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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 (Spec.), Trans-esophageal (Cardiac, Non-Cardiac) - Adult/Pediatric, Wound (Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biospy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intraluminal, Gynecology, Urology, and Laparoscopic clinical applications.

The modes of operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave 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 text describes a 510(k) premarket notification for the Hitachi Noblus™ Ultrasound Diagnostic System. This document asserts the substantial equivalence of the Noblus™ to legally marketed predicate devices, rather than detailing a specific study to prove acceptance criteria for novel functionalities.

Therefore, the acceptance criteria and details of a proving study as typically applied to new or significantly modified aspects requiring such validation are not fully present in the provided text. The document instead focuses on demonstrating that the new combined features and transducers of the Noblus™ are substantially equivalent to existing cleared devices, implying that the acceptance criteria for those existing devices are met.

However, I can extract the relevant information regarding the device's claimed performance based on its stated equivalence and the non-clinical testing performed.

Here's an interpretation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission asserting substantial equivalence, formal acceptance criteria as a quantitative threshold for novel performance claims are not explicitly stated for new features. Instead, the "acceptance criteria" here implicitly refer to the device performing comparably to the predicate devices for their respective indications. The "reported device performance" is essentially that it functions in the specified modes and applications similar to the already cleared predicate devices.

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

The document explicitly states "Non-clinical Testing" and "Clinical testing: None required." This indicates that no new clinical test set with a specific sample size was collected or analyzed for the purpose of this specific 510(k) submission to prove the device meets acceptance criteria for novel claims. The primary basis for equivalence is comparison to previously cleared devices. If any non-clinical testing involved datasets (e.g., for algorithm validation if there were any, which isn't explicitly detailed as a novel algorithm here), the details are not provided in this summary.

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

Given that "Clinical testing: None required" and the submission relies on substantial equivalence to existing devices, there is no mention of a new test set requiring new ground truth established by experts specifically for this submission. The ground truth for the predicate devices would have been established during their respective clearance processes.

4. Adjudication Method for the Test Set:

Not applicable, as no new clinical test set (with specific ground truth requiring adjudication) was explicitly described for this submission.

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

No, an MRMC comparative effectiveness study is not mentioned as having been done for this submission. The submission is based on substantial equivalence, comparing the device to existing cleared devices rather than assessing performance improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document describes an ultrasound system with various imaging modes and features, including "Real Time Tissue Elastography" with a "strain ratio feature." While Elastography involves algorithms, the submission doesn't detail a standalone algorithmic performance study independent of human interpretation. The claim is that the feature itself is substantially equivalent to a predicate device's feature, implying that its standalone performance would be comparable, but no specific study is described.

7. The Type of Ground Truth Used:

For the features deemed substantially equivalent to predicate devices, the presumed "ground truth" would have been established during the clearance of those predicate devices. This could include various types of clinical data, expert consensus, and in some cases, pathology or outcome data, depending on the specific application addressed by each predicate. For the Real Time Tissue Elastography, the comparison is functionally qualitative ("provides color graph of tissue strain... to assist in visualization and perimeter of a tumor, lump or mass in liver, breast, thyroid, etc. for biopsy purposes") rather than being tied to definitive pathology for this specific submission's evaluation.

8. The Sample Size for the Training Set:

Not applicable. This is a 510(k) demonstrating substantial equivalence for an ultrasound system, not a submission for a de novo AI/ML algorithm that would undergo specific training and validation studies with disclosed training set sizes. The "training" for the device's various imaging modes is inherent in its engineering and design based on established ultrasound physics and technologies, and comparison to predicate devices, not typically in the sense of an AI/ML training dataset.

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

Not applicable, as there's no mention of an AI/ML training set in the context of this 510(k) summary. The development of the Noblus™ system relies on established medical device development practices and comparisons to already cleared technologies.

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The Hitachi Aloka Medical. Ltd. UST-5310 / UST-5311 transducers for use with the PROSOUND ALPHA6 Diagnostic Citrasound scanner are intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrassund evaluation during Intra-operative and Intra-operative (neurosurgery) procedures.

The device is not indicated for Ophthalmic applications.

Linear Array transducer

The provided text describes a 510(k) premarket notification for diagnostic ultrasound transducers (Hitachi Aloka Medical, Ltd. UST-5310 and UST-5311). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to prove novel performance benefits.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, as would be common for AI/ML-based diagnostic devices. Instead, the acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to existing predicate devices.

