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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 VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/Fujifilm medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastromtestination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.

This system is intended to be used in coniunction with Fuiifilm endoscopes to provide illumination, visual display and data storage during endoscopic procedures.

The EPX-4440HD Digital Video Processor with FICE and light source consists of three components used in conjunction with one another:

The VP-4440HD Video Processor: The Processor relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. The Processor incorporates internal or external digital storage capacity. The Processor also controls the light projected to the body cavity. The Processor provides for optional structural enhancement at the user's option. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 120V/60MzJ0.8A. The Processor is housed in a steel-polycarbonate case measuring 390x105x460mm.

The XL-4450 Light Source: The Fujinon/Fujifilm endoscope employs fiber bundles to transmit light from the light source and subsequently to the body cavity. The Light Source employs a 300W Xenon lamp with a 75W emergency back-up Halogen lamp. Brightness control is performed by the user. The device is AC operated at a power setting of 120V/60MzJ3.3A. The Light Source is housed in a steel-polycarbonate case measuring 390x155x450mm.

The DK-4440E Keyboard: The Keyboard is used to enter pertinent procedural information (patient, physician, date, etc.) for display on the video monitor and digital/analog storage systems. The Keyboard is also used to control operational features of the VP-4440HD Processor. The Keyboard resembles a standard computer keyboard in size and shape.

The VP-4440HD Digital Video Processor with FICE and light source is the same as the cleared EPX-4440HD Digital Video Processor and Light source (K102466) device, with the exception of the addition of the imaging algorithm termed "FICE" (Flexible spectral-Imaging Color Enhancement). As with the predicate device, the subject processor receives an image from the endoscope via a connector cable. The subject processor is capable of bi-directional communication that allows importation and exportation of various patient and procedural data between EMR (Electronic Medical Record) systems.

FICE is an image processing feature that a licensed medical practitioner (user) can utilize, as an adiunctive tool, to supplement the white light endoscopic examination. FICE extracts spectral images of specific wavelength components from the original full spectral (white light) image through an image processing algorithm that, assigns a spectral wavelength component in the Red (R), Green (G) and Blue (B) spectrum and displays the enhanced color image. FICE may enhance color contrast to improve visibility of the selected structures, borders of areas of interests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Clinical Study): Each subject underwent two (2) gastrointestinal endoscopic examinations during a single clinical procedure. The document doesn't explicitly state the total number of subjects or individual images in the test set.
• Data Provenance: Prospective clinical trial. The country of origin of the data is not specified.

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

• Number of Experts: Multiple blinded investigators. The exact number is not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Images were analyzed independently by "multiple blinded investigators using a 4-point Likert scale." The document does not specify a formal adjudication method (e.g., 2+1, 3+1 consensus). It appears to rely on the "overall means between all readers."

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

• MRMC Study: Yes, a reader concurrence study was performed, which is a type of MRMC study comparing FICE (an AI/image processing feature) to optical filtering (NBI).
• Effect Size: The study aimed to establish "substantial equivalence of diagnostic visualization (e.g. image quality) to the predicate optical filtering method." The reported outcome is that "Overall means between all readers demonstrated at least comparable image quality of each FICE setting in one or more locations within the gastrointestinal tract." This indicates FICE performed similarly to or as well as NBI for image quality; a specific quantitative effect size of human reader improvement with AI assistance vs. without is not provided, as the study focused on comparability rather than improvement. The FICE feature itself is described as an "adjunctive tool," not necessarily a comprehensive AI diagnosis system.

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

• Based on the provided text, the FICE feature is described as an "adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy." The clinical study focused on readers evaluating image quality generated by FICE. There is no indication of a standalone performance study of the FICE algorithm without human interpretation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The clinical study compared the "overall image quality" observed by multiple blinded investigators using a Likert scale. This suggests a form of expert consensus/reader perception for image quality as the ground truth. It's important to note that the FICE feature is "not intended to replace histopathological sampling as a means of diagnosis," indicating that the "ground truth" for diagnosis in a clinical sense would still be pathology. However, for the purpose of this study measuring the effectiveness of the FICE image processing, reader evaluation of image quality served as the primary measure.

8. The Sample Size for the Training Set

• The document describes performance testing for an image processing feature (FICE) which is integrated into a video processor. It does not explicitly mention a "training set" in the context of machine learning model development. This suggests the FICE algorithm might be based on pre-defined spectral filters or rule-based image processing rather than a deep learning model that requires a dedicated training set. If there was a training phase for the algorithm, its sample size is not disclosed.

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

• As a dedicated "training set" is not mentioned and the FICE algorithm's nature isn't fully detailed as a deep learning model, the method for establishing ground truth for a training set is not applicable or not provided in this document.

