(14 days)
The ACCUVIX XQ ™ system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal (including infertility monitoring of follicle development), Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal, Muscular-skeletal, Urology, TCD, Cardiac (Adult, Pediatric), and Peripheral-vascular (Carotid, Arterial, Venous) applications.
The ACCUVIX XQ "M is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging, Harmonic imaging, and PW Spectral Doppler mode on the CRT display. It also provides the 3D imaging mode using the 3D probe in the Mechanical scan mode. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.
The provided document is a 510(k) summary for the ACCUVIX XQ™ Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and outlining the intended uses and technical characteristics.
Crucially, this document does NOT contain information about specific clinical studies or performance metrics (like sensitivity, specificity, etc.) that would typically define acceptance criteria and prove a device meets those criteria for image analysis software or AI algorithms.
The information provided describes a diagnostic ultrasound system and its transducers, which are hardware devices. The "performance" being discussed relates to their ability to produce various types of ultrasound images and measurements, and their compliance with safety standards. It does not describe a device that interprets images or performs a specific diagnostic task for which concrete performance metrics would be required.
Therefore, many of the requested points cannot be extracted from this document.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:
Acceptance Criteria and Device Performance (Based on available information)
The ultimate "acceptance criterion" for this type of device (a diagnostic ultrasound system) in a 510(k) submission is typically demonstrating substantial equivalence to existing legally marketed predicate devices, and adherence to relevant safety and performance standards. The device's performance is implicitly tied to its ability to function as intended across various clinical applications.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate ultrasound systems | ACCUVIX XQ™ is substantially equivalent to SONOACE 9900 PLUS (K032329) and SONOACE 9900 (K012867, K002185) |
| Compliance with electromechanical safety standards | Meets UL 60601-1, C22.2 No. 601.1, EN 60601-1, EN 60601-1-2, IEC 61157, ISO10993 |
| Ability to acquire and display various ultrasound modes | Acquires and displays 2D, M, Color Doppler, Power Doppler, Harmonic imaging, PW Spectral Doppler, and 3D imaging modes. |
| Provision of anatomical measurements and analysis packages | Provides measurement of anatomical structures and analysis packages for clinical diagnostic purposes. |
| Display of acoustic output indices (Mechanical Index, Thermal Index) | Real-time acoustic output display with Mechanical Index and Thermal Index, automatically displayed. |
| Performance across specified clinical applications with listed transducers | Demonstrated for various applications (Fetal, Abdominal, Pediatric, Small Organ, etc.) and specific transducers, including modes of operation (B, M, PWD, CWD, Color Doppler, Combined, Other). Specific transducer models listed. |
| Hazard analysis with "Moderate" level of concern | Hazard analysis performed, "Level of Concern" classified as "Moderate". |
Study Details (Cannot be fully answered due to nature of document)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. This document describes a hardware device (ultrasound system) and its transducers. It discusses general intended uses and compliance with technical standards, not the performance of an AI or image analysis algorithm that would typically require a test set of patient data. The "studies" referenced are conformity to electromechanical safety standards.
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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. There is no mention of a test set requiring expert-established ground truth for an AI or image analysis task.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No such test set or adjudication is described.
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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
- No. This document describes a diagnostic ultrasound system, not an AI or image analysis software that assists human readers. No MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a hardware device. No standalone algorithm performance is discussed.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. No ground truth for image interpretation or diagnosis is discussed. The "ground truth" here would relate to whether the machine produces images correctly and within safety limits, which is assessed through engineering tests and inspections against standards.
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The sample size for the training set
- Not applicable. This document does not describe an AI or machine learning algorithm requiring a training set.
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How the ground truth for the training set was established
- Not applicable. No training set is described.
Summary of what the document implies about "studies":
The "studies" are primarily engineering and safety tests to ensure the device meets specified electromechanical standards (UL, C22.2, EN, IEC, ISO10993) and that its acoustic output is within declared limits. The "conclusion" section states: "The submission contains the results of a hazard analysis and the 'Level of Concern for potential hazards has been classified as 'Moderate'". It also mentions that the device "will be manufactured in accordance with the voluntary standards listed." A post-clearance special report is requested to contain "complete information, including acoustic output measurements based on production line devices."
The document is a regulatory filing for a medical imaging hardware system, not a software or AI device for image analysis. Therefore, the types of clinical studies and performance criteria typically associated with AI/software devices (like sensitivity, specificity, sample size of test/training data, expert adjudication, etc.) are absent.
§ 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.