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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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Esaote's Model 7340 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 7340 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculo-skeletal applications. The 7340 system provides imaging for venous system measurements.

Model 7340 is a portable ultrasound system used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, Multi View (MView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The 7340 is equipped with a LCD Color Display. The full alphanumeric keyboard allows complete on-screen data entry of patient information and onscreen annotations. The 7340 can drive phased (PA), convex (CA), linear array (LA), Doppler probes and BiScan probes. The 7340 is equipped with an internal Hard Disk and with a DVD-RW disk drive that can be used for image storage. Data can also be stored directly to external archiving media (hard-disk, PC, server) via a LAN/USB port. Optional accessory devices available for the 7340 include an S-VHS video recorder; a monochrome or color page printer and a mobile trolley equipped with an insulation transformer. Model 7340 can be equipped with an internal battery that provides power when no main power is available.

The 7340 system has been cleared by FDA via K081794 and K091009.

Model 7340 upgrade, defined herein, combines the features of the Model 7340 with other, previously cleared software features and new software capabilities to assist a physician in making venous measurements. The venous imaging software package includes:

• 1. Dedicated Presets for Venous System Imaging, CFM and Doppler
• 2. QDP Quality Doppler Profiles Technology based on Multigate Doppler algorithm
• 3. Optimized Probe management for Venous Intracranial Doppler

The 7340 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

The provided text is a 510(k) summary for the Esaote Model 7340 ultrasound system upgrade (K110688). This document primarily focuses on establishing substantial equivalence to predicate devices and detailing the intended uses and technological characteristics. It does NOT contain information about specific performance acceptance criteria or detailed study results for the device's clinical performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

However, I can extract information related to general non-clinical testing and the type of ground truth implied by regulatory standards.

Here's a breakdown of what can be inferred or explicitly stated from the document regarding the study and acceptance criteria proving device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

• None explicitly stated for clinical performance. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards for safety and performance, rather than reporting on specific clinical performance metrics with acceptance criteria benchmarks.

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

• Not specified. The document does not describe any specific clinical test or validation set with patient data. The non-clinical testing mentioned refers to engineering verification and validation against technical standards.

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

• Not applicable for clinical ground truth. Since no clinical test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set or adjudication method 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:

• No MRMC study mentioned. This document predates widespread AI integration in medical devices and does not describe any such study. The device is an "Ultrasound Imaging System" with software features to assist in "venous measurements" and "venous system imaging."

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

• Not applicable. The device is an ultrasound system with software features, not a standalone AI algorithm. It's an imaging device for physician use.

7. The Type of Ground Truth Used:

• Implied ground truth through adherence to recognized standards and substantial equivalence. The primary "proof" that the device performs as intended relies on:
  • Substantial Equivalence: The device's "technological characteristics" (including clinical uses, flow profile capabilities, and safety standards) are deemed "equivalent" to those of previously cleared predicate devices (Esaote 7340, Aloka SD5500, Aloka 4000). The implication is that if the predicate devices were safe and effective, and this device is equivalent, then it is also safe and effective.
  • Non-Clinical Testing against Recognized Standards: Verification and validation tests were conducted "in accordance with design controls per CFR 820.30" and designed to meet specific international and national standards. These standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2) effectively serve as the "ground truth" for the device's technical and safety performance. This includes electrical safety, electromagnetic compatibility, essential performance, and acoustic output measurements.

8. The Sample Size for the Training Set:

• Not applicable. The document does not describe a machine learning algorithm with a training set. The "upgrade" consists of dedicated presets, a specific Doppler technology, and optimized probe management, which are software features, not a trainable AI model.

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

• Not applicable. As no training set for a machine learning model is mentioned, there's no information on how its ground truth would have been established.