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This instrument is intended to be used with a PENTAX video processor (including light source), documentation equipment, monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach, and duodenum.

The PENTAX Video Upper G.I. scopes (EG Family), Model Numbers: EG-2990i, EG-2790i, EG-1690K. EG-2490K. EG-2790K. EG-2990K. EG-3490K. EG-3890TK, EG27-i10. EG29-i10 are used with a Video Processor.

The PENTAX Video Upper G.I. scopes (EG Family) are composed of the following main parts: an Insertion Portion, Control Body and PVE Connector.

The Insertion Portion is inserted into the body cavity of patient. The Insertion includes the Distal End and Bending Section. The Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water, Suction Cylinder, Remote Control Button, Magnification Control Lever, and Instrument Channel Inlet. The Air/Water Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob.

The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the Air/Water Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, the air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed. the fluid and air are suctioned. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary.

The Magnification Control Lever is used to magnify the image on the video monitor, as necessary. As this magnification function is performed electrically, focus and depth of field do not change.

Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel.

The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle.

The Light Guide of the Distal End is used to illuminate the body cavity by light which is carried through the Light Carrying Bundle, The Light Carrying Bundle guides the light from Light Guide Plug which is connected to the Light Source inside the Video Processor.

The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.

This document describes a 510(k) premarket notification for the PENTAX Video Upper G.I. Scopes (EG Family). This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of AI/ML or clinical efficacy.

Therefore, many of the requested elements pertaining to acceptance criteria and performance studies for AI/ML devices or new clinical functionalities are not present in this regulatory filing. The document primarily details non-clinical tests performed to ensure fundamental safety and performance.

Here's a breakdown of the information available based on your request:

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

The document does not provide a table of acceptance criteria with specific performance metrics for clinical efficacy. Instead, it states that the "EG Family Master Device (EG-2990i) test results satisfy the acceptance criteria specified by the above applicable standards." The applicable standards listed are for aspects like electrical safety, electromagnetic compatibility, biocompatibility, reprocessing, and general requirements for medical electrical equipment and endoscopes.

• IEC 60601-1 (Basic Safety & Essential Performance)
• IEC 60601-1-1 (Safety for Medical Electrical Systems)
• IEC 60601-1-2 (EMC)
• ISO 10993-1, -5, -10 (Biological Evaluation: Cytotoxicity, Irritation, Sensitization)
• IEC 60601-2-18 (Endoscopic Equipment Specific Requirements)
• ISO 8600-1, -3, -4 (Optics & Photonics, Field of View, Direction of View, Max Width of Insertion Portion)
• AAMI TIR12, TIR30 (Designing, Testing, Labeling Reusable Medical Devices for Reprocessing)
• ANSI/AAMI TIR79 (Steam Sterilization & Sterility Assurance)
• ISO 13485 (Quality Management Systems)
• ISO 14971 (Risk Management)
• IEC 60601-1-4 (Programmable Medical Systems)
• IEC 60601-1-6 (Usability)
• IEC 62366 (Usability Engineering)
• IEC 62304 (Medical Device Software)
• IEC 60417/ISO 7000-DB-12M (Graphical Symbols)
• ISO 15223-1 (Symbols for Labels)
• IEC 60878 (Graphical Symbols for Electrical Equipment) |
  | Biocompatibility | Confirmed by testing Cytotoxicity, Sensitization, and Intracutaneous Reactivity in accordance with ISO 10993-1, 5, and 10 and FDA's guidance for surface device, mucosal membrane contact less than 24 hours. |
  | Reprocessing Validation | Validated cleaning and high-level disinfection for reusable devices using simulated use conditioned test samples, following FDA's Draft Guidance (May 2, 2011), AAMI TIR 12:2010, AAMI TIR 30:2011, and AAMI TIR79:2010. All study results satisfied specified acceptance criteria. Reprocessing Instructions (Manual) also validated for completeness, understandability, and executability by the user. |
  | EMC and Electrical Safety | Acceptable level confirmed by testing in accordance with IEC 60601-1-2; IEC 60601-1-4; IEC 60601-1-6; and IEC 60601-2-18 standards. |

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

The document relates to a traditional medical device (endoscope) and does not describe clinical studies with "test sets" in the context of evaluating an AI/ML algorithm's performance on a dataset of patient data. The "test results" refer to engineering and bench testing against recognized standards. Therefore, information about sample size for a test set and data provenance in the way it's requested for AI/ML is not applicable or provided.

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

Not applicable, as this is not an AI/ML device requiring expert-established ground truth from medical image interpretation for performance evaluation. The "ground truth" for this device would relate to engineering specifications and regulatory compliance.

