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The InstaFAN device is intended for sampling targeted submucosal and extramural lesions within or adjacent to the gastrointestinal tract through the accessory channel of a curvilinear echo-endoscope. Use only with EUS endoscopes.

InstaFAN is an endoscopic ultrasound-guided fine needle aspiration/fine needle biopsy device that collects several samples from different locations in a single pass. The InstaFAN can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope and delivered to the gastrointestinal tract. The InstaFAN device is comprised of a central single 19-gauge needle and five peripheral 25-gauge needles. The device has a single handle design that contains two moving parts. The distal section of the handle controls the central needle, which can be activated first on its own or together with the proximal section of the handle to deploy all five needles simultaneously. The needles are used to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. Aspiration/biopsy samples are obtained by penetrating the lesion with the needle(s) while applying suction with the syringe.

The provided FDA 510(k) clearance letter for the InstaFAN device explicitly states that "Clinical testing was not required for the subject device; therefore, this section is not applicable." This means the document does not contain information about acceptance criteria, actual device performance (in terms of clinical outcomes), sample sizes for test or training sets, ground truth establishment methods, or details related to multi-reader multi-case (MRMC) studies.

The clearance was based on:

1. Non-Clinical Performance Testing:

   • Verification of needle performance (tensile, elasticity, bend strength).
   • Verification of overall device performance (EUS connection force, bend strength, force required to move needles, insertion force, and needle orientation).
   • The results showed the device met its specifications.

2. Animal Studies:

   • Conducted on the InstaFAN device.
   • Results met the safety and performance criteria to demonstrate substantial equivalence to the predicate.

Therefore, I cannot populate the requested tables or provide details based on a clinical study for this device, as one was not required or described in the provided text for its 510(k) clearance.

If this were a device requiring clinical data, the information you requested would typically be found in dedicated sections of the submission detailing the clinical study protocol, results, and statistical analysis.

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The ultrasonic gastrovideoscope (hereinafter called endoscope) is intended to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs.

The endoscope should be used in the medical institution. The operator of the endoscope should be a physician or a medical staff supervised by a physician, both of whom have received sufficient training in clinical endoscopy technology.

The subject device, Ultrasonic Gastrovideoscope, is consisting of insertion, control section and connector section. The insertion is consisting of a distal end, a bending section and an insertion tube. This Ultrasonic Gastrovideoscope is intended to use in conjunction with Endoscopic Image Processor (HD-550Exp, HD-550, HD-550Pro, HD-550S, HD-510 and HD-500Plus), light source (VLS-55Q, VLS-55T, VLS-51D and VLS-51T), ultrasound system (P60 Exp, P60, P60 Pro, P60 CV, P60S and P60 VO) and monitor to provide endoscopic images for the examination and diagnosis of the upper gastrointestinal tract and to perform the ultrasound examination and diagnosis of the upper gastrointestinal sub-mucosa and the surrounding organs.

The Ultrasonic Gastrovideoscope is a reusable device. The Ultrasonic Gastrovideoscope has only one model EG-UR5.

The prospective clinical value of the enhanced imaging modes (EWL, SFI, and VIST) has not been demonstrated, and no clinical claims are made.

The provided text describes the acceptance criteria and the study conducted for the Sonoscape Medical Corp. Ultrasonic Gastrovideoscope (EG-UR5).

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by testing against recognized standards and comparing performance to a predicate device. The document repeatedly states that the device's performance is "similar" to or "meets the requirements" of the predicate device and relevant standards.

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

The document does not explicitly state the sample size for test sets (e.g., number of devices tested for each non-clinical test). The studies appear to be non-clinical bench testing rather than clinical studies on human subjects.

• Data Provenance: The tests were conducted by the manufacturer, Sonoscape Medical Corp., in China, as indicated by their address. The data is retrospective in the sense that it was collected as part of the device development and verification process before submission for FDA clearance.

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

• Not Applicable. As this was a non-clinical submission, the "test set" refers to physical device testing against standards and predicate devices, not clinical data requiring expert human interpretation for ground truth.

