(15 days)
The M5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdomen, gynecology, obstetrics, small parts (breast, testes, thyroid, etc.), pediatrics, transcranial, cardiac, peripheral vascular, urology, orthopedics, intraoperative and musculoskeletal (general and superficial) exams.
The M5 Diagnostic Ultrasound System is a general purpose, mobile, software controlled ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, Color mode, PW mode, CW mode, Power mode, DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 2.0 MHz to 12.0 MHz.
The provided 510(k) summary for the M5 Diagnostic Ultrasound System is a general submission for a diagnostic medical device and as such, does not contain information about acceptance criteria or specific study results that prove the device meets acceptance criteria defined by performance metrics like sensitivity, specificity, or AUC.
Instead, the submission focuses on demonstrating substantial equivalence to pre-existing legally marketed predicate devices. This means the device is being cleared based on its similarity in technological characteristics, functionality, intended uses, and safety to already approved devices, rather than through extensive clinical performance studies with specific acceptance criteria that would typically be seen for novel AI/ML-driven devices.
Therefore, many of the requested categories of information related to AI/ML device performance studies are not applicable to this document.
Here's a breakdown of the available and unavailable information based on your request:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this type of submission are primarily about demonstrating substantial equivalence to predicate devices in terms of technology, safety, and intended use as per FDA regulations for traditional 510(k) clearances.
- Reported Device Performance: Not reported in terms of specific diagnostic performance metrics. The document states that the system has been "evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety" and found to conform to applicable medical safety standards (UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, IEC 60601-1-4 and ISO 10993-1). This is about engineering and safety performance, not diagnostic accuracy.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. This submission does not describe a clinical performance study with a test set of patient data to evaluate diagnostic accuracy.
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 such test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No such test set or adjudication process is described.
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 a diagnostic ultrasound system, not an AI/ML-driven diagnostic aid that assists human readers. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware/software system, not a standalone AI algorithm. Its performance is inherent to its ability to acquire and display ultrasound images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth for diagnostic performance is described. The "ground truth" in this context is the general understanding of diagnostic ultrasound capabilities as established by predicate devices and standards.
8. The sample size for the training set:
- Not applicable. This submission does not describe an AI/ML algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is described.
In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence based on technical specifications and safety standards, rather than clinical performance data from studies commonly associated with AI/ML device clearances.
§ 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.