(58 days)
The Acclarix AX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include:
- Abdominal
- Gynecology
- Obstetric
- Cardiac
- Small parts
- Urology
- Musculoskeletal
- Peripheral vascular
- Adult Cephalic
Acclarix AX3 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Acclarix AX3 Series Diagnostic Ultrasound System:
Based on the provided FDA 510(k) summary, the device in question, the Acclarix AX3 Series Diagnostic Ultrasound System, is a diagnostic ultrasound system. For this type of device, the "acceptance criteria" and "device performance" in the context of FDA clearance typically refer to compliance with recognized performance standards and safety requirements rather than a specific algorithmic performance metric. Similarly, "proving the device meets acceptance criteria" is primarily demonstrated through non-clinical testing.
The document explicitly states: "Clinical testing is not required." This is a critical piece of information. Since no clinical testing was performed for the purpose of this 510(k) clearance, many of the requested bullet points, particularly those related to human readers, ground truth establishment, and training/test set details for AI-based performance, are not applicable.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Compliance with ANSI/AAMI ES60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. |
| Basic Safety & Essential Performance | Compliance with IEC 60601-2-37 (Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment). |
| Acoustic Output | Acoustic output testing conducted as per the guideline "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated June 27, 2019. The summary states that acoustic output values are "below the limits of FDA." This implies the device met the safety limits for acoustic output. |
| Biocompatibility of Patient-Contacting Parts | Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process), ISO 10993-5 (Tests for in vitro cytotoxicity), and ISO 10993-10 (Tests for irritation and skin sensitization). |
| Substantial Equivalence | The overall acceptance criterion for 510(k) clearance is demonstrating substantial equivalence to legally marketed predicate devices. The non-clinical performance testing (listed above) concluded that "the subject devices are as safe and as effective as the predicate devices." Key similarities to the primary predicate (Acclarix AX4, K171900) include: Intended Use/Indications for Use, Mode of Operations, Transducer Types, and Acoustic Output. Differences identified (lack of Intra-operative, Pediatric and Neonatal applications; no 3D/4D; different transducer models) were deemed not to raise different questions of safety or effectiveness. |
Study Details (Based on available information)
-
Sample size used for the test set and the data provenance:
- No test set for clinical performance was used as clinical testing was not required.
- For non-clinical performance (electrical safety, EMC, acoustic output, biocompatibility), the "sample size" would refer to the number of devices or components tested. This specific number is not provided in the summary, but it would typically involve a statistically relevant sample or a representative unit for each test.
- Data Provenance: Not applicable in the context of clinical data for performance evaluation. For non-clinical testing, the testing was conducted by Edan Instruments, Inc. as part of their verification and validation process (implied by "Verification and validation testing has been conducted").
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as clinical testing (which would involve expert review for ground truth) was not required for this 510(k) submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication was used.
-
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. The device is a diagnostic ultrasound system, not an AI-assisted interpretation device in the context of this 510(k) submission. This type of study is not relevant to its clearance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware-based diagnostic imaging system, not an AI algorithm requiring standalone performance evaluation in the typical sense.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" would be established by the specifications defined in the relevant international standards (e.g., electrical safety limits in ANSI/AAMI ES60601-1, acoustic output limits as per FDA guidelines). Compliance with these standards serves as the "ground truth" for safe and effective operation.
-
The sample size for the training set:
- Not applicable as no AI training set was used for this device for the purpose of 510(k) clearance.
-
How the ground truth for the training set was established:
- Not applicable as no AI training set was used.
§ 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.