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Intended Use:
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

Indications to Use:
The clinical applications and exam types include:
Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult Trans-cramial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Transesophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).

The Ultrasound System 2300 is a multi-purpose mobile, software-controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms which are offered in different configurations/ models intended for urology, general imaging, surgical and anesthesiology applications.
The system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a conventional keyboard or a glass touchpad, a 19" Clinical Display Monitor (CDM). In addition, a variety of system accessories are available such as baskets, foot switch, printer start-up kit, remote control, and extra holders.

Here's a breakdown of the acceptance criteria and the study details for the Prostate Volume Assist (PVA) feature, as derived from the provided document:

Acceptance Criteria and Device Performance (Prostate Volume Assist - PVA)

Study Details for Prostate Volume Assist (PVA)

1. Sample size used for the test set and the data provenance:

   • Test Images Total: 975 (Healthy) + 1461 (Diseased) = 2436 images.
   • Data Provenance:
     • Czech Republic (for 9018 transducer data)
     • Amsterdam, Holland (for 9048 transducer data)
   • Retrospective/Prospective: Not explicitly stated, but the description "Data from a clinical end-user test in the Czech Republic" and "data acquired in Amsterdam, Holland" suggests retrospective use of collected data for the test set.

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

   • Number of Experts: Not specified as a precise number (e.g., "3 experts"). It states "clinical experts validation testing" and "The human caliper setters scored the images individually."
   • Qualifications of Experts: "The clinical personnel had an average of about 15 years' experience in ultrasound."

3. Adjudication method for the test set:

   • The document implies individual scoring by "human caliper setters" rather than an explicit adjudication method like 2+1 or 3+1. "The human caliper setters scored the images individually." The comparison is then made against these individual manual placements.

4. 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 involving human readers improving with AI assistance was directly described. The study focused on validating the algorithm's performance against manual placement, indicating a standalone performance assessment of the AI. The PVA feature is described as "a workflow improvement to an existing prostate volume measurement and calculation tool" and "allows a faster and more efficient workflow," but specific effect sizes for human reader improvement with AI assistance (e.g., reduction in reading time, increase in accuracy) are not provided.

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

   • Yes, a standalone performance assessment of the algorithm was done. The acceptance criteria and reported device performance directly evaluate "the automatic initial caliper placement" and "the prostate volume calculation of PVA" against manual placement, implying the algorithm's performance without human input for the initial placement. The final verification involved visual evaluation by clinical experts comparing the initial algorithmic placement to manual placement.

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

   • Expert Manual Measurement: The ground truth for volume estimation was established by "manually placed calipers" by "clinical personnel" with extensive experience.

7. The sample size for the training set:

   • Training Images Total: 505 (Healthy) + 13447 (Diseased) + 4104 (Synthesized data) = 18056 images.

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

   • The document does not explicitly detail the method for establishing ground truth for the training set. It only mentions the types of images (healthy, diseased, synthesized) used for training. However, given that the validation uses expert manual measurements as ground truth, it is highly probable that the training data also utilized expert annotations or measurements, potentially with additional synthesized data to augment the dataset.

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Intended Use:
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.

Indications to Use:
The clinical applications and exam types include:
Fetal (including Obstetrics), Abdominal, Pediatric, Intra-operative Neuro (also known as Neurosurgery), Laparoscopic, Small Organ (also known as Small Parts), Adult Cephalic is also known as Adult Trans-cranial), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Transesophageal (Cardiac) and Peripheral Vessel (also known as Peripheral Vascular).

Modes of Operation:

• 2D (B-Mode) including Tissue Harmonic Imaging
• M-Mode
• PWD Mode
• CFM Mode (C, VFI)
• Power Doppler
• Contrast Imaging
• CW Doppler
• Strain Elastography

Environment:
The Ultrasound System 2300 is intended for use in the professional healthcare environment (e.g. hospitals, physician offices)

Contraindications:
The Ultrasound System 2300 is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
The Cardiac Adult application is not intended for direct use on the heart.

The Ultrasound System 2300 is a multi-purpose mobile, software-controlled diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms which are offered in different configurations/ models intended for urology, general imaging, surgical and anesthesiology applications.

The system consists of a mobile console (engine) that provides digital acquisition, processing and display capabilities. The user interface includes a conventional keyboard or a glass touchpad, a 19" Clinical Display Monitor (CDM). In addition, a variety of system accessories are available such as baskets, foot switch, printer start-up kit, remote control, and extra holders.

The Ultrasound System 2300 is available in the following marketing configurations:

• 1. bk3000 available with a conventional keyboard configuration. The bk3000 is primarily intended for applications such as urology and general imaging
• 2. bk5000 available with a conventional keyboard configuration. The bk5000 is primarily intended for surgery applications.
• 3. bkActiv is a configuration available with a glass user interface (UI). bkActiv is primarily intended for surgical and anesthesiology applications.

All configurations run on the previously cleared SW platform and HW platform (engine) (K180737). The various configurations of the Ultrasound System 2300 are intended to be used for different applications as described above with various transducers and options.

The provided text does not contain detailed information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) summary for an ultrasound system, focusing on its substantial equivalence to a predicate device.

Specifically, the "Performance Data" section (page 19-20) only mentions non-clinical performance (bench testing) related to safety and compliance with voluntary standards (e.g., acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety). It explicitly states:

• "Animal Testing: Not applicable - animal testing was not required to support substantial equivalence to the predicate device."
• "Clinical Studies: Not applicable – clinical studies were not required to support substantial equivalence to the predicate device."

Therefore, I cannot extract the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, as no such study is described in this document.

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