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EchoGuide is a vascular ultrasound imaging device meant to aid in identification of the cannulation site on the skin of mature arteriovenous fistulas/grafts (AVFs/AVGs) in adult patients by appropriately trained healthcare providers in clinical settings. This device is not meant to replace the current standard of care cannulation methods.

EchoGuide is a 3D automated ultrasound solution designed to provide the benefits of ultrasound for arteriovenous fistula/graft cannulation without the need for extensive training. EchoGuide uses a three-dimensional probe to acquire live coronal plane images, in addition to automating imaging settings, to allow users to quickly assess the position, trajectory, and size of an arteriovenous fistula/graft. Users can then mark the position and trajectory of the access on the patient's skin before removing the probe and proceeding with cannulation.

The EchoGuide probe houses a 2D array on a track. The piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed. The transducer is a 52 mm linear (192 element) motorized probe capable of capturing a volume of data. The motorized probe collects a series of 2D images to capture a volume. Through image analysis and processing, the volumes are sliced to create live coronal plane renderings.

The ultrasound system has a laptop form factor, with a bottom touch screen for user interaction and an additional top screen for display. The ultrasound system includes a transmitter and receiver, are all self-contained within the case. The ultrasound system interfaces with the probe through a port on the right side of the system.

The EchoGuide user interface defaults to a conventional 2D ultrasound image when the system powers on. Users can switch between this view, and the live coronal imaging via controls on the bottom screen of the ultrasound. Users can freeze the imaging and capture a snapshot of the fistula/graft as well. The snapshot displays a static view of the fistula/graft in the coronal and transverse planes.

EchoGuide is intended to be used in a clinical setting at the point of hemodialysis care.

This document primarily focuses on the FDA 510(k) clearance process for "EchoGuide (Version 1)" and its substantial equivalence to predicate devices, rather than a detailed report of a study proving the device meets specific performance acceptance criteria for an AI algorithm. The provided text touches on non-clinical and clinical testing but does not provide the granular details required to answer all parts of your request, particularly regarding specific performance metrics (e.g., sensitivity, specificity, accuracy), expert qualification for ground truth, and the specifics of AI-assisted human reader studies.

Here's an analysis based on the information provided, highlighting what can be discerned and what is missing:

Acceptance Criteria and Device Performance for EchoGuide (Version 1)

The provided FDA 510(k) clearance letter and summary primarily discuss the substantial equivalence of the EchoGuide device to existing predicate devices, focusing on its intended use, technological characteristics, and conformance to general safety and performance standards for imaging devices. It does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy for identifying cannulation sites) for an AI component.

The document mentions "imaging accuracy and quality" as confirmed by a clinical study, but without providing the quantitative acceptance criteria or the reported performance values against these criteria.

Missing Information:

• A specific table of acceptance criteria for AI-driven performance metrics (e.g., a specific target sensitivity or accuracy).
• Reported device performance values against these specific AI-driven criteria. The text only vaguely states "confirms the imaging accuracy and quality of EchoGuide for in vivo use."

Study Details (Based on available information):

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, this level of detail is not provided in the given FDA 510(k) document. The document focuses on showing substantial equivalence and conformance to general device standards.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: The document states, "Data from a non-significant risk observational study was used to confirm in vivo imaging adequacy of EchoGuide for the exam of hemodialysis accesses." It further specifies that "Images were collected on upper arm arteriovenous fistulae." However, the exact sample size (number of patients or images) for this "test set" is not specified.
• Data Provenance: The study was described as a "prospective, single arm, non-randomized, observational study." The country of origin is not explicitly stated, but given the FDA clearance, it's highly likely to be US data or data suitable for US regulatory submission.

3. Number and Qualifications of Experts for Ground Truth:

• The document does not provide any information on the number of experts used to establish ground truth or their specific qualifications (e.g., "Radiologist with X years of experience").
• It mentions the device is "meant to aid in identification of the cannulation site...by appropriately trained healthcare providers in clinical settings," but doesn't detail how the 'true' cannulation sites were established for the study.

4. Adjudication Method:

• The document does not provide any information on the adjudication method used for establishing ground truth (e.g., 2+1, 3+1 consensus).

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

• The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The focus is on the device's imaging quality for in vivo use.
• Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm-Only) Performance:

• The device is described as an "ultrasound solution designed to provide the benefits of ultrasound for arteriovenous fistula/graft cannulation" and automates "imaging settings" to allow users to "assess the position, trajectory, and size." It also states, "EchoGuide is a vascular ultrasound imaging device meant to aid in identification of the cannulation site...by appropriately trained healthcare providers."
• This phrasing suggests that the device (likely including algorithmic processing for image presentation and perhaps automated measurements/guidance, but without explicit AI claims) is intended to be used by a human operator to assist in a task. It is not presented as a standalone diagnostic algorithm that outputs a decision on its own.
• The document does not explicitly describe a standalone ("algorithm-only") performance study in terms of metrics like sensitivity, specificity, or AUC as one might see for a diagnostic AI. The "imaging accuracy and quality" mentioned is likely related to the visual representation and utility for a human user.