4. Adjudication Method for the Test Set

• None. Since there was no clinical test set requiring human interpretation, no adjudication method was used. The evaluation involved technical measurements and comparisons to established standards and the predicate device's specifications.

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

• No. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was performed.

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

• Not Applicable. The device is an endoscope, a hardware medical device that directly captures images and performs ultrasound. It is not an AI algorithm or software-only device, so the concept of "standalone algorithm performance" does not apply in this context. Its performance is intrinsically tied to human operation and interpretation.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests was established by:

• Technical Specifications and Performance of the Predicate Device (K130206): The subject device's performance was compared directly to that of the PENTAX EG-3670URK Ultrasound Video Gastroscope.
• International Standards: Compliance with standards such as ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-18, IEC 60601-2-37 (particular requirements), and ISO 8600 (endoscope performance).
• FDA Guidance Documents: For example, "Mitigating the risk of Cross-Contamination from valves and Accessories Used for irrigation through Flexible Gastrointestinal Endoscopes" for backflow prevention.

8. The Sample Size for the Training Set

• Not Applicable. This device is a hardware endoscope, not an AI or machine learning system. Therefore, there is no "training set" in the context of algorithm development.

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

• Not Applicable. See point 8.

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The EndoSound Vision System (EVS), when affixed to an endoscope, is intended to provide ultrasonic visualization of, and ultrasound guided therapeutic access to the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The EVS, mounted on an endoscope, is introduced orally when indications consistent with the requirement for a GI procedure are met.

The EVS is a prescription only device to be used by a qualified physician.

The clinical environments where the system can be used include clinics, hospitals, and ambulatory surgery centers.

The EndoSound Vision System® (EVS) is an add-on ultrasound system designed to attach externally to an upper gastrointestinal (GI) endoscope (gastroscope/upper (EGD) endoscope). Once attached, it temporarily converts an EGD endoscope to a fully capable EUS endoscope. The EVS consists of:

• an electronic ultrasound beamformer/image analyzer (EVSScanner),
• a reusable transducer assembly (Ultrasound Transducer Module (UTM)), .
• . a cable/connector to interface the transducer to the beamformer (Transducer Extension Cable (TEC)).
• a sterile, disposable mounting kit with an operator control mechanism (Ultrasound Disposable Kit (UDK-T)) used to externally affix the EVS to a standard gastroscope/upper (EGD) endoscope and to provide needle and transducer angle control.

When attached to an upper GI endoscope, the EVS enables real-time ultrasound imaging, ultrasound quided needle aspiration and other EUS quided procedures within the upper gastrointestinal tract and surrounding organs. Native functions of the gastroscope including video imaging, articulation insufflation and suctioning are available after attachment of the EVS device. The system works in tandem with a PC computer/monitor/tablet connected via a USB 3.0 cable that runs custom software (EVSViewer) and provides the user interface and ultrasound display.

The provided document is a 510(k) summary for the EndoSound Vision System (EVS). It describes the device, its intended use, comparison to predicate devices, and various safety and performance tests. However, it does not contain details about an AI/algorithm performance study with specific acceptance criteria. The "study that proves the device meets the acceptance criteria" refers to a general series of verification and validation tests, and an animal study, primarily focused on the physical and functional aspects of the ultrasound system itself and not explicitly on the performance of a software algorithm that performs diagnostic analysis or image interpretation to address specific clinical outcomes (e.g., detecting pathologies).

The EVSViewer software mentioned primarily handles image processing and display, and integration with the EVS UTM probe, rather than performing AI-driven diagnostic interpretations. The document states: "The EVSViewer is the software run on a PC/monitor which processes the ultrasound data received from the EVSScanner module and displays the ultrasound image. It also functions to produce the user interface on the computer monitor." It further details minor changes to the software related to probe integration, recognition, usage counter, field of view lock, and splash screen/icons, none of which suggest an AI component for image analysis or diagnostic support.

Therefore, for the specific questions regarding acceptance criteria and a study proving an AI/algorithm-based device meets these criteria, the provided text does not offer the necessary information. It details traditional medical device testing for an ultrasound system.

However, I can extract information about the general safety and effectiveness studies conducted for the device as a whole, based on the provided text.

