(59 days)
The Portable Ultrasound Diagnostic Scanner is intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Abdomen; Small Parts; Obstetrics; Gynecology; Cardiology; Peripheral Vessels; Urology; Pediatrics; Neonate; Trans-cranial; Musculoskeletal; Fetal; Intra-operative; Transvaginal.
The Portable Ultrasound Diagnostic Scanner comprises of a console, a cart, an AC adaptor, and several transducers and printers. The console is a portable ultrasound diagnostic device with an integrated keyboard and LCD display. It is capable of digital acquisition, processing and display. The mobile cart with multiple socket-outlet and extension transducer connector improves the mobility by having all accessories on it.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SIGMA P5/OMEGA P7/LAMBDA P9 Portable Ultrasound Diagnostic Scanner:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly state quantitative "acceptance criteria" for the device's imaging performance (e.g., specific resolution, penetration depth, or diagnostic accuracy metrics). Instead, it primarily establishes substantial equivalence to a predicate device (GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound System) by demonstrating similar technological characteristics and compliance with relevant safety and performance standards.
The "reported device performance" is implicitly that the device performs equivalently to the predicate device and meets the general safety and performance standards for diagnostic ultrasound systems.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety & Performance Standards Compliance | Complies with AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012; IEC 60601-1-2: 2007; IEC 60601-2-37: 2007; NEMA UD 2: 2004; ISO 10993-5:2009; ISO 10993-10:2010. |
| Similar Intended Use | Intended use is similar to the predicate device, covering abdominal, small parts, obstetrics, gynecology, cardiology, peripheral vessels, urology, pediatrics, neonate, trans-cranial, musculoskeletal, fetal, intra-operative, and transvaginal imaging. |
| Similar Technological Characteristics | Employs the same fundamental technological characteristics as the predicate devices (e.g., imaging modes, acoustic track, power supply, acoustic output, electrical safety, EMC, performance, biocompatibility, software level of concern, design). |
| No New Risks | Differences between the proposed and predicate device do not affect basic design principles, usage, effectiveness, or safety, and raise no new risks. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Non-clinical testing," and references "results of performance and compliance testing conducted on Portable Ultrasound Diagnostic Scanner." The testing focuses on compliance with international and national safety and performance standards (e.g., IEC 60601, NEMA UD 2, ISO 10993).
- Sample Size: Not specified in terms of patient or imaging data. The testing appears to be primarily device-centric (e.g., electrical safety, acoustic output, biocompatibility) rather than a clinical performance study using patient data.
- Data Provenance: The nature of the "non-clinical test results" suggests they are derived from laboratory and engineering tests of the device itself. There is no indication of patient data being used for the "test set" in the context of clinical performance. The manufacturer is "Beijing East Whale Imaging Technology Co., Ltd." in CHINA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided because the testing described is non-clinical and related to device compliance with engineering and safety standards, not a clinical performance study requiring expert ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable, as the document describes non-clinical engineering and safety compliance testing, not a clinical study involving human readers and adjudicated ground truth.
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. The device described is an ultrasound diagnostic scanner, and the submission is for its substantial equivalence to a predicate ultrasound system based on technological similarities and compliance with standards. It is not an AI-powered diagnostic device, nor does the document mention any MRMC studies or AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Not applicable. This is not an algorithm-only device. It's a complete ultrasound diagnostic scanner intended for use by a physician.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The type of "ground truth" for the non-clinical tests would be the established specifications and limits defined by the referenced standards (e.g., maximum acoustic output levels, electrical impedance, biocompatibility test results). There is no clinical "ground truth" (like pathology or expert consensus on diagnoses) discussed in this document.
8. The Sample Size for the Training Set
Not applicable. This device is an ultrasound scanner, not an AI/machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/machine learning model discussed in this document.
Summary of the Study (as described in the 510(k) Summary):
The study described is a non-clinical performance and compliance testing program. It aims to demonstrate that the SIGMA P5/OMEGA P7/LAMBDA P9 Portable Ultrasound Diagnostic Scanner (and its various probe configurations) is substantially equivalent to a legally marketed predicate device (GE Healthcare Vivid i and Vivid q Diagnostic Ultrasound System).
The primary evidence presented for this substantial equivalence is:
- Compliance with recognized safety and performance standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, ISO 10993-5, and ISO 10993-10.
- Similar intended use: The indications for use broadly overlap with the predicate device across various anatomical regions and clinical applications.
- Similar technological characteristics: The document details a side-by-side comparison (table on pages 11-12) showing that the proposed device shares the same classification, product codes, regulation numbers, panel, class, probe types (though specific model names differ, the general categories are similar), acoustic track, imaging modes, power supply, acoustic output limits, electrical safety, EMC, performance standards, biocompatibility standards, software level of concern, and design with the predicate.
The conclusion is that "the differences between the proposed device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the proposed device. And no new risk is raised regarding to effectiveness and safety. The proposed device is substantial with the predicated device." This means the "study" effectively demonstrates that the device functions within established safety parameters and has similar capabilities to an already-approved device, thus meeting the requirements for 510(k) clearance by proving substantial equivalence.
§ 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.