(7 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (liver, pancreas, and gall bladder), Intraoperative Neurological, Pediatric, Small Organ (breast, testes and thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
The Aloka SSD-4000 Ver.3.1 functions in the same manner as its predicates and other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-4000 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow. The SONOReal accessory (K023473) is an add on device.
The provided document is a 510(k) Summary for the Aloka Model SSD-4000 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.
Therefore, the document does not contain the information typically found in a study proving a device meets specific acceptance criteria, and many of your requested items cannot be extracted.
Here's an analysis of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
-
Not present. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic accuracy. It asserts that the device functions in the same manner and has the same capabilities (gray-scale and Doppler) as its predicates. The safety acceptance criteria are related to acoustic power output levels and compliance with various electrical and physical safety standards.
Here's a table of the safety compliance criteria mentioned:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Acoustic Power Output Levels | Below the maximum levels allowed by the FDA. |
| Patient Contact Material Safety Standards | Evaluated for safety via the same standards and methods as other Aloka products; found to be safe for intended uses. |
| Electrical and Physical Safety Standards | Complies with electrical and physical safety standards as other Aloka products. |
| Compliance with NEMA-UD2: 1992 | Complies with NEMA-UD2: 1992. |
| Compliance with AIUM 1994 | Complies with AIUM 1994 "Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment". |
| Compliance with IEC-60601-1 (2001-09 Class A) | Complies with IEC-60601-1 (2001-09 Class A). |
| Compliance with UL 2601-1, 2nd ed. (1997) | Complies with UL 2601-1, 2nd edition (1997), Part 1, 2nd edition including Amendments 1&2. |
| Compliance with ISO10993-1:1997 | Complies with ISO10993-1:1997. |
| SonoReal Accessory Standards | Met UL-2601-1, EN 60601-1-A1 & A2, and EN-60601-1-1 standards; CE marked to Directive 93/42/EEC per Annex II, Class IIa. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not present. As this is a 510(k) submission based on substantial equivalence, there is no mention of a test set with patient data, sample sizes, or data provenance. The assessment relies on technical comparisons to predicate devices and adherence to regulatory standards.
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 present. No test set requiring ground truth established by experts is described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not present. No test set or adjudication method 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 present. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool. Therefore, no MRMC study or AI-related comparative effectiveness is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not present. This device is not an algorithm, but a hardware diagnostic ultrasound system with an optional 3D accessory. No standalone algorithm performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present. As there is no test set for diagnostic accuracy, no ground truth type is specified.
8. The sample size for the training set
- Not present. The document does not describe a training set as it pertains to AI or machine learning. The "development and production" mentioned relate to traditional medical device manufacturing processes and quality assurance.
9. How the ground truth for the training set was established
- Not present. This is not applicable as no training set for an algorithm is described.
§ 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.