(10 days)
The device is intended for use by a qualified physician for ultrasound evaluation of the Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Transvaginal , Trans-rectal, Gynecological and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Transrectal, Transvaginal, Fetal, Abdominal, Gynecological, Cardiac, Peripheral Vascular, Small Organ, Intra-operative, Neonatal Cephalic.
The Prosound Alpha 6 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.
This is a 510(k) premarket notification for the Aloka Prosound Alpha 6 Diagnostic Ultrasound System. It is focused on demonstrating substantial equivalence to a predicate device (Aloka SSD-4000 K040719), rather than establishing new performance criteria or efficacy through clinical trials. As such, the document does not contain the typical details of a study designed to prove a device meets specific acceptance criteria in the way an AI/CADe device approval would.
Here's an breakdown based on the provided text, highlighting the absence of information typically requested for AI/CADe approvals:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific performance metrics or acceptance criteria for the Aloka Prosound Alpha 6 in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) that would typically be expected for a device proving novel diagnostic capabilities. Instead, the "acceptance criteria" are implied to be technical comparability and conformance to safety standards, and the "performance" is stated as being "substantially equivalent" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technical comparability to predicate device (Aloka SSD-4000 K040719) | "technically comparable and substantially equivalent" |
| Same technological characteristics as predicate device | "has the same technological characteristics" |
| Same key safety and effectiveness features as predicate device | "has the same key safety and effectiveness features" |
| Same intended uses and basic operating modes as predicate device | "has the same intended uses and basic operating modes" |
| Conformance with applicable medical device safety standards | "found to conform with applicable medical device safety standards" |
| Compliance with 21 CFR 820, ISO 9001:2000, ISO 13485 quality systems | "confirms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems" |
| Safe and effective performance (as per diagnostic ultrasound history) | "Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "None Required" for clinical tests for the purpose of demonstrating substantial equivalence. Therefore, there is no test set, sample size, or data provenance relevant to proving diagnostic performance against predefined acceptance criteria. Clinical practices, FDA guidelines, and established patient examination methods are cited as sufficient to confirm intended uses and features.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test set was used to assess diagnostic performance of the new device itself, there were no experts used to establish ground truth in this context. The "ground truth" for the substantial equivalence claim relies on the established safety and effectiveness of the predicate device and the general understanding of diagnostic ultrasound.
4. Adjudication Method for the Test Set
As there was no clinical test set, there was no adjudication method employed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This submission focuses on substantial equivalence based on technical specifications and established safety, not on improving human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The Aloka Prosound Alpha 6 is a diagnostic ultrasound system, not an AI or algorithm-only device. Therefore, a standalone algorithm performance study was not applicable and not conducted. It's a medical imaging hardware and software system used by humans.
7. The Type of Ground Truth Used
The concept of "ground truth" as it applies to diagnostic accuracy for a new device's performance is not directly addressed. Instead, the ground truth for this 510(k) submission is the established safety and effectiveness record of the predicate device (Aloka SSD-4000) and general diagnostic ultrasound technology. The "truth" is that its technical characteristics and intended uses align with a device already cleared by the FDA, implying similar safety and effectiveness.
8. The Sample Size for the Training Set
The Aloka Prosound Alpha 6 is a traditional ultrasound system, not an AI/ML device that requires a training set in the computational sense. Therefore, there is no training set mentioned or applicable.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
§ 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.