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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (liver, pancreas and gall bladder), Intraoperative Neurological (Neurological burr hole), Pediatric, Small Organ (breast, testes and thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD.

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This document is a 510(k) premarket notification correction letter for the Aloka SSD-5000 V5.0 Ultrasound System, dated December 8, 2003. It primarily focuses on correcting the list of transducer model numbers and reiterating the "Indications for Use" for the device and various transducers.

Based on the provided information, there is no acceptance criteria or study data in this document that proves the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, etc. This document is an FDA clearance letter, which means the device has been deemed substantially equivalent to a predicate device.

Instead, the tables presented in the document specify the intended use and modes of operation for the ultrasound system and its various transducers across different clinical applications. The "P" (previously cleared by FDA) and "E" (added under Appendix E) in the tables indicate which indications for use have already been cleared or are being added in this submission, rather than reporting performance metrics.

Therefore, since the request asks for specific details about acceptance criteria and a study that proves the device meets those criteria, and this document does not contain that type of information, I must state that the requested information cannot be extracted from the provided text.

Here is a breakdown of why each point of your request cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance: This document does not contain acceptance criteria (e.g., target sensitivity, specificity, accuracy) nor reported device performance metrics from a study. It only lists the "Intended Use" for various clinical applications and the compatible "Modes of operation" for the ultrasound system and its transducers.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is present. The document is an administrative FDA clearance, not a clinical study report.

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): No information regarding experts, ground truth establishment, or their qualifications is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Since no test set is mentioned, no adjudication method is described.

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: This document predates widespread AI in medical imaging and does not contain any MRMC study data or AI-related performance metrics.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No information on standalone algorithm performance is included.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth information is mentioned.

8. The sample size for the training set: No training set or its size is mentioned.

9. How the ground truth for the training set was established: No information regarding the establishment of ground truth for a training set is provided.

In summary, this document is an FDA regulatory clearance, not a scientific or clinical study report. It confirms the device's substantial equivalence to previously cleared devices for its stated intended uses, but it does not detail specific performance criteria or the studies used to meet them in the way clinical studies for AI/CAD products typically would.

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