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The Stone Clear ultrasonic propulsion device is indicated for the repositioning of residual stone fragments post-lithotripsy that are located in the upper urinary tract of adult patients to facilitate passage, where any individual fragment is less than or equal to 5 mm.

The Stone Clear device consists of a commercially available third-party diagnostic ultrasound imaging unit (GE LOGIQ P9, K181783, Imaging Workstation) that is integrated with a SonoMotion-manufactured signal generator and therapy probe.

The Imaging Workstation and associated ultrasound imaging provide the user interface and real-time image guidance for the Stone Clear procedure, while the Generator controls and drives the Therapy Probe. The Therapy Probe delivers the ultrasound pulses to reposition stones. The Imaging Probe and Therapy Probe are coaxially aligned, with the Imaging Probe docking into the housing of the Therapy Probe through an adapter. A foot pedal is used to initiate the therapy from the Generator.

The provided text describes the regulatory information, device description, nonclinical/bench studies, and clinical information (including results and benefit-risk determination) for the Stone Clear ultrasonic urinary stone propulsion device.

However, the provided text does not contain any information about acceptance criteria or a study design to prove that an AI/ML algorithm meets acceptance criteria. The "Stone Clear" device is a physical medical device, not an AI/ML algorithm. The "Software" section primarily describes the device's control firmware and user interface, without any indication of AI/ML components for classification, prediction, or diagnostic assistance.

Therefore, I cannot fulfill the request as it asks for information that is not present in the provided input text. The prompt's questions pertain to acceptance criteria and studies for AI/ML performance (e.g., sample size for test/training sets, data provenance, expert labeling, MRMC studies, standalone performance, ground truth establishment), which are irrelevant to the description of the Stone Clear device.

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The Versana Premier is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Premier clinical applications include : Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Pediatric, VascularPeripheral Vascular, Musculoskeletal Conventional, Musculosketal Superficial, Thoracic/Pleural, Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular access). Modes of operation include : B. M. PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. Versana Premier is intended to be used in a hospital or medical clinic.

The Versana Premier is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers. The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. The operator control panel includes function keys, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device. The variety of transducers include convex, linear, sector, dual and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial. Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating during scanning. The system has a HDMI port, VGA connection port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer box of the console and an option for external Printer USB Isolator for other printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the external Bluetooth USB adapter is connected to the system.

The provided text is a 510(k) Premarket Notification Submission for the GE Versana Premier ultrasound system. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving that a new AI-powered diagnostic device meets specific performance acceptance criteria through a dedicated clinical study.

Therefore, the information required to populate the fields related to acceptance criteria, ground truth, sample size, expert adjudication, and comparative effectiveness studies is not present in this document. The document explicitly states: "The subject of this premarket submission, Versana Premier, did not require clinical studies to support substantial equivalence."

The only mention of an "Artificial Intelligence (AI) feature" is "Whizz Label," and no performance data or study details are provided for this feature. The document indicates that the Versana Premier employs "the same fundamental scientific technology as its predicate device and reference devices," and that it is "substantially equivalent ... with regard to intended use, imaging capabilities, technological characteristics, imaging modes, hardware, and safety effectiveness."

Here's what can be extracted from the document regarding the AI feature, acknowledging the absence of the requested study details:

• AI Feature Mentioned: Whizz Label is an Artificial Intelligence (AI) feature that is being added.

All other requested information cannot be found in the provided document:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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: Explicitly stated that clinical studies were not required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac); Intraoperative (Neuro); Laparoscopic; Pediatic; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/ Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial);Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

The ZS3 and z.one pro Ultrasound Systems are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The system utilizes zone technology which allows the system to collect more data at one time, thereby optimizing image quality.

The exam dependent default settings for the ZS3 and z.one pro allow the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control enables the advanced user to set the system based on image appearance preference. The architecture of the ZS3 and z.one pro Ultrasound Systems support system integration to a variety of upgradable options and features. Up to three transducers can be connected to the multi-transducer port permitting easy transducer transition. The system can be operated on either battery or AC power.

This document describes the 510(k) premarket notification for the ZS3 and z.one pro Ultrasound Systems. This is a notification of intent to market a medical device, asserting its substantial equivalence to previously cleared devices. Therefore, the information provided focuses on demonstrating this equivalence through non-clinical testing and comparison to predicates, rather than extensive clinical studies or formal acceptance criteria for an AI/CADe device.

Based on the provided information, the device is an ultrasound system and not an AI/CADe device. As such, the typical acceptance criteria and study design for AI/CADe devices (multireader multi-case studies, ground truth establishment by multiple experts, defined performance metrics like sensitivity/specificity, etc.) are not applicable to this submission.

The acceptance criteria here pertain to the ultrasound system's performance and safety standards, and the "study" proving acceptance is a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an ultrasound system and not an AI/CADe device, the acceptance criteria are based on compliance with recognized safety and performance standards for ultrasound equipment. The "reported device performance" is implicitly that the device conforms to these standards.

