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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal, Intra-operative, Intra-operative (Neuro), Laparoscopic, Pediatric, Neonatal Cephalic, Trans-rectal & vaginal, Musculo-skeletal, Gynecological, Cardiac-(Adult, Neonatal, Pediatric), TEE & Peripheral Vascular.
The device is not indicated for Ophthalmic applications.

The Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.

The provided document is a 510(k) summary for the Hitachi Aloka Medical Prosound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device and specifying the intended uses for various transducers. It does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document states:

• "I. Non-clinical Tests: The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards."
• "2. Clinical Tests: None Required."

Given this, I cannot extract specific acceptance criteria related to clinical performance or a study proving the device meets those criteria from the provided text.

Therefore, the requested table and information cannot be fully populated as the core information (acceptance criteria and a study demonstrating meeting them) is not present in the provided 510(k) summary for clinical performance.

However, I can provide the non-clinical acceptance criteria that were met.

1. Table of Acceptance Criteria and Reported Device Performance

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 "Clinical Tests: None Required." Therefore, there is no information on a sample size for a clinical test set or data provenance from such a study. For non-clinical tests, specific sample sizes (e.g., number of units tested for acoustic output) are not detailed in this summary, but implied to be sufficient to demonstrate conformity to 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)

• No clinical test set was used, so no experts were involved in establishing ground truth for a test set in the context of clinical performance.

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

• No clinical test set was used, so no adjudication method is 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

• No MRMC study was mentioned, nor is this device described as having AI capabilities.

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

• This device is a Diagnostic Ultrasound System; it does not appear to be an algorithm-only device, and no standalone performance study in that context is mentioned.

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

• No clinical ground truth was established as clinical tests were not required. The "ground truth" for non-clinical aspects was defined by applicable safety and performance standards.

8. The sample size for the training set

• Not applicable. This document pertains to regulatory submission for a diagnostic ultrasound system, not typically an AI-based system that requires a training set in the machine learning sense.

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

• Not applicable. (See point 8)

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The device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Trans-vaginal , Trans-rectal, Gynecological, Musculo-sketal and Neonatal Cephalic applications. The device is not indicated for Ophthalmic applications.

The Prosound F75 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display.

The provided document is a 510(k) summary for the Aloka Prosound F75 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study for a novel device. Therefore, many of the requested categories for acceptance criteria and clinical study details are not applicable in this context.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like an ultrasound system undergoing 510(k) clearance, the "acceptance criteria" are generally established through engineering and performance testing against recognized standards to demonstrate that the device performs as intended and is safe and effective. The "reported device performance" is then the outcome of these non-clinical tests. The key acceptance criterion for a 510(k) is substantial equivalence to a predicate device.

• Acoustic output
• Biocompatibility
• Cleaning & disinfection effectiveness
• Electromagnetic compatibility
• Electrical and mechanical safety.
  They were found to conform with applicable medical device safety standards. |
  | Quality System Compliance | The design, development, and quality process conforms with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems. |
  | Intended Use Alignment with Traditional Clinical Practices | Intended uses and other key features are consistent with traditional clinical practices and FDA guidelines. |

Study Details:

For this 510(k) submission, the primary "study" is the demonstration of substantial equivalence through non-clinical testing and comparison to a legally marketed predicate device.

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

• Sample Size for Test Set: Not applicable for this type of submission. This 510(k) does not involve a clinical test set in the way a novel AI device might. The review is based on internal technical evaluations, compliance with standards, and comparison to a predicate device.
• Data Provenance: Not applicable. The "data" are primarily technical specifications, test reports for acoustic output, biocompatibility, etc., and a comparison matrix to the predicate device. These are internal company documents and safety standard compliance reports.

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)

• Number of Experts & Qualifications: Not applicable. Ground truth, in the context of clinical studies with expert consensus, is not part of this 510(k) pathway for an ultrasound system. The "ground truth" here is adherence to engineering specifications and safety standards, and functional equivalence to the predicate device.

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

• Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses in clinical studies, which were not conducted for 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

• MRMC Comparative Effectiveness Study: No. This device is a diagnostic ultrasound system, not an AI-powered image analysis tool designed to assist human readers, or a novel therapy. Therefore, an MRMC study is not relevant to its clearance.

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

• Standalone Performance Study: No. This device is an imaging system operated by a human physician, not an algorithm, and the concept of "standalone performance" for an algorithm is not applicable.

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

• Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (Aloka Alpha 10), and the objective measurements demonstrating that the new device meets recognized safety and performance standards (e.g., acoustic output limits, electrical safety, biocompatibility, cleaning efficacy).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth for it.

In summary: The Aloka Prosound F75 Diagnostic Ultrasound System obtained 510(k) clearance by demonstrating substantial equivalence to a predicate device (Aloka Alpha 10) through technical comparisons and compliance with recognized safety and performance standards. It did not involve clinical trials, expert consensus studies, or AI algorithm performance evaluations as typically seen for novel software or AI/ML devices.

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