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The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800, and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative (abdominal), pediatric, small organs (thyroid, breast and testicle), trans-vaginal, trans-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-skeletal (both conventional and superficial), laparoscopic and Thoracic/Pleural. This system provides high-quality ultrasound images in the following modes: B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler and Combination Doppler, as well as Speckle-tracking, Tissue Harmonic Imaging, Combined Modes, Shear wave, Elastography, and Acoustic attenuation mapping. This system is suitable for use in hospital and clinical settings by physicians or legally qualified persons who have received the appropriate training.

In addition to the aforementioned indications for use, when EUS transducer GF-UCT180 and BF-UC190F are connected, Aplio i800 Model TUS-AI800/E3 provides image information for diagnosis of the upper gastrointestinal tract and surrounding organs, airways, tracheobronchial tree and esophagus.

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V8.5 are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex, and sector array with frequency ranges between approximately 2MHz to 33MHz.

Based on the provided FDA 510(k) clearance letter for the Canon Medical Systems Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5, the document does not contain the detailed information required to describe specific acceptance criteria and the study that proves the device meets those criteria.

This document is a regulatory clearance letter, which affirms that the device is substantially equivalent to a previously cleared predicate device. It confirms that the manufacturer has submitted evidence to demonstrate this equivalence and that the FDA has found it acceptable. However, it does not explicitly provide the specific performance metrics (like sensitivity, specificity, accuracy, or specific measurements) that would typically constitute "acceptance criteria" for a novel AI/software feature, nor does it detail a study that would "prove" these criteria were met in the way one might expect for a new algorithmic claim.

The document states:

• "Risk Analysis and verification and validation activities demonstrate that the established specifications for these devices have been met."
• "Additional performance testing included in the submission was conducted in order to demonstrate that the requirements for the new transducers and improved software functionality were met."
• "The results of all these studies demonstrate that the subject devices meet established specifications and perform as intended and in accordance with labeling."

This indicates that internal testing was performed, and specifications were met, but the specifics of these tests, the acceptance criteria, and the raw performance data are not disclosed in this public clearance letter.

Therefore, I cannot fill in the requested table and answer many of the specific questions.

Here's an attempt to answer what can be inferred or directly stated from the provided text, with explicit notes about what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not provided in the document.
• Data Provenance (e.g., country of origin, retrospective or prospective): Not provided in the document.

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

• Number of Experts: Not provided in the document.
• Qualifications of Experts: Not provided in the document.

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

• Adjudication Method: Not provided in the document.

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

• MRMC Study: Not indicated or described in the document. The document focuses on modifications to existing software functionalities and new transducers, implying an update to an existing ultrasound system rather than a new AI-assisted diagnostic aid with a human-in-the-loop study.
• Effect Size: Not applicable as an MRMC study is not mentioned.

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

• Standalone Performance Study: Not explicitly described or detailed in the document. The submission mentions "improved software functionality" but does not present standalone performance metrics for any specific algorithm.

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

• Type of Ground Truth: Not provided in the document.

8. The sample size for the training set

• Sample Size for Training Set: Not provided in the document. The document discusses software improvements and migrations of existing functionalities, implying iterative development and validation rather than a new de novo AI model requiring a distinct training set description in this context.

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

• Ground Truth Establishment for Training Set: Not provided in the document.

Summary of what the document does provide regarding safety and effectiveness:

The clearance letter primarily establishes that the updated device (Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5) is substantially equivalent to its predicate device (Aplio i900/i800/i700, Diagnostic Ultrasound System, V8.1, K233195). This means the FDA has determined that the modifications (new transducers and software workflow/image quality improvements) do not raise new questions of safety or effectiveness and that the device performs as intended.

The safety assessment notes:

• Design and manufacturing under Quality System Regulations (21 CFR § 820) and ISO 13485 Standards.
• Conformance with applicable standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62359, and ISO 10993-1.
• Risk Analysis, verification, and validation activities were performed.
• Cybersecurity documentation was included per FDA guidance.
• Software documentation appropriate for the Basic Documentation Level was included per FDA guidance.

In essence, while the document confirms that testing was done and specifications were met to achieve substantial equivalence, it does not disclose the granular details of those tests, the specific performance metrics (acceptance criteria), or the methodologies (like sample sizes, expert qualifications, or ground truth establishment) that would be present in a detailed performance study report.

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