Search Results

The EB-1970UK, Ultrasound Video Bronchoscope, 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 EB-1970UK, Ultrasound Video Bronchoscope, must be used with a Pentax Video Processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination and video signals. The ultrasound umbilical connector will be attached to the ultrasound scanner unit.

The control body includes controls for up/down anqulation, suction control, video processor remote control buttons, and ports for manual balloon insufflation/ evacuation and accessory inlet. A sterile, single use disposable latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. It is designed to be inflated with a specific volume of water during the procedure so that the effective transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer can take place.

The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple 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).

The provided text describes the PENTAX Ultrasound Video Bronchoscope EB-1970UK and its regulatory submission. However, it does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity with a test set, expert readers, or ground truth data.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized non-clinical standards.

Here's an analysis based on the information provided and what is missing:

Acceptance Criteria and Study Details

The document details the device's conformance to various non-clinical standards and protocols, which serve as the "acceptance criteria" for safety and fundamental performance. However, there is no mention of a clinical or performance study with a test set of data, human readers, or a specific ground truth for diagnostic accuracy metrics.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable for a clinical performance test. The testing focused on compliance with engineering, safety, and sterilization standards through in-house and external lab protocols. There isn't a defined "test set" of patient data in the context of diagnostic accuracy.

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

• Not applicable. No clinical performance study involving expert assessment of diagnostic accuracy is described.

4. Adjudication method for the test set:

• Not applicable. No clinical performance study involving expert adjudication is described.

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 device is an Ultrasound Video Bronchoscope, not an AI-powered diagnostic system. No MRMC study or AI assistance is mentioned.

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

• No. This device is an instrument used by a clinician, not a standalone algorithm.

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

• Not applicable. For the non-clinical tests conducted, the "ground truth" was typically defined by the specified requirements and methodologies of the referenced standards (e.g., specific chemical levels for biocompatibility, sterility for reprocessing, electrical thresholds for safety).

8. The sample size for the training set:

• Not applicable. No training set for a diagnostic algorithm is mentioned.

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

• Not applicable. No training set for a diagnostic algorithm is mentioned.

Summary of what the document does provide regarding acceptance criteria and performance:

The document primarily focuses on demonstrating that the PENTAX Ultrasound Video Bronchoscope EB-1970UK meets the acceptance criteria for safety and basic functional performance by complying with a comprehensive list of FDA-recognized consensus standards and in-house test protocols for:

• Electrical safety
• Electromagnetic compatibility
• Biocompatibility of materials
• Reprocessing and sterilization effectiveness
• Usability
• Software life cycle processes
• Risk management
• Quality management systems
• Specific optical and mechanical characteristics relevant to endoscopes.

The "study" in this context refers to the comprehensive series of non-clinical design verification and validation tests performed according to these standards, with the reported device performance being that "All the study results satisfy the acceptance criteria specified by the above applicable standards." The ultimate conclusion is that the device is "as safe and effective and substantially equivalent" to its predicate device based on these non-clinical evaluations.

Ask a specific question about this device

The PENTAX Video Bronchoscopes (EB Family) have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

The PENTAX Video Bronchoscopes (EB Family); Model Numbers: EB-1970TK, EB-1170K, EB-1570K, EB-1575K, EB-1970K, EB-1975K, EB-1990i are used with a Video Processor. The PENTAX Video Bronchoscopes (EB 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 Portion includes the Distal End and Bending Section. The Objective Lens, Light Guide, and Instrument Channel 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 lever, Suction Cylinder, Suction nipple, Remote Button, and Instrument Channel Inlet. The Suction Control Valve is attached to the Suction Cylinder. The Inlet Seal is attached to the Instrument Channel Inlet. The Bending Section is bent by the Angulation Control lever to operate the endoscope angulation. 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. Endotherapy Device such as Biopsy Forceps is inserted from the Instrument Channel Inlet into the body cavity through the instrument channel. The PVE Connector is connected to the Video Processor via an Electrical Contacts. The PVE Connector includes the Electrical Contacts and Light Guide Plug. The Light Guide Plug is connected to the Light Source inside the Video Processor. 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 quides the light Guide Plug which is connected to the Light Source. 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. The PENTAX Video Bronchoscopes are reusable semi-critical devices. Since they are packaged non-sterile, they must be high-level disinfected or sterilized BEFORE initial use. Prior to each subsequent procedure, they must be subjected to an appropriate cleaning and either high-level disinfection or sterilization processes.

