 device is a diagnostic ultrasound system with modified software for 3D reconstruction and analysis, not an AI-assisted diagnostic tool as understood in the context of MRMC studies for AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is a diagnostic ultrasound system. While it has software for image acquisition, analysis, storage, and retrieval, the primary performance would inherently involve a human operator and interpretation. No "standalone algorithm" performance is described in the context of diagnostic accuracy. The "standalone" performance here refers to the software's ability to perform its specified functions (acquisition, reconstruction, analysis, storage, retrieval) which are implicitly covered by the software validation.
7. The type of ground truth used
No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as a benchmark for evaluating the modified software's performance, as the submission focuses on functional equivalence and software validation rather than a diagnostic accuracy study.
8. The sample size for the training set
Not applicable. The document describes a software modification to an existing ultrasound system, not a machine learning or AI model that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as no training set is discussed.
Summary of the Study Discussed in the Document:
The provided documents indicate that the "study" for the modified U-2000 software primarily consisted of software validation according to the company's software quality assurance procedures, as certified in the original 510(k) Notification. This validation ensures that the software correctly performs its intended functions (acquisition, analysis, storage, and retrieval of digital 3D ultrasound image data sets and multiplaner reformatting capabilities).
The basis for regulatory clearance (510(k)) is substantial equivalence to an existing legally marketed predicate device (Echotech 3D Freescan) regarding features, specifications, and intended use, rather than a de novo performance study against explicit effectiveness criteria. The FDA's letter confirms this substantial equivalence determination based on the provided information. The new indications listed for the USI-2000 system and its transducers (7.5 MHz and 10 MHz) relate to expanded clinical applications for various modes of operation (B, M, PWD, Color Doppler, Amplitude Doppler, and combined modes) in areas like Abdominal, Small Organ, Peripheral Vascular, and Musculoskeletal imaging.
§ 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.