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The 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.), Intra-operative (Neuro.), Transesophageal (Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Musculoskeletal (Convent. / Superfic.), 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, M mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D 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 O
• Ultrasound transducer accessories (standard and optional) to maximize functional usage of transducer(s) O in various modes of operation
• A computer system to control the transducer and analyze the signals resulting from the reflected echoes O
• A video monitor with optional image recorder to display the computed image or derived Doppler data O

The provided text is related to a 510(k) premarket notification for the NOBLUS™ Ultrasound Diagnostic System. It primarily focuses on the device's intended use and comparison to a predicate device, rather than detailed acceptance criteria and study results for device performance. Therefore, I can only extract limited information relevant to your request.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "FDA Track" and "Transmit Channel" as comparative characteristics, implying these were evaluated, though specific acceptance criteria values or performance metrics are not explicitly stated in a tabular format as you requested. The comparison indicates the devices performed equivalently.

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

The document states "No new hazards were identified with the subject device and its transducers have been evaluated..." and "No new safety or effectiveness questions are raised related to these changes." This phrasing indicates that evaluations were performed, but no specific sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective) is provided. The evaluation appears to be based on design, materials, and compliance with standards rather than clinical data from a test set.

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

Since no clinical testing necessitating a test set and ground truth establishment is mentioned, this information is not available in the provided text. The evaluation method described focuses on engineering and regulatory compliance.

4. Adjudication method for the test set:

Not applicable, as no clinical test set requiring adjudication is mentioned.

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 device is an ultrasound diagnostic system, not an AI-assisted diagnostic tool for human readers. The document does not mention any AI capabilities or comparative effectiveness studies of this nature.

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

Not applicable. The device is an ultrasound diagnostic system, which inherently involves human operation and interpretation. The document does not describe any standalone algorithm performance testing.

7. The type of ground truth used:

Not explicitly stated for performance evaluation as the evaluation methods lean towards engineering and regulatory compliance. For the broader context of diagnostic ultrasound, the "ground truth" would generally be established by definitive diagnostic methods (e.g., pathology, surgical findings, clinical follow-up) for the conditions being diagnosed. However, these are not directly referenced as part of this device's "study" for acceptance criteria.

8. The sample size for the training set:

Not applicable. This is a medical device submission for an ultrasound system, not an AI/machine learning model that typically requires a training set.

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

Not applicable, as there is no training set mentioned for an AI/machine learning model.

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The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved crosssectional images that display the internal structure of the images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The indications for use for the OASIS Specialty Coils are as follows:

• The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used . for MRI imaging of the human cervical spine, and thoracic spine.
• . The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for MRI imaging of the abdomen.
• The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple . array device used for MRI imaging of the abdomen.
• The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array . device used for MRI imaging of the foot.

The MR-CTL-120, OASIS CTL Coil is a recieve-only multiple array device used for obtaining diagnostic images of the human cervical spine, and thoracic spine with the OASIS MRI System.

The MR-QFC-120, OASIS QD Flexible Body Coil (L) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.

The MR-QFC-120, OASIS QD Flexible Body Coil (XL) is a recieve-only multiple array device used for obtaining diagnostic images of the abdomen with the OASIS MRI System.

The MR-RFC-120, OASIS Rapid Foot Coil is a recieve-only multiple array device used for obtaining diagnostic images of the foot with the OASIS MRI System.

This document, K073310, is a 510(k) premarket notification for several specialty magnetic resonance imaging (MRI) coils manufactured by Hitachi Medical Corporation. The purpose of a 510(k) submission is to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective.

The provided document describes the intended use and technological characteristics of the OASIS Specialty Coils (CTL Coil, QD Flexible Body Coils (L and XL), and Rapid Foot Coil) and asserts their substantial equivalence to predicate devices (ECHELON Whole Spine (CTL) Coil, ALTAIRE Flex Body (Large) Coil, ALTAIRE Flex Body (Extra Large) Coil, and OASIS RAPID Head Coil).

*However, the document does not contain any information regarding specific acceptance criteria, study designs, sample sizes for test or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies related to device performance.

