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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Neonatal Cephalic, Fetal, Pediatric and Neonatal Abdominal. Typical examinations performed using this transducer are: General abdominal studies including organ surveys, assessment, and retro-peritoneal cavity studies. Pediatric scans of organs and bony structures. Neonatal head studies. Biopsy guidance for tissue or fluid sampling.

The S-VNA 5-8(B) transducer is a mechanically steered curved array (Volume) probe. This is identical to the previously cleared (K940942) endocavitary S-VDW 5-8 probe, with the same materials, same acoustic module, and the same technical performance. The primary mechanical difference with the endocavity S-VDW 5-8 probe is the modified (shorter) shaft, designed to allow use on the outer surface of the body. The VOLUSON® Neonatal transducer S-VNA5-8(B) is an electronic wideband sector-transducer with a center frequency of 6.5 MHz and with switchable scan angles. The direction of insonation is forward in relation to the transducer's longitudinal axis. This device is a hand-held, 128 element, curved linear array probe. In addition to B-Mode and M-Mode, this probe can be operated in steerable pulsed Doppler, Color Doppler, Color Power Angio Doppler, and 3D Imaging. Similar to the S-VDW 5-8 transducer, the S-VN A5-8(B) also allows the performance of a 3D volume scan by internally sweeping the array in a lateral direction, automatically upon a key press. The images thus obtained from sectional planes perpendicular to each other can be displayed synoptically on the screen. This device is intended for use with the Combison/Voluson C530D Diagnostic Ultrasound Scanner for transcutaneous imaging as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria.

This submission K984639 is for a diagnostic ultrasound transducer (S-VNA 5-8(B)) and does not contain detailed information about a study with acceptance criteria and reported device performance in the context of clinical accuracy or diagnostic efficacy. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards for the hardware itself.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) cannot be extracted from the provided text as they are not relevant to this type of 510(k) submission.

However, I can provide information based on what is available regarding safety and technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k) premarket notification, the "acceptance criteria" are primarily related to safety, electrical, and acoustic output standards, and substantial equivalence to predicate devices. The "reported device performance" in this context refers to the device's adherence to these standards and its functional equivalence to existing devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical performance study with a "test set" in the traditional sense of evaluating diagnostic accuracy or efficacy with patient data. The evaluation is centered on hardware specifications, safety standards, and technological equivalence to predicate devices. Therefore, these details are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable, as no clinical performance study with a test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set

Not applicable, as no clinical performance study with a test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or described in this submission. This type of study is typically used for AI-augmented diagnostic systems to assess the impact on human reader performance, which is not the subject of this 510(k).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This submission is for a medical device hardware (ultrasound transducer) and its associated system, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this submission relates to:

• Engineering specifications and safety standards: The device's physical construction, electrical properties, and acoustic output are measured against established engineering and regulatory limits.
• Predicate device characteristics: The ground truth for substantial equivalence is the previously cleared specifications and performance of the predicate devices (K974813, K974269, and especially K940942 for the core transducer design). The claim is that the new transducer is "identical" or "substantially equivalent" in key aspects.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device.

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