7. Type of Ground Truth Used:

• The document refers to a "non-significant risk observational study" where "Images were collected on upper arm arteriovenous fistulae." The study's primary objective was "data collection." It confirms "in vivo imaging adequacy."
• The nature of the ground truth is not explicitly stated beyond being related to "in vivo imaging adequacy" for "hemodialysis accesses." For specific "identification of the cannulation site," ground truth could potentially involve:
  • Expert consensus (e.g., radiologists/sonographers outlining the vessel)
  • Pathology (unlikely for this application)
  • Outcomes data (e.g., successful cannulation rates after using the device, but this is usually a separate clinical utility study)
  • Perhaps direct measurements or annotations from images performed by clinicians in the study.
• The specific method for establishing the 'true' cannulation site or vessel parameters is not detailed.

8. Sample Size for Training Set:

• The document describes a clinical evaluation/validation study, but it does not provide information on the sample size of any training set used for the development of the EchoGuide's algorithms (if it uses machine learning/AI models). This information is typically found in design validation documentation, not necessarily in the public 510(k) summary focused on substantial equivalence.

9. How Ground Truth for Training Set Was Established:

• Since information on a training set is not provided, there is no information on how ground truth for such a set would have been established.

Summary of Missing Information Critical for Full Response:

The provided document, being a 510(k) clearance letter and summary, primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to general performance standards, rather than providing a detailed clinical study report for an AI-driven device with specific performance metrics against pre-defined acceptance criteria. Therefore, many of the specific details requested regarding AI performance studies, sample sizes, expert qualifications, and ground truth establishment are not present in this particular type of FDA document.

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The EchoSure diagnostic ultrasound system and its transducer are in clinical examinations of blood vessels that are marked with an EchoMark LP implant. The system provides measurements and information about blood flow.

The system is intended for use by trained medical health care professionals in support of clinical diagnosis.

EchoSure is a portable diagnostic ultrasound system which applies the latest technologies to produce optimal images and provide information about blood flow in vessels. Various image parameter adjustments, dual high-resolution displays, and a custom probe are configured to provide clear and stable images. The system operates in B-Mode and Color Flow Doppler Mode. EchoSure is comprised of the EchoSure Ultrasound, the EchoSure Application, and the EchoSure Probe.

This document describes the Sonavex EchoSure Diagnostic Ultrasound System, which is intended for clinical examinations of blood vessels marked with an EchoMark or EchoMark LP implant. The system provides measurements and information about blood flow and is intended for use by trained medical healthcare professionals in support of clinical diagnosis.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabulated format with corresponding performance metrics as would typically be seen for a new device claiming improved performance. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K173265, WinProbe UltraVision 2 Diagnostic Ultrasound System) by outlining similar technical characteristics and adherence to relevant safety and performance standards.

The table below summarizes key comparisons between the EchoSure and its predicate, acting as implicit "acceptance criteria" through comparative equivalence:

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

The document states: "Clinical studies are not required to support equivalence for these conventional ultrasound systems." This implies that there was no specific clinical test set used for the EchoSure device itself to prove its performance in human subjects, beyond the non-clinical safety and performance data. The FDA clearance is based on substantial equivalence to a predicate device and adherence to recognized standards.

Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable as no clinical studies were performed for this specific submission.

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

As no clinical test set was required or performed for direct evaluation of the EchoSure device's performance in a clinical setting, there's no information about experts establishing ground truth for a test set. The submission relies on the established safety and performance of the predicate device and compliance with standards.

4. Adjudication Method for the Test Set:

Since a clinical test set was not used to evaluate device performance, an adjudication method for a test set is not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No MRMC comparative effectiveness study was done, as confirmed by the statement "Clinical studies are not required."

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

The EchoSure is a diagnostic ultrasound system, not an algorithm-only device. Its performance is intrinsically tied to human operation and interpretation. Therefore, a "standalone algorithm only" performance study is not applicable in this context. The document emphasizes its use "by trained medical health care professionals."

7. The type of ground truth used:

Given the reliance on substantial equivalence and non-clinical testing, the "ground truth" for the EchoSure's clearance is primarily based on:

• Compliance with recognized electrical, mechanical, safety, EMC, acoustic output, and biocompatibility standards (e.g., ISO 10993, IEC 60601 series). These standards serve as the "ground truth" for ensuring the device meets fundamental safety and engineering performance requirements.
• Demonstrated performance specifications during bench testing. These tests confirm that risk controls were properly implemented, design outputs meet design inputs, and the device is suitable for its intended use within a laboratory/engineering context.

8. The sample size for the training set:

The EchoSure is a conventional diagnostic ultrasound system, not an AI/ML-driven device that requires a "training set" in the machine learning sense. Therefore, information about a training set sample size is not applicable.