The document primarily focuses on:

• Device Identification: Naming the new devices and their predicate devices.
• Intended Use: Specifying the anatomical regions for which each coil is designed (cervical spine, thoracic spine, abdomen, foot).
• Device Description and Function: Briefly explaining that these are receive-only multiple array devices for obtaining diagnostic images with the OASIS MRI System.
• Scientific Concepts: A general overview of MRI principles.
• Physical and Performance Characteristics (General): Describes the number of elements in each coil and that signals are independently processed to enhance performance. It does not provide specific performance metrics or acceptance thresholds.
• Technological Characteristics: States they are similar to predicate devices.
• Conclusion: The submitter's opinion that the devices are substantially equivalent.
• FDA Response: The FDA's letter granting 510(k) clearance based on substantial equivalence to predicate devices.

Given the content of this 510(k) submission, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use matching predicate devices, rather than a clinical performance study with specific acceptance criteria and detailed results.

Therefore, for each point requested, the answer will be:

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

Explanation: The document describes the technological characteristics and intended use of the coils, stating they are similar to predicate devices. It does not provide specific performance metrics or quantitative acceptance criteria that would typically be seen in a clinical performance study for image quality or diagnostic accuracy.

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

• Sample Size (Test Set): Not specified in the provided document.
• Data Provenance: Not specified in the provided document.

Explanation: The document does not describe a performance study with a test set of data. The submission relies on demonstrating substantial equivalence to predicate devices based on design and intended use, rather than presenting a new clinical data 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)

• Number of Experts: Not applicable, as no test set requiring ground truth establishment is described.
• Qualifications of Experts: Not applicable.

Explanation: As no performance study with a test set is detailed, there's no mention of experts establishing ground truth.

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

• Adjudication Method: Not applicable, as no test set requiring ground truth establishment is described.

Explanation: Without a performance study or test set, adjudication methods are not relevant to the information provided.

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 Study: No, an MRMC comparative effectiveness study was not described.
• Effect Size: Not applicable.

Explanation: This device is a passive MRI coil, not an AI-powered diagnostic tool. The submission is for hardware (coils), and an MRMC study comparing human reader performance with and without AI assistance is not relevant to this type of device.

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

• Standalone Performance Study: No, a standalone performance study was not described.

Explanation: This device is a passive MRI coil and does not involve an algorithm for standalone performance evaluation.

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

• Type of Ground Truth: Not applicable, as no performance study requiring ground truth is described.

Explanation: Since no performance study to establish the device's diagnostic performance is detailed, no ground truth types are mentioned. The submission focuses on device characteristics and equivalence.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable, as no training set for an algorithm is described.

Explanation: This is a hardware submission, not an AI/algorithm submission, so the concept of a training set is not relevant here.

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

• Ground Truth Establishment (Training Set): Not applicable.

Explanation: As no training set or algorithm is described, the method for establishing its ground truth is not relevant.

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Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: General (Track I only), Specific (Tracks I & III) including Ophthalmic, Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Intra-luminal, Other (spec.), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Other (spec.), Peripheral vessel, Other (spec.).

The Hitachi EUB-5500 Diagnostic Ultrasound Scanner is a Track 3 Diagnostic Ultrasound Pulsed Doppler and Pulsed Echo Imaging System capable of the following operating functions: B Mode, M Mode, Pulsed Doppler Color Flow, Continuous Wave Doppler, Amplitude Doppler, Harmonic imaging, Superficial musculoskeletal imaging, 3D imaging, 4D imaging.

I am sorry, but the provided text only contains an FDA 510(k) premarket notification for the Hitachi EUB-5500 Diagnostic Ultrasound Scanner. It details the device description, safety compliance, and intended uses for various transducers.

The document does not describe any acceptance criteria for device performance, nor does it present any study or data proving the device meets acceptance criteria. It is primarily a regulatory filing for substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance, as it is not present in the given text.

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Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

EUB-6500 Diagnostic Ultrasound Scanner

The provided text outlines the intended use and modes of operation for various transducers of the Hitachi EUB-6500 Diagnostic Ultrasound Scanner. It does not contain information about acceptance criteria for a specific outcome, nor does it describe a study proving the device meets particular performance metrics.

Instead, this document appears to be part of a 510(k) premarket notification to the FDA, detailing the intended uses for different transducers associated with the EUB-6500 system. The "E" and "P" notations in the tables indicate whether an intended clinical application and mode of operation was "Added under Appendix E" (meaning new for this submission) or "Previously Cleared" (referring to a previous submission, K013723).

Therefore, I cannot provide the requested information as it is not present in the provided text. The document is a regulatory submission outlining intended uses, not a performance study.

