Search Results

The C2 CryoBalloon™ EndoGrip is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.

The C2 CryoBalloon™ EndoGrip is an accessory product that is used in conjunction with therapeutic endoscopes and therapeutic catheters (the C2 CryoBalloon™ Catheter of the C2 CryoBalloon™ Ablation System). The C2 CryoBalloon™ EndoGrip consists of a Clip Base, Rubber Grip, and Compression Spring. This is supplied non-sterile. The EndoGrip is used to anchor catheters in place relative to the scope. In a clinical application, once the endoscope is delivered into the gastric anatomy and positioned at its desired location the physician may insert the catheter through the endoscope. When the catheter is located properly in its axial position, the EndoGrip is positioned against the biopsy valve by depressing the clip mechanism and sitting the catheter on the rubber grips. The revised design allows for placing the EndoGrip after the CryoBalloon catheter is in place in the scope and for repositioning without having to completely withdraw and reinsert the catheter. The C2 CryoBalloon™ EndoGrip is designed for one-time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID) or a C2 Sidecar (FG -1011), which serves as an external channel for therapeutic devices when a therapeutic endoscope is unavailable for use.

The PENTAX Medical C2 CryoBalloon™ EndoGrip (K193036) is an accessory for endoscopic procedures. The information provided in the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than an AI/ML-driven study. Therefore, sections typically relevant to AI/ML device studies (such as MRMC studies, effect size of AI assistance, sample size for training sets, etc.) are not applicable here.

Here's a breakdown of the available information regarding acceptance criteria and performance testing:

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

• Withstands 10 endoscopic delivery cycles.
• Compatible with endoscopic devices.
• Resists dislodgement forces.
• Resists kinking. | All tests passed and met predetermined acceptance criteria. The device performs as intended in the specified use conditions and performs comparably to the legally marketed predicate device. |
  | Usability Testing | Validation of user needs. | All tests passed and met predetermined acceptance criteria. |

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

The document does not specify the exact sample size for the test set for dimensional verification, simulated use, and usability testing. It refers to these as "evaluations" and "testing" without providing numerical details for the quantity of devices or cycles tested.

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

This information is not provided. The performance testing appears to be primarily engineering and functional verification, rather than clinical efficacy studies requiring expert ground truth for interpretation of medical images or data.

4. Adjudication method for the test set

Not applicable. The described tests are functional and physical performance evaluations where outcomes are objective (e.g., successful attachment, resistance to dislodgement) rather than subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document describes performance testing for an endoscopic accessory, not an AI/ML-driven diagnostic or therapeutic device that would typically involve human-in-the-loop performance evaluation.

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

No, this is not applicable. The device is a physical accessory (EndoGrip), not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The type of ground truth used

The "ground truth" for the performance testing cited would be direct physical measurements and engineering specifications, or the successful completion of specified functional tasks. For example:

• Physical characteristic evaluations: Ground truth would be the design specifications and manufacturing tolerances.
• Simulated use, performance, and reliability testing: Ground truth would be the defined functional requirements (e.g., "device can be attached," "withstand 10 cycles," "resist dislodgement").
• Usability testing: Ground truth would be the user needs and successful completion of tasks by users.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML system 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 this device.

Ask a specific question about this device

The PENTAX Medical 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: Esophagus, Stomach, 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 PENTAX Medical ED-3490TK Video Duodenoscope is used with a PENTAX compatible Video Processor (software controlled device). The duodenoscope 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 devices contain light carrying bundles to illuminate the body cavity and a charge couple device (CCD) to collect image data. The instruments contain a working channel through which biopsy devices or other devices may be introduced.

This appears to be an FDA 510(k) clearance letter and summary for a medical device, specifically a duodenoscope. The core of this submission is not about an AI/ML-driven device's performance in terms of diagnostic accuracy or effect on human readers, but rather about an updated version of an existing device, primarily focusing on revisions to its reprocessing instructions for use (RIFU) based on human factors testing.

Therefore, many of the standard questions regarding AI/ML device performance (like MRMC studies, standalone algorithm performance, training set details, ground truth establishment for diagnostic tasks) are not applicable to this document. The "device performance" here refers to the device's physical and functional characteristics, and the "study" is a human factors study on the RIFU, not a clinical trial assessing medical outcomes or AI diagnostic accuracy.

