(15 days)
The device is intended for use by a qualified physician for ultrasound evaluation of fetal, abdominal, pediatric, neonatal cephalic, cardiac, small parts, transvaginal, transrectal, peripheral-vascular, muscular-skeletal(conventional and superficial).
The M5 is a portable general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-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 and convex linear array with a frequency range of approximately 2.5 MHz to 14 MHz.
This 510(k) summary describes a diagnostic ultrasound system (M5) and its transducers. The document primarily focuses on regulatory information and intended use rather than specific performance studies with acceptance criteria, ground truth, or statistical analyses. Therefore, much of the requested information cannot be extracted from the provided text.
Here is the information that can be extracted or reasonably inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in terms of clinical accuracy or diagnostic efficacy. Instead, it refers to compliance with established standards and substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device is "as safe and effective as the legally marketed predicate devices" for its stated intended uses.
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1. | Conforms to applicable medical device safety standards. |
| Acoustic Output | Conformance to NEMA UD 2 Acoustic Output Measurement Standard: 2004 and NEMA UD 3 Output Display Standard. | Acoustic output is measured and calculated per NEMA UD 2 and NEMA UD 3. |
| Effectiveness | Substantially equivalent to predicate devices for stated intended uses. | Device is "as safe and effective as the legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The filing refers to "testing" performed for safety and effectiveness but does not detail any clinical studies, their sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document, as no specific clinical study with ground truth establishment is detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document, as no specific clinical study with adjudication is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided in the document. The device is a diagnostic ultrasound system; there is no mention of AI assistance or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not provided in the document. The device is a diagnostic ultrasound system, not an algorithm being tested in a standalone capacity.
7. The Type of Ground Truth Used
This information is not provided in the document, as no specific clinical study with ground truth is detailed. The basis for safety and effectiveness is primarily stated as conformance to standards and substantial equivalence to predicate devices, rather than a direct comparison against a clinical ground truth for a new indication.
8. The Sample Size for the Training Set
This information is not provided in the document. There is no mention of a "training set," which typically refers to data used for machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document for the reasons stated above.
§ 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.