Summary of what the document does provide:

• Device Name: Model 7340 upgrade
• Intended Use: Diagnostic general ultrasound studies across various applications (Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small Organs, Musculoskeletal, Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative, Laparoscopic, Urologic). Includes imaging for guidance of biopsy, needle placement, peripheral nerve blocks, and venous system measurements.
• Predicate Devices: Esaote 7340 (K081794, K091009), Aloka SD5500 (K032875, K033311), Aloka 4000 (K003739, K040719).
• New Features in Upgrade: Dedicated Presets for Venous System Imaging (CFM and Doppler), QDP Quality Doppler Profiles Technology (based on Multigate Doppler algorithm), Optimized Probe management for Venous Intracranial Doppler.
• Safety and Performance Validation: Non-clinical testing conducted per CFR 820.30 and adherence to recognized standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2.
• Quality System: Manufactured under ISO 9001:2000 and ISO 13485 certified quality system.

The document demonstrates the device's "substantial equivalence" to previously cleared devices and its compliance with established safety and performance standards for diagnostic ultrasound systems. It does not provide data from clinical trials or specific performance metrics with acceptance criteria as one might expect for a novel AI-driven diagnostic device today.

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

The SSD-3500 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.

Here's an analysis of the provided information regarding the Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) premarket notification for a diagnostic ultrasound system. In a 510(k) submission for a device like this, the "acceptance criteria" are generally that the new device (Aloka SSD-3500 Ver. 7.8) demonstrates substantial equivalence to a previously cleared predicate device (Aloka SSD-3500 Ver. 7.0). This means the new device must have the same intended use, similar technological characteristics, and demonstrate similar safety and effectiveness.

Since this is a substantial equivalence claim for an ultrasound system, the acceptance criteria don't typically involve specific performance metrics like sensitivity or specificity in a diagnostic task, but rather confirmation that the device functions as intended and meets relevant safety standards.

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

The document explicitly states: "2. Clinical Tests: None Required."
Therefore, there is no test set, sample size, or data provenance related to clinical performance testing for this submission. The device's substantial equivalence is based on technical specifications and comparison to a predicate device, not on new clinical performance data from a specific 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 tests were required, there was no test set and therefore no ground truth established by experts for performance evaluation in this submission.

4. Adjudication Method for the Test Set

As there was no clinical test set, no adjudication method was used for establishing ground truth.

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 comparative effectiveness study was conducted or required for this 510(k) submission. This device is a diagnostic ultrasound system, not an AI-powered diagnostic application that would typically undergo such a study to evaluate human reader improvement with AI assistance.

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

No standalone algorithm performance study was conducted. This device is a conventional diagnostic ultrasound system, not an artificial intelligence algorithm that would typically have a standalone performance evaluation.

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

As mentioned above, no specific clinical ground truth was established for performance evaluation in this 510(k) submission because clinical testing was not required. The "ground truth" for the submission is the regulatory acceptance of its predicate device (Aloka SSD-3500 Ver. 7.0) and the demonstrated technical equivalence and adherence to safety standards.

8. The Sample Size for the Training Set

Since no AI/machine learning algorithm is part of this submission, there is no training set mentioned or used.

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

Not applicable, as there is no training set for an AI/machine learning algorithm in this submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Aloka SSD-3500 Ver. 7.8 Diagnostic Ultrasound System meets its acceptance criteria is a technical and regulatory comparison study against a legally marketed predicate device, the Aloka SSD-3500 Ver. 7.0 (K060059).

The manufacturer (Aloka Co., Ltd.) provided documentation and analysis demonstrating that the new version is "technically comparable and substantially equivalent" to the predicate. This involved:

• Documentation of Shared Characteristics: Confirming that the Aloka SSD-3500 Ver. 7.8 has the "same technological characteristics, key safety and effectiveness features, and has the same intended uses and basic operating modes" as the predicate device.
• Non-Clinical Testing: The device and its transducers underwent various non-clinical evaluations to confirm compliance with applicable medical device safety standards. These tests covered:
  • Acoustic output
  • Biocompatibility
  • Cleaning & disinfection effectiveness
  • Electromagnetic compatibility
  • Electrical safety
  • Mechanical safety
• Quality System Conformance: The manufacturer confirmed that their design, development, and quality processes align with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems.

The FDA's review of this submission found that "the device is substantially equivalent... to legally marketed predicate devices," thus confirming it meets the regulatory acceptance criteria for market clearance. Clinical testing was not required because the device was demonstrating equivalence to an already approved device and no new questions of safety or effectiveness were raised.

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

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

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

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

Study Details:

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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