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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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FUJIFILM Ultrasonic Endoscope EG-740UT is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. This product is intended to be used with a FUJIFILM ultrasonic processor.

This product is not intended for use on children and infants.

FUJIFILM Ultrasonic Endoscope EG-740UT is comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering air/suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor, light source, and ultrasonic processor. The endoscopes are used in combination with FUJIFILM's video processors, light sources, ultrasonic processors, and peripheral devices such as monitor, printer, foot switch, and cart.

Here's an analysis of the acceptance criteria and study information for the FUJIFILM Ultrasonic Endoscope EG-740UT, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify a "test set" in the context of clinical data for performance evaluation. The performance data presented are primarily from bench testing and compliance with established standards for various aspects like resolution, biocompatibility, electrical safety, etc. It does not appear to involve human patient data or a clinical study test set in the traditional sense.

Therefore, information on sample size for a test set and data provenance (country, retrospective/prospective) is not applicable or not provided in this document for evaluating device performance against clinical outcomes. The studies cited are for engineering, safety, and reprocessing validations.

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

As there's no clinical "test set" with ground truth established by experts for diagnostic performance, this information is not applicable or not provided in this document. The evaluations are against technical specifications and regulatory standards.

4. Adjudication Method for the Test Set

Since there is no clinical "test set" requiring expert judgment for ground truth, an adjudication method is not applicable or not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned in the provided text. The document focuses on the technical performance and safety of the device itself, not on differences in human reader performance with or without AI assistance. Therefore, information on effect size for human readers is not applicable or not provided.

6. Standalone (Algorithm Only) Performance Study

No standalone algorithm performance study is mentioned. The device is an endoscope, a medical instrument, not an AI algorithm. Therefore, this is not applicable or not provided.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation in this document is established by:

• Technical specifications/measurements: For metrics like resolution, field of view, bending capability, flow rates, etc. These are objective measurements against predefined engineering targets.
• Compliance with consensus standards: For biocompatibility (ISO 10993), electrical safety (IEC 60601), laser safety (IEC 60825, IEC 62471), endoscope specifics (ISO 8600-1), usability (IEC 62366-1), and reprocessing (FDA guidance). These standards themselves define the acceptable "truth" for device characteristics and safety.

8. Sample Size for the Training Set

As this is a medical device (endoscope) undergoing 510(k) clearance, and not an AI/ML algorithm, there is no concept of a "training set" in the context of learning data. The device's design and manufacturing are based on established engineering principles and prior device models, not on a machine learning training process.

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

Since there is no "training set," this information is not applicable or not provided.

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The Spiration ANET Electrosurgical Applicator is indicated for coagulation of soft tissue when used in conjunction with a compatible radiofrequency generator.

The Active Needle Endoscopic Treatment (ANET) Applicator (Model # ANET-00) is a disposable bipolar electrosurgical applicator intended for the coagulation and necrosis of soft tissue. Each Applicator consists of a needle (proximal electrode) with a coil (distal electrode). The needle and coil serve as the bipolar electrodes, so there is no need for an external ground pad. The ANET Applicator is compatible with the cleared Olympus ESG-100 Electrosurgical Generator (K072307) and endoscopes with a working inner diameter of 2.2mm or greater, such as those cleared in K093395 and K100584. Other radiofrequency generators will be added as compatibility is established. To perform ablation, the flexible catheter portion is first inserted into a compatible ultrasound endoscope working channel, then pushed forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a mechanism locking onto the single use adapter biopsy valve. The handle facilitates advancement of the needle/proximal electrode during puncture of the targeted ablation site. Once the proximal electrode is positioned, a separate handle control facilitates advancement of the distal electrode. Saline and power connections at the handle of the device deliver fluid (1-3cc/min) and energy respectively to the distal portion of the device. The needle size of the device is 19 gauge (19G). During operation, radiofrequency (RF) current is passed between the distal electrode and the proximal electrode to thermally coagulate the tissue. The ANET device is provided sterile and is intended for single patient use. The device should only be used within a healthcare setting by physicians knowledgeable and experienced in RF ablation.

The provided text describes the ANET Electrosurgical Applicator and its substantial equivalence determination to a predicate device (Habib EUS RFA 6700). However, it does not include specific quantitative acceptance criteria or detailed study results (like statistical performance measures, sample sizes, expert qualifications, or ground truth establishment) typically associated with the type of request. The information provided is more general, focusing on the types of tests performed to demonstrate safety and performance.

Therefore, I cannot populate all sections of your requested table and information. I will extract what is available and note what is missing.

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or reported device performance in the format of specific metrics and target values (e.g., "sensitivity > 90%"). Instead, it states that the device "successfully passed all performance testing" and that its "lesion dimensions...are equivalent to those obtained with the predicate device under the same test conditions and specified power levels."

Detailed Study Information (Based on available text)

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

   • Sample Size: Not explicitly stated for any of the performance tests (biocompatibility, sterilization, electrical safety, mechanical/functional, or comparative bench-top). The text only mentions "devices tested."
   • Data Provenance: Not specified. These appear to be laboratory bench-top tests conducted by the manufacturer, not clinical studies involving human patients or specific geographic origins.

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

   • Not applicable as the reported studies are primarily bench-top validation tests comparing the physical and functional characteristics of the device/ablation lesions, not diagnostic performance studies requiring expert interpretation of medical images or pathologies.