The provided text is a 510(k) summary for PENTAX Video Bronchoscopes (EB Family). It describes the device, its intended use, and indicates that safety and performance data (non-clinical tests) have been conducted. However, it does not contain information about a clinical study involving AI or human readers, acceptance criteria related to such a study, or reported performance against clinical metrics.

Instead, the document focuses on compliance with established medical device standards and non-clinical testing.

Here's a breakdown of what can be extracted based on the request, and what cannot:

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

The document lists several international and industry standards that the device's test results satisfy. These standards serve as the "acceptance criteria" for various aspects of the device's non-clinical performance. The "reported device performance" is generally stated as meeting these criteria.

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

This information is not provided in the document. The document refers to "Design Verification and Validation testing" and "simulated use conditioned test samples" for reprocessing, but does not specify sample sizes or data provenance in the context of clinical or AI-based testing. This document describes non-clinical testing.

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)

This information is not provided in the document. No expert review for establishing ground truth is mentioned, as the studies are non-clinical and focus on adherence to standards.

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

This information is not provided in the document. No adjudication method is described, consistent with the non-clinical nature of the tests.

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

The document does not mention or describe any MRMC comparative effectiveness study, nor does it refer to AI or human reader assistance. The device in question is a video bronchoscope, not an AI-assisted diagnostic tool.

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

This information is not applicable as the document describes a physical medical device (video bronchoscope), not a standalone algorithm.

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

For the non-clinical tests described, the "ground truth" is typically defined by technical specifications, established performance criteria within the referenced standards, and objective measurements according to the test protocols. For example, for biocompatibility, the ground truth is the chemical and biological response observed in controlled in vitro and in vivo tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity). For reprocessing, the ground truth is the reduction of microbial load or absence of residue to predetermined levels.

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device, not an AI model that requires a training set.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The EC-3890LI, Video Colonoscope is intended to provide optical visualization (via a video monitor) of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes but is not restricted to the organs, tissues and subsystems: Large Bowel and Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

The EC-3890L, Video Colonoscope must be used with a Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body and umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices or other devices may be introduced. The Video Processor, EPK-I, contains a 300 watt short Arc Xenon lamp which provides white light is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collect image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

The provided text is a 510(k) summary for the PENTAX EC-3890LI, Video Colonoscope. It describes the device, its intended use, and comparison to predicate devices, but does not contain information about acceptance criteria or specific studies proving the device meets those criteria.

Generally, 510(k) submissions for devices like colonoscopes focus on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance testing and comparison of technical specifications, rather than clinical efficacy studies with predefined acceptance criteria in the way a pharmaceutical trial or a software AI device would.

Therefore, many of the requested details cannot be extracted from this document as they are not typically included in this type of submission for such a device.

Here's a breakdown of what can and cannot be answered from the provided text:

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

• Cannot be answered from the provided text. The document states: "The submission for substantial equivalence is not based on an assessment of clinical performance data." It mentions "system performance testing" was included in the submission, but does not detail the acceptance criteria or results of that testing.

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

• Cannot be answered from the provided text. Since clinical performance data was not the basis of the submission, there is no mention of a "test set" in this context.

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):

• Cannot be answered from the provided text. No such information is provided.

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

• Cannot be answered from the provided text. No such information is provided.

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:

• Cannot be answered from the provided text. This device is a video colonoscope, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant to this submission.

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

• Cannot be answered from the provided text. This device is a colonoscope, not an algorithm.

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

• Cannot be answered from the provided text. Ground truth is not a concept applied to this type of device where substantial equivalence is demonstrated through technical and functional comparisons.

8. The sample size for the training set:

• Cannot be answered from the provided text. This device is a colonoscope, not an AI model requiring a training set.

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

• Cannot be answered from the provided text. This device is a colonoscope, not an AI model, and therefore no ground truth for a training set is relevant.

Summary of what the document does provide regarding "studies":

The document states: "The submission for substantial equivalence included literature describing the system including; specifications, the identification of standard set components and optional accessories, tables to summarize the comparisons to the predicated device(s), and system performance testing. The submission for substantial equivalence is not based on an assessment of clinical performance data."

This indicates that the "study" for this device involved comparing its specifications and performance characteristics against a predicate device (EC-3800L, Video Colonoscope) and demonstrating that it is substantially equivalent, thereby not requiring new significant clinical studies. The "system performance testing" would likely refer to engineering and functional tests to ensure the device meets its design specifications (e.g., image quality, angulation range, water/air delivery, suction, channel patency, biocompatibility, electrical safety), but the specific acceptance criteria and results are not detailed in this summary.