Given the document provided, here's an attempt to address the relevant points and explain why others are not applicable:

Acceptance Criteria and Study for PENTAX Medical ED-3490TK Video Duodenoscope (K192280)

This 510(k) submission primarily focuses on improved "Reprocessing Instructions for Use (RIFU)" for the PENTAX Medical ED-3490TK Video Duodenoscope, not on the diagnostic/imaging performance of an AI/ML component. The "study" mentioned is a human factors study to ensure the RIFU are clear and lead to proper reprocessing, thereby enhancing safety and effectiveness in that aspect.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific submission, the "performance" is related to the usability and clarity of the Reprocessing Instructions for Use (RIFU), assessed through human factors testing.

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

The document states a "Human Factors study" was conducted to revise the RIFU.

• Sample Size: The specific sample size for the human factors test set is not provided in this 510(k) summary. Human factors studies typically involve a defined number of representative users.
• Data Provenance: The data provenance (e.g., country of origin, retrospective/prospective) is not specified in this summary. Human factors studies are inherently prospective, as they involve users interacting with the instructions and device in a controlled setting.

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

This question is not applicable in the traditional sense of diagnostic ground truth for an AI model.

The "ground truth" here would be the correct/intended reprocessing steps. The human factors study evaluates whether users can correctly follow those steps based on the RIFU. This involves observing user performance. The "experts" would be the designers of the RIFU and the human factors specialists who designed and analyzed the study, not annotators for image data. The document does not specify the number or qualifications of these internal experts.

4. Adjudication Method for the Test Set

This question is not applicable as there is no diagnostic "ground truth" being adjudicated between multiple human readers or an AI. The human factors study involved evaluating user performance based on whether they correctly followed the revised RIFU. The evaluation method would be specified in the human factors study protocol but is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size of AI vs. Without AI Assistance

Not applicable. This submission is for a physical medical device (duodenoscope) and revised instructions for its reprocessing, not for an Artificial Intelligence (AI) or Machine Learning (ML) driven diagnostic or assistive device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. See point 5. There is no standalone algorithm being evaluated.

7. The Type of Ground Truth Used

The "ground truth" in the context of this human factors study is the correct and complete set of reprocessing steps as defined by the manufacturer and relevant standards. The study sought to confirm that the revised RIFU enabled users to achieve this "ground truth" through their actions. It is not an expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" of data is used to train an algorithm. The "training" here refers to the user's ability to learn and follow the instructions, which is what the human factors study assesses.

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

Not applicable. See point 8.

Ask a specific question about this device

The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.

The subject and marketed predicate device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter of 3.7 mm and maximum length of 105 cm. The subject device is a cryosurgical system comprised of four components including a Catheter (sterile, single use), Controller (non-sterile, reusable), Foot Pedal (non-sterile, reusable), and Cartridge (non-sterile, single use).

The subject and marketed predicate device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by adjusting the endoscope and Catheter The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

The PENTAX Medical C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It doesn't present a specific table of quantitative acceptance criteria for clinical performance that would typically be found in a clinical trial report. Instead, the "acceptance criteria" are implied to be the successful completion of various design verification and validation tests, ensuring the device performs as intended and is as safe and effective as its predicate.

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

The document describes preclinical (bench) performance testing, not a clinical study with a "test set" of patients. Therefore, information regarding human sample size and data provenance (country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary. The testing performed was related to design verification and validation of the device's physical, reliability, and safety specifications.

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

Not applicable, as this document refers to preclinical engineering and safety testing, not a clinical study requiring expert ground truth for patient data.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through preclinical performance testing, not a comparative clinical trial with human readers.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):

This device is not an AI algorithm. It is a cryosurgical tool. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance discussed relates to the device's physical and functional operation.

7. Type of Ground Truth Used:

For the performance data discussed (sterilization, biocompatibility, EMC, electrical safety, and design verification/validation), the "ground truth" is established through:

• Standardized testing procedures: Adherence to recognized national and international standards (e.g., ISO 11135, ISO 10993-1, IEC 60601-1-2, ES60601-1).
• Engineering specifications and design requirements: The device's performance is measured against predefined engineering and design specifications.
• Comparison to the predicate device: The performance is also judged in the context of being similar to the legally marketed predicate device.

