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

The Aloka Prosound 2 Diagnostic Ultrasound System is a light weight, full-digital portable imaging and analysis system. It consist of a high resolution LCD flat panel monitor that provides excellent image quality and processing. The user interface includes a computer type keyboard. specialized controls and a display.

The provided 510(k) summary for the Aloka Prosound 2 Diagnostic Ultrasound System states "Clinical Tests: None Required." Therefore, there is no study presented in this document that proves the device meets specific acceptance criteria based on clinical performance.

The submission focuses on demonstrating substantial equivalence to a predicate device (Aloka SSD-500, K900805) and other cleared Aloka systems. Substantial equivalence relies on comparing the technological characteristics, safety, effectiveness features, and intended uses of the new device to a legally marketed predicate. In this context, the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate.

Here's a breakdown of the information requested, based on the provided text:

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

Since no clinical studies were performed to establish performance against specific acceptance criteria, this table cannot be directly populated from the provided information. Instead, the acceptance criteria are implicitly that the device is substantially equivalent to the predicate device in terms of safety and effectiveness, and that it conforms to applicable medical device safety standards.

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

Not applicable, as no clinical tests or test sets were used for performance evaluation as part of this 510(k) submission.

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

Not applicable, as no clinical tests or ground truth establishment by experts were described in this 510(k) summary.

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

Not applicable, as no clinical tests or adjudication methods were described in this 510(k) summary.

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 an ultrasound imaging device, not an AI-assisted diagnostic tool, and no MRMC study was conducted or mentioned.

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

Not applicable, as this is an ultrasound imaging device, not an algorithm that performs standalone analysis.

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

Not applicable, as no clinical tests requiring ground truth were conducted for this 510(k) submission. The "ground truth" for substantial equivalence is the safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set

Not applicable, as there is no mention of a training set for an algorithm. The device's design and development conform to quality systems rather than a data-driven training process for an AI.

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

Not applicable, as there is no mention of a training set or its ground truth.

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The Aloka DAS-RS1 is intended to acquire, read, display, store and review DICOM image and data, including the ability to analyze and print reports primarily for Aloka diagnostic ultrasound systems.

The Aloka DAS-RS1 system is a software based medical image system. This system receives, reviews and store patient exam images and data, prepare/print reports and communicates with Aloka Ultrasound systems. This system has a PC workstation that can be used to analyze the data for report generation. The software allows for the download of DICOM files to a single PC from a single Aloka Ultrasound system located within the same facility.

Acceptance Criteria and Study for Aloka DAS-RS1

Based on the provided 510(k) summary for the Aloka DAS-RS1, the device did not undergo a clinical study with specific acceptance criteria that translate to performance metrics (e.g., sensitivity, specificity). The submission explicitly states:

"Clinical Tests: None Required to confirm safety and effectiveness. However, evaluation in a clinical setting was performed to ensure usability, reliability, reliability and compatibility within the intended environment."

This indicates that the Aloka DAS-RS1, as a Picture Archiving and Communication System (PACS) device, was cleared based on its substantial equivalence to a predicate device (Philips Medical Systems QLAB Software, K021966) and adherence to general safety and effectiveness standards, rather than specific performance benchmarks derived from a clinical trial.

Therefore, many of the requested details regarding acceptance criteria and a study proving their attainment cannot be provided as they were not part of this clearance process.

Here's an analysis of the provided information concerning the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission ("None Required to confirm safety and effectiveness" in a clinical context), there are no specific quantitative acceptance criteria or reported device performance metrics in the document that would typically be found in a study proving clinical efficacy (e.g., sensitivity, specificity, accuracy). The acceptance was based on:

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

• Sample Size: Not applicable. No specific test set for clinical performance evaluation (e.g., disease detection) was described. The "evaluation in a clinical setting" was for usability, reliability, and compatibility, but no details on sample size for this were provided.
• Data Provenance: Not applicable, as no data for clinical performance metrics were presented or required for this 510(k). The "evaluation in a clinical setting" would likely have involved internal testing or limited pilot use, but specific origins (e.g., country) are not mentioned.

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

• Number of Experts: Not applicable. No ground truth for clinical performance was established as part of this 510(k) for the reasons stated above.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No specific test set requiring adjudication of clinical outcomes was part of this submission.

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

• Was it done?: No. An MRMC study was not conducted or required for this submission. The device is a PACS system, not an AI diagnostic tool intended to improve human reader performance in a comparative study setup.
• Effect size of improvement: Not applicable.

