(14 days)
The ACCUVIX A30 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Fetal, Abdominal, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Cardiac Adult, Cardiac Pediatric, Peripheral vessel.
The ACCUVIX A30 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging, PW/CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging. 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The ACCUVIX A30 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The ACCUVIX A30 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided document is a 510(k) Premarket Notification for the SAMSUNG MEDISON CO., LTD. ACCUVIX A30 Diagnostic Ultrasound System, dated August 29, 2011. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study with performance metrics.
The document does not contain any information regarding specific acceptance criteria for device performance, a study that proves the device meets such criteria, test set sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance studies, or details about training sets.
Instead, the document focuses on:
- Device Description: General features and imaging modes of the ACCUVIX A30.
- Intended Uses and Clinical Applications: A broad list of body parts and types of examinations the system and its transducers can be used for (e.g., Fetal, Abdominal, Cardiac Adult, Peripheral vessel).
- Technological Characteristics & Substantial Equivalence: A statement that the ACCUVIX A30 is substantially equivalent in safety, effectiveness, and functionality to previously cleared predicate devices (ACCUVIX XG Diagnostic Ultrasound System (K103397) and ACCUVIX V20 Diagnostic Ultrasound System (K092159)). This is the primary "proof" required for a 510(k) submission.
- Compliance with Safety Standards: A list of international and national safety and EMC standards the device has been designed to meet (e.g., UL 60601-1, IEC60601-2-37).
- Indications for Use for each transducer: Detailed tables for each transducer (C1-4, C2-6IC, C5-8, EC4-9IS, L4-7, L5-13IS, L7-16IS, P2-4BA, V2-6, V5-9, CW2.0, CW4.0, CW6.0) indicating which clinical applications and modes of operation ("new indication" or "previously cleared by FDA") are supported.
Therefore, since this is a 510(k) summary demonstrating substantial equivalence, and not a standalone clinical performance study, most of the requested information regarding acceptance criteria and performance study details is not present in the provided text.
Summary of available information:
| Information Category | Details from Document |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Acceptance Criteria: Not explicitly stated as performance metrics in the context of a clinical study. The device is deemed acceptable if it demonstrates substantial equivalence to predicate devices and complies with relevant safety and technical standards. |
Reported Device Performance: The document states the ACCUVIX A30 "is substantially equivalent with respect to safety, effectiveness, and functionality" to two predicate ultrasound systems (ACCUVIX XG (K103397) and ACCUVIX V20 (K092159)). The "performance" is implicitly considered equivalent to these predicates across the listed clinical applications and modes of operation. The tables for each transducer detail the specific clinical applications and modes they cover, indicating whether they are "new indications" (N) or "previously cleared by FDA" (P) from the predicate devices. This represents the functional capabilities and intended uses that were found to be substantially equivalent. |
| 2. Sample Size (test set) & Data Provenance | Not applicable or not provided. This is a 510(k) submission based on substantial equivalence, not a performance study as described. |
| 3. Number & Qualifications of Experts | Not applicable or not provided. Ground truth for a test set by experts is not described. |
| 4. Adjudication Method | Not applicable or not provided. |
| 5. MRMC Comparative Effectiveness Study | No. The document does not describe an MRMC study or any quantified effect size of human readers improving with AI assistance. |
| 6. Standalone (Algorithm Only) Study | No. The device is a diagnostic ultrasound system with various imaging modes, not an AI algorithm evaluated for standalone performance. The document describes the system's ability to acquire and display ultrasound data and analysis packages which provide information "used to make a diagnosis by competent health care professionals." |
| 7. Type of Ground Truth Used | Not applicable or not provided. The basis for clearance is substantial equivalence to predicate devices, which implies that their established clinical utility and safety profiles serve as the "ground truth" for the new device's acceptable performance. |
| 8. Sample Size for Training Set | Not applicable or not provided. This is not a machine learning/AI device where a training set is typically described. |
| 9. How Ground Truth for Training Set was Established | Not applicable or not provided. |
§ 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.