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The intended uses of this system and its accessories are as follows: Evaluating Soft Tissue by Ultrasound Imaging, using B-mode and M-mode: for Fetal, Abdominal, 3-D Visualization (non measuring), Small organ (thyroid and breast), Musculoskeletal (Conventional), Peripheral Vessel, Transvaginal, Transrectal and Needle Guidance.

The devices referenced in this submission represent a highly portable, softwarecontrolled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes or deviations from indications for use different from those demonstrated in previously cleared devices, inclusive of the predicate devices so claimed. The devices included in this submission are as follows: Voyager Ultrasound System utilizing as hardware and firmware an ultrasound engine contained in a very small in-line enclosure with only an 'image-freeze' control button; A probe, C-4, of a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 4 (±12%) MHz; A probe, C-10, a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 8.0 (±20%) MHz; A probe EC, a mechanical configuration providing a single crystal sector scan, or M-mode operation, at an ultrasonic frequency of approximately 8,0 (±20%) MHz. Software able to reside in a laptop inclusive of a non-metrological 3-D image rendering capability and, a means to enable the use of needle guidance techniques on each probe model.

The provided document describes a 510(k) submission for the Ardent Sound Voyager Compact Imaging System, specifically regarding the addition of M-Mode capabilities and an Endocavity probe.

Based on the content, here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards rather than establishing new performance acceptance criteria for a novel device. The "acceptance criteria" presented are fundamentally about meeting established safety and performance benchmarks for diagnostic ultrasound systems as defined by regulatory standards and existing cleared devices.

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 explicitly states: "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices in Section 1.5." This indicates that no clinical test set (i.e., patient data) was used for this submission. The "testing" primarily involved engineering and performance verification against standards.

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

Not applicable, as no clinical test set or human interpretation ground truth was established for this submission. The submission relies on technical compliance and equivalence to predicate devices, which would have had their own ground truth establishment studies during their original clearances.

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

Not applicable, as no clinical test set requiring expert adjudication was used.

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 and its probes, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This is not an algorithm-only device.

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

For the technical performance of the device (acoustic output, biocompatibility, cleaning):

• Acoustic Output: Measured values against industry standards (AIUM, NEMA, IEC).
• Biocompatibility: Lab testing results against ISO 10993-1.
• Cleaning/Disinfection: Verification against established effectiveness protocols.

For the substantial equivalence claim regarding clinical utility:

• Predicate devices: The "ground truth" for the clinical effectiveness and safety of the intended uses (B-mode, M-mode, specific applications like fetal, abdominal, etc., and needle guidance) is based on the prior clearance of the predicate ultrasound systems. The submission asserts that the new device's intended uses and operating modes are "available in the predicative devices."

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Speq ultrasound system is for non-invasive imaging of the human body and is intended for the following applications: Fetal, Abdominal, Pediatric, Musculo-skeletal, Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications.

The Signostics Pty Ltd Speq ultrasound system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode or M-Mode on an LCD display.

The provided text is a 510(k) Summary for the Signostics Pty Ltd Speq Ultrasound System. It describes the device, its classification, and comparison to predicate devices, along with its indications for use. However, it does not contain any information regarding acceptance criteria, studies proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or comparative effectiveness studies.

The document states that the Speq ultrasound system is "substantially equivalent to the predicate devices listed above. All systems transmit ultrasonic energy into patients, then process received echoes to produce on-screen images of anatomic structures within the body. All systems allow for measurements of structures to aid in diagnosis." This statement of substantial equivalence is the basis for regulatory clearance, rather than a detailed performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance studies based on the provided text. The document focuses on regulatory clearance through substantial equivalence, not detailed efficacy or performance studies with specific metrics.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal (new indication)

Portascan Bladder Scanner; Portascan Probe (3.5 MHz/5.0 MHz Transabdominal & Bladder)

This looks like an FDA 510(k) clearance letter for the Portascan Bladder Scanner, not a study document. It establishes substantial equivalence to a predicate device and gives permission to market the device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them. It doesn't describe the performance of the device, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The provided text only contains:

• Regulatory Information: Device name, regulation numbers, product codes, and the FDA's determination of substantial equivalence.
• Intended Use: The clinical applications for which the device is cleared, specifically for "Abdominal" imaging (indicated by 'N' for new indication in the first table of the "Diagnostic Ultrasound Indications for Use Form" for the "Portascan System"). The second table identifies the "Portascan Probe" manufactured by Pie Medical with a previous 510(k) number as the system.

