(131 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
For ASU-1003: Fetal, Transvaginal. Mixed mode operation includes B/M-Mode.
For UST-9121: Abdominal. Mixed mode operation includes B/M.
For UST-9124: Fetal, Transvaginal. Mixed mode operation includes B/M.
The transducers are to be used for diagnostic ultrasound imaging in Urological, Abdominal, Intraoperative, Surgical and Endoscopic applications.
Diagnostic Ultrasound Transducers
This document describes a 510(k) premarket notification for diagnostic ultrasound transducers (ASU-1003, UST-9121, UST-9124) manufactured by Aloka Co., Ltd. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
The information provided does not contain details about a study conducted to prove the device meets specific acceptance criteria in the way a clinical trial or performance evaluation of an AI/software device would. Instead, this is a regulatory submission for ultrasound transducers, which are hardware components. The "acceptance criteria" here refer to regulatory compliance and demonstrating substantial equivalence to predicate devices, primarily through technical specifications and intended use.
Therefore, many of the requested points regarding acceptance criteria, study design, expert ground truth, and AI performance are not applicable to this document. The document focuses on regulatory classification and comparison to existing products.
Here's an attempt to answer the questions based on the provided text, acknowledging the limitations for an ultrasound transducer submission:
1. A table of acceptance criteria and the reported device performance
For ultrasound transducers, the "acceptance criteria" and "performance" are typically related to their technical specifications (e.g., frequency range, imaging modes, acoustic output) and their equivalence to predicate devices. The document states that the devices are substantially equivalent to their predicates.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Device Regulatory Classification: Be classified as Class II, Tier II, Code 90 ITX (Diagnostic Ultrasound Transducers) | The devices (ASU-1003, UST-9121, UST-9124) are classified as Class II, Review Category Tier II, Code 90 ITX. |
| Intended Use: Be suitable for diagnostic ultrasound imaging in specified clinical applications. | Aloka SSD-1000 system with these transducers is intended for Urological, Abdominal, Intraoperative, Surgical, and Endoscopic applications. Specific transducers (ASU-1003, UST-9121, UST-9124) have subsets of these applications (e.g., Fetal, Abdominal, Transvaginal). |
| Technical Equivalence to Predicate Devices: Demonstrate similar fundamental technology, intended use, and performance characteristics to legally marketed predicate devices. | The document explicitly lists predicate devices for each new transducer (ASU-1003 to ASU-1000C-3.5, UST-9121 to UST-9114-3.5, UST-9124 to UST-9103-5) and states substantial equivalence to these predicates. |
| Acoustic Output Requirements: Meet acoustic output standards (implied by the FDA's request for a postclearance special report on acoustic output). | The FDA requires a postclearance special report containing acoustic output measurements based on production line devices, implying that these measurements must meet approved levels. (Specific levels are not stated in this document). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical study with a test set of patient data. The "test set" in this context would likely refer to engineering tests of the transducers themselves to confirm design specifications and safety, rather than a dataset for evaluating an algorithm's performance on patient data. No sample size, data provenance, or retrospective/prospective nature regarding clinical data are mentioned.
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. The ground truth for this type of device (ultrasound transducer) would be established through engineering specifications, safety standards, and performance evaluation against those standards, not through expert review of clinical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this document does not describe a study involving expert adjudication of clinical data.
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 for an ultrasound transducer, not an AI or software device. 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 an ultrasound transducer, not an algorithm, so performance is inherently "human-in-the-loop" as it requires a sonographer/clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this regulatory submission is based on technical specifications, safety standards, and substantial equivalence to legally marketed predicate devices. This includes meeting performance characteristics of the predicates and complying with FDA regulations for diagnostic ultrasound transducers. The FDA's request for a postclearance special report on acoustic output, for instance, implies objective, measurable standards for acoustic power.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set or ground truth for training.
§ 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.