(12 days)
The ACCUVIX V7 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, Obstetrics, Gynecology, Extremity, Urology, Breast. Renal, Vascular, Pediatric, Abdomen, Cardiac, Neonatal, Fetal Echo, Carotid, Varicose, Fetal Abdominal, Small organ, Intra-operative, Cephalic, Muscular-skeletal, Trans-rectal, Trans-vaginal, Contrast Agent, Transesophageal and Peripheral-vascular applications.
The ACCUVIX V7 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 ACCUVIX V7 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. 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) Premarket Notification for the ACCUVIX V7 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical studies with specific acceptance criteria and performance metrics typically associated with novel device approvals.
Therefore, the document does not contain details about acceptance criteria or a study proving the device meets them in the context of clinical performance like sensitivity, specificity, or reader studies. Instead, the "acceptance criteria" for a 510(k) are generally the demonstration of substantial equivalence to a predicate device and compliance with applicable recognized standards.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance:
No such table is provided in the document. The submission focuses on demonstrating equivalence to predicate devices and adherence to relevant safety and performance standards for ultrasound equipment.
2. Sample size used for the test set and data provenance:
Not applicable. The document does not describe a clinical performance study with a test set of patient data to evaluate algorithmic performance. The evaluations mentioned are primarily engineering and safety compliance tests.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable. There is no mention of a test set with ground truth established by experts for clinical performance evaluation.
4. Adjudication method for the test set:
Not applicable. No test set for clinical performance is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of AI on human reader performance, which is not relevant to a 510(k) for a general diagnostic ultrasound system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The ACCUVIX V7 is a diagnostic ultrasound system, not an AI algorithm intended for standalone performance evaluation in a clinical decision-making context.
7. The type of ground truth used:
Not applicable in the context of clinical performance metrics. The "ground truth" for this submission revolves around:
- Compliance with recognized standards: UL 60601-1, CSA C22.2 No. 601.1, IEC60601-2-37, EN/IEC60601-1, EN/IEC60601-1-2, NEMA UD 2-2004, NEMA UD 3-2004, IEC 61157, ISO10993 (as listed in Section 4).
- Substantial equivalence to predicate devices: ACCUVIX XQ Diagnostic Ultrasound System (K052911) and SA8000 Diagnostic Ultrasound System (K013627). This is the primary "ground truth" for a 510(k) – that the new device is as safe and effective as existing legally marketed devices.
8. The sample size for the training set:
Not applicable. This device is a diagnostic ultrasound system and not an AI/ML algorithm that undergoes training on a dataset in the typical sense.
9. How the ground truth for the training set was established:
Not applicable, as no training set for an AI/ML algorithm is mentioned.
Summary of Device Acceptance and Evidence from K060087:
The acceptance of the ACCUVIX V7 Diagnostic Ultrasound System is based on demonstrating substantial equivalence to predicate devices (ACCUVIX XQ Diagnostic Ultrasound System, K052911; and SA8000 Diagnostic Ultrasound System, K013627) and compliance with relevant safety and performance standards.
Acceptance Criteria (as implied by a 510(k) submission):
- Technological Characteristics: The device must have technological characteristics similar to the predicate device, or if different, demonstrate that these differences do not raise new questions of safety or effectiveness.
- Intended Use: The device must have the same intended use as the predicate device, or if different, demonstrate that this difference does not raise new questions of safety or effectiveness.
- Performance Standards: The device must demonstrate compliance with recognized industry and international safety and performance standards for diagnostic ultrasound equipment.
- Acoustic Output: Acoustic output levels must be within established limits for diagnostic ultrasound equipment, often verified through measurement against NEMA UD 2 and IEC 61157 standards.
- Biocompatibility: Materials in contact with patients must meet biocompatibility standards (e.g., ISO10993).
- Electrical Safety and EMC: The device must comply with electrical safety and electromagnetic compatibility standards (e.g., UL 60601-1, IEC60601-1, IEC60601-1-2).
Study/Evidence that Proves the Device Meets Acceptance Criteria:
The document implicitly refers to various forms of evidence:
- Substantial Equivalence Argument: The core of the 510(k) is the argument (in Section 6) that the ACCUVIX V7 is substantially equivalent to the predicate devices. This typically involves comparing design features, materials, energy source, and intended uses. The letter from the FDA confirms this determination.
- Compliance with Standards (Section 4): Medison Co. Ltd. states that the ACCUVIX V7 has been designed to meet a comprehensive list of product safety standards, including:
- UL 60601-1 (Safety for Medical Equipment)
- CSA C22.2 No. 601.1 (Safety for Medical Equipment)
- IEC60601-2-37 (Diagnostic Ultrasound Safety Standards)
- EN/IEC60601-1 (Safety for Medical Equipment)
- EN/IEC60601-1-2 (EMC for Medical Equipment)
- NEMA UD 2-2004 (Acoustic Output Measurement Standard)
- NEMA UD 3-2004 (Real-Time Display of Acoustic Output Indices)
- IEC 61157 (Declaration of Acoustic Output)
- ISO10993 (Biocompatibility)
- Acoustic Output Measurements: The FDA's clearance letter explicitly requires a "postclearance special report" containing "complete information, including acoustic output measurements based on production line devices, requested in Appendix G" of their guidance document. This indicates that actual measurements are a critical component of verifying safety for acoustic output.
- Indications for Use (Sections 5-25): The detailed tables outlining the clinical applications and modes of operation for the main system and each transducer (e.g., C1-4EC, L4-7EL, MPT4-7AC) demonstrate how the device's intended use aligns with established practices and the predicate devices. "N" indicates a new indication, implying Medison provided justification for its safe inclusion, while "P" indicates previously cleared indications (through predicate devices).
In summary, for a traditional diagnostic ultrasound system like the ACCUVIX V7, "acceptance criteria" are met through a demonstration of engineering compliance to recognized standards and a showing of substantial equivalence to already cleared devices, rather than through extensive clinical trials with statistical endpoints.
§ 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.