(10 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
- Fetal OB/GYN
- Abdominal
- Intraoperative (abdominal organs)
- Small Organs (breast, thyroid, testicle)
- Pediatric
- Neonatal Cephalic
- Trans-Vaginal
- Trans-Rectal
- Peripheral Vascular
- Cardiac
- Musculo-skeletal (conventional)
- Musculo-skeletal (superficial)
Includes imaging for guidance of biopsy.
The SA6000/Ultramark 400 scanner is a multiple-application ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based (OS:Windows NT) parameter controls, and recording. The selection of eight transducers to be offered with the system permits a wide range of clinical applications. The various transducers adapt the system for the specific imaging tasks. Eight different models of transducers are available and any two may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. Patient contact materials have been tested for biocompatibility in accordance to their intended use and are used for each individual transducer. The SA-6000/Ultramark 400 uses digital beamforming technology. SA-6000/Ultramark 400 supports a variety of Linear and Convex probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz. SA-6000/Ultramark 400 provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of SA-6000/Ultramark 400 are B, B/B, B/M, and M. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
This is a premarket notification for a diagnostic ultrasound system (SonoAce 6000/Ultramark 400). The document asserts substantial equivalence to predicate devices rather than providing a study demonstrating performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not applicable or cannot be extracted from this document.
Here's an analysis based on the provided text:
1. Table of acceptance criteria and the reported device performance:
This document does not contain a table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or reported device performance against such metrics. Premarket notifications for ultrasound systems typically focus on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and intended use, rather than clinical performance studies with specific acceptance criteria.
The only "limits" mentioned are for acoustic output:
| Metric | Acceptance Criteria (Maximum Range) | Reported Device Performance |
|---|---|---|
| ISPTA,3 | 94 mW/cm² | 94 mW/cm² |
| MI | 1.9 | 1.9 |
2. Sample size used for the test set and the data provenance:
Not applicable. The document does not describe a clinical test set or data provenance for evaluating diagnostic performance. The submission relies on establishing substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set:
Not applicable. No test set adjudication 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, not an AI or CAD (Computer-Aided Detection/Diagnosis) system. It does not incorporate AI for independent analysis or human-in-the-loop assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a diagnostic imaging system operated by a human, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth for diagnostic performance is described in this submission. The "ground truth" implicitly referred to is the established clinical utility and safety profile of the predicate devices.
8. The sample size for the training set:
Not applicable. This document does not describe the development of a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. No training set ground truth establishment is described.
Summary based on the document:
The Medison SonoAce 6000/Ultramark 400 Diagnostic Ultrasound System's acceptance criteria and proven performance within this 510(k) submission are based on demonstrating substantial equivalence to existing, legally marketed predicate devices (Medison SA 1500, K924432, and ATL Level 10 HDI Ultrasound, K961459). The primary "study" proving this equivalence is the comparison of:
- Intended Use: The device is intended for the same clinical applications as the predicate devices (e.g., Fetal, Abdominal, Small Organs, Cardiac, Peripheral Vascular, Musculoskeletal).
- Technological Characteristics: The device operates identically to predicate devices, using piezoelectric material to transmit and receive sound waves for 2D and M-mode imaging. It uses digital beamforming technology.
- Acoustic Output Limits: The device's acoustic output (ISPTA,3 and MI) is stated to be within the same limits as predicate Track 1 devices. The document explicitly lists these maximum ranges as the "limits" which the device performance meets.
- Biocompatibility: Patient contact materials have been tested for biocompatibility in accordance with their intended use.
The FDA's review letter (pages {3} and {4}) confirms that the agency found the device substantially equivalent for the stated indications for use, conditional on submitting a post-clearance special report with acoustic output measurements from production units. This type of submission does not typically include detailed clinical performance studies as would be seen for novel AI/CAD systems or devices requiring new safety/effectiveness claims.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.