Here's a summary of the device's acceptance criteria and the studies mentioned, as much as can be gleaned from the text:

Device: EndoSound Vision System (EVS) - an add-on ultrasound system for upper GI endoscopes.

Acceptance Criteria and Reported Device Performance (General Device Performance, not AI-specific):

The document broadly refers to "Verification and validation testing" and "Successful results of testing" but does not explicitly list quantitative acceptance criteria in a table format for specific performance metrics of an AI. Instead, it discusses the device's functional equivalence and safety.

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

• Test Sets:
  • Biocompatibility: Not specified beyond "components of the EVS in contact with the patient."
  • Reprocessing/Sterilization: Not specified (e.g., number of units tested).
  • Animal Testing: 3 live animal models. The regimen was implemented four times in each animal. Data provenance is not specified beyond "GLP lab study." It is a prospective study.
  • Phantom and In Vivo Study (for Ultrasound Scanning Comparison): Not explicitly quantified, but mentioned that "Phantom and in vivo study comparison images show similar scanning resolution, image quality and ultrasound image performance."
  • Verification and Validation Testing (general): Not specified.

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

• Animal Testing: "An expert endoscopist as the user under the supervision of the GLP quality director and the study director." The specific number and exact qualifications beyond "expert" are not detailed.
• For other tests (biocompatibility, reprocessing, etc.), expert interpretation is inherent in GLP lab studies, but specific numbers and qualifications of human experts establishing "ground truth" (in the sense of diagnostic image interpretation) are not mentioned.

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

• Not explicitly described for any of the studies mentioned. The animal study mentions "an expert endoscopist as the user under the supervision of the GLP quality director and the study director," implying some form of oversight, but not a specific adjudication protocol for diagnostic ground truth.

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 described. The document does not mention human reader studies, nor does it describe AI assistance for diagnostic tasks. The focus is on the substantial equivalence of the ultrasound imaging system and its physical components.

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

• No standalone algorithm performance study was described. The "EVSViewer software" is described as processing and displaying ultrasound data, not performing automated diagnostic or interpretive functions.

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

• Animal study: "Clinically relevant damage was identified, either radiologically, endoscopically, or macroscopically" suggesting a combination of imaging and direct visual/physical assessment as ground truth for safety. For performance, it was a comparative assessment of image quality and device behavior relative to a predicate device.
• Other tests relying on established and regulated testing methodologies (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety).

7. The sample size for the training set:

• Not applicable. The document does not describe the development or training of an AI algorithm, so there is no training set mentioned. The "firmware modification" and "EVSViewer software" changes are related to device control and display, not AI.

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

• Not applicable. As no AI training set is mentioned, no ground truth establishment process for it is described.

In summary: The provided 510(k) summary focuses on the substantial equivalence of the EndoSound Vision System as an ultrasound imaging device to existing predicate devices, and its safety. It does not contain information about an AI/algorithm-based diagnostic device, nor does it specify AI-related acceptance criteria or studies to prove such criteria. The reported studies are typical for a hardware and basic software medical device submission.

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The Acquire S Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

The Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is an endoscopic ultrasound biopsy needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The device sheath length can be adjusted to accommodate different model echoendoscopes. The need to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. Both the sheath and needle length can be adjusted based on distance to the target lesion. The sheath and needle length adjustments are set and locked by the physician by using the locking knob mechanisms on the handle of the device. A sample is obtained by penetrating the lesion with the needle while applying suction and manipulating the needle in a back and forth motion to acquire a sample. The sample can be prepared per normal institutional protocol. The Acquire™ Needle has echogenic (visible under ultrasound) features at the distal end to facilitate real time visualization of the device under ultrasound.

Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.

This document describes the Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K223616) and its substantial equivalence to a predicate device. This is a medical device submission, not an AI/ML device submission, and therefore, the acceptance criteria and study detailed below relate to the physical device's performance, not an algorithm's.

Here's the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a physical medical device and the submission focuses on demonstrating substantial equivalence to a predicate, the "acceptance criteria" are generally that the device performs as intended and is safe and effective for its indicated use, similar to the predicate. The performance reported here refers to the results of non-clinical testing.

