Search Results

The Portable Digital Color Doppler Ultrasound System is intended for ultrasound imaging in B (2D), Color Doppler and Pulsed Wave imaging modes.

It is indicated for ultrasound imaging and fluid flow analysis in the following applications: Abdominal, Small Organ, Musculoskeletal, Peripheral Vessel, Urology, and Carotid.

The Portable Digital Color Doppler Ultrasound System is intended for use in environments where healthcare is provided by appropriately trained and qualified healthcare professionals.

The Portable Digital Color Doppler Ultrasound System is a portable, general-purpose, software-controlled ultrasound system. It consists of a handheld ultrasound main unit and software. The system is engineered to produce real-time ultrasound images, with an emphasis on capturing detailed anatomical structures and evaluating blood flow patterns using color Doppler technology. It includes features for measurements, image storage and review, as well as printing and recording capabilities. This portable system enables point-of-care ultrasound applications, providing healthcare professionals with a convenient way to visualize anatomical structures and assess blood flow dynamics.

This document is a 510(k) Pre-market Notification for a Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L). The information provided focuses on demonstrating substantial equivalence to already-cleared predicate devices, rather than presenting a standalone study with specific performance acceptance criteria and results.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth are not available within this document. The submission primarily relies on non-clinical testing to demonstrate safety and effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not explicitly define acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) like you would find in a clinical study report for an AI/algorithm-driven device.

Instead, the "acceptance criteria" here are implied by compliance with recognized standards and the demonstration of equivalent technical and performance properties to predicate devices. The document essentially states that the device "passed testings according to" various standards (listed below) and that "the proposed devices are substantially equivalent to the predicate devices" because "the minor differences don't raise any additional questions on effectiveness."

Therefore, a table of specific acceptance criteria and reported device performance metrics (e.g., sensitivity, specificity) cannot be generated from the provided text. The document focuses on showing compliance with general safety and performance standards for ultrasound systems.

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

Not provided. This document details non-clinical testing for compliance with standards, not a clinical test set with specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. No ground truth establishment by experts for a test set is described in this document. The testing described is primarily non-clinical compliance testing.

4. Adjudication Method 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

No. A MRMC comparative effectiveness study is not mentioned or implied. This device is an ultrasound system, not an AI or algorithm-assistance tool for human readers in the context of diagnostic interpretation.

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

Not applicable. This device is an ultrasound system, not a standalone algorithm/AI for diagnostic interpretation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable. The document describes non-clinical testing against established engineering and safety standards for ultrasound devices, not against a clinical ground truth for diagnostic accuracy.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned as this device is an ultrasound imaging system, not an AI/algorithm that requires a training set.

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

Not applicable. As no training set is mentioned, the method for establishing ground truth for a training set is not applicable.

Summary of Available Information from the Document:

The document emphasizes non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on safety and general performance in accordance with recognized standards.

Non-clinical Testing Summary (from Section 5 of the 510(k) Summary):

The Portable Digital Color Doppler Ultrasound System has passed testing according to the following standards:

1. ANSI AAMI ES60601-1:2005/R12012 & A1:2010/R)2012 & A2:2010/RJ2012 (Cons. Text) Incl. AMD2:2021): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
2. IEC 60601-1-2 Editor 4.1 2020-09 CONSOLIDATED VERSION: Medical electrical equipment - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
3. IEC TR 60601-4-2 Editor 1.0 2016-05: Medical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity performance of medical electrical equipment and medical electrical systems.
4. IEC 60601-1-6 Editor 3.2 2020-07 CONSOLIDATED VERSION: Medical electrical equipment - Part 1-6: Safety and essential performance - Collateral standard: Usability.
5. IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION: Medical devices - Part 1: Application of usability engineering to medical devices.
6. IEC 60601-2-37 Edition 2.1 2015: Medical electrical equipment for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment.
7. IEC 62359 Edition 2.1 2017-09 CONSOLIDATED VERSION: Ultrasonics - Field characterization - Test methods for the measurement of mechanical indices related to medical diagnostic ultrasonic fields.
8. NEMA UD 3-2004 (R2009): Standard for Real-Time Display of Thermal and Mechanical Acoustic Output for Diagnostic Ultrasound Equipment.
9. IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION: Medical device software life cycle processes.

Conclusion stated: The non-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.

Ask a specific question about this device

The SonoScape S9 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

The SonoScape S9 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.

The provided text describes a 510(k) summary for the SonoScape S9 Portable Digital Color Doppler Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria based on a clinical performance study with AI.

Therefore, many of the requested details about acceptance criteria driven by AI performance, sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies, are not explicitly mentioned in this type of submission.

However, I can extract information related to the device's technical specifications and the type of non-clinical testing performed to establish safety and effectiveness for substantial equivalence.

