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Voluson™ Performance 16 / Voluson™ Performance 18 are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson™ Performance 16 / Voluson™ Performance 18 clinical applications include: Fetal/Obstetrics; Abdominal (including Renal and Gynecology/ Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TR); Transvaginal (TV).

Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson™ Performance 16 / Voluson™ Performance 18 system are intended to be used in a hospital or medical clinic.

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

Based on the provided FDA 510(k) clearance letter, the device in question, Voluson™ Performance 16/18, is a general-purpose diagnostic ultrasound system. The document explicitly states that "The subject of this premarket submission, Voluson™ Performance 16/18 did not require clinical studies to support substantial equivalence."

This means that no clinical study was conducted to prove the device meets specific acceptance criteria based on its performance in a clinical setting against a defined ground truth. Instead, the substantial equivalence determination relies on comparisons to predicate devices, non-clinical tests (acoustic output, biocompatibility, electrical/mechanical safety, etc.), and the migration of existing, already-cleared AI features.

Therefore, many of the requested details about acceptance criteria, study methodologies, and performance metrics (clinical study details, sample sizes, expert qualifications, ground truth, MRMC studies, standalone performance) are not available in this document because a clinical performance study was not deemed necessary for this 510(k) clearance.

Here's a breakdown of what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:

Since no clinical performance study was conducted to establish new acceptance criteria for direct device performance in terms of diagnostic accuracy or reader improvement, a table of this nature cannot be provided from this document. The "acceptance criteria" here are related to non-clinical safety and performance standards for an ultrasound system, and the "reported device performance" is a statement of compliance with these standards and equivalence to predicates.

Regarding the Study That Proves the Device Meets Acceptance Criteria:

As noted, no clinical study was conducted for this specific 510(k) clearance. The basis for clearance is substantial equivalence to legally marketed predicate devices, supported by non-clinical testing and the migration of already-cleared AI features.

Therefore, for the remaining points (2-9), the answer is largely that this information is not applicable or not provided in this 510(k) summary because a de novo clinical performance study was not performed.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used for a de novo performance study. The AI features were migrated from already-cleared devices (Voluson Expert 22/20/18, K242168), implying their original validation would have occurred with those previous clearances. Details of those previous validations are not in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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. No MRMC study was performed for this clearance. The AI features are already cleared on previous devices, and their performance improvement with AI assistance would have been part of those prior clearances, not described here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated for this clearance. Given it's an ultrasound system, the AI features (SonoPelvicFloor 3.0, SonoAVCfollicle 2.0, Fibroid Mapping, SonoLyst Live) are typically integrated tools that assist the sonographer or physician, rather than standalone diagnostic algorithms. Their standalone performance would have been assessed during their original clearance (K242168).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this specific clearance. For the migrated AI features, their original ground truth establishment would have been part of the K242168 submission.

8. The sample size for the training set: Not applicable, as no new training was described for this submission. The AI features are migrated and not undergoing new development or training for this device.

9. How the ground truth for the training set was established: Not applicable for this submission. This would pertain to the original development and clearance of the migrated AI features, information not provided in this document.

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