• Device Durability: All testing was passing.
• Stylet Removal Force: All testing was passing.
• Needle Extension Length: All testing was passing.
• Adjustable Catheter Length: All testing was passing.
• Stylet Cap Tensile: All testing was passing.

Overall: ""All testing was passing and demonstrates the device's ability to fulfill non-clinical performance bench testing...requirements." |
| Simulated use testing | Performed. All testing was passing. (Implied by the summary statement: "All testing was passing...") |
| Biocompatibility | Performed per the requirements of ISO 10993. All testing was passing. (Implied by the summary statement: "All testing was passing...") |
| Sterilization validation | Performed per the requirements of ISO 11135. All testing was passing. (Implied by the summary statement: "All testing was passing...") |
| Substantial Equivalence | Demonstrated to the currently cleared Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845). |

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

The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is non-clinical performance bench testing, simulated use testing, biocompatibility, and sterilization validation. Therefore, there are no details about sample size for a patient test set or data provenance (country of origin, retrospective/prospective). The closest equivalent of "samples" would be the number of devices or components tested in the bench/simulated use tests, which is not provided.

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

This information is not applicable and not provided. The "ground truth" for a physical device like this is its mechanical and material performance against established engineering and medical standards, not diagnostic accuracy requiring expert interpretation.

4. Adjudication method for the test set

This information is not applicable and not provided. The testing involves objective mechanical and material properties, not subjective assessments requiring adjudication.

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

An MRMC comparative effectiveness study is not applicable as this is a physical medical device, not an AI/ML diagnostic tool used for image interpretation. No such study was mentioned or performed.

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

This refers to AI/ML device performance. This device is a physical biopsy needle, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.

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

The "ground truth" for this device's performance is established by engineering and quality standards, and predefined performance specifications for mechanical properties (durability, force, length adjustments) and biological safety (biocompatibility, sterility). The goal is to ensure the device performs reliably and safely, analogous to the predicate.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

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

This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

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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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Endoscope Model EG-580UT

FUJIFILM Endoscope Model EG-580UT 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.

Endoscope Model EG-580UR

FUJIFILM Endoscope Model EG-580UR 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.

Endoscope Models EG-580UT and EG-580UR are 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 portion contains class 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 qlass 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 or diagnostic ultrasound systems, and peripheral devices such as monitor, printer, foot switch, and cart.

Based on the provided text, the document is a 510(k) summary for FUJIFILM Endoscope Models EG-580UT and EG-580UR. It describes the devices and compares them to a predicate device (K183433). The primary purpose of this document is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific performance criteria for AI assistance in image analysis.

The document discusses acceptance criteria for two endoscopic specifications: "Resolution" of the endoscope's camera, not an AI-driven image analysis technology. Therefore, many of the requested details regarding AI-specific studies (e.g., sample size for test/training sets, expert adjudication, MRMC studies, ground truth for AI) are not applicable here as this document does not describe the validation of an AI/ML medical device.

However, I can extract the information related to the device's optical performance criteria as presented.

Here's the breakdown of the information that is available in the document:

1. Table of acceptance criteria and the reported device performance (for Endoscopic Resolution, not AI performance):

Important Note: The document presents these "Acceptance Criteria" under the "Resolution" characteristic of the proposed device, directly implying that the device meets these specifications, as it's part of the substantial equivalence claim. There isn't a separate section detailing the "reported performance" against these, beyond stating them as the device's characteristic.

Study Type and Details (Based on available information in the document):

• Type of Device: This document describes Endoscope Models EG-580UT and EG-580UR, which are physical medical devices (endoscopes) used for ultrasonic imaging of the upper GI tract. It is not an AI/ML-driven diagnostic or assistive device.

• Study Purpose: The studies mentioned are primarily for demonstrating the safety and effectiveness of the endoscopes by showing substantial equivalence to a predicate device, focusing on reprocessing, biocompatibility, EMC, ultrasonic safety, and acoustic output. The document explicitly states: "The proposed devices share the same intended use, physical characteristics, and principle of operation as the predicate device. The differences have been evaluated for the EMC, ultrasound endoscopic safety, and acoustic output. There remains no new concern regarding the safety and effectiveness of the proposed device."

