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The Diagnostic Ultrasound System Aplio i900 Model TUS-AI900,Aplio i800 Model TUS-AI800, Aplio i700 Model TUS-Al700 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-rectal, neonatal cephalic, adult cephalic, cardiac (both adult and pediatic), 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, Power 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-UCT 180 is connected, Aplio i800 Model TUS-AI800 /E3 provides image information for diagnosis of the upper gastromtestinal tract and surrounding organs.

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V8.1 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 33 MHz.

The provided document details the 510(k) summary for the Aplio i900, Aplio i800, and Aplio i700 Software V8.1 Diagnostic Ultrasound System. The report primarily focuses on demonstrating substantial equivalence to a predicate device (Aplio i900/i800/i700, Diagnostic Ultrasound System, V7.0, K223017) by highlighting new and improved features and the testing conducted to support their safety and effectiveness.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes "pre-specified performance criteria" being passed for new and improved features. While specific quantitative acceptance criteria are not explicitly laid out in a table format in the provided text, the outcome of the tests indicates that these criteria were met. The general acceptance criterion for all new and improved features appears to be: "perform equivalently to the predicate device, and as described in labeling." and "meet established specifications and perform as intended".

For Left Atrial Appendage (LAA) Analysis, the acceptance criteria appear to be the ability to:

1. Produce equivalent measurement results as existing manual measurements.
2. Achieve workflow improvements compared to existing manual workflows.
3. Provide measurement results useful for the planning of transcatheter LAAO.

For Strain Ratio Measurement, the acceptance criterion appears to be the ability to:

1. Calculate strain ratio equivalent to the known elasticity values.

For Ultra Wideview for Mecha4D, the acceptance criterion appears to be:

1. Capability of the scan range for 4D mode to be increased with Mecha4D transducer model, PVT-675MVS, for which availability of the existing Ultra Wideview feature is expanded.

For Olympus EUS Transducer integration, the acceptance criterion appears to be:

1. Successful integration of the cleared Olympus Medical Systems Corporation manufactured EUS transducer model, GF-UCT180, with the Aplio i800 Model TUS-AI800A/E3, V8.1, in accordance with requirements pre-specified by Olympus Medical Systems Corporation.

2. Provide measurement results useful for planning transcatheter LAAO. | "confirmed workflow improvements compared to existing manual workflow in the establishment of a shape model of the left atrial appendage, as well as the ability of LAA Analysis to provide measurement results which are useful for the planning of transcatheter LAAO." |
   | Strain Ratio Measurement | Calculate strain ratio equivalent to the known elasticity values. | "demonstrated the ability of Strain Ratio Measurement to calculate strain ratio equivalent to the known elasticity values." |
   | Ultra Wideview for Mecha4D| Capability of scan range increase for 4D mode with Mecha4D transducer. | "demonstrated the capability of the scan range for 4D mode to be increased with Mecha4D transducer model, PVT-675MVS, for which availability of the existing Ultra Wideview feature is expanded." |
   | Olympus EUS Transducer | Successful integration with Aplio i800 Model TUS-AI800A/E3, V8.1, in accordance with Olympus Medical Systems Corporation's pre-specified requirements. | "demonstrated the successful integration of the cleared Olympus Medical Systems Corporation manufactured EUS transducer model, GF-UCT180, with the Aplio i800 Model TUS-AI800A/E3, V8.1, in accordance with requirements pre-specified by Olympus Medical Systems Corporation." |

Overall Acceptance Statement: "By passing all prespecified performance criteria, it was demonstrated that the new and improved features included in this submission perform equivalently to the predicate device, and as described in labeling."

Study Information

The document describes several studies conducted as "Non-clinical Testing" and "Clinical Testing".

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

   • LAA Analysis (Non-clinical): 10 clinical data sets. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
   • LAA Analysis (Clinical): 10 in-vivo cine data. Data provenance is not specified.
   • Strain Ratio Measurement: Elasticity phantoms used. Not patient data.
   • Ultra Wideview for Mech4D: Not specified as involving specific patient data sets; likely internal technical validation.
   • Olympus EUS Transducer integration: Not specified as involving specific patient data sets; likely internal technical validation.

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

   • For the Clinical LAA Analysis study, the evaluation was "by a cardiologist". The specific number of cardiologists (e.g., one or multiple) and their years of experience/specific qualifications are not provided.
   • For other studies (Non-clinical LAA Analysis, Strain Ratio Measurement, Ultra Wideview, EUS Integration), no external expert ground truth establishment is mentioned; ground truth likely derived from existing manual measurements, known phantom values, or engineering specifications.

3. Adjudication method for the test set:

   • No adjudication method (e.g., 2+1, 3+1) is described for any of the studies mentioned. For the clinical LAA study, it states "evaluated by a cardiologist," implying a single assessment unless explicitly stated otherwise.

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

   • No MRMC comparative effectiveness study is mentioned. The clinical LAA study only mentions evaluation by "a cardiologist" and "workflow improvements compared to existing manual workflow," but it does not quantify human reader improvement with AI vs. without AI assistance in an MRMC setting.

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

   • The description of "LAA Analysis (Non-clinical)" and "Strain Ratio Measurement" where the device's output is compared to "manual measurements" or "known elasticity values" suggests a form of standalone performance evaluation for those specific functionalities, though "algorithm only" is not explicitly stated. The LAA clinical study describes assisting the human workflow.

6. The type of ground truth used:

   • LAA Analysis (Non-clinical): "existing manual measurements" for comparison.
   • LAA Analysis (Clinical): Implicitly, the "cardiologist's" assessment and established clinical utility for "planning of transcatheter LAAO" served as the reference for confirming clinical usefulness and workflow improvement.
   • Strain Ratio Measurement: "known elasticity values" from elasticity phantoms.
   • For other functionalities, ground truth seems to be based on technical specifications and successful integration ("requirements pre-specified"). There is no mention of pathology or broader outcomes data for ground truth.

7. The sample size for the training set:

   • The document does not specify any training set size for the AI/software features. The information provided is solely on the testing phase to demonstrate equivalence and performance. This is common for this type of submission (510k for a software update to an existing device).

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

   • Since no training set is mentioned or described, the method for establishing its ground truth is also not provided.

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