8. Sample Size for the Training Set:

Not applicable, as this is not an AI/machine learning device that requires a training set.

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

Not applicable, as this is not an AI/machine learning device.

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 Medical Video Colonoscope EC34-i10T Series is compatible with the PENTAX Medical EPK-i7010 Video Processor (K150618) and PENTAX Medical EPK-i5010 Video Processor (K143727). They scopes are composed of three main components: 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 Distal End also contains an Air/Water Nozzle and Water Jet Nozzle. The Bending Section of the Insertion Body is used to operate the endoscope angulation and is bent by the Angulation Control Knob on the Control Body. The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Button, and Instrument Channel Inlet. Endotherapy Device such as Biopsy Forceps may be 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 Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug that 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 is converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor. The EC34-i10T series includes three models: EC34-i10TF, and EC34-i10TF, and EC34-i10TM. These models are identical in all parameters and only differ in length of the insertion of the scopes.

The provided text describes a 510(k) premarket notification for a new medical device, the PENTAX Medical Video Colonoscope EC34-i10T Series. The document focuses on demonstrating that this new device is substantially equivalent to a previously cleared predicate device (PENTAX Medical EC34-i10L Video Colonoscope).

The nature of this submission (demonstrating substantial equivalence to a predicate device) means that the testing performed largely confirms that the new device maintains the safety and effectiveness characteristics of the predicate, despite minor dimensional and material changes. It does not involve a study to "prove the device meets the acceptance criteria" in the way one might for a novel diagnostic algorithm or a therapy with specific performance metrics against a defined standard. Instead, the acceptance criteria are largely met by demonstrating performance comparable to the predicate and compliance with relevant safety and reprocessing standards.

Therefore, the requested information, particularly regarding "device performance," "sample sizes," "ground truth," "experts," and "MRMC comparative effectiveness study," is not directly applicable in the context of this 510(k) submission, as it relates to a colonoscope, not an AI/ML-based diagnostic tool. The document primarily focuses on validation of reprocessing, biocompatibility, electrical safety, EMC, software, and optical/usability performance against established standards or the predicate device.

However, I can extract the relevant information that is present in the document related to acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Reprocessing Validation: The document states that "The following testing has been performed for the PENTAX Medical Video Colonoscope EC34-i10T Series." This implies specific units of the device were tested. Sample sizes are not explicitly provided (e.g., how many colonoscopes were subjected to cleaning or HLD efficacy testing), but it would typically involve a statistically relevant number of units as per reprocessing validation standards. Data provenance is not mentioned, but these types of studies are typically conducted by the manufacturer or accredited testing labs.
• Biocompatibility: Involves testing of patient-contacting materials. Sample sizes are not specified but would be dictated by ISO 10993-1.
• Electrical Safety and EMC: Involves testing of device units. Sample sizes are not specified but are typically one or a few units for compliance testing.
• Optical Testing: The document states "PENTAX Medical completed optical testing of the PENTAX Medical Video Colonoscope EC34-i10T compared to the predicate, PENTAX Medical Video Colonoscope EC34-i10L." This indicates at least one unit of each (subject and predicate) was used for comparison.
• Usability Testing: The document states "A comparison of the usability of the PENTAX Medical Video Colonoscope EC34-i10T to PENTAX Medical i10 and k10 series of scopes was conducted." Sample sizes for the tested scopes are not mentioned, nor are the number of users involved in the usability assessment.

All these studies appear to be prospective (conducted specifically for this submission) in nature, performed by the manufacturer or their designated testing facilities. No country of origin for the data is specified, but given the manufacturer's location (Montvale, New Jersey, USA) and the submission to the FDA, it's reasonable to infer a U.S. or international standard-compliant testing environment.

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

This is not applicable to this type of device and submission. Colonoscopes are physical instruments, and their performance is evaluated through engineering and biological testing, not by establishing "ground truth" through expert clinical interpretation in the context of a diagnostic AI.

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

This is not applicable as there is no "ground truth" adjudication process involving experts for a physical device like a colonoscope.