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

As the device does not utilize a machine learning algorithm requiring a training set, this question is not applicable.

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The EchoMark and EchoMark LP are indicated for radiographic marking of sites in soft tissue. In addition, the EchoMark LP are indicated for situations where a soft tissue site needs to be marked for future medical procedures.

The EchoMark and EchoMark LP are implantable ultrasound-visible markers used to facilitate visualization of a soft tissue site. The EchoMark and EchoMark LP are comprised of 70:30 poly(L-lactide-co-caprolactone) (PLC) which resorbs completely in one year or more. The EchoMark LP (low profile) is identical but smaller in size than the EchoMark. Both have identical performance and technological characteristics. The EchoMark and EchoMark LP are provided sterile and are single use devices. The EchoMark material is entirely polymeric and therefore has no clinically relevant diamagnetic or ferromagnetic potential. This device is MR safe.

The provided text describes a 510(k) submission for the EchoMark and EchoMark LP devices. It details the device's characteristics, indications for use, comparison to predicate devices, and safety and performance data. However, it does not contain the specific acceptance criteria and detailed performance study results that typically prove a device meets those criteria, particularly for an AI/algorithm-based device. This submission is for an implantable radiographic marker, which is a physical medical device, not a software or AI-driven diagnostic tool.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device submission as described in the provided document. The document focuses on material biocompatibility, physical performance, and visibility characteristics.

Based on the provided text, here's what can be extracted and what cannot:

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

The document describes types of tests performed and their successful completion, but does not provide quantitative acceptance criteria or specific numerical performance results in a table format. It states that the device "met all specified criteria" and "did not raise new safety or performance questions."

• Safety Testing (ISO 10993 Biocompatibility):
  • Acceptance Criteria Implied: Non-toxic, non-sensitizing, non-mutagenic, non-irritating, biocompatible.
  • Reported Performance: "Results from the tests indicate that the device is non-toxic, non-sensitizing, non-mutagenic and non-irritating therefore biocompatible for its intended use."
• Performance Testing (Bench):
  • Acceptance Criteria Implied: Risk controls properly implemented, design outputs meet design inputs, device suitable for intended use.
  • Reported Performance: "Successful completion of the following tests confirmed that risk controls were properly implemented, and design outputs meet design inputs and device is suitable for its intended use." Specific tests include:
    • ISO 11135 Sterility testing validated to SAL of 10-6
    • ISO 11607-1 Packaging validation distribution simulation
    • Bench Suturability and Suture Retention
    • Labeling verification
    • Geometric analysis of EchoMark and EchoMark LP
    • In vitro EchoMark and EchoMark LP degradation study
• Performance Testing (Animal & Cadaver):
  • Acceptance Criteria Implied: Met specified criteria for visibility, echogenicity, degradation, suturability, and non-migration.
  • Reported Performance: "The EchoMark and EchoMark LP met all specified criteria and did not raise new safety or performance questions." Specific tests include:
    • Ultrasound Visibility and Orientation Verification
    • Ultrasound Echogenicity
    • Ultrasound Accelerated Aging Echogenicity
    • Suturability Timing Study
    • Tissue Marker Migration Study
    • Instructions for Use Validation in Cadaver

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

• The document mentions "GLP Swine Testing" (for biocompatibility and performance) and "Cadaver" studies for performance validation. Specific sample sizes are not provided.
• Data Provenance: The studies were conducted as part of the regulatory submission process, implying they are prospective studies specifically designed for this purpose. The country of origin of the data is not specified, but given the FDA submission, it's likely U.S.-based or from a facility compliant with U.S. regulatory standards.

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

• This is not applicable for this type of device. The "ground truth" for a physical implantable marker is typically objectively measurable (e.g., material degradation, dimensions, visibility under imaging modalities, biological response in animal models) rather than expert interpretation of images or data.

4. Adjudication method for the test set:

• This is not applicable as there is no mention of subjective expert assessment requiring adjudication.

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

• This is not applicable. This is a physical marker, not an AI-driven diagnostic or assistance tool. Therefore, no MRMC study or effect size on human readers is relevant or mentioned.

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

• This is not applicable. This is a physical marker, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device relies on:
  • Objective material properties: Chemical analysis of degradation, mechanical testing (suturability, retention).
  • Direct biological observation: Histologic evaluation in animal models (GLP Swine Testing) to confirm safety and bioabsorption.
  • Imaging visibility: Verification using ultrasound in animal and cadaver models.

8. The sample size for the training set:

• This is not applicable as this is not an AI/machine learning device. There is no "training set."

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

• This is not applicable for the reason stated above.

In summary, the provided document details the regulatory submission for a physical implantable medical device, not a software or AI-driven diagnostic system. Therefore, many of the questions related to AI/algorithm performance are not addressed and are outside the scope of this specific device type.

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