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

This document describes a 510(k) submission for an ultrasound imaging system. As such, it does not involve a "test set" or "data provenance" in the sense of a machine learning model's evaluation data. Instead, validation is based on non-clinical tests (electrical safety, acoustic output, biocompatibility, etc.) performed on the physical device and its components, in accordance with recognized industry standards. The data provenance would be the results from these engineering and biological safety tests. The specific "sample size" of devices or components tested is not detailed in this summary but is generally part of standard engineering verification and validation.

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

Not applicable. This is not an AI/CADe device, and therefore, an expert-established "ground truth" for a diagnostic test set is not relevant to its 510(k) submission. The "ground truth" for a device like this is its adherence to safety and performance standards.

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" in the context of diagnostic interpretation that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. This is an ultrasound imaging system, not an AI/CADe device designed to assist human readers, so such a study is not relevant.

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

Not applicable. This is not an AI/CADe device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is its compliance with established safety and performance standards for diagnostic ultrasound equipment, as detailed in section 7 ("Non-clinical Tests") of the 510(k) summary. This includes standards for electrical safety, acoustic output, biocompatibility, and software development, rather than clinical outcomes or expert consensus on image interpretation.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware/software medical device (ultrasound system), not an AI/CADe system that undergoes machine learning training with a specific "training set."

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

Not applicable, as there is no "training set" for this type of device. The specifications and performance are established through engineering design, quality control, and adherence to regulatory standards.

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Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals for ultrasound imaging, measurement and analysis of the human body and fluid. Venue Go clinical applications include the following: Abdominal (including Gynecology and Urology), Thoracic/Pleural, Ophthalmic, Fetal/Obstetrics, Small Organ (including breast, testes, thyroid), Peripheral vascular, Adult and neonatal cephalic, Musculoskeletal (Conventional and Superficial), Cardiac (Adults and Pediatric), Transesophageal, Transrectal, Transvaginal, Intraoperative and Imaging guidance for interventional procedures (e.g. Nerve block, biopsy, vascular access).

Venue Go is a general-purpose diagnostic ultrasound system intended for use by qualified healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. The Venue Go is a compact, portable system with a small footprint. The system can be hand carried using an integrated handle, placed on a horizontal surface, attached to a mobile cart or wall mounted. It has a high resolution color LCD monitor, with a simple, multi-touch user interface that makes the system intuitive. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time.

The Venue Go utilizes a variety of linear, convex, and phased array transducers which provide high imaging performance and support standard acquisition modes. Some biopsy kits are available for needle-guidance procedures.

The system has the capability for displaying the patient's ECG trace synchronized to the scanned image. This allows the user to view an image from a specific time of the ECG signal. The ECG signal can be input directly from the patient or as an output from an ECG monitoring device. ECG information is not intended for monitoring or diagnosis.

A barcode reader is available to be used as an input device. Venue Go is capable of wireless communication through a builtin Wireless LAN device. The system meets DICOM requirements to support users image storage and archiving needs (local PACS or products such as O-Path) and allows for output to printing devices. The user documentation is available electronically. An additional accessory that will also be available for the customer will be a roller bag.

The provided text is a 510(k) Premarket Notification Submission for the GE Venue Go Ultrasound System. This type of submission is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device against existing ones rather than detailing a study that proves the new device meets specific, quantitative acceptance criteria for clinical performance.

The document states: "The subject of this premarket submission, Venue Go, did not require clinical studies to support substantial equivalence." This means that traditional clinical performance studies with specific quantitative acceptance criteria or comparative effectiveness studies (like MRMC studies) demonstrating improvement with AI assistance were not performed or submitted for this specific premarket notification.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Venue, LOGIQ e, LOGIQ P9) through:

• Identical or similar intended use and clinical applications.
• Similar imaging capabilities and technological characteristics.
• Compliance with applicable medical device safety standards (e.g., electrical, electromagnetic, mechanical safety, biocompatibility, acoustic output).
• Quality assurance measures applied during development (risk analysis, requirements reviews, design reviews, various levels of testing: unit, integration, performance, safety).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study for this specific device, nor can I answer questions about sample sizes, expert ground truth establishment, adjudication methods, or MRMC studies, as these types of clinical performance evaluations were explicitly not required or conducted for this 510(k) submission.

The document indicates that new indications or features are being added to the device (e.g., Intraoperative indication, new transducers and imaging modes). For these new features, substantial equivalence is established by showing that they were previously cleared on other predicate devices. For instance:

• The Intraoperative indication was cleared on LOGIQ e (K151028).
• L4-12t-RS, L8-18i-RS, and 6S-RS transducers were cleared in LOGIQ e (K151028).
• The Neonatal Cephalic application for L8-18i-RS was cleared in LOGIQ P9 (K181783).
• New applications for L4-12t-RS and 6S-RS, and new imaging modes like "Color M Doppler" and "Combined Modes" were cleared in LOGIQ P9 (K181783) or existing predicates.

In summary, the "acceptance criteria" for a 510(k) device like this are primarily demonstrated through substantially equivalent performance to existing, legally marketed predicate devices by showing similar features, technology, and compliance with recognized safety standards in non-clinical tests, rather than through new clinical performance studies with quantitative metrics.

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