(22 days)
The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include: Abdominal Gynecology (including endovaginal) Obstetric Cardiac Small parts (Breast, Testes, Thyroid, etc.) Urology Musculoskeletal Peripheral vascular Intra-operative
The Acclarix AX8 is a portable laptop diagnostic ultrasound system, intended for use by a qualified physician or sonographer for ultrasound evaluation in Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers, which applies advanced technologies such as HPRF, Dual screen display, Panorama, Spatial Compounding Imaging, Frequency Compounding Imaging, Multi-Beam-Forming, Speckle Resistance Imaging (eSRI), One-Key Optimization, B-Steer, Digital Zoom, Needle Visualization, etc. Various image parameter adjustments, 15 inch LCD display with 10 inch touch screen and 5 inch track pad and diverse probes are configured to acquire and display clear and stable ultrasound images.
The provided document is a 510(k) premarket notification for the Edan Instruments Acclarix AX8 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical studies against specific acceptance criteria for diagnostic performance.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning advanced diagnostic performance (e.g., sensitivity, specificity, accuracy) for a given clinical task.
Instead, the document highlights:
- Substantial equivalence: The device is claimed to be substantially equivalent to predicate devices (Acclarix AX8 r.10 Diagnostic Ultrasound System/K150999 and U50 Diagnostic Ultrasound System/K142511).
- Compliance with safety and technical standards: The device complies with standards like IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), and acoustic output testing guidelines, as well as biocompatibility standards (ISO 10993 series).
- Intended Use and Clinical Applications: The document lists the intended use as "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and specifies various clinical applications (e.g., Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative).
Missing Information:
The document explicitly states: "Clinical testing is not required." This means there is no study presented in this document that would provide acceptance criteria for diagnostic accuracy, sensitivity, specificity, etc., nor a study proving the device meets such criteria for a specific clinical task.
Therefore, I cannot provide the following information based on the given text:
- A table of acceptance criteria and the reported device performance: No such criteria or performance metrics for diagnostic effectiveness are detailed.
- Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned as clinical testing was not required.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set is described.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted. The focus is on substantial equivalence to existing devices.
- Standalone performance (algorithm only without human-in-the-loop performance): This is not an AI-driven diagnostic algorithm but a general-purpose ultrasound imaging system, so this concept does not apply in the context of this document.
- Type of ground truth used: Not applicable as diagnostic performance metrics (which require ground truth) are not provided.
- Sample size for the training set: Not applicable as this is not an AI algorithm requiring a training set in the sense of machine learning for diagnostic tasks.
- How the ground truth for the training set was established: Not applicable.
Summary of available information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Substantial Equivalence: Demonstrated "same intended use, similar product design, same performance effectiveness, performance safety as the predicate device" (K150999 and K142511).
- Reported Device Performance:
- Safety Standards Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, -5, -10, -12, AIUM, NEMA UD 2, UD 3.
- Acoustic Output: Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0), Derated ISPTA: 720W/cm2 maximum, Mechanic Index ≤ 1.9 maximum or Derated ISPPA 190 W/cm2 max. Ophthalmic use: TI = Max (TIS_as, TIC) ≤1; ISPTA.3 ≤ 50m/W/cm2; and MI
§ 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.