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The intended use of the ETG-4000 is the measurement of relative levels of cerebral deoxyhemoglobin and oxyhemoglobin.

The ETG-4000 is a device that measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin and total hemoglobin (678-1200 m) that sam near-infrared light (670-1300nm) that can the surface area of the cerebra. Sed is absorbed by the hemoglobin in the blood.

The ETG-4000 displays the changes of overall Hemoglobin concentration in time- course images (motion images and still images) based on the data from multiple point measurements.

This is a non-invasive test that is done by contacting an array of small optical fiber tips on the surface of the scalp.

The ETG-4000 beams frequency modulated near-infrared light into the surface of the brain. The light passes through the scalp, skull and upper layer of illiough several or the optical noves read by the hemoglobin in the blood and is reflected back and is collected by optical fibers.

The ETG-4000 measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin at multiple points on the head simultaneously by utilizing the changes of light absorption.

The ETG-4000 provides data that show the activity status of the cerebral cortex by displaying the changes of oxy-hemoglobin and deoxy-hemoglobin concentration in the brain surface, and the metabolic and circulatory status of the cerebral cortex in a time-course graphic representation of oxy-hemoglobin, deoxy-hemoglobin and total hemoglobin, 2D dynamic images and 3D dynamic images.

This document is a 510(k) summary for the Hitachi ETG-4000 Optical Topography System. It states that the device measures relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin and total hemoglobin using near-infrared light. It is intended for non-invasive measurement of cerebral activity by displaying changes in hemoglobin concentration over time. The document claims substantial equivalence to the predicate device, Hitachi ETG-100 (K011320), based on similar materials, technology, and functional methodology. It also states that the device is non-invasive and complies with applicable safety standards.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical thresholds or performance metrics (e.g., accuracy, sensitivity, specificity, or error rates). The document focuses on demonstrating substantial equivalence to a predicate device (Hitachi ETG-100, K011320) rather than setting and meeting new performance acceptance criteria as would typically be seen for a novel device or a device with new claims.

The closest statements to "reported device performance" are:

• "The ETG-4000 system has been developed and validated in accordance with design controls and applicable standards."
• "Testing has permitted the determination that the system is safe and effective for the indicated applications."
• "There are no new safety issues associated with this system as compared with the predicate device."

Since specific numerical acceptance criteria are not provided, a table cannot be meaningfully constructed. The "performance" is implicitly tied to demonstrating equivalence to the predicate device, which itself would have had its own "performance" deemed acceptable at the time of its clearance.

2. Sample Size for the Test Set and Data Provenance

The document does not provide any information regarding the sample size used for a test set or the provenance of any data (e.g., country of origin, retrospective or prospective). The submission relies on design control validation and comparison to a predicate device, not a distinct clinical performance study with a test set as typically defined for algorithm-driven devices.

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

The document does not mention the use of experts to establish a ground truth for a test set. This type of information is usually found in submissions for diagnostic algorithms that require expert interpretation for ground truth labeling. The ETG-4000 is described as measuring physiological changes, not making diagnostic interpretations independently.

4. Adjudication Method for the Test Set

Since no test set or expert ground truth establishment is mentioned, there is no information on an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is an "Optical Topography System" that measures physiological parameters. It does not appear to be an AI-assisted diagnostic tool that would be evaluated in the context of human reader performance.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study for an algorithm. The ETG-4000 itself is the device designed to measure and display physiological data. Its performance is stated to be safe and effective, and substantially equivalent to its predicate.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to performance studies for diagnostic AI algorithms (e.g., pathology, outcomes data, expert consensus) is not discussed in this 510(k) summary. The device measures "relative changes in tissue concentration of oxy-hemoglobin and deoxy-hemoglobin and total hemoglobin." The "truth" of these measurements would be a comparison to a gold standard measurement method or established physiological norms, but this type of comparative study is not detailed.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This indicates that the ETG-4000, as described in this 2004 submission, is likely a hardware-based measurement system with embedded algorithms, rather than a machine learning or AI algorithm that would typically require a distinct training phase with a large dataset.

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

Since no training set is mentioned, there is no information on how ground truth for a training set was established.

