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

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Transrectal, Transvaginal, Fetal, Abdominal, Gynecological, Cardiac, Peripheral Vascular, Small Organ, Intra-operative, Neonatal Cephalic.

The Prosound Alpha 6 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.

This is a 510(k) premarket notification for the Aloka Prosound Alpha 6 Diagnostic Ultrasound System. It is focused on demonstrating substantial equivalence to a predicate device (Aloka SSD-4000 K040719), rather than establishing new performance criteria or efficacy through clinical trials. As such, the document does not contain the typical details of a study designed to prove a device meets specific acceptance criteria in the way an AI/CADe device approval would.

Here's an breakdown based on the provided text, highlighting the absence of information typically requested for AI/CADe approvals:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific performance metrics or acceptance criteria for the Aloka Prosound Alpha 6 in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) that would typically be expected for a device proving novel diagnostic capabilities. Instead, the "acceptance criteria" are implied to be technical comparability and conformance to safety standards, and the "performance" is stated as being "substantially equivalent" to the predicate device.

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

The document explicitly states "None Required" for clinical tests for the purpose of demonstrating substantial equivalence. Therefore, there is no test set, sample size, or data provenance relevant to proving diagnostic performance against predefined acceptance criteria. Clinical practices, FDA guidelines, and established patient examination methods are cited as sufficient to confirm intended uses and features.

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

Since no clinical test set was used to assess diagnostic performance of the new device itself, there were no experts used to establish ground truth in this context. The "ground truth" for the substantial equivalence claim relies on the established safety and effectiveness of the predicate device and the general understanding of diagnostic ultrasound.

4. Adjudication Method for the Test Set

As there was no clinical test set, there was no adjudication method employed.

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 conducted or described in this document. This submission focuses on substantial equivalence based on technical specifications and established safety, not on improving human reader performance with or without AI assistance.

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

The Aloka Prosound Alpha 6 is a diagnostic ultrasound system, not an AI or algorithm-only device. Therefore, a standalone algorithm performance study was not applicable and not conducted. It's a medical imaging hardware and software system used by humans.

7. The Type of Ground Truth Used

The concept of "ground truth" as it applies to diagnostic accuracy for a new device's performance is not directly addressed. Instead, the ground truth for this 510(k) submission is the established safety and effectiveness record of the predicate device (Aloka SSD-4000) and general diagnostic ultrasound technology. The "truth" is that its technical characteristics and intended uses align with a device already cleared by the FDA, implying similar safety and effectiveness.

8. The Sample Size for the Training Set

The Aloka Prosound Alpha 6 is a traditional ultrasound system, not an AI/ML device that requires a training set in the computational sense. Therefore, there is no training set mentioned or applicable.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (specify), Intraoperative Neurological, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mixed mode operation includes B/M, B/PWD, B/Bflow/PWD. Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast, testes and thyroid.

The Aloka SSD-5500 V6.0 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-5500 V6.0 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

The provided text is a 510(k) summary for the Aloka Model SSD-5500 V6.0 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study performance metrics or acceptance criteria for a novel AI algorithm. Therefore, much of the requested information regarding acceptance criteria and performance against those criteria, as well as specific details about test and training sets, expert qualifications, and comparative effectiveness studies, is not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present specific quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs equivalently to the listed predicate devices across various clinical applications and operation modes.

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

• The document does not explicitly state a sample size for a test set or the provenance (country of origin, retrospective/prospective) of any specific data used to evaluate the substantial equivalence from a performance perspective.
• The evaluation appears to be based on a comparison to characteristics and performance of existing legally marketed predicate devices, rather than a new clinical study with a distinct test set for performance metrics. The tables listing "P" (previously cleared by FDA) and "E" (added under Appendix E) suggest that the current device is being compared to the established performance of the predicate device for those indications.

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.
• Given that this is a 510(k) submission asserting substantial equivalence to predicate devices, it's unlikely that new "ground truth" establishment by a panel of experts for a novel device performance study was required or conducted in the manner of a de novo submission. The "ground truth" for the predicate devices' performance would have been established during their initial clearances.

4. Adjudication Method:

• This information is not provided in the document.

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 applicable and therefore not provided. The Aloka SSD-5500 V6.0 is a diagnostic ultrasound system, not an AI-powered image analysis or diagnostic aid designed to be used in conjunction with human readers to improve their performance. It's a standalone imaging device.

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

• The device being evaluated is a standalone diagnostic ultrasound system. Its performance is inherently "standalone" in the sense that it generates images and Doppler information directly. However, it is not an "algorithm only" device; it's a complete hardware and software system for image acquisition and display. The clinical performance is tied to the images and data it produces, which are then interpreted by a human operator/physician.