• AI/ML Application: There is no mention of an AI/ML component in these endoscopes or in their validation. Therefore, questions related to AI-specific study designs (test/training sets, experts, MRMC, standalone performance, ground truth for AI) are not applicable to the information provided in this document.

Here are the answers to the other questions based only on the provided text, noting their applicability:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not applicable for AI/ML performance testing. The document describes performance testing for the endoscope's physical specifications (e.g., resolution, bending capability, acoustic output). It does not specify sample sizes for these tests in terms of patient data or clinical images. Data provenance is also not mentioned for these engineering/performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable for AI/ML performance testing. Ground truth, in the context of diagnostic performance (especially for AI), would typically involve expert interpretations or pathological findings. The "ground truth" for the device's resolution (e.g., 0.08mm line pair readable) is an objective engineering specification, not established by human experts in the way clinical ground truth is.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable for AI/ML performance testing. Adjudication methods are relevant for resolving discrepancies in expert opinions, typically in diagnostic studies involving human readers or AI. This document does not describe such a study.

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:
* No. Not applicable as this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No. Not applicable as this is not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* For the endoscopic resolution, the ground truth is based on physical measurement against a standardized test chart (square wave chart). For other performance tests like reprocessing, biocompatibility, EMC, and acoustic output, the ground truth is established by adherence to specific international standards (ISO, IEC) and FDA guidance documents.

8. The sample size for the training set:
* Not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established:
* Not applicable. There is no mention of a training set.

In summary, this FDA 510(k) summary focuses on demonstrating that new endoscope models are substantially equivalent to a previously cleared device based on their physical and operational characteristics, and compliance with various engineering and safety standards. It does not pertain to the validation of an AI-driven image analysis device.

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The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation. Modes of Operation: B-mode

This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities. Modes of Operation: B-mode

The FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 consists of five components: 1) processor (SP-900), 2) probe (PB2020-M2), 3) control pad (CP-900), 4) scanner (RS-900), and 5) power cord. SP-900 generates ultrasound waves into the body cavity by driving the ultrasonic transducer installed in PB2020-M2, which is inserted through the forceps channel of an endoscope. SP-900 processes the reflected ultrasound signals which PB2020-M2 receives in the body cavity and further converts the processed electrical signals to relay to a monitoring system. SP-900 can acquire and display real-time ultrasound data in B-mode. CP-900 is used to control operational features of SP-900. RS-900 provides the mechanical scanning for acquiring a two-dimensional image. The power cord supplies power to SP-900.

This FDA 510(k) summary describes the substantial equivalence of the FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 to their predicate devices. It focuses on the comparison of technological characteristics and safety testing, rather than an AI/ML-driven device's performance evaluation against specific acceptance criteria related to diagnostic accuracy or clinical outcomes.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/ML device, such as those related to diagnostic performance (sensitivity, specificity, AUROC), expert ground truth establishment, MRMC studies, and training/test set details, are not applicable to this submission.

This submission is for a medical imaging device (ultrasound processor and probe), not an AI/ML diagnostic or assistive device. The "performance data" section focuses on electrical safety, EMC, biocompatibility, and reprocessing validation, which are standard for such hardware devices to demonstrate safety and effectiveness.

However, I can extract the information that is present and indicate where the requested information is not applicable (N/A) based on the provided document.

Device Name: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2

Device Type: Medical Ultrasonic Processor and Probe

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (ultrasound hardware), the "acceptance criteria" are related to safety, electrical performance, biocompatibility, and reprocessing effectiveness, not diagnostic accuracy metrics typically seen with AI/ML algorithms. The document asserts that the device meets these criteria through various tests.

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The device is designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope in adult patients only.

The proposed Endoscopic Ultrasound Aspiration Needle is a sterile single-use device, designed to sample targeted submucosal and extraluminal gastrointestinal lesions through the accessory channel of suitable ultrasound videoendoscope. The Endoscopic Ultrasound Aspiration Needle consists of an Aspiration Needle and negative suction device. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 2 years.