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Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
N = new indication.
*Combination of each operating mode, B, M, PWD, CWD and Color Doppler.
** Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Additional Comments:
Subscript "a": Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis).
Subscript "b": Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures).
Subscript "c": Includes thyroid, parathyroid, breast, scrotum, penis.
Subscript "d": Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy.
Subscript "e": Includes imaging for guidance of transrectal biopsy.
Subscript "f": Includes imaging for guidance of transvaginal biopsy.
Subscript "g": For pediatric patients.
Subscript "h": Includes imaging for guidance of transrectal biopsy.

The Imagin 2011 0000 Diagnoons aging system capable of the following operating pulsed Doppler und palsed continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.

The Hitachi EUB-8500 Diagnostic Ultrasound Scanner (K013722) received clearance as a general ultrasound imaging system.

The provided document describes the intended uses for the EUB-8500 system with various transducers, indicating where it has "new indications" (marked with "N") for specific clinical applications and modes of operation. However, it does not contain information about acceptance criteria or specific studies proving the device meets those criteria with performance metrics such as accuracy, sensitivity, or specificity.

This document is a 510(k) premarket notification letter from the FDA, which confirms substantial equivalence to legally marketed predicate devices. It focuses on device description, safety (acoustic output and general electrical safety standards), and lists the cleared transducers and their intended uses.

Therefore, I cannot provide the requested information for the following points based on the provided text:

1. A table of acceptance criteria and the reported device performance: This is not present in the document. The document lists the intended uses for each transducer, but not performance metrics or acceptance criteria for those uses.
2. Sample size used for the test set and the data provenance: No test set details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No details on expert-established ground truth for a test set.
4. Adjudication method for the test set: No details on adjudication.
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, as this is a device clearance for an ultrasound scanner, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a device clearance for an ultrasound scanner, not an algorithm.
7. The type of ground truth used: Not specified.
8. The sample size for the training set: Not specified.
9. How the ground truth for the training set was established: Not specified.

Summary of available information from the document:

• Device Description: The Hitachi EUB-8500 Diagnostic Ultrasound Scanner is a diagnostic imaging system capable of pulsed Doppler, continuous Wave Doppler, Color Flow (including Amplitude Doppler), harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.
• Safety:
  • As a Track 3 ultrasound device, it includes real-time display of Thermal and Mechanical Acoustic Output Indices, complying with NEMA standards (OD 3) and FDA guidelines (April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance).
  • It also complies with general safety standard IEC 60601-1 (1998) Medical Electrical Equipment, Part 1, General Requirements for Safety.
• Intended Use: The document details the intended uses for the EUB-8500 system with various transducers (EUP-B314, EUP-C514, EUP-ES322, EUP-ES52M, EUP-ES533, EUP-F531, EUP-L54M, EUP-L53S, EUP-OL334, EUP-R53W, EUP-S50, EUP-TC3, EUP-U533, EUP-V53W) across different clinical applications and modes of operation (B, M, PWD, CWD, Color Doppler, Combined, and Other (Amplitude Doppler, Harmonic Imaging, 3D Imaging)). "N" indicates a new indication for a specific application/mode combination. Subscripted notes (a-h) provide further clarification on certain clinical applications (e.g., guidance for biopsy).

The substantial equivalence determination is based on the device's adherence to established safety standards and its demonstration of equivalent technology and intended uses to predicate devices. This type of clearance does not typically involve efficacy studies with detailed performance metrics or clinical study data like those requested for deep learning algorithms.

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Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
General (Track I only), Specific (Tracks I & III)
Mode of Operation: B, M, Pulsed Doppler, Continuous Wave Doppler, Color Doppler, Combined (Spec.), Other (Spec.)
Other (Spec.) includes Amplitude Doppler, Harmonic Imaging and 3D Imaging.
Specific clinical applications vary by transducer.

The Hitachi EUB-6500 Diagnostic Ultrasound Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B, M, Pulsed Doppler, Continuous Wave Doppler, Color Flow (including Amplitude Doppler). It is also intended for harmonic imaging, superficial musculoskeletal imaging, and 3D imaging.

The provided text does not contain information about acceptance criteria or specific studies to prove device performance for the Hitachi EUB-6500 Diagnostic Ultrasound Scanner.