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

• For the purpose of this 510(k) submission, the "ground truth" for the new device's performance is established by demonstrating its substantial equivalence to the performance and characteristics of its predicate devices. The predicate devices themselves would have had their performance (and hence their implicitly "ground-truth-validated" capabilities) established through various means at the time of their clearance, which could have included expert consensus, physical phantom testing, and clinical evaluations. The document does not specify how the predicate devices' performance was originally validated, only that the new device meets those established standards.

8. The Sample Size for the Training Set:

• This information is not applicable and therefore not provided. This device is a traditional diagnostic ultrasound system, not an AI/ML-driven device that requires a "training set" of data in the sense typically associated with machine learning algorithms.

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

• This information is not applicable and therefore not provided, as the device doesn't rely on a "training set" in the AI/ML context.

In summary:

This 510(k) submission for the Aloka Model SSD-5500 V6.0 Diagnostic Ultrasound System primarily demonstrates its substantial equivalence to previously cleared predicate devices by comparing their technological characteristics, methods of use, safety, and indications. It does not contain details about specific clinical studies with distinct acceptance criteria, test/training sets, or expert ground truth establishment as would be expected for a novel AI/ML device. The "proof" the device meets acceptance criteria is fundamentally its demonstrated sameness in key aspects to already cleared devices and adherence to relevant safety standards.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (liver, pancreas and gall bladder), Intraoperative Neurological, Pediatric, Small Organ (breast, testes and thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial. Mixed mode operation includes B/M, B/PWD, M/CD, B/CD/PWD.

The Aloka SSD-3500 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka SSD-3500 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

The Aloka Model SSD-3500 Diagnostic Ultrasound System is substantially equivalent to previously cleared predicate devices (Aloka SSD-4000 and SSD-5500). The submission focuses on demonstrating substantial equivalence rather than presenting a performance study with specific acceptance criteria that would typically be seen for novel devices or AI/CAD systems.

Therefore, the "acceptance criteria" for this submission are primarily met by demonstrating similarity in:

• Intended Use: The device is indicated for the same diagnostic ultrasound applications as the predicate devices.
• Technological Characteristics: The device utilizes essentially the same technologies for imaging, Doppler functions, and signal processing.
• Method of Use: The device has the same method of use as the predicate devices.
• Safety Standards: The device complies with acoustic power output levels below FDA maximums, uses patient contact materials evaluated by the same standards, and meets electrical and physical safety standards (NEMA-UD2: 1992, AUM 1994, IEC-60601-1, UL 2601-1, ISO10993-1:1997).

Since this is a substantial equivalence submission for an ultrasound system, not an AI/CADe device, the typical elements of an AI/CADe performance study (test set, ground truth, expert readers, MRMC study, standalone performance) are not applicable or explicitly provided in the document. The "study" proving acceptance criteria is the comparison to predicates and adherence to established safety standards for diagnostic ultrasound equipment.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission is for a diagnostic ultrasound system, not an AI/CADe device that undergoes clinical performance testing with a specific test set of cases. The acceptance is based on substantial equivalence to existing devices and adherence to engineering and safety standards.
• Data Provenance: Not applicable for a separate "test set" in the context of an AI/CADe submission. The data supporting the submission would be from internal testing and comparisons with the predicate devices, not an independent, annotated clinical dataset.

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

• Not applicable. Ground truth establishment by experts for a test set is specific to AI/CADe evaluations. This submission primarily relies on comparisons to already cleared devices and adherence to established engineering and safety standards validated through internal testing.

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

• Not applicable. Adjudication methods are used in AI/CADe studies to establish ground truth from multiple expert opinions.

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 is designed to assess the impact of an AI/CADe device on human reader performance. This submission is for a diagnostic ultrasound system and does not involve AI assistance for image interpretation.

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

• No. This device is a diagnostic ultrasound system, which inherently involves a human operator to acquire and interpret images. There is no "algorithm only" performance reported in the context of AI/CADe.

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

• Not applicable in the context of a clinical performance study using a test set. The validation of the device relies on demonstrating performance within acceptable limits as defined by engineering standards and functional equivalence to predicate devices, rather than a clinical ground truth regarding disease presence. Performance is measured in terms of image quality, acoustic output, and other technical specifications.

8. The sample size for the training set:

• Not applicable. This device is not an AI/CADe system where a "training set" would be used to develop an algorithm.

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

• Not applicable for the same reason as above.

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