Ask a specific question about this device

The ED-3490TK, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to the Biliary Tract via the Upper GI Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophogus, Stomach, Duodenum, Common Bile, Hepatic, and Cystic Ducts. This instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric populations.

The ED-3490TK, Video Duodenoscope, must be used with a Video Processor (software controlled device). The endoscope has a flexible insertion tube, a control body and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices or other devices may be introduced. The Video Processor, EPK-i, contains a 300 watt short Arc Xenon lamp which provides white light that is focused at the connected video endoscope lighteuide prone. The endoscope light carrying bundles present the light to the body cavity and the CCD collects image data. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

The provided text does not contain information about acceptance criteria and a study proving device performance for the PENTAX ED-3490TK, Video Duodenoscope.

The 510(k) summary explicitly states: "The substantial equivalence is not based on an assessment of clinical performance data." This indicates that no clinical study was conducted to demonstrate the device's performance against specific acceptance criteria. The submission for substantial equivalence relied on comparisons to a predicate device, specifications, and system performance testing (which typically refers to non-clinical tests like electrical safety, biocompatibility, and mechanical performance, not clinical outcome or diagnostic accuracy).

Therefore, I cannot provide the requested information.

Ask a specific question about this device

The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, 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.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy

The EG-3870UTK, Ultrasound Video Gastroscope, must be used with a Pentax Video processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. 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 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. The instrument is immersable (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope operator manual cleaning instructions).

The provided text is related to a 510(k) premarket notification for the "EG-3870UTK, Ultrasound Video Gastroscope." It describes the device, its intended use, and its comparison to predicate devices. However, the submission explicitly states that "The substantial equivalence is not based on an assessment of clinical performance data."

Therefore, the document does not contain information about:

• Acceptance criteria for device performance.
• Any study (clinical or otherwise) that proves the device meets acceptance criteria.

The core of this submission is a claim of substantial equivalence to existing legally marketed predicate devices, primarily based on design specifications, standard components, and a comparison table, rather than new performance data.

Consequently, none of the specific information requested in your prompt (such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance) is present in the provided text. The device's clearance is based on its similarity to previously cleared devices, implying that its performance is expected to be equivalent, but no new performance studies are detailed in this document.

Ask a specific question about this device

The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, 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.

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy

The EG-3670URK, Ultrasound Video Gastroscope, must be used with a Pentax Video processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water/ and suction. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, suction selection control, balloon insufflation/ evacuation, 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 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 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. The instrument is immersable (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope operator manual cleaning instructions).

The provided 510(k) summary for the PENTAX EG-3670URK Ultrasound Video Gastroscope does not contain information about acceptance criteria or a study that proves the device meets such criteria.

The submission explicitly states: "The submission for substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical drawings, material lists, labeling, standard components, optional accessories, and system performance testing (which likely refers to technical specifications rather than diagnostic performance in a clinical context) and acoustic power data.

No clinical study, performance metrics, or ground truth establishment is described in this 510(k) summary.

Ask a specific question about this device

The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to the organs, tissues, and subsystems: 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 EB-1970UK, Ultrasound Video Bronchoscope, must be used with a Pentax Video Processor (a software controlled device) and must be used with an Ultrasound Scanner (a software controlled device). The endoscope has a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, and suction. The ultrasound umbilical connector will be attached to the ultrasound scanner unit. The control body includes controls for up/ down angulation, suction control, video processor remote control buttons, and ports for manual balloon insufflation/ evacuation and accessory inlet. The endoscope contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect endoscopic image data, and a 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 focused at the endossope 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 immersable (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope operator manual cleaning instructions).

The provided document, K081518, is a 510(k) summary for the Pentax EB-1970UK Ultrasound Video Bronchoscope.

The document explicitly states: "The substantial equivalence is not based on an assessment of clinical performance data." This means that traditional acceptance criteria based on clinical outcomes or diagnostic accuracy thresholds are not applicable or provided in this submission. The device's clearance is based on its substantial equivalence to predicate devices through technical specifications and performance testing (likely bench testing, and electrical/mechanical safety) rather than clinical performance studies.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in terms of diagnostic accuracy or clinical effectiveness with human readers, cannot be fully provided from the given text.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria Type	Acceptance Criteria (Threshold)	Reported Device Performance
   Substantial Equivalence	To be substantially equivalent to predicate devices (Olympus BF type UC-160F, Pentax EB-1830T3, Hitachi EUB-5500) based on specifications and performance testing.	The FDA determined the device is substantially equivalent to legally marketed predicate devices.
   Functionality	Perform optical visualization, ultrasonic visualization, and therapeutic access to the pulmonary tract.	The device's description indicates it is designed for these functions. Specific performance metrics (e.g., image resolution, channel diameter) are summarized as being compared to predicates.
   Safety (Acoustic Output)	Not explicitly stated in the summary, but implicit for an ultrasound device.	A post-clearance special report for acoustic output measurements based on production line devices is required.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical performance test set data is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical performance test set data is provided.

