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The Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Fetal, Abdominal, Pediatric, Musculo-skeletal (conventional, superficial) , Peripheral Vascular, Trans-rectal, Trans-vaginal, Small organ (breast, thyroid and testes) , Cephalic (neonatal and adult) , Cardiac (adult and pediatric) and Urology exams.

The Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, Color-Mode, Power/Dirpower Mode, THI, Smart3D, 4D, iScape, Biopsy Guidance or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include Linear array, Convex array probe.

The provided document is a 510(k) premarket notification for the Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through novel clinical studies.

Therefore, many of the requested details about specific acceptance criteria and a study proving those criteria are not present in this document because it's not a de novo or PMA submission that would typically require such detailed performance data from a new study. The document primarily focuses on demonstrating that the new device is as safe and effective as a previously cleared device.

However, I can extract the information available from the document that is relevant to your request:

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

The document does not specify quantitative acceptance criteria or report specific device performance metrics in the way a clinical study would for a novel device. Instead, it relies on demonstrating that the new device has "the same intended uses, technological characteristics, is comparable in key safety and effectiveness features, and has the same basic operating modes as the predicate devices."

The key performance aspect mentioned is that "The acoustic power levels of Z5/Z50/Z50T/Z50S/Z50 Pro are below the limits of FDA, which is the same as the predicated device Z5 (K130695)". This implicitly means the acoustic output meets FDA limits as specified by relevant standards.

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 explicitly states: "Not applicable. The subject of this submission, Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This means there was no specific "test set" of patient data or images used in a clinical study to evaluate the device's performance as would be done for a new device. The evaluation is based on technical comparisons to predicate devices and adherence to recognized standards.

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)

Not applicable, as no clinical studies with a test set requiring ground truth establishment were conducted or reported in this submission.

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

Not applicable, as no clinical studies with a test set requiring adjudication were conducted or reported in this submission.

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. The document is for a diagnostic ultrasound system and does not mention any AI components or MRMC studies.

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

Not applicable. The device is a diagnostic ultrasound system, not an algorithm, and the submission does not describe standalone algorithm performance.

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

Not applicable, as no clinical studies requiring ground truth were conducted or reported in this submission.

8. The sample size for the training set

Not applicable, as the document is not about an AI/ML algorithm that would require a training set. The evaluation is based on compliance with standards and comparison to predicate devices.

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

Not applicable, as the document is not about an AI/ML algorithm that would require a training set or its associated ground truth.Conclusion from the Document:

The Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (Mindray Z5 (K130695), Z6 (K182603), and DC-40 (K183377)). This equivalence was supported by:

• Having the same intended uses and basic operating modes.
• Comparable technological characteristics.
• Acoustic power levels remaining below FDA limits, similar to the predicate device.
• Compliance with recognized electrical, physical, and software safety standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO14971, ISO 10993-1).
• No clinical studies were deemed necessary to support this substantial equivalence claim.

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