(346 days)
This modification has no effect on intended use of the HP ultrasound systems.
The modification addressed in this submission is a change from analog to digital circuit technology for the front end of the HP ultrasound imaging systems listed above.
This document is a 510(k) summary for a modification to an existing ultrasound imaging system. It focuses on demonstrating substantial equivalence to predicate devices for a change from analog to digital circuit technology in the front end. Therefore, it does not contain the detailed performance study information typically found in submissions for novel devices or those requiring clinical efficacy studies with specific acceptance criteria.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the way typically expected for a new device's clinical performance. Since this is a modification to an existing device, the "acceptance criteria" discussed are primarily related to safety, compliance with medical device standards, and functional equivalence to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance to medical device safety standards (e.g., IEC 601, UL 2601) | Stated as "shown by compliance" |
| Software safety verified by hazard analysis and software validation | Stated as "verified by hazard analysis and software validation to ensure performance specifications are met" |
| Performance specifications met | Stated as "ensure performance specifications are met" |
| Substantial equivalence to legally marketed predicate devices (ATL HDI 3000, Toshiba SSA-380A) regarding safety, effectiveness, and intended use | Stated as "demonstrate that the modified HP ultrasound imaging systems are substantially equivalent to legally marketed predicate devices" |
2. Sample size used for the test set and the data provenance
Not applicable. This submission is for a technological modification and primarily relies on engineering validation, safety testing, and comparison to predicate devices, not a clinical "test set" with a specific sample size of patient data. There is no mention of patient data being used for this specific filing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a clinical test set is not discussed as this is a technological modification submission.
4. Adjudication method for the test set
Not applicable. There is no mention of a clinical test set or adjudication.
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 document pertains to an ultrasound imaging system and does not mention AI or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device; it's a hardware modification to an imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth in the context of clinical data is not discussed. For this submission, the "ground truth" for the claims of safety and equivalence would be the established safety standards, the validated performance specifications of the device, and the characteristics of the predicate devices.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable (as above).
§ 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.