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The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluid. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

The RS85 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan* Mode or as a combination of these modes. The RS85 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that may aid in making a diagnosis by competent health care professionals. The RS85 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided text is a 510(k) summary for the SAMSUNG MEDISON RS85 Diagnostic Ultrasound System. It mostly focuses on claiming substantial equivalence to a predicate device (RS85 Diagnostic Ultrasound System K182932) by demonstrating that the proposed device has the same intended use, imaging capabilities, technological characteristics, and safety and effectiveness.

Here's an analysis of the acceptance criteria and study information based only on the provided document:

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

The document does not explicitly state acceptance criteria in terms of specific performance metrics or thresholds. Instead, it claims substantial equivalence to its predicate device (RS85 Diagnostic Ultrasound System K182932). The "device performance" reported is that the "proposed RS85 is same to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness."

The table provided lists comparisons between the proposed RS85 (version V1.05) and its predicate (K182932). This table indicates:

• Clinical Application: No addition (meaning identical to the predicate).
• Operation of modes: No addition (meaning identical to the predicate).
• Applied transducers: No addition (meaning identical to the predicate).
• SW Features: Improvement of cleared software (Setup&Preference, Patient Management, Measurement, ScanMode(CEUS+), S-Fusion).
• HW Features: No addition (meaning identical to the predicate).

Since no specific quantitative acceptance criteria or performance numbers are given for the device, a table of acceptance criteria vs. reported performance cannot be fully constructed in the traditional sense of numerical targets. The "acceptance criterion" appears to be equivalence to the predicate device's existing performance, which is implicitly considered acceptable.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." This indicates that no dedicated clinical test set with a specific sample size was used for this 510(k) submission. Instead, the submission relies on non-clinical tests and the established safety and effectiveness of its predicate device through technical comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical studies were performed for this submission (as stated in section 11 "Summary of Clinical Tests"), there is no information provided on experts establishing ground truth for a test set. The substantial equivalence claim is based on non-clinical performance and a comparison to a previously cleared device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

As per item 2 and 3, no clinical test set was used, and therefore, no adjudication method is mentioned.

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

The document explicitly states, "The subject of this premarket submission, RS85, did not require clinical studies to support substantial equivalence." Furthermore, the described improvements in "SW Features" (e.g., Setup&Preference, Patient Management, Measurement, ScanMode(CEUS+), S-Fusion) are functional enhancements to the ultrasound system itself, not features implying AI assistance for human image interpretation that would warrant an MRMC study. Therefore, no MRMC comparative effectiveness study was done, and no effect size for human reader improvement with/without AI assistance is provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is an ultrasound system with software features, not a standalone algorithm. The "SW Features" listed are improvements to the existing cleared software. There is no indication of a standalone algorithm-only performance study.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

As no clinical study was conducted for this submission, no information on the type of ground truth used is provided. The submission relies on non-clinical testing and comparison to the predicate device, K182932, whose ground truth establishment would have been part of its original clearance.

8. The sample size for the training set

The document does not describe any specific "training set" for an algorithm. The software features are described as "improvement of the cleared Software" for a diagnostic ultrasound system. This implies software updates or enhancements to an existing system, rather than the development of a new AI/ML algorithm that would undergo a distinct training phase. Therefore, no sample size for a training set is provided.

9. How the ground truth for the training set was established

As no training set is mentioned in the context of an algorithm, no information is provided on how ground truth for a training set was established.

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