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

Not applicable. Adjudication methods are typically employed in studies where human experts provide interpretations that need to be reconciled to establish a consensus ground truth, which is not the type of study described here.

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 such MRMC study was done or reported. This document is for an endoscope, not an AI-assisted diagnostic tool.

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

This is not an algorithm-only device. It is a physical medical instrument. Therefore, this question is not applicable.

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

The "ground truth" for this device is compliance with established engineering standards, safety regulations, and performance specifications for endoscopes (e.g., optical properties, mechanical integrity, electrical safety, biocompatibility, reprocessing effectiveness). This is verified through various physical and chemical tests, rather than clinical ground truth like pathology or expert consensus on medical images.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm in this submission.

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This instrument is intended to be used with a PENTAX Video Processor (including light source), documentation equipment, Monitor, Endotherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve.

The PENTAX Video Colonoscopes (EC Family), Model Numbers: EC-3890TLK, EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC-3890LZi, EC34-i10L, EC38i10L are used with a Video Processor. The EC-3890TLK is composed of the following main parts: an Insertion Portion, Control Body and PVE Connector. The Insertion Portion is inserted into the body cavity of patient. The Insertion includes the Distal End and Bending Section. The Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle are located on the Distal End of the Insertion Portion. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water, Suction Cylinder, Remote Button, Suction Selector Cylinder, and Instrument Channel Inlet. The AirMater Feeding Valve is attached to the Air/Water Cylinder, and the Suction Control Valve is attached to the Suction Cylinder. The Suction Channel Selector is attached to the Suction Selector Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The Bending Section is bent by the Angulation Control Knob to operate the endoscope anqulation. The Angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the AirMater Nozzle. When the hole at the top of Air/Water Feeding Valve is covered, the air is delivered. When the Air/Water Feeding Valve is pushed, the water is delivered. The Suction Control System is used to suction the fluid and air in body cavity from the Instrument Channel. When the Suction Control Valve is pushed, the fluid and air are suctioned. The EC-3890TLK has two channels; the primary channel and secondary one. Suction Channel Selector is used to switch between the primary and secondary channels as necessary. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The Water Jet System is used to stream forward the sterile water from Water Jet Nozzle. The Light Guide of the Distal End is used to illuminate the body cavity by light which is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug which is connected to the Light Source inside the Video Processor. The CCD built into the Distal End receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PENTAX Video Colonoscopes (EC Family):

This document describes the safety and performance testing for a traditional medical device (colonoscope), not an AI/ML-enabled device. Therefore, many of the requested fields pertinent to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, and standalone performance) are not applicable or explicitly mentioned in the provided text.

The acceptance criteria are primarily related to general safety and performance standards for endoscopes and medical electrical equipment.

Acceptance Criteria and Device Performance for PENTAX Video Colonoscopes (EC Family)

1. Table of Acceptance Criteria and Reported Device Performance

Regarding AI/ML-Specific Information:

The provided text details the submission for PENTAX Video Colonoscopes (EC Family), which are traditional endoscopy devices. The safety and performance data presented are for the physical device itself (electrical safety, biocompatibility, reprocessing, etc.) as per various international standards. There is no mention of artificial intelligence (AI) or machine learning (ML) within this document. Therefore, the following AI/ML-specific points cannot be addressed from the given text:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a physical device submission, not an AI/ML algorithm. Testing was on the physical device and its components.
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. Ground truth for AI/ML is usually related to disease presence/absence or other assessments by human experts. For this device, "ground truth" refers to compliance with engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as there is no AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, the "ground truth" or acceptance criteria are defined by recognized consensus standards (e.g., IEC, ISO, AAMI) regarding safety, performance, and functionality.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study for PENTAX Video Colonoscopes (EC Family):

The study was a comprehensive non-clinical design verification and validation testing program focused on ensuring the device meets established safety and performance standards for endoscopes. The testing confirmed:

• Design Compliance: Adherence to 21 CFR Part 820.30 (Design Control).
• Safety (Electrical & Mechanical): Compliance with IEC 60601 series for basic safety, essential performance, and specific requirements for endoscopic equipment (IEC 60601-1, IEC 60601-1-1, IEC 60601-2-18, IEC 60601-1-4).
• Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.
• Biocompatibility: Confirmation that materials are safe for patient contact, tested according to ISO 10993 series for cytotoxicity, sensitization, and intracutaneous reactivity.
• Reprocessing Validation: Validation of cleaning and high-level disinfection procedures through simulated use conditioned test samples, adhering to FDA draft guidance and AAMI TIR standards to ensure the device can be effectively reprocessed for reuse. User comprehensibility of reprocessing instructions was also validated.
• Usability: Compliance with IEC 60601-1-6 and IEC 62366.
• Software Life Cycle: Compliance with IEC 62304 (if applicable to the device's embedded software).
• Optical Characteristics: Compliance with ISO 8600 series for field of view, direction of view, and insertion portion dimensions.
• Quality Management and Risk Management: Compliance with ISO 13485 and ISO 14971.
• Labeling and Symbols: Compliance with relevant IEC and ISO standards for graphical symbols.