To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report from the 510(k) submission.

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Pie Medical's 50L Tringa ultrasound system is to be used by or under the direction of a physician to perform general non-invasive and invasive diagnostic ultrasound imaging studies, to include: abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular and musculoskeletal (conventional and superficial). The system provides ultrasound guidance for freehand or biopsy guided placement of needles and catheters in vascular or other anatomical structures.

The 50L Tringa ultrasound system is a lightweight, low-output, portable, real-time, ultrasound scanner used to acquire and display images in 2D, M or a combination of these modes. The 50L Tringa system has one linear probe and can be operated via rechargeable battery and/or mains connection.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Ko33604 device:

Based on the provided 510(k) summary for the 50L Tringa Ultrasound Imaging System (K033604), there is no specific information detailing acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) or studies designed to prove the device meets such criteria in terms of diagnostic capability.

This document primarily focuses on establishing substantial equivalence to predicate devices. Substantial equivalence is determined by demonstrating that the new device has the same intended use as a legally marketed predicate device and has either the same technological characteristics or, if it has different technological characteristics, that the new device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness. This often involves comparing technical specifications and safety standards rather than new clinical outcome studies.

Therefore, many of the requested elements for a detailed study description are not present in this type of 510(k) submission.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable or available in this document. The submission establishes equivalence based on intended use and technological characteristics compared to predicate devices. Performance is implied to be equivalent to the predicate devices and compliant with safety standards.

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

Not applicable. This submission does not describe a clinical performance study with a test set of patient data to measure diagnostic accuracy. Instead, it relies on demonstrating equivalence to predicate devices, which generally means no new clinical data is presented for diagnostic performance.

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

Not applicable. No test set requiring ground truth establishment by experts is described in this regulatory submission.

4. Adjudication Method for the Test Set

Not applicable. No test set or expert ground truth establishment is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done or reported in this document. The submission is for substantial equivalence, not a comparative effectiveness study that measures the improvement of human readers with AI assistance. Ultrasound systems like this are tools, not AI assistants.

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

Not applicable. This device is an ultrasound imaging system, a hardware and software system that provides images for a human operator (physician) to interpret. It's not an AI algorithm that produces a standalone diagnostic output.

7. The Type of Ground Truth Used

Not applicable. No diagnostic performance study is described that would require a ground truth. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. The device is an ultrasound imaging system, not an AI model trained on a dataset.

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

Not applicable. As above, this device is an ultrasound imaging system.

Summary of How the Device Meets Acceptance Criteria (and Substantial Equivalence)

The primary method for "proving" the device meets implied acceptance criteria is through demonstrating substantial equivalence to legally marketed predicate devices, as allowed under the 510(k) pathway.

The core of the submission involves a comparison:

Reference: Section 807.92(a)(3) and the "Additional Substantial Equivalence Information" table.

Conclusion from Equivalence:
The 50L Tringa demonstrates substantial equivalence by offering similar or expanded clinical applications and technological characteristics compared to the predicate devices. Where there are differences (e.g., expanded intended uses like "Pediatric," "Neonatal Cephalic," "Intraoperative" relative to Predicate 1, or differences in imaging modes compared to Predicate 2's Color Doppler), the submission implies these do not raise new questions of safety or effectiveness, or that the device is at least as safe and effective. The compliance with recognized safety standards (EN60601-1, Track 1) is a key part of demonstrating safety.

The FDA's letter (K033604) confirms this by stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

The "study" used to "prove" acceptability is the substantial equivalence comparison against predicate devices, and adherence to recognized electrical and ultrasound safety standards, rather than a clinical performance study for diagnostic accuracy.

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