(13 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transducer S-VNW 5-10: Pediatric, small organs (including thyroid, testicles, salivary gland, breast, and lymph nodes); peripheral vascular; and musculoskeletal-conventional.
Transducer S-VAW 4-7: Fetal, abdominal, pediatrics, and small organs.
Transducer S-VNW 5-10 is a multielement, mechanically steered linear array (volume) probe for use with the Combison 530D Diagnostic Ultrasound System. The center frequency is 7.5 MHz, and the nominal transmit frequency range is 5 to 10 MHz. The scan width is 40 mm and the maximum depth range is 75 mm.
Transducer S-VAW 4-7 is a multielement curved array probe for use with the Combison 530D system. The center frequency is 4.5 MHz, and the nominal transmit frequency range is 4 to 7 MHz. The image starting width is approximately 70 mm and the maximum depth range is 200 mm.
Operating Modes: Both Transducer S-VNW 5-10 and Transducer S-VAW 4-7 operate in B-mode (including three-dimensional volume imaging), M-mode, Pulsed Doppler, and Color Flow modes.
The provided text describes two diagnostic ultrasound transducers, Model S-VNW 5-10 Voluson Small Parts Transducer and Model S-VAW 4-7 Voluson Abdominal Transducer, intended for use with the Combison 530D Diagnostic Ultrasound System. The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria in the typical sense of a diagnostic AI product.
Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or training set details) is not applicable or not explicitly detailed in this type of regulatory submission for a hardware device like an ultrasound transducer.
Here's an attempt to answer the questions based only on the provided text, with clear indications where information is unavailable:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "Measurement accuracy, precision of volume reconstruction, electrical and thermal safety, and software performance have been tested in accordance with applicable guidelines and standards with satisfactory results." However, specific numerical acceptance criteria (e.g., "accuracy > 90%") and their corresponding precise performance values are not provided. This level of detail is typically not included in a 510(k) summary for a transducer.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Measurement Accuracy | Satisfactory |
| Precision of Volume Reconstruction | Satisfactory |
| Electrical Safety | Satisfactory |
| Thermal Safety | Satisfactory |
| Software Performance | Satisfactory |
| Acoustic Output | Measured as specified in pertinent FDA recognized standards and reported according to Track 3. (A specific numerical output is not given, but compliance with standards is implied.) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions testing was done, but no details on the number of cases or subjects are provided.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
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. This pertains to clinical performance evaluation, which is not detailed for this hardware submission. The "ground truth" for a transducer primarily relates to its physical performance characteristics (e.g., accuracy of measurements, safety parameters) rather than diagnostic interpretations requiring human experts to establish ground truth in a clinical sense.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/Not specified. This is relevant for clinical performance studies involving human interpretation or consensus, which is not detailed here.
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 Comparative Effectiveness Study: No. This is a submission for an ultrasound transducer, not an AI-based diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: Not applicable/No. This device is a diagnostic ultrasound transducer, a hardware component that requires human operation and interpretation. It is not an algorithm that performs in a standalone manner. The performance of the transducer (e.g., image quality, measurement accuracy) is what's being assessed, always in the context of human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for the tests mentioned (measurement accuracy, precision of volume reconstruction, electrical/thermal safety, software performance, acoustic output) would typically refer to validated engineering measurements against known physical standards, phantom studies, and adherence to regulatory safety limits and technical specifications. It is not clinical "ground truth" derived from pathology or expert consensus on patient cases.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/Not specified. This device is a hardware component. The concept of a "training set" is generally associated with machine learning models, which are not detailed as part of this submission. Device design and validation rely on engineering principles and testing against specifications, not machine learning training.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable/Not specified. See the explanation for point 8.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.