The "Master Device (EC-3890TLK)" was used for testing, and its results were stated to satisfy the acceptance criteria of all applicable standards, indicating the entire EC Family is substantially equivalent and safe/effective.

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The PENTAX EPK-i5010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation.

The PENTAX EPK-i5010 includes PENTAX i-Scan™ a digital, post-processing imaging enhancement technology. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan is compatible with PENTAX k-series and i-series gastrointestinal videoscopes and colonovideoscopes.

The PENTAX EPK-i5010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor is intended for endoscopic diagnostic, treatment and video observation. It is intended to process electrical signals from a video endoscope.

The PENTAX EPK-i5010 offers an optional digital, post-processing imaging enhancement technology called the PENTAX i-Scan™ modes 1, 2, and 3, which is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels. i-Scan 1 provides the user with a view that sharpens surface vessels and enhances surface texture of the mucosa. i-Scan 2 provides the user with increased visibility of blood vessels while also providing the same enhancements to the mucosa achieved in i-Scan 1. i-Scan 3 provides the user with increased visibility of blood vessels including dimly illuminated far-field regions while also providing the same enhancement to the mucosa achieved in i-Scan 1. The user can select either white light image or i-Scan modes by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a keyboard button. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.

The EPK-i5010 video processor incorporates the hardware of the EPK-i5020 video processor model (K 113873) and the PENTAX i-Scan™ technology.

The EPKi-5010 is compatible with PENTAX flexible and rigid k-Series and i-Series videoscopes. The subject premarket notification is specific for gastrointestinal videoscopes and colonovideoscopes.

The provided text describes the PENTAX EPK-i5010 Video Processor and its i-Scan™ technology, intended for endoscopic diagnosis, treatment, and video observation. However, it does not contain specific acceptance criteria for "device performance" in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) or a detailed study specifically designed to prove these criteria are met for the i-Scan technology itself.

Instead, the document focuses on:

• Substantial Equivalence: The primary aim of the 510(k) submission is to demonstrate that the PENTAX EPK-i5010 is substantially equivalent to legally marketed predicate devices, meaning it does not introduce new questions of safety or effectiveness.
• Safety: The clinical studies mentioned are primarily to establish the safety of the device, not its diagnostic performance against specific acceptance criteria for imaging enhancement.

Based on the provided text, here is an analysis of the requested information:

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

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 mentions 7 clinical studies for safety evaluation:

• Sample Size: A total of 975 patients.
• Data Provenance:
  • Germany (3 studies)
  • Japan (1 study)
  • Korea (3 studies)
• Retrospective/Prospective: Not specified, but "clinical studies" typically imply prospective data collection for safety and efficacy endpoints. However, without further details, it cannot be definitively determined from this summary.

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)

The document does not provide this information. The clinical studies mentioned were for safety, and there's no indication of a diagnostic performance evaluation with expert-established ground truth for the i-Scan technology.

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

The document does not provide this information as it does not detail a diagnostic performance study requiring ground truth 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

• MRMC Study: No, the document does not describe a MRMC comparative effectiveness study. The i-Scan technology is described as an "optional adjunct" and "not intended to replace histopathological sampling," implying it's a visual enhancement tool rather than a diagnostic AI that would be compared with human performance or AI assistance.
• Effect Size: Not applicable, as no MRMC study or quantitative diagnostic performance study is described.

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

No, the document does not describe a standalone performance study for the i-Scan algorithm. The i-Scan is an imaging enhancement technology integrated into a video processor, intended to be used by a clinician during endoscopy. It's not presented as a standalone diagnostic algorithm.

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

The document does not specify a type of ground truth because it does not detail a diagnostic performance study where ground truth would be needed for evaluating the i-Scan's diagnostic accuracy. The safety studies would primarily rely on adverse event reporting and clinical observation for safety endpoints.

8. The sample size for the training set

The document does not provide this information. As a post-processing imaging enhancement technology, the i-Scan likely uses algorithms that are developed and refined, but the document does not specify a "training set" in the context of machine learning model development or validation.

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

The document does not provide this information as it does not mention a training set or the establishment of ground truth for it.

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