(14 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial.
Modes of operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler.
Combined (specify): See Below
Additional Comments: Mixed mode operation includes BM, BPWD, MCD, B/CD/PWD, B/CD/CWD
Applications: Small Parts-breast, testes & thyroid, abdominal, gynecological, fetal, neonatal, cardiac.
The Aloka SSD-Alpha 5 Ver. 1.0 diagnostic ultrasound system and transducers. 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-Alpha 5 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The provided text is a 510(k) summary for the Aloka SSD-Alpha 5 diagnostic ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Aloka SSD-5500) rather than presenting a performance study with acceptance criteria in the context of a new AI algorithm or a specific diagnostic task.
Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth type for studies) are not present in this document.
The document discusses the device's technical characteristics and intended uses, comparing them to the predicate device to establish substantial equivalence. It does not detail a specific clinical performance study to "prove the device meets acceptance criteria" in the way a novel AI diagnostic device would.
Here's an attempt to address the questions based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria and reported device performance for a specific diagnostic task. The "acceptance criteria" discussed are related to general safety and technical standards for ultrasound devices, and the "performance" is implicitly deemed equivalent to the predicate device.
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Acoustic Output | Below maximum levels allowed by FDA | The SSD-Alpha 5 acoustic power output levels are below the maximum levels allowed by the FDA. |
| Quality Assurance | Subjected to the same Quality Assurance systems as predicate | The SSD-Alpha 5 is subjected to the same Quality Assurance systems in development and production as other products including the SSD-5500. |
| Patient Contact Material Safety | Evaluated for safety via same standards/methods as predicate | The patient contact materials used in the SSD-Alpha 5 have been evaluated for safety via the same standards and methods as the above mentioned product marketed by Aloka. These materials have been found to be safe for their intended uses. |
| Electrical and Physical Safety | Complies with standards as predicate devices | The SSD-Alpha 5 complies with electrical and physical safety standards as other products currently marketed by Aloka such as the: SSD-5500 (K032875). |
| Compliance with Standards (e.g., NEMA-UD2, AIUM, IEC, UL, ISO) | Compliance with specific listed standards | Aloka Co., Ltd. Certifies that the SSD-Alpha 5 complies with NEMA-UD2: 1992, AIUM 1994 "Acoustic Output Labeling Standard", IEC-60601-1 (2001-09 Class A), UL 2601-1, 200 edition (1997), Part 1, 200 edition including Amendments 1&2 and ISO10993-1:1997. All testing will be completed, prior to distribution, to meet the requirements of the standards listed above. |
| Premarket Notification | Submission of postclearance special report with acoustic output measurements | Condition of substantial equivalence is submission of a postclearance special report containing complete information, including acoustic output measurements based on production line devices, and other requested information. |
2. Sample size used for the test set and the data provenance
No specific test set or clinical study data (in terms of patient cases) is mentioned for evaluating the diagnostic performance of the Aloka SSD-Alpha 5. The submission relies on demonstrating substantial equivalence to its predicate device (Aloka SSD-5500) based on similar technological characteristics and intended uses.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set 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 is not an AI diagnostic device, and no MRMC comparative effectiveness study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No specific ground truth for a diagnostic performance study is mentioned in the context of this 510(k) submission. The device's "ground truth" for its general function is based on its ability to produce images and flow analysis according to established ultrasound physics and engineering principles, and its equivalence to a predicate device.
8. The sample size for the training set
Not applicable. This is not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable.
§ 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.