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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 Hitachi Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal, Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications.

The modes of Operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, and Real Time Tissue Elastography.

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 standard Lithium ion computer battery to allow for system portability
• A video monitor with optional image recorder to display the computed image or derived Doppler data

The provided document is a 510(k) summary for the Hitachi Noblus™ Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than novel performance claims requiring extensive clinical studies with specific acceptance criteria.

The document explicitly states: "Clinical testing: None required" [Section 1.1b, Page 1]. This indicates that the device's performance was not evaluated against specific acceptance criteria in a dedicated clinical study for this 510(k) submission. Instead, substantial equivalence was demonstrated through non-clinical testing and comparison to a predicate device already cleared by the FDA.

Therefore, many of the requested details about acceptance criteria and clinical study methodology are not applicable or available in this document.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/available. This submission does not provide specific performance metrics or acceptance criteria for a new clinical study. The device's performance is implicitly accepted as equivalent to the predicate device (Hitachi HI VISION Avius Diagnostic Ultrasound Scanner [K102901]) based on technical comparisons and adherence to safety standards.

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

Not applicable/available. As no clinical testing was required or conducted for this 510(k) submission to establish acceptance criteria, there is no test set sample size or data provenance to report. The evaluation was based on non-clinical testing and comparison to a predicate device.

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

Not applicable/available. Since no new clinical testing was performed to establish performance against acceptance criteria, there was no need for experts to establish ground truth for a test set in this submission.

4. Adjudication Method for the Test Set

Not applicable/available. No clinical test set was used to assess performance against acceptance criteria.

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, as explicitly stated "Clinical testing: None required." The submission focuses on demonstrating substantial equivalence.

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

Not applicable/available. This device is an ultrasound system with various imaging modes, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply in this context. The operational modes (B mode, PW mode, CW mode, Color Doppler, etc.) are integrated features of the ultrasound system and are inherently used with human operators.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable/available. No new clinical data requiring ground truth establishment was generated for this 510(k) submission.

8. The Sample Size for the Training Set

Not applicable/available. The Hitachi Noblus™ Diagnostic Ultrasound System is a medical imaging device, not an AI/ML model that requires a training set in the conventional sense. The "training" for such devices typically involves engineering and optimizing hardware and software components based on known physics, signal processing principles, and image quality standards, rather than specific clinical image datasets.

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

Not applicable/available. As the device is not an AI/ML model requiring a training set, the concept of establishing ground truth for a training set does not apply.

Summary of Device Substantiation:

The Hitachi Noblus™ Diagnostic Ultrasound System gained FDA clearance (K130308) by demonstrating substantial equivalence to an existing legally marketed predicate device, the Hitachi HI VISION Avius Diagnostic Ultrasound Scanner [K102901].

The substantiation was based on:

• Non-clinical Testing: The device and its transducers were evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, electrical safety, and mechanical safety, conforming to applicable medical device safety standards [Section 1.1b, Page 1].
• Technical Comparison: The subject device was shown to be technically comparable to the predicate device, sharing the same fundamental and scientific technologies, intended use, indications for use, gray scale and Doppler capabilities, essential technology for imaging, Doppler functions, signal processing, and acoustic levels below FDA limits [Section 1.1b, Page 1].
• Quality System Compliance: Both subject and predicate devices are manufactured in accordance with FDA 21 CFR 820 Quality System Regulations and designed/manufactured to the same electrical and physical safety standards [Section 1.1b, Page 1].
• Biocompatibility: Materials used were tested according to tripartite biocompatibility guidance and ISO 10993-1 [Section 1.1b, Page 1].
• Cleaning and Disinfection: Instructions for cleaning, disinfection, and sterilization are provided [Section 1.1b, Page 1].

The clearance process for such a device relies on these comparisons to ensure the new device is as safe and effective as a previously cleared device, without the need for new clinical trials if substantial equivalence can be adequately demonstrated through other means.

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