(52 days)
The 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
The Acclarix series contains the Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems sharing a software platform (Edan Ultrasound Software Platform, also abbreviated as EUP) and the most parts of hardware platform from Edan Instruments. The Acclarix AX8 is a portable laptop diagnostic ultrasound system. A simple way to summarize the difference is that the Acclarix LX8 is a cart based version of the Acclarix AX8.
This FDA 510(k) K180862 document describes the Acclarix LX8 and Acclarix AX8 Diagnostic Ultrasound Systems, focusing on their intended use, clinical applications, and comparison to predicate devices to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a "table of acceptance criteria" in the format of specific thresholds for quantitative performance metrics (e.g., sensitivity, specificity, accuracy) and then report actual device performance against those thresholds. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.
The "acceptance criteria" can be inferred as meeting the safety and performance requirements of standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993 for biocompatibility, as well as adherence to FDA guidelines for acoustic output (NEMA UD 2, UD3). The reported device performance is that it complies with these standards and has similar performance effectiveness and safety to the predicate devices.
We can synthesize the comparison tables (Table 2-1, 2-2, 2-3) to show how the device's characteristics meet or are similar to the predicate devices, which implies meeting the established performance and safety profiles.
Inferred "Acceptance Criteria" and Reported Performance:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety and Essential Performance Standards Compliance | The Acclarix AX8 and Acclarix LX8 Diagnostic Ultrasound Systems comply with: |
- IEC 60601-1 Electrical Safety
- IEC 60601-1-2 Electromagnetic Compatibility
- IEC 60601-2-37 Requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
- NEMA UD 3 Standard for real-time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment. |
| Acoustic Output Compliance | Acoustic output testing performed as per FDA guidelines ("Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" dated September 9, 2008). - Track 3: MI, TIS, TIC, TIB (TI Range 0-6.0)
- Derated ISPTA: 720 W/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 ≤ 0.23 |
| Biocompatibility of Patient Contact Materials | Complies with ISO 10993-1, ISO 10993-5, and ISO 10993-10. |
| Intended Use (Comparison to Predicate) | Same as predicate devices (Diagnostic ultrasound imaging or fluid flow analysis of the human body). |
| Indications for Use (Comparison to Predicate) | Same as predicate devices (extensive list including Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal cephalic, Adult cephalic). |
| General Product Design & Features (Comparison to Predicate) | Similar in product design, principle of operation, and transducer types/frequency range to predicate devices. Differences in modes of operation, measurements, display, and transducer ports are noted but do not raise questions of effectiveness and safety. |
| Performance Effectiveness (Comparison to Predicate) | Similar performance effectiveness to the predicate device. Differences are noted but deemed not to affect basic design principle, usage, effectiveness, and safety. |
| Performance Safety (Comparison to Predicate) | Similar performance safety to the predicate device. Differences are noted but deemed not to affect basic design principle, usage, effectiveness, and safety. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify any sample size for a test set in the context of clinical performance evaluation (e.g., number of patients/scans). This is because the submission primarily relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.
Similarly, there is no information provided regarding data provenance (country of origin, retrospective or prospective) for clinical data, as formal clinical testing with patient data was not a required component of this 510(k) submission.
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):
As no "test set" in the sense of clinical cases evaluated for ground truth is described in the document, there is no information regarding the number or qualifications of experts used to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Since there is no described test set or expert evaluation of clinical cases, there is no adjudication method mentioned in the document.
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:
The document does not mention any MRMC comparative effectiveness study, nor does it discuss AI assistance or its effect size on human reader performance. The device described is a diagnostic ultrasound system, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a diagnostic ultrasound system, not an algorithm, so a "standalone" algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As there were no clinical studies described, there is no mention of the type of ground truth used for performance evaluation. The "ground truth" for the non-clinical testing would be the engineering specifications and compliance with recognized standards.
8. The sample size for the training set:
The document describes a diagnostic ultrasound system, not an AI or machine learning algorithm that requires a training set. Therefore, there is no information regarding the sample size for a training set.
9. How the ground truth for the training set was established:
Since no training set for an algorithm is discussed, there is no information on how ground truth for a training set was established.
§ 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.