The provided text describes a 510(k) summary for a medical device and does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details for an AI/ML powered device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of technological characteristics: This involves a table (Table 7.1) comparing various features of the proposed device (Adapt Endoscopic Ultrasound Aspiration Needle) and the predicate device (Endoscopic Ultrasound Aspiration Needle, K172309).
• Performance data (bench testing): A list of bench tests performed to ensure the device works as intended. These tests are:
  • Smooth Actuation of Handle
  • Leakage
  • Ultrasound Visibility
  • Puncture Force
  • Stiffness
  • Durability
  • Stylet Removal Force
  • Locking Force of Handle
  • Tensile Strength
• Shelf-life and packaging integrity testing: Based on accelerated aging and ISO standards.
• Sterilization validation: In accordance with ISO 11135.
• Biocompatibility evaluation: In accordance with ISO 10993-1 and FDA guidance, including tests for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, and Hemolysis.

The text explicitly states that no animal study and no clinical study were included in the submission. This implies that no human-in-the-loop performance, standalone algorithm performance, or clinical effectiveness data would be available from this document.

Therefore, I cannot fulfill your request for the specific information you asked for, as the provided text pertains to a traditional medical device (an aspiration needle) and its regulatory submission, not an AI/ML powered device with related performance metrics.

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The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed) includes three endoscope models EG34-J10U. EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes, and is used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with FDA cleared PENTAX Medical Video Processors (a software-controlled device) and FDA cleared Hitachi Ultrasound Scanners (a softwarecontrolled device). The endoscopes have a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE umbilical connector will be attached to the Video Processor and has connections for illumination, video signals, air, water, and suction. The ultrasound scanner umbilical connector will be attached to the ultrasound scanner unit. A sterile, single use disposable natural rubber latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. During an ultrasound endoscopy procedure, the latex balloon is inflated with water. The water that is contained within the balloon creates a water field that covers the transducer. The water field enables more effective transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a linear or radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced. The video processor contains a lamp that provides white light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received, and the signals are passed to the ultrasound scanner for processing and display. EG34-J10U, EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes are connected to the ultrasound scanner ARIETTA 70 and the ALOKA ARIETTA 850 via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector. The instrument is immersible (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope Operators Manual cleaning instructions).

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (Proposed) connects with a video processor and an ultrasound scanner, both of which are software-controlled devices. The endoscope has a flexible insertion tube, a control body, PVE connector, and scanning unit connector. The PVE connector attaches to the video processor and has connections for illumination and video signals. The ultrasound umbilical connector attaches to the ultrasound scanner unit. The control body includes remote buttons for functions assigned from the video processor. It also includes controls for up/down angulation or neutral position control, and ports for manual balloon insufflation/evacuation, and an accessory inlet. The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a convex array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices may be introduced. The video processor contains a lamp that provides white light focused at the endoscope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and the signals are passed to the ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories). EB19-J10U is connected to the ultrasound scanners ARIETTA 70, ALOKA ARIETTA 850, and Noblus via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.

The provided text appears to be a 510(k) summary for medical devices, specifically endoscopic ultrasound systems and a video bronchoscope, from PENTAX of America, Inc. It describes the devices, their indications for use, and a comparison to predicate devices, focusing on the addition of compatibility with a new diagnostic ultrasound system (ALOKA ARIETTA 850).

However, the document does not contain specific acceptance criteria or a study design in the way one might expect for a clinical performance study measuring diagnostic accuracy (e.g., sensitivity, specificity, AUC) or human reader improvement with AI assistance. Instead, it focuses on engineering and performance testing to demonstrate substantial equivalence to predicate devices after a minor modification (compatibility with a new ultrasound scanner).

Therefore, a table of acceptance criteria and reported device performance as typically understood for diagnostic accuracy would be largely inapplicable here. The "performance data" section details verification/validation methods used to mitigate identified risks, which serve as the acceptance criteria for these specific engineering tests.