Here's a breakdown of what can and cannot be answered based on the provided document:

What can be answered (related to substantial equivalence and non-clinical testing):

• Acceptance Criteria (Indirect): The acceptance criteria are implicitly conformance to recognized safety and performance standards for diagnostic ultrasound equipment, and having technological characteristics similar to the predicate device, demonstrating equivalent capability. The "reported device performance" is the confirmation that these standards were met.
• Sample Size for Test Set: Not applicable in the context of clinical performance evaluation for AI. The testing described is laboratory-based non-clinical testing for standards compliance.
• Data Provenance: Not applicable, as no clinical test set data from patients is described. The testing is laboratory (acoustic output, electrical, thermal, mechanical safety, biocompatibility).
• Number of Experts for Ground Truth & Qualifications: Not applicable. Ground truth for clinical performance is not established as this is a non-clinical submission.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No. This is not a study involving human readers and AI assistance.
• Standalone (algorithm only) Performance: No, as there isn't an AI algorithm described that would operate in a standalone manner. The device is a diagnostic ultrasound system.
• Type of Ground Truth Used: Not applicable. The "ground truth" here is compliance with established engineering and safety standards, not clinical diagnostic accuracy.
• Sample Size for Training Set: Not applicable. This device does not inherently involve a "training set" in the context of an AI/ML algorithm.
• How Ground Truth for Training Set was Established: Not applicable.

Table of Acceptance Criteria and Reported Device Performance (based on regulatory compliance):

Study Proving Device Meets Acceptance Criteria:

The study described is a series of non-clinical laboratory tests designed to demonstrate compliance with recognized consensus standards and to show that the S9 Portable Digital Color Doppler Ultrasound System is substantially equivalent to a previously cleared predicate device (SonoScape Company Limited, Diagnostic Ultrasound System, Model S6, K112602).

• Nature of the Study: This was a non-clinical validation focused on safety, electromagnetic compatibility, acoustic output, and biocompatibility, rather than a clinical performance study involving patient data and diagnostic accuracy.
• Acceptance Criteria for the Study: The implicit acceptance criteria were successfully passing all relevant tests defined by the listed international and national standards (IEC, ISO, NEMA) and demonstrating that the device's technical specifications and performance characteristics align closely enough with the predicate device to warrant substantial equivalence.
• Sample Size Used for Test Set: This is not a "test set" in the context of clinical data for AI performance. The "test set" here refers to the device and its transducers undergoing various physical and electrical tests. No specific number of "tests" or "samples" (like patient cases) is provided, as it's a conformity assessment to standards.
• Data Provenance: The data provenance is laboratory testing conducted by the manufacturer, SonoScape Company Limited, for regulatory submission to the FDA. It is not retrospective or prospective clinical data from human patients/cases.
• Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable. No human expert "ground truth" for diagnostic accuracy was established in this type of testing. The "ground truth" is adherence to the technical specifications of the standards.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is for evaluating human performance, often with or without AI assistance, which is not relevant to this submission.
• Standalone (Algorithm Only) Performance: Not applicable. The device is an ultrasound system, not an AI algorithm.
• Type of Ground Truth Used: Standards conformance and engineering specifications. The "ground truth" for this submission is that the device physically performs according to established industry safety and performance benchmarks. It is not based on expert consensus, pathology, or outcomes data from patient diagnoses.
• Sample Size for the Training Set: Not applicable. This device does not describe an AI or machine learning component that would require a training set.
• How the Ground Truth for the Training Set was Established: Not applicable.

In summary, the provided document is a regulatory submission for a medical device (ultrasound system) based on substantial equivalence, which primarily relies on non-clinical testing for safety and basic performance characteristics against established standards and a predicate device. It does not describe a clinical performance study, especially not one involving AI or detailed human reader evaluation.

Ask a specific question about this device

The SonoScape S2 device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.

The SonoScapeS2 Portable Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 4D.

This document details the acceptance criteria for the SonoScape S2 Portable Digital Color Doppler Ultrasound System and the study supporting its compliance.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against recognized medical device safety standards and acoustic output measurement standards to ensure substantial equivalence to its predicate device. The performance is documented through adherence to these standards rather than specific imaging metrics in this summary.

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

The provided document describes non-clinical laboratory testing to verify the device's conformance to safety and performance standards. It does not mention a clinical test set involving human patient data the way AI/CAD devices typically do. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided in this summary.

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

As there is no mention of a human-read clinical test set being used to assess the device's diagnostic performance (as it is a imaging system and not an AI/CAD system evaluated on diagnostic accuracy against human experts), this information is not applicable and not provided in the document.

4. Adjudication Method for the Test Set

Given that performance was assessed against engineering and safety standards rather than humanexpert interpretations of clinical images, an adjudication method for a test set is not applicable and not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This device is an ultrasound imaging system, not an AI or CAD (Computer-Aided Detection/Diagnosis) system. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with or without AI assistance is not applicable to this submission and was not performed.

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

Again, this is an ultrasound imaging system, not an AI algorithm. A standalone performance evaluation in the context of an algorithm's diagnostic accuracy is not applicable here. The "standalone" performance for this device would be its ability to produce images and measurements according to its technical specifications, which was confirmed through laboratory testing against established standards.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this device's acceptance criteria is defined by recognized international and national standards for medical electrical equipment safety, electromagnetic compatibility, ultrasonic medical diagnostic equipment, acoustic output measurement, and biocompatibility. The device's conformance to these engineering and safety standards serves as its "ground truth."

8. The Sample Size for the Training Set

Since this is not an AI/Machine Learning device, the concept of a "training set" is not applicable. The device's functionality is based on established physics principles and engineering design, not on learning from a dataset.

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

As there is no training set for this type of medical device, this information is not applicable.

Ask a specific question about this device