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:

This is not applicable. The device is a video colonoscope, not an AI-assisted diagnostic tool. No human reader studies with or without AI assistance were conducted or reported.

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

This is not applicable. The device is a video colonoscope, not an algorithm.

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

This is not applicable for the reasons outlined above. The "ground truth" for colonoscope performance is adherence to engineering specifications, safety standards, and functional equivalence to a predicate device, demonstrated through direct physical and electrical testing.

8. The sample size for the training set:

This is not applicable. This is a hardware device, not a machine learning algorithm requiring a training set. The device does utilize software, but it is explicitly stated that "The subject devices utilize the same software as the predicate device," implying the software was previously
validated and no new training was performed for this submission.

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

This is not applicable. See points 7 and 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 Medical Video Upper GI Scope EG34-i10 is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. The PENTAX Medical Video Upper GI Scope EG34-i10 is compatible with the PENTAX Medical EPK-i7010 Video Processor (K150618) and PENTAX Medical EPK-i5010 Video Processor (K143727).

The PENTAX Medical Video Upper GI Scope EG34-i10 is composed of three main components: an Insertion Portion, Control Body and PVE Connector. The Insertion is inserted into the body cavity of patient. The Insertion Portion includes the Distal End and Bending Section. The Distal End of the Insertion Portion includes the Objective Lens, Light Guide, Instrument Channel, Air/Water Nozzle, and Water Jet Nozzle.

The Air/Water Feeding System is used to deliver the air and water to the Objective Lens from the Air/Water Nozzle. The Air/Water Feeding Valve is attached to the Air/Water Cylinder. 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. A Water Jet System is used to stream forward the sterile water from the Water Jet Nozzle.

The Control Body is held by the user's hand. The Control Body includes the Angulation Control Knob, Angulation Lock Knob/Lever, Air/Water Cylinder, Suction Cylinder, Remote Control Button, and Instrument Channel Inlet. The Bending Section is bent by the Angulation Control Knob to operate the endoscope angulation Lock Knob/Lever is used to adjust the rotation torque of the Angulation Control Knob. The Remote Button is used to operate the function of video processor and external device from the control body, as necessary.

The Inlet Seal is attached to the Instrument Channel Inlet. Endotherapy Device such as Biopsy Forceps may be 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 Light Guide of the Distal End is used to illuminate the body cavity by light that is carried through the Light Carrying Bundle. The Light Carrying Bundle guides the light from Light Guide Plug that 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 is converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the Monitor.

The PENTAX Medical Video Upper Gl Scope EG34-i10 is a reusable semi-critical device. Since it is packaged non-sterile, it must be high-level disinfected or sterilized before initial use. Prior to each subsequent procedure, it must be subjected to an appropriate cleaning and either highlevel disinfection or sterilization processes.

This FDA 510(k) summary describes the PENTAX Medical Video Upper GI Scope EG34-i10, a reusable semi-critical device intended for endoscopy and endoscopic surgery within the upper digestive tract. The submission primarily focuses on demonstrating substantial equivalence to its predicate device, the PENTAX Video Upper GI Scopes EG29-i10 (K131902), by showing that minor differences in dimensional specifications and materials do not adversely impact safety or effectiveness.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria and reported device performance in the format usually seen for AI/software-based medical devices with specific performance metrics like sensitivity, specificity, or AUC. Instead, it details various engineering and performance tests conducted to establish substantial equivalence. The "acceptance criteria" are implied by the successful completion and "passing results" of these engineering tests, confirming that the device meets relevant standards and performs comparably to the predicate.

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

The document describes device performance testing and validation, not a study with a traditional "test set" of clinical data for a diagnostic algorithm. The tests conducted (reprocessing, biocompatibility, electrical safety, EMC, optical, usability) involve physical samples of the device and its components, or measurements under controlled lab conditions.

• Sample Size: Not specified in terms of number of devices or units used for each test, but it is implied that a sufficient number was tested to demonstrate compliance and comparability. These are engineering tests, not statistical clinical trials with patient populations.
• Data Provenance: The data comes from internal testing conducted by PENTAX Medical, as implied by the "PENTAX Medical completed optical testing" and "Testing revealed..." statements. These are laboratory-based, prospective engineering tests rather than retrospective or prospective clinical data.