Here's an attempt to answer your questions based on the provided text, acknowledging the nature of the submission:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, the "acceptance criteria" are the satisfaction of relevant international standards and the reported "performance" is that the devices passed these checks.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text describes engineering, electrical safety, and acoustic output testing. It does not involve a "test set" of patient data or clinical images. The testing was conducted on the devices themselves or their interaction with the new ultrasound scanner. Therefore, typical patient-data related sample size and provenance information are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for this type of engineering and performance testing is established by compliance with international standards and technical specifications, not by expert clinical consensus on patient data.

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

Not applicable. There was no clinical test set requiring adjudication. The verification and validation activities were based on standardized measurements and testing protocols.

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

No MRMC study was done. This submission is for an endoscopic ultrasound system and video bronchoscope with a minor modification (compatibility with a new diagnostic ultrasound system), not an AI-assisted diagnostic tool.

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

Not applicable. The devices are visualization tools for human operators, not standalone algorithms.

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

The "ground truth" in this context is the compliance with established international standards and FDA guidance for medical device safety and performance. This includes:

• IEC 60601-2-37: 2007 +A1: 2015 (Electrical safety standard for ultrasonic medical diagnostic and monitoring equipment)
• IEC 60601-1-2: 2014 (EMD standard for medical electrical equipment)
• FDA guidance, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers"

8. The sample size for the training set

Not applicable. This submission is for hardware devices (endoscopes) and their compatibility, not for an AI algorithm that requires a training set.

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

Not applicable, as there was no training set for an AI algorithm.

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The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The EG34-J10U, EG36-J10UR and EG38-J10UT Ultrasound Upper GI Video Scopes, are endoscopes used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with cleared Pentax Video Processors (a softwarecontrolled device) and cleared Hitachi Ultrasound Scanners (a software-controlled device). The endoscopes have a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE umbilical connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound scanner umbilical connector will be attached to the ultrasound scanner unit. A sterile, single use disposable natural rubber latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. During an ultrasound endoscopy procedure, the latex balloon is inflated with water. The water that is contained within the balloon creates a water field that covers the transducer. The water field enables more effectively transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a linear or radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced.

The provided text is a 510(k) premarket notification for the PENTAX Medical EG-J10U Endoscopic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, many of the requested details, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information (which are typical for AI/ML device submissions), are not present in this document.

The document primarily addresses hardware, software, and reprocessing aspects of the endoscopic ultrasound system. The "performance data" mentioned refers to non-clinical testing for functionality, safety, human factors, reprocessing validation, sterilization, shelf life, software verification/validation, EMC, electrical safety, and optical testing, rather than clinical performance metrics for a diagnostic or AI/ML algorithm.

Here's an attempt to answer the questions based on the available information, noting significant gaps:

1. A table of acceptance criteria and the reported device performance:

The document describes performance testing in general terms rather than specific quantifiable acceptance criteria with corresponding results in a table format. It states that the system "has been successfully tested for its functions, performance and safety as per FDA recognized consensus standards." For optical testing, it notes "All results show that there are no differences between the subject device, and the predicate device."

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

• Sample Size: Not specified in the document for any of the non-clinical tests.
• Data Provenance: Not specified. The tests are described as being conducted "as a part of Design Verification and Validation" and for "support of the substantial equivalence determination," implying internal company testing rather than clinical trials.

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

• Not applicable / Not specified. This document describes a medical device, not an AI/ML algorithm that requires expert ground truth for diagnostic accuracy. The "human factors" study involved reprocessing staff, not clinical experts establishing ground truth for diagnostic images.

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

• Not applicable / Not specified. No adjudication method is mentioned as it's not a diagnostic AI/ML study.

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:

• No. This is not an AI-assisted device. The document does not describe any MRMC studies or human reader improvement with AI assistance.

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

• Not applicable. This is not an AI/ML algorithm. The device is a physical endoscope with associated control software.

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

• Not applicable. The "ground truth" for this device's performance testing would be engineering specifications, industry standards (e.g., IEC standards for electrical safety), and validated reprocessing protocols, rather than clinical ground truth for disease states.

8. The sample size for the training set:

• Not applicable. This document describes a medical device, not an AI/ML algorithm requiring a training set.

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

• Not applicable. As above, no training set for an AI/ML algorithm is described.

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