4. Adjudication method for the test set: Not applicable. No clinical performance test set data is provided.

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. This document predates widespread AI in medical devices, and no clinical effectiveness study is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an instrument used by a human operator; it's not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The ground truth for proving substantial equivalence was likely based on the technical specifications and safety standards met by the predicate devices.

8. The sample size for the training set: Not applicable. This device is not an AI/machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. This device is not an AI/machine learning algorithm requiring a training set.

Conclusion from document:

The 510(k) clearance for the Pentax EB-1970UK Ultrasound Video Bronchoscope was based on its substantial equivalence to existing, legally marketed predicate devices (Olympus BF type UC-160F, Pentax EB-1830T3, and Hitachi EUB-5500). This determination was made primarily through a comparison of technical specifications and performance testing (likely bench testing, electrical, and mechanical safety, as is common for such devices) rather than clinical performance data or studies involving human readers or patient outcomes. The submission explicitly states: "The substantial equivalence is not based on an assessment of clinical performance data." A post-clearance requirement for acoustic output measurements on production units was noted, indicating ongoing safety monitoring for the ultrasound component.

Ask a specific question about this device

The EG-3670URK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems; Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

The EG-3670URK, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlled device) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Scanner Umbilical Connector. The PVE Connector connects to the Video Processor and has connections for illumination, video signals, air/water and suction. The Scanner Connector is connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon injection/ evacuation, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect image data, and a radial array ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy devices, may be introduced. The Video Processor contains a lamp that provides white light that is focused at the PVE Connector Lightguide Prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects 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 signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories as described in the Endoscope operator Manual cleaning instructions).

This is an interesting case where the provided document is a 510(k) summary for a medical device, but it explicitly states that the submission for substantial equivalence was not based on an assessment of clinical performance data. Instead, it relied on a comparison of specifications and standard components to predicate devices. Therefore, the device was cleared without a study demonstrating that it meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity.

As a result, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, because such a study was not performed or submitted for this particular 510(k) clearance.

Here's a breakdown of what can be extracted from the document in relation to your request, and why other parts cannot be answered:

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

• Cannot be provided. The 510(k) summary explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical, performance, data." Therefore, there are no reported device performance metrics against acceptance criteria related to clinical efficacy or diagnostic accuracy. The substantial equivalence was based on a comparison to predicate devices, implying that if the new device is sufficiently similar to an already cleared device, it is considered safe and effective for its intended use without new performance data.

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

• Cannot be provided. No test set data was used because no study assessing clinical or performance data was conducted for this 510(k) submission.

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)

• Cannot be provided. As no test set was used, no ground truth was established by experts for performance evaluation.

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

• Cannot be provided. No test set, no adjudication method.

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

• Cannot be provided. This device is an ultrasound video gastroscope, not an AI-powered diagnostic tool. No MRMC study or AI-related comparative effectiveness study was performed or is relevant to this traditional medical device clearance.

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

• Cannot be provided. Not applicable. This is a physical medical device (endoscope with ultrasound capability), not a standalone algorithm.

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

• Cannot be provided. No ground truth was established for performance evaluation.

8. The sample size for the training set

• Cannot be provided. No training set was used as no performance study was conducted.

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

• Cannot be provided. No training set, no ground truth establishment for it.

Summary of Device and 510(k) Clearance:

The EG-3670URK Ultrasound Video Gastroscope was cleared based on substantial equivalence to existing predicate devices (Pentax EG-3630UR Video Ultrasound Gastroscope and Hitachi EUB-5500 Ultrasound Diagnostic Scanner). The manufacturer provided specifications, standard components, and accessories, along with comparison tables to illustrate similarity to the predicates. This type of clearance, common for many medical devices, does not require new clinical performance data if the device is deemed sufficiently similar to a legally marketed predicate device.

The FDA's clearance letter (K061068) confirms this, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." The only specific post-clearance requirement mentioned is a "special report" containing acoustic output measurements based on production line devices, which relates to safety rather than clinical efficacy or diagnostic performance in a clinical study context.

Ask a specific question about this device