The document is a 510(k) premarket notification letter from the FDA, and it focuses on:

• Device Description: A general overview of the Hitachi EUB-6500's capabilities and operating modes.
• Safety Compliance: Statements regarding adherence to NEMA and IEC standards for acoustic output and general electrical safety.
• Substantial Equivalence Determination: The FDA's finding that the device is substantially equivalent to legally marketed predicate devices.
• Intended Use Tables: Detailed tables that outline the specific clinical applications and modes of operation for various transducers used with the EUB-6500. For each application, "N" indicates a new indication, and subscripts provide additional context (e.g., "Na" for abdominal imaging including biopsy guidance).
• Post-Clearance Special Report Requirement: A condition for marketing requiring submission of acoustic output measurements from production line devices.

Therefore, I cannot fulfill your request to describe acceptance criteria and associated studies, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for the Hitachi EUB-6500 based on the provided text.

This document is primarily a regulatory communication confirming marketing clearance based on substantial equivalence, not a performance study report.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: endoscopic observation of the gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts).

The subject device consists of:

• EUB-525/EUB-2000 Diagnostic Ultrasound Scanner
• SP-711UA Ultrasonic Probe Connecting Unit
• TL-1A Translator
• Probe (PL Series or PL26-7.5 Series)
• Balloon and Sheath

The Hitachi EUB-525/EUB-2000 operating controls and their associated functions do not change with the addition of the Fujinon SP-711 Sonoprobe system. The operating controls specific to the Fujinon SP-711 system are described in the operation manuals included with this document in Section 7.

The transducers subject to this submission are the same transducers described in the previously cleared 510(k) K011252. They are: PL1726-20, PL1726-15, PL1726-12, PL1726-7.5, PL1926-20, PL1926-15, PL1926-12, PL1926-7.5, PL2226-20, PL2226-15, PL2226-12, PL2220-20, PL2220-15, PL2220-12, PL2220-7.5.

The PL26-7.5 probe series includes one type for use with a balloon/sheath and the other type for use without a balloon. The only difference between probes is the structure of the tip. The probes made for use with a balloon/sheath have a groove on the tip to catch the balloon head. The probes made for use without a balloon are slightly shorter. The choice of the probe type is at the discretion of the physician. Since ultrasound waves are stronger in water, the physician may choose to use the balloon version to improve image quality. The probes made for use with a balloon/sheath are designated with a "B" (i.e. PL26B-7.5) and must be used with a balloon adapter, balloon sheath, and balloon as described in the operation manual.

The provided text is a 510(k) summary for the Hitachi EUB-525/EUB-2000 Diagnostic Ultrasound Scanner with the Fujinon SP711UA/SP711 Sonoprobe System. It asserts substantial equivalence to a predicate device (Fujinon SP711 Sonoprobe system, K011252) and Hitachi EUB-525 (K981434).

The document states "Performance Data: Identical to device previously cleared by the FDA under 510(k) K011252." This indicates that the device's performance was not re-evaluated for this specific submission, but rather, reliance was placed on the performance data of the predicate device. Therefore, direct acceptance criteria and studies demonstrating the current device's compliance with those criteria are not detailed in this document, as the argument is based on equivalence.

However, based on the information provided, here's a breakdown of what can be inferred and what information is missing:

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

The document does not explicitly state acceptance criteria or provide a table of performance metrics for the current device. It relies on the "identical" performance of the predicate device. The performance of a diagnostic ultrasound system is generally evaluated based on image quality, penetration depth, resolution, accuracy of measurements, and safety (acoustic output).

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

This information is not available in the provided text. Since the submission relies on substantial equivalence and "identical" performance to predicate devices, there is no mention of a new test set or associated data provenance for this specific 510(k).

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)

This information is not available in the provided text. As no new "test set" or independent performance study is described for this submission, there is no mention of experts establishing ground truth.

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

This information is not available in the provided text.

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 information is not available in the provided text. The device described is a diagnostic ultrasound system with sonoprobes, not an AI-assisted diagnostic tool.

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

This information is not available in the provided text. The submission describes hardware for diagnostic ultrasound, not a standalone algorithm.

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

This information is not available in the provided text. In a substantial equivalence submission for a diagnostic imaging device, the "ground truth" for the predicate device's performance would typically refer to clinical diagnosis, pathology, or other established diagnostic methods used to validate the imaging capabilities. However, this is not detailed in the provided summary.

8. The sample size for the training set

This information is not available in the provided text. The document describes a medical device, not a machine learning algorithm requiring a "training set."

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

This information is not available in the provided text. This question is not applicable to the type of device described in the submission.