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

• Was it done?: Not applicable in the context of an AI algorithm's performance. The DAS-RS1 is a software system for image handling and analysis, not an AI algorithm performing a diagnostic task independently. Its "standalone" function refers to its ability to process and store images, which was verified through non-clinical tests and compatibility assessments.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical performance. The "ground truth" for this device's clearance was its ability to perform its intended functions (acquire, read, display, store, review DICOM data, analyze, print reports) reliably and safely, and its substantial equivalence to a predicate device. This was verified through design specifications, software development standards, risk analysis, and compatibility testing.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. The Aloka DAS-RS1 is a data analysis and archiving system, not a machine learning model that requires a training set in the conventional sense for a diagnostic algorithm. Its development involved traditional software engineering and testing, not AI model training.

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

• How Established: Not applicable, as there was no training set for an AI model.

In summary, the Aloka DAS-RS1 received 510(k) clearance as a "Picture Archiving and Communication System" based on substantial equivalence to a predicate device and adherence to software development, quality system, and safety standards. It was not cleared as an AI-powered diagnostic tool, and therefore, the type of performance data typically associated with such tools (e.g., sensitivity, specificity, MRMC studies) was neither required nor provided.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Peripheral Vascular, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular) applications. The device is not indicated for Ophthalmic applications.

The Aloka Prosound 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 keyboard, specialized controls and a video display.

Here's a breakdown of the acceptance criteria and study information for the Aloka Prosound 6 Diagnostic Ultrasound System, based on the provided document:

Acceptance Criteria and Device Performance

The provided 510(k) summary for the Aloka Prosound 6 Diagnostic Ultrasound System does not specify quantitative acceptance criteria or provide specific performance metrics in a table. Instead, it relies on substantial equivalence to a predicate device.

The "reported device performance" is implicitly that it performs as safely and effectively as the predicate device (Aloka SSD-1400 Diagnostic Ultrasound System K972465) for the listed indications for use.

Stated Performance / Equivalence Claims:

• Same Technological Characteristics: The Prosound 6 has the same technological characteristics as the Aloka SSD-1400.
• Key Safety and Effectiveness Features: It possesses the same key safety and effectiveness features as the predicate.
• Physical Design, Construction, Materials: Identical to the predicate device.
• Intended Uses and Basic Operating Modes: Same as the predicate device.
• Conformity to Standards: The device and its transducers "have been found to conform with applicable medical device safety standards" (e.g., for acoustic output, biocompatibility, cleaning & disinfection, EMC, electrical and mechanical safety).
• Quality Systems: Design, development, and quality process conform with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems.

Study Information

The provided documentation explicitly states:

• Clinical Tests: None Required.

This indicates that no clinical study, in the traditional sense of evaluating device performance against specific clinical endpoints or acceptance criteria with patient data, was performed or presented for this 510(k) submission.

Therefore, the following points, which would typically describe such a clinical study, are not applicable based on the given information:

2. Sample size used for the test set and the data provenance: Not applicable, no clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no clinical test set.
4. Adjudication method for the test set: Not applicable, no clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an ultrasound system, not an AI-assisted diagnostic tool, and no clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an ultrasound system, not an algorithm, and no clinical study was performed.
7. The type of ground truth used: Not applicable, no clinical test set.
8. The sample size for the training set: Not applicable, as this is a medical device clearance based on substantial equivalence, not an AI model being trained.
9. How the ground truth for the training set was established: Not applicable.

Summary of Approach:

The Aloka Prosound 6 Diagnostic Ultrasound System gained clearance through the 510(k) pathway by demonstrating substantial equivalence to an already legally marketed predicate device (Aloka SSD-1400). This regulatory pathway often relies heavily on non-clinical testing (such as engineering and safety assessments) and comparison of technical specifications, rather than new clinical trials to establish safety and effectiveness for well-understood device types like diagnostic ultrasound systems.

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The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal /Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo- skeletal Conventional, Urology (including prostate), Transesophageal, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular). The device is not indicated for ophthalmic applications.

The Aloka SSD-Alpha 7 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 keyboard, specialized controls and a video display. This configuration will provide user enhancements and expanded use.

The Aloka SSD-Alpha 7 Diagnostic Ultrasound System is a medical device that received 510(k) clearance (K072285) for various diagnostic ultrasound imaging and fluid flow analysis applications in the human body. As per the provided documents, no specific acceptance criteria or a dedicated clinical study proving the device meets quantitative acceptance criteria were included in this 510(k) submission.

Instead, the submission states:

• "Clinical Tests: None Required. Intended uses and other key features are consistent with traditional clinical practices, FDA guidelines and established methods of patient examination."
• "Diagnostic ultrasound has accumulated a long history of safe and effectiveness performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka SSD-Alpha 7 Diagnostic Ultrasound System and its transducers is substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems."

This indicates that the clearance for the Aloka SSD-Alpha 7 was based on its substantial equivalence to a predicate device (Aloka SSD-Alpha 10 Diagnostic Ultrasound System K043196), not on a new clinical study demonstrating performance against specific acceptance criteria. The focus was on comparing technical characteristics, safety features, physical design, construction, materials, and intended uses to the predicate device.

