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The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac Adult - TEE; Cardiac Neonatal; Cardiac Pediatric - TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.

An ultrasound diagnostic system with the following features:

• Ultrasound transducer(s) = to generate the transmitted ultrasound energy and detect the reflected echoes
• Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) in various modes of operation
• A computer system to control the transducer and analyze the signals resulting from the reflected echoes
• A video monitor with optional image recorder to display the computed image or derived Doppler data

This is not a study that proves a device meets acceptance criteria, but rather a 510(k) Premarket Notification from the FDA for a diagnostic ultrasound system. It declares the "Hitachi Prosound F75 Diagnostic Ultrasound System" substantially equivalent to a previously cleared predicate device (Hitachi Prosound F75 Diagnostic Ultrasound Scanner [K123828]).

Therefore, most of the requested information (acceptance criteria, reported device performance, sample size for test/training sets, data provenance, number and qualifications of experts, adjudication method, MRMC study, standalone performance, and ground truth type) is not applicable as this document is not a clinical or performance study of a device against specific acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical characteristics and intended use.

Here's the relevant information found in the document:

1. A table of acceptance criteria and the reported device performance
Not applicable. This document is a 510(k) submission asserting substantial equivalence, not a performance study against specific acceptance criteria. It focuses on comparing technical features with a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set was used for this submission. The submission relies on non-clinical testing and comparison to an already cleared device.

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. No ground truth establishment by experts was mentioned as part of this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used 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
Not applicable. This is not an AI-assisted device, and no MRMC comparative effectiveness study was done or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a diagnostic ultrasound system, not an algorithm, and no standalone performance study was mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical ground truth was established or used for this 510(k) submission. The submission is based on substantial equivalence to a predicate device.

8. The sample size for the training set
Not applicable. No training set was used for this type of submission.

9. How the ground truth for the training set was established
Not applicable. No training set was used for this type of submission.

Summary of what is provided in the document:

• Device: Hitachi Aloka Medical, Ltd. Prosound F75 Diagnostic Ultrasound System
• Predicate Device: Hitachi Prosound F75 Diagnostic Ultrasound Scanner [K123828]
• Basis for Acceptance/Clearance: Substantial Equivalence to the predicate device.
• Testing Performed (Non-Clinical):
  • Acoustic output evaluation
  • Biocompatibility (in accordance with ISO 10993-1)
  • Cleaning & disinfection effectiveness
  • Electromagnetic compatibility
  • Electrical safety
• Findings: The device conforms to applicable medical device safety standards and is substantially equivalent in safety and effectiveness to the predicate device.
• Key points of equivalence (as stated in the document):
  • Same indications for diagnostic ultrasound imaging and fluid flow analysis.
  • Same gray scale and Doppler capabilities.
  • Same essential technology for imaging, Doppler functions, and signal processing.
  • Acoustic level below Track 3 FDA limits.
  • Manufactured in accordance with FDA 21 CFR 820 Quality System Regulations.
  • Designed and manufactured to the same electrical and physical safety standards.
  • Manufactured with biocompatible materials.
  • Provides instructions for cleaning, disinfection, and sterilization.
  • Additional functions are enhanced or blended versions of previously cleared features.

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

The Prosound F75, formerly named Aloka 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 changes made to the Prosound F75 are the expanded indications: Adult/ Pediatric Cardiac- TEE, Neonatal/Pediatric, Cardiac, Intraoperative Neurosurgery, and Trans-esoph (non-cardiac).

The provided text is a 510(k) Summary of Safety and Effectiveness for the Hitachi Aloka Medical, Ltd. Prosound F75 Diagnostic Ultrasound System. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. Crucially, it explicitly states:

"No new hazards were identified with the addition of the added Indications. The clinical safety and effectiveness of the system and transducers have been identified in the previous Aloka Prosound F75 submission (K110207), with the above predicates as well as this submission. The clinical safety and effectiveness of the added indications are well accepted for use with ultrasound systems including the predicate device, Aloka Prosound F75 (K110207).

... 2. Clinical Tests: None Required."

This indicates that no new primary clinical study was conducted for this specific 510(k) submission (K123828) to establish effectiveness against acceptance criteria for the expanded indications. Instead, the submission relies on the established safety and effectiveness of the previously cleared device (K110207) and predicate devices, leveraging existing knowledge and accepted medical practice for ultrasound systems.

Therefore, many of the requested details about a study and acceptance criteria (such as reported performance, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) are not present in this document as no new clinical studies were performed for this specific submission.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The acceptance criteria are implicitly met by demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the Aloka Prosound F75 (K110207) and other identified ultrasound systems (K033311, K032875). The key points for substantial equivalence, which serve as the "acceptance criteria" here, are:

• Indicated for diagnostic ultrasound imaging and fluid flow analysis.
• Same gray scale and Doppler capabilities.
• Uses essentially the same technologies for imaging, Doppler functions, and signal processing.
• Acoustic output levels below Track 3 FDA limits.
• Manufactured under equivalent quality and manufacturing systems.
• Manufactured of materials with equivalent biosafety.
• Designed and manufactured to the same electrical and physical safety standards.

Reported Device Performance:
The document does not provide specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the expanded indications. Instead, it states that the clinical safety and effectiveness are "well accepted for use with ultrasound systems" and have been "identified in the previous Aloka Prosound F75 submission (K110207)". This means the performance is considered equivalent to the predicate devices, which are presumed to have established acceptable performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. No new test set data from a clinical study was presented for this 510(k) submission.
• Data Provenance: Not applicable for new clinical data. The submission relies on existing data from previous 510(k) submissions (K110207, K033311, K032875) which would have covered the safety and effectiveness of the base technology. The origin of that data is not specified in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. No new test set requiring expert ground truth establishment was conducted for this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable. No new test set was conducted for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for this submission. The submission explicitly states "Clinical Tests: None Required."

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 (hardware and software), not an algorithm-only device. No standalone performance study (in the sense of an AI algorithm) was conducted or needed for this hardware system and its expanded indications.

7. The Type of Ground Truth Used

• Not applicable for this specific submission to demonstrate effectiveness for the expanded indications. The "ground truth" for the current submission is the established safety and effectiveness of the predicate devices. Any ground truth used for the original predicate device (K110207) or other predicate devices for their respective clinical applications would have been established at that time (e.g., clinical diagnosis, surgical findings, pathology, or other accepted diagnostic methods for ultrasound). This document does not elaborate on that.

8. The Sample Size for the Training Set

• Not applicable. This device is a diagnostic ultrasound system, not a machine learning algorithm that requires a "training set" in the conventional sense. Its "effectiveness" is based on the established performance of the underlying ultrasound technology already cleared with predicate devices.

9. How the Ground Truth for the Training Set was Established

• Not applicable, as there is no "training set" for this type of device.

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