(12 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (liver/pancreas/gall-bladder/abdominal, gynecological, fetal, neonatal, cardiac), Pediatric, Small Organ (breast/testes/thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional. Mixed mode operation includes BM, BPWD, MCD, BICD/PWD, BICWD, BICWCWD.
The Aloka SSD-Alpha 10 functions in the same manner as its predicate and other Aloka 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-Alpha 10 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The Aloka SSD-Alpha 10 diagnostic ultrasound system and its transducers were found substantially equivalent to the predicate device, the Aloka SSD-5500 (K032875). This determination is based on the devices functioning in the same manner, having similar technological characteristics, and being indicated for the same diagnostic ultrasound applications.
The acceptance criteria for the Aloka SSD-Alpha 10 are implicitly demonstrated by its substantial equivalence to the predicate device. This means that the new device must meet the same performance and safety standards as the predicate device. The general controls provisions of the Act, including annual registration, device listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration, also serve as acceptance criteria. Additionally, the device is required to comply with specific electrical, physical, and acoustic safety standards before distribution.
Here's a breakdown of the requested information, drawing from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Summary) |
|---|---|
| Same function as Aloka SSD-5500 (predicate device K032875) | Functions in the same manner as its predicate and other Aloka diagnostic ultrasound devices. |
| Similar technological characteristics to Aloka SSD-5500 | Similar in technological characteristics to its predicate system: SSD-5500 (K032875). Uses the same technologies for imaging, Doppler functions, and signal processing. |
| Indicated for the same diagnostic ultrasound applications as Aloka SSD-5500 | Indicated for the same diagnostic ultrasound applications as Aloka's SSD-5500. A series of "Indications for Use" forms specifies the clinical applications and modes of operation, indicating "P" (previously cleared by FDA) for those matching the predicate. New indications are marked "N". |
| Same gray-scale and Doppler abilities as Aloka SSD-5500 | Has the same gray-scale and Doppler abilities as Aloka's ultrasound system SSD-5500. |
| Acoustic power output levels below maximum allowed by FDA | Acoustic power output levels are below the maximum levels allowed by the FDA. (Post-clearance special report required for production units). |
| Subject to same Quality Assurance systems as SSD-5500 | Subjected to the same Quality Assurance systems in development and production as other products including the SSD-5500. |
| Patient contact materials evaluated for safety via same standards/methods as predicate | Patient contact materials have been evaluated for safety via the same standards and methods as the predicate. These materials have been found to be safe for their intended uses. |
| Complies with electrical and physical safety standards (as predicate) | Complies with electrical and physical safety standards as other products currently marketed by Aloka such as the: SSD-5500 (K032875). Also certifies compliance with NEMA-UD2:1992, AIUM 1994, IEC-60601-1 (2001-09 Class A), UL 2601-1, 2nd edition (1997) Part 1, 2nd edition including Amendments 1&2 and ISO 10993-1:1997. |
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 explicitly mention a "test set" in the context of clinical performance evaluation for acceptance criteria. The clearance is based on substantial equivalence to a predicate device, not on a new clinical study with a defined test set. The data provenance is因此not applicable in this type of 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)
Not applicable, as no new clinical test set with ground truth established by experts is described in this substantial equivalence summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical test set requiring expert adjudication 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 submission is for a diagnostic ultrasound system, not an AI-assisted device, and 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 not an AI algorithm and thus no standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as the clearance is based on substantial equivalence to a predicate device, rather than a de novo clinical evaluation requiring independent ground truth. The "ground truth" here is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
Not applicable. This document is a 510(k) summary for a medical device (ultrasound system), not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
§ 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.