Therefore, the following information cannot be provided from the given documents:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance.
6. If a standalone performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any test set.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Summary of available information regarding compliance and equivalence:

The device's clearance relies on:

• Non-clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, electrical and mechanical safety. These tests found the device to conform with applicable medical device safety standards.
• Substantial Equivalence: The device is considered technically comparable and substantially equivalent to the Aloka SSD-Alpha 10 (K043196) and other cleared Aloka systems. This substantial equivalence is the primary "proof" of its safety and effectiveness under the 510(k) pathway.
• Quality Systems: The design, development, and quality processes conform with 21 CFR 820, ISO 9001:2000, and ISO13485 quality systems.
• Post-clearance requirement: The FDA requested a post-clearance special report containing complete information, including acoustic output measurements based on production line devices, referencing Appendix G of their "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." This ensures ongoing compliance with approved acoustic output levels.

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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, M/CD, B/CD/PWD. Intraoperative applications: include liver, pancreas and gall bladder. Small parts applications include breast. testes and thyroid.

The Aloka SSD-3500 Ver. 7.0 diagnostic ultrasound system and transducers. High frequency sound waves are transmitted into the body by a piezoelectric 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 Ver. 7.0 transducers 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 SSD-3500 Ver. 7.0 diagnostic ultrasound system and its transducers. This document confirms the device is substantially equivalent to a predicate device (Aloka SSD-3500 Ver. 1.0) and outlines its intended uses and compliance with relevant standards.

However, the document does not contain specific acceptance criteria, study data, sample sizes for test and training sets, or details about ground truth establishment, expert qualifications, or adjudication methods as typically found in a study demonstrating device performance. It is a regulatory clearance document, not a clinical study report.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: This information is not present. The document asserts "substantial equivalence" to a predicate device, meaning its performance is considered equivalent, but no specific performance metrics or acceptance criteria for that equivalence are detailed here.
• Sample sizes for the test set and data provenance: No such details are included.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such study is described.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of what can be extracted from the document regarding the device and its assessment:

Device: Aloka SSD-3500 Ver. 7.0 Diagnostic Ultrasound System and its associated transducers.

Nature of Assessment: Substantial equivalence (510(k) clearance) to a legally marketed predicate device, the Aloka SSD-3500 Ver. 1.0 (K023996). This means the FDA determined the new device is as safe and effective as the predicate device. The assessment primarily relies on comparing the new device's technological characteristics, indications for use, and compliance with standards to the predicate device.

Key statements of equivalence (from page 4):

• "The Aloka SSD-3500 Ver. 7.0 functions in the same manner as other diagnostic ultrasound devices and its predicate."
• "The Aloka SSD-3500 Ver. 7.0 and its transducers are substantially equivalent to its predicate; the Aloka SSD-3500 Ver. 1.0 and its transducers."
• "The SSD-3500 Ver. 7.0 is indicated for the same diagnostic ultrasound applications to Aloka's ultrasound system: SSD-3500 Ver. 1.0 (K023996)."
• "The SSD-3500 Ver. 7.0 has the same gray-scale and Doppler abilities to Aloka's ultrasound system: SSD-3500 Ver. 1.0 (K023996)."
• "The SSD-3500 Ver. 7.0 uses essentially the same technologies for imaging, Doppler functions and signal processing as the following product currently marketed by Aloka: SSD-3500 Ver. 1.0 - (K023996)."
• "The SSD-3500 Ver. 7.0 has the same method of use as the following products currently marketed by Aloka: SSD-3500 - (K023996)."
• "The SSD-3500 acoustic power output levels are below the maximum levels allowed by the FDA."
• "The SSD-3500 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka such as the: SSD-3500 -(K023996)."
• "The patient contact materials used in the SSD-3500 Ver. 7.0 have been evaluated for safety via the same standards and methods as the above mentioned products marketed by Aloka. These materials have been found to be safe for the intended uses."
• "The SSD-3500 Ver. 7.0 complies with electrical and physical safety standards as other products currently marketed by Aloka such as its predicate: SSD-3500 - (K023996)."
• "Aloka Co., Ltd. Certifies that the SSD-3500 Ver. 7.0 complies with NEMA-UD2:2004 Rev. 3- (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment), NEMA-UD3: 2004 Rev.2- (Standard for Real Time Display of Thermal & Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment), and IEC-60601-1-2: 2001 - (Medical Electrical Equipment Part 1-2: General requirements for Safety-Collateral standard: Electromagnetic compatibility-Requirements and Tests)."

