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510(k) Data Aggregation
(202 days)
Diagnostic ultrasound imaging and Doppler analysis of the human body... Medical disciplines that use transesophageal diagnostic ultrasound include Cardiology, Surgery and Trauma.
The Aloka UST-5258-5 functions in the same manner as 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 UST-5258-5 transducer 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 UST-5258-5 diagnostic ultrasound transducer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in this document.
However, based on the information provided, we can infer some aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating equivalence in technological characteristics and safety to a predicate device (Aloka UST-5228-5).
| Acceptance Criteria (Inferred) | Reported Device Performance (as stated in the document) |
|---|---|
| Same diagnostic ultrasound applications as predicate device | The UST-5258-5 is indicated for the same diagnostic ultrasound applications as other products currently marketed by Aloka and others. (Implies satisfactory performance for these applications.) |
| Same gray-scale and Doppler abilities as predicate device | The UST-5258-5 has the same gray-scale and Doppler abilities as other products currently offered by Aloka and others. (Implies equivalent image quality and Doppler functionality.) |
| Uses essentially the same technologies | The UST-5258-5 uses essentially the same technologies for imaging, Doppler functions, and signal processing as other products currently marketed by Aloka and others. (Implies equivalent functionality and performance due to shared underlying technology.) |
| Same method of use as predicate device | The UST-5258-5 has the same method of use as other products currently marketed by Aloka and others. (Implies similar operational performance for users.) |
| Acoustic power output levels below FDA maximum | The UST-5258-5 acoustic power output levels are below the maximum levels allowed by the FDA. (Implies compliance with safety standards regarding acoustic output.) |
| Subject to the same Quality Assurance systems | The UST-5258-5 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka. (Implies consistent manufacturing quality and control, leading to expected performance.) |
| Patient contact materials safety | The patient contact materials used in the UST-5258-5 have been evaluated for safety via the same standards and methods as other products marketed by Aloka and others. These materials have been found to be safe for the intended uses. (Implies meeting biocompatibility and safety standards.) |
| Compliance with electrical and physical safety standards | The UST-5258-5 complies with the same electrical and physical safety standards as other products currently marketed by Aloka and others. (Implies meeting regulatory safety requirements.) |
| Functionality (transmitting and receiving sound waves, imaging, Doppler) | The Aloka UST-5258-5 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body... differences in the acoustic impedance... reflect... energy back to the transducer... processed into an image. The Aloka UST-5258-5 transducer can also use the Doppler shift... to detect and display flow. (Demonstrates basic operational functionality.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document primarily focuses on demonstrating substantial equivalence through a comparison of device characteristics rather than a separate clinical or performance study with a defined test set.
- Data Provenance: Not specified. Given the nature of a 510(k) submission for substantial equivalence based on technical characteristics, it's unlikely that a test set with specific data provenance (country, retrospective/prospective) was used in the way one would for a clinical trial of a novel device. The "data" here would be the technical specifications and existing safety data of the device itself and its predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. Since there is no explicit mention of a test set requiring ground truth establishment by experts, this information is not present. The "ground truth" for a substantial equivalence claim is often the established performance and safety of the predicate device.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set:
- Adjudication method: Not applicable/not specified. There is no indication of a test set requiring adjudication in the context of this 510(k) summary.
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:
- MRMC Study: No. This is a submission for a diagnostic ultrasound transducer, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed or described.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is an ultrasound transducer, a hardware component that requires a human operator and an ultrasound system. It does not operate as a standalone algorithm.
7. The type of ground truth used:
- Ground Truth: In the context of this 510(k) for substantial equivalence, the "ground truth" and basis for comparison are the well-established performance, safety, and technological characteristics of the predicate device (Aloka UST-5228-5) and other legally marketed diagnostic ultrasound transducers. The assumption is that if the new device shares these characteristics and meets safety standards, its performance will be equivalent and acceptable.
8. The sample size for the training set:
- Sample Size: Not applicable/not specified. Ultrasound transducers are hardware devices; they do not have "training sets" in the sense of machine learning algorithms. Their design and functionality are based on engineering principles and established medical imaging physics.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable/not specified. As there is no training set, there is no ground truth to establish for it.
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