Summary of Device and Acceptance:

The device, a combination of the Hitachi EUB-525/EUB-2000 Diagnostic Ultrasound Scanner and the Fujinon SP711 Sonoprobe system, gained FDA clearance through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices (Hitachi EUB-525, K981434, and Fujinon SP711 Sonoprobe system, K011252).

The acceptance criteria for this submission were implicitly met by asserting that the device's intended use, technological characteristics, and performance data are identical to those of its predicate devices. This means that formal, new clinical trials or performance studies were not conducted for this specific submission. Instead, the FDA accepted the manufacturer's claim that the new device does not introduce new questions of safety or effectiveness compared to the already cleared devices. The "Indications for Use Forms" for the system and various transducers confirm the clinical applications and modes of operation that are either "previously cleared" (P) or "new" (N) but are cleared based on the substantial equivalence.

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Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:
General (Track I only)
Specific (Tracks I & III)
Ophthalmic
Fetal
Abdominal
Intra-operative (Spec.)
Intra-operative (Neuro.)
Laparoscopic
Pediatric
Small Organ (Spec.)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skel. (Convent.)
Musculo-skel. (Superfic.)
Intra-luminal
Other (spec.)
Cardiac Adult
Cardiac Pediatric
Trans-esophageal (card.)
Other (spec.)
Peripheral vessel
Other (spec.)

The Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B (including harmonic imaging), M, Pulsed and Continuous Doppler, and Color Flow (including Amplitude Doppler). It is intended for general ultrasound imaging of the human body, with specific uses under the general applications of cardiac, peripheral vessel, and fetal imaging and other.

The provided documentation for the Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a 510(k) premarket notification summary. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance studies with acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the document does not contain the explicit acceptance criteria, specific study designs, sample sizes, expert qualifications, adjudication methods, or detailed ground truth information as requested. Instead, it describes compliance with existing standards and refers to the device's intended uses.

However, I can extract and infer some information based on the typical requirements for a 510(k) submission for an ultrasound device.

Here's an attempt to address your points, with the caveat that detailed information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present a table of quantitative acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or clinical outcomes. Instead, performance is established by demonstrating compliance with recognized safety standards and substantial equivalence to predicate devices for specific clinical applications and operational modes.

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

• Sample Size: The document does not specify any sample size for a clinical test set. 510(k) submissions for diagnostic ultrasound equipment primarily rely on engineering performance data, compliance with standards, and comparison to predicate devices, rather than de novo clinical trial data.
• Data Provenance: Not applicable, as detailed patient data or clinical study data is not presented. The "study" here refers to the demonstration of compliance with standards and the technical specifications that show equivalence.

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

• This information is not provided in the document. A 510(k) for a diagnostic ultrasound does not typically require a human-read diagnostic performance study with expert-established ground truth in the same way an AI/CADe device might. The focus is on the technical capability of the imaging system.

4. Adjudication Method for the Test Set

• Not applicable, as a clinical test set with adjudicated ground truth is not 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

• No, an MRMC comparative effectiveness study was not done. This device is a diagnostic ultrasound scanner, not an AI or CADe (Computer-Aided Detection/Diagnosis) system designed to assist human readers. Thus, there is no AI component for human readers to improve with or without.

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

• No, a standalone algorithm performance study was not done. This is a hardware imaging device, not a standalone algorithm.

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

• For the purpose of this 510(k), the "ground truth" for the device's performance relies on compliance with established engineering standards (e.g., NEMA UD-3, IEC 601-1) for acoustic output and electrical safety, and the technical specifications demonstrating that the device can acquire images suitable for the listed clinical applications in various modes, similar to its predicate devices. There is no mention of pathology, expert consensus on clinical cases, or outcomes data in this summary.

8. The Sample Size for the Training Set

• Not applicable. This device is a diagnostic ultrasound scanner; it is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a device would relate to engineering design and testing, not data-driven model training.

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

• Not applicable, as there is no training set for an AI/ML algorithm.

In summary, the provided document demonstrates the Hitachi EUB-6000 Ultrasound Diagnostic Scanner meets acceptance criteria primarily through compliance with recognized safety and performance standards and by establishing substantial equivalence to existing legally marketed predicate ultrasound devices for its specified intended uses. It is crucial to understand that a 510(k) submission for a primary imaging device like this differs significantly from submissions for AI/CADe software, which would typically contain the detailed performance study information you requested.

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