(53 days)
The Edan AX4 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
- Pediatric
- · Neonatal (including abdominal and cephalic)
- · Adult Cephalic
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
The Acclarix AX4 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.
The provided text is a 510(k) Pre-market Notification for the Acclarix AX4 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data to define acceptance criteria for novel device performance. Therefore, the document does not describe acceptance criteria for device performance based on a study, nor does it present results from such a study.
Instead, it asserts substantial equivalence by comparing the Acclarix AX4 to a predicate device (Acclarix AX8 Diagnostic Ultrasound System, K171824) across various parameters, including intended use, indications for use, safety standards, patient contact materials, modes of operation, measurements, principle of operation, acoustic output, transducer types, and features.
The document states that "Clinical testing is not required" for this submission, further indicating that no study was conducted to prove the device meets specific performance acceptance criteria beyond demonstrating equivalence to the predicate.
However, based on the information provided, I can respond to some of your specific questions related to the non-clinical testing performed to support substantial equivalence.
1. A table of acceptance criteria and the reported device performance:
The document does not provide specific performance acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, or effect size. Instead, it relies on demonstrating compliance with recognized safety and performance standards, and sameness in various operational and technical specifications compared to the predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Acclarix AX4) |
|---|---|
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body |
| Indications for Use | Abdominal, Gynecology (including endovaginal), Obstetric, Cardiac, Small parts (Breast, Testes, Thyroid, etc.), Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal (including abdominal and cephalic), Adult Cephalic. While the general list is similar, the document notes a "Difference" in the specific list of indications between the Acclarix AX4 and the predicate Acclarix AX8 R1.3. For the Acclarix AX4 System specifically, the provided tables show which applications are "P" (previously cleared) or "N" (new indication) for each transducer (e.g., P5-1Q transducer lists "N" for Abdominal, Adult Cephalic, Adult Cardiac, Pediatric Cardiac). |
| Installation and Use | Portable (laptop), Mobile Equipment |
| 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 |
| Patient Contact Materials | Compliant with ISO 10993 |
| Mode of Operations | B-Mode, M-Mode, Color, PDI/DPDI, PW, CW, 3D/4D |
| Measurements | B-Mode: Distance, Circ/Area, Angle, Volume, Stenosis ratio; M-Mode: Distance, Time, Slope and Heart Rate; D-Mode: Velocity, RI, Time, PI, Heart Rate, Auto Trace PG, S/D, ΔV, Acceleration, PHT, VTI |
| Principle of Operation | Applying high voltage burst to the Piezoelectric material in the transducer and detect reflected echo to construct diagnostic image |
| Acoustic Output | Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0), Derated ISPTA: 720 mW/cm2 maximum, Mechanic Index ≤ 1.9 maximum or Derated ISPPA 190 W/cm2 max. Ophthalmic use: TI = Max (TIS_as, TIC) ≤1; ISPTA.3 ≤ 50 mW/cm2; and MI ≤ 0.23 |
| Transducer Frequency | 1-17 MHz |
| Features | 3D/4D, CW, 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, Auto IMT |
Note: The document explicitly states "Clinical testing is not required." The basis for clearance is substantial equivalence to a predicate device, supported by non-clinical testing demonstrating compliance with recognized standards and comparable specifications.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical performance study was conducted. The non-clinical testing involved device verification and validation activities against standards and specifications.
3. 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. No clinical ground truth was established from expert review for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical ground truth was established.
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. This device is an ultrasound system, not an AI-assisted diagnostic tool, and no MRMC comparative effectiveness study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an ultrasound system, not an algorithm, and no standalone performance study was mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this 510(k) submission, the "ground truth" for the device's acceptability relies on its compliance with international safety and performance standards and its substantial equivalence to a previously cleared predicate device, rather than diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
Not applicable, as no AI/machine learning model was trained for this device.
9. How the ground truth for the training set was established
Not applicable, as no AI/machine learning model was trained for this device.
§ 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.