The "performance" of the device is assessed by its technical comparability and safety.

• Found to conform to applicable medical device safety standards.
• Biocompatibility testing conducted in accordance with ISO 10993-1.
• Acoustic level below Track 3 FDA limits. |
  | Manufacturing | Manufactured in accordance with FDA 21 CFR 820 Quality System Regulations. |
  | Technology | Same essential technology for imaging, Doppler functions, and signal processing as predicate devices. |
  | Modes of Operation | Same modes of operation (B, M, PWD, CD, PowerFlow, and combinations). |
  | Intended Use/Indications | Indicated for diagnostic ultrasound imaging during Intra-operative and Intra-operative (neurosurgery) procedures, similar to predicate but with a difference in sterilization methodology (single-use sterile vs. reusable). |
  | Sterilization | Designed to be sterilized via EtO. The subject device is supplied sterile, while the predicate is supplied non-sterile with instructions for cleaning, disinfection, and sterilization. |
  | Materials | New material: Ethylene Vinyl Acetate, but all other materials previously cleared by FDA. |

2. Sample size used for the test set and the data provenance

No clinical test set or data provenance is mentioned. The submission explicitly states "Clinical testing: None required." This indicates that the regulatory pathway for these transducers did not require a clinical study with a test set of patient data, as the device is deemed substantially equivalent based on technical specifications and non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical testing with a test set was required or performed for this submission.

4. Adjudication method for the test set

Not applicable, as no clinical testing with a test set was required or performed.

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 device is a diagnostic ultrasound transducer, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a hardware component (ultrasound transducer), not a standalone algorithm.

7. The type of ground truth used

Not applicable in the context of clinical performance. The "ground truth" for this submission revolves around technical and safety standards compliance and substantial equivalence to a legally marketed predicate device. This is demonstrated through non-clinical testing (acoustic output, biocompatibility, electrical safety, etc.) as opposed to clinical outcomes or expert consensus on image interpretation.

8. The sample size for the training set

Not applicable. This is a hardware device (ultrasound transducer), not an AI/ML system requiring a training set.

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

Not applicable. No training set or associated ground truth establishment is mentioned or relevant for this type of device.

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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 Aloka Medical. Ltd. AriettaS70 /AriettaV70 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultration of Abdominal. Cardiac. Intra-operative. I ctal. Pediative. Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal. Musculoskeletal. Neonatal Cephalic. Adult Cephalie, Endoscopy, Intra-luminal, Gynecology, Urology and Laparoscopic clinical applications.

The Modes of Operation are B mode. PW mode (Pulsed Wave Doppler). CW mode (Continuous Wave Doppler). Color Doppler. Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, Real Time Tissue Elastography, and Real Time Virtual Sonography.

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) O in various modes of operation
• o A computer system - to control the transducer and analyze the signals resulting from the reflected echocs
• O A video monitor with optional image recorder - to display the computed image or derived Doppler data

This document is a 510(k) Summary of Safety and Effectiveness for the Hitachi Aloka Medical, Ltd. Arietta70 / AriettaV70 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving specific acceptance criteria and performance data for the device itself in terms of diagnostic accuracy or effectiveness measures.

Instead, the document details non-clinical testing to ensure the device's safety and technical performance against established standards, and then states that no clinical testing was required to prove substantial equivalence. Therefore, there is no study described here that directly "proves the device meets the acceptance criteria" in the sense of diagnostic performance or clinical outcomes.

However, based on the provided text, we can infer the "acceptance criteria" relate to safety, performance according to medical device standards, and substantial equivalence to legally marketed predicate devices.

Here's the breakdown of the information requested, based on what is available in the provided text:

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

Since no specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device in comparison to acceptance criteria, the table will reflect the general safety and technical performance demonstrated through non-clinical testing and comparison to predicate devices.

2. Sample size 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 data is described. The evaluation was based on non-clinical testing, engineering analysis, and bench testing, as well as comparison to predicate devices, rather than a clinical study with a patient test set.

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 clinical test set with associated ground truth established by experts is described.

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

Not applicable. No clinical test set requiring adjudication 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

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

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

Not applicable. The document describes an ultrasound diagnostic system, not a standalone algorithm.

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

Not applicable. No clinical ground truth was established as no clinical studies were performed or required for this 510(k) submission. For non-clinical testing, adherence to recognized standards and technical specifications served as the "ground truth" for performance.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning or AI-based device submission requiring such data.

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

Not applicable. There is no training set described.

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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 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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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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