Transducers and their Indications for Use: The document lists numerous transducers and their cleared clinical applications and modes of operation (e.g., Fetal, Abdominal, Cardiac, Small Organ, Peripheral Vascular, etc., with modes like B, M, PWD, Color Doppler, Amplitude Doppler). These are presented as "previously cleared by FDA" (P) or "new indication" (N). Each indication for use form specifies which modes (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined, Other) are cleared for various clinical applications for that specific transducer.

Study: The document does not describe a clinical study of the device's performance in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it's a regulatory submission affirming that the device is substantially equivalent to a previously cleared device based on design, intended use, technology, safety, and adherence to performance standards (NEMA-UD2, NEMA-UD3, IEC-60601-1-2). The "study" here is the comparison and certification process to meet regulatory requirements for 510(k) clearance.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (liver/pancreas/gall-bladder/abdominal, gynecological, fetal, neonatal, cardiac), Pediatric, Small Organ (breast/testes/thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional. Mixed mode operation includes BM, BPWD, MCD, BICD/PWD, BICWD, BICWCWD.

The Aloka SSD-Alpha 10 functions in the same manner as its predicate and other Aloka 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-Alpha 10 transducers can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.

The Aloka SSD-Alpha 10 diagnostic ultrasound system and its transducers were found substantially equivalent to the predicate device, the Aloka SSD-5500 (K032875). This determination is based on the devices functioning in the same manner, having similar technological characteristics, and being indicated for the same diagnostic ultrasound applications.

The acceptance criteria for the Aloka SSD-Alpha 10 are implicitly demonstrated by its substantial equivalence to the predicate device. This means that the new device must meet the same performance and safety standards as the predicate device. The general controls provisions of the Act, including annual registration, device listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration, also serve as acceptance criteria. Additionally, the device is required to comply with specific electrical, physical, and acoustic safety standards before distribution.

Here's a breakdown of the requested information, drawing from the provided text:

1. A table of acceptance criteria and the 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 does not explicitly mention a "test set" in the context of clinical performance evaluation for acceptance criteria. The clearance is based on substantial equivalence to a predicate device, not on a new clinical study with a defined test set. The data provenance is因此not applicable in this type of submission.

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

Not applicable, as no new clinical test set with ground truth established by experts is described in this substantial equivalence summary.

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

Not applicable, as no new clinical test set requiring expert adjudication is described.

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

Not applicable. This submission is for a diagnostic ultrasound system, not an AI-assisted device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI algorithm and thus no standalone algorithm performance was evaluated.

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

Not applicable, as the clearance is based on substantial equivalence to a predicate device, rather than a de novo clinical evaluation requiring independent ground truth. The "ground truth" here is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. This document is a 510(k) summary for a medical device (ultrasound system), not an AI model requiring a training set.

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

Not applicable, as there is no training set for an AI model.

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

Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (specify), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial.

Modes of operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler.

Combined (specify): See Below

Additional Comments: Mixed mode operation includes BM, BPWD, MCD, B/CD/PWD, B/CD/CWD

Applications: Small Parts-breast, testes & thyroid, abdominal, gynecological, fetal, neonatal, cardiac.

The Aloka SSD-Alpha 5 Ver. 1.0 diagnostic ultrasound system and transducers. 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-Alpha 5 transducers 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 SSD-Alpha 5 diagnostic ultrasound system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Aloka SSD-5500) rather than presenting a performance study with acceptance criteria in the context of a new AI algorithm or a specific diagnostic task.

Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth type for studies) are not present in this document.

The document discusses the device's technical characteristics and intended uses, comparing them to the predicate device to establish substantial equivalence. It does not detail a specific clinical performance study to "prove the device meets acceptance criteria" in the way a novel AI diagnostic device would.

Here's an attempt to address the questions based on the available information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria and reported device performance for a specific diagnostic task. The "acceptance criteria" discussed are related to general safety and technical standards for ultrasound devices, and the "performance" is implicitly deemed equivalent to the predicate device.

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

No specific test set or clinical study data (in terms of patient cases) is mentioned for evaluating the diagnostic performance of the Aloka SSD-Alpha 5. The submission relies on demonstrating substantial equivalence to its predicate device (Aloka SSD-5500) based on similar technological characteristics and intended uses.

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

Not applicable. No ground truth establishment for a test set is described.

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

Not applicable. No adjudication method for a test set is described.

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

Not applicable. This is not an AI diagnostic device, and no MRMC comparative effectiveness study is mentioned.

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

Not applicable. This is a diagnostic ultrasound system, not a standalone algorithm.

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

Not applicable. No specific ground truth for a diagnostic performance study is mentioned in the context of this 510(k) submission. The device's "ground truth" for its general function is based on its ability to produce images and flow analysis according to established ultrasound physics and engineering principles, and its equivalence to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set in the conventional sense.

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

Not applicable.

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