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

   • Not applicable for the types of engineering and bench-top performance tests described.

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 study was mentioned. This device is an electrosurgical applicator used for coagulation/ablation, not an AI-powered diagnostic tool.

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

   • This is not an AI algorithm; therefore, this question is not applicable. The performance tests described (e.g., lesion dimensions, mechanical function) are for the physical device itself.

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

   • For the comparative bench-top validation testing, the "ground truth" for comparison was the performance of the predicate device (Habib EUS RFA 6700) under the same test conditions and specified power levels. The measurement of "lesion dimensions" would be considered the objective outcome being compared, likely measured directly from the tissue (e.g., using calipers or imaging).
   • For other tests (biocompatibility, electrical safety, mechanical/functional), the "ground truth" or reference was adherence to established international standards (e.g., ISO, IEC) and the manufacturer's own pre-determined specifications.

7. The sample size for the training set:

   • Not applicable. This device is a medical instrument, not a machine learning model that undergoes "training."

8. 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 device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (Neurosurgery); Pediatric; Small Organ; Neonatal Cephalic; Trans-rectal; Trans-vaginal; TEE (non-cardiac); Musculo-skeletal; Cardiac Adult; Cardiac, Adult -TEE; Cardiac - Neonatal; Cardiac - Pediatric; Cardiac Pediatric, TEE; Peripheral Vascular; and Gynecological applications. The device is not indicated for Ophthalmic applications.

The Prosound F75, formerly named Aloka Prosound F75, Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer type keyboard, specialized controls and a display. The changes made to the Prosound F75 are the expanded indications: Adult/ Pediatric Cardiac- TEE, Neonatal/Pediatric, Cardiac, Intraoperative Neurosurgery, and Trans-esoph (non-cardiac).

The provided text is a 510(k) Summary of Safety and Effectiveness for the Hitachi Aloka Medical, Ltd. Prosound F75 Diagnostic Ultrasound System. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. Crucially, it explicitly states:

"No new hazards were identified with the addition of the added Indications. The clinical safety and effectiveness of the system and transducers have been identified in the previous Aloka Prosound F75 submission (K110207), with the above predicates as well as this submission. The clinical safety and effectiveness of the added indications are well accepted for use with ultrasound systems including the predicate device, Aloka Prosound F75 (K110207).

... 2. Clinical Tests: None Required."

This indicates that no new primary clinical study was conducted for this specific 510(k) submission (K123828) to establish effectiveness against acceptance criteria for the expanded indications. Instead, the submission relies on the established safety and effectiveness of the previously cleared device (K110207) and predicate devices, leveraging existing knowledge and accepted medical practice for ultrasound systems.

Therefore, many of the requested details about a study and acceptance criteria (such as reported performance, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) are not present in this document as no new clinical studies were performed for this specific submission.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The acceptance criteria are implicitly met by demonstrating substantial equivalence to existing, legally marketed predicate devices, specifically the Aloka Prosound F75 (K110207) and other identified ultrasound systems (K033311, K032875). The key points for substantial equivalence, which serve as the "acceptance criteria" here, are:

• Indicated for diagnostic ultrasound imaging and fluid flow analysis.
• Same gray scale and Doppler capabilities.
• Uses essentially the same technologies for imaging, Doppler functions, and signal processing.
• Acoustic output levels below Track 3 FDA limits.
• Manufactured under equivalent quality and manufacturing systems.
• Manufactured of materials with equivalent biosafety.
• Designed and manufactured to the same electrical and physical safety standards.

Reported Device Performance:
The document does not provide specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the expanded indications. Instead, it states that the clinical safety and effectiveness are "well accepted for use with ultrasound systems" and have been "identified in the previous Aloka Prosound F75 submission (K110207)". This means the performance is considered equivalent to the predicate devices, which are presumed to have established acceptable performance.

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

• Sample Size: Not applicable. No new test set data from a clinical study was presented for this 510(k) submission.
• Data Provenance: Not applicable for new clinical data. The submission relies on existing data from previous 510(k) submissions (K110207, K033311, K032875) which would have covered the safety and effectiveness of the base technology. The origin of that data is not specified in this summary.

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

• Not applicable. No new test set requiring expert ground truth establishment was conducted for this 510(k) submission.

4. Adjudication Method for the Test Set

• Not applicable. No new test set was conducted for this 510(k) submission.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done for this submission. The submission explicitly states "Clinical Tests: None Required."

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

• Not applicable. The device is a diagnostic ultrasound system (hardware and software), not an algorithm-only device. No standalone performance study (in the sense of an AI algorithm) was conducted or needed for this hardware system and its expanded indications.

7. The Type of Ground Truth Used

• Not applicable for this specific submission to demonstrate effectiveness for the expanded indications. The "ground truth" for the current submission is the established safety and effectiveness of the predicate devices. Any ground truth used for the original predicate device (K110207) or other predicate devices for their respective clinical applications would have been established at that time (e.g., clinical diagnosis, surgical findings, pathology, or other accepted diagnostic methods for ultrasound). This document does not elaborate on that.

8. The Sample Size for the Training Set

• Not applicable. This device is a diagnostic ultrasound system, not a machine learning algorithm that requires a "training set" in the conventional sense. Its "effectiveness" is based on the established performance of the underlying ultrasound technology already cleared with predicate devices.

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

• Not applicable, as there is no "training set" for this type of device.

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