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

Not applicable. This device is not an AI/ML algorithm requiring expert ground truth or adjudication for diagnostic performance. Its validation is based on engineering standards and comparisons to a physical predicate device.

4. Adjudication method for the test set

Not applicable. As this is not a study requiring expert clinical adjudication for diagnostic outcomes, no such method was employed.

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 device is an endoscope, a hardware instrument, not an AI-assisted diagnostic tool. No MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device does not involve a standalone algorithm for performance evaluation.

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

Not applicable in the context of clinical diagnostic ground truth. The "ground truth" for the engineering tests would be defined by the specifications, standards (e.g., IEC, ISO), and the performance characteristics of the predicate device. For example:

• For reprocessing: Standardized microbiological assays or chemical residue tests demonstrating inactivation/removal targets.
• For optical testing: Direct measurement of light properties and comparison to predicate's measured values, and adherence to photobiological safety standards.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/ML system.

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

Not applicable. This device does not involve a training set.

Ask a specific question about this device

The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the VIDEO NASO-PHARYNGO-LARYNGOSCOPE VNL9-CP and VIVIDEO VIDEO PROCESSOR CP-1000. It is intended to be used with a medical video monitor for endoscopic examination between the upper respiratory tracts of the nasal passage and the vocal cords. This PENTAX Medical VIVIDEO ENT Videoscope Solution must only be used in a clinical or ambulatory medical environment.

The PENTAX Medical VIVIDEO ENT Videoscope Solution includes the video processor CP-1000 and the video nasopharyngo-laryngoscope VNL9-CP. The naso-pharyngoscope consists of a handheld device with a flexible thin insertion tube. The illuminating LED is integrated in the handle while light is transmitted to the distal end through a bundle of fiber optic cables within the insertion tube. A CMOS video sensor is located at the bendable distal tip. The video signal of the sensor is transferred to the CP-1000 Video Processor for video image together with other information on an attached monitor and for recording video sequences or still images to a USB storage device.

The provided text describes the PENTAX Medical VIVIDEO ENT Videoscope Solution and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria for device performance, nor does it detail a study proving the device meets specific performance criteria related to diagnostic accuracy or clinical outcomes.

The "Acceptance Criteria and Reported Device Performance" section below can only detail the general categories of testing performed, as specific performance metrics and their corresponding acceptance thresholds are not explicitly stated in the document.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of clinical diagnostic performance or image data. The testing described (optical, reprocessing, biocompatibility, software, EMC/ES) primarily relates to engineering and safety performance, not clinical diagnostic accuracy. Therefore, information on sample size and data provenance for a clinical test set is not provided.

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

This information is not provided as there is no mention of a clinical test set or ground truth established by experts for diagnostic performance.

4. Adjudication method for the test set

This information is not provided as there is no mention of a clinical test set or adjudication process.

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

This information is not provided. The device is an ENT Videoscope Solution, an imaging device, and the submission focuses on its equivalence to a predicate imaging device. There is no mention of AI features or a comparative effectiveness study involving human readers with or without AI assistance.

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

This information is not provided. The device is described as an imaging tool for endoscopic examination; there is no indication of it being an AI algorithm that performs standalone diagnoses.

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

This information is not provided, as there is no mention of a clinical ground truth for diagnostic performance. The ground truth for the performance tests (e.g., optical properties, reprocessing effectiveness) would be established by the respective testing standards and methodologies.

8. The sample size for the training set

This information is not provided, as there is no mention of an AI component or a training set for an algorithm.

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

This information is not provided, as there is no mention of a training set.

Ask a specific question about this device

1. PENTAX Medical VIDEO PROCESSOR EPK-3000

The PENTAX Medical VIDEO PROCESSOR EPK-3000 is intended to be used with the PENTAX VNL8-J10, VNL11-J10, and VNL15-J10 endoscopes, light sources (including strobe), video monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation.

The PENTAX Medical VIDEO PROCESSOR EPK-3000 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.

2. PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series

The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL8-J10, VNL11-J10, and VNL15-J10) are intended to be used with a PENTAX EPK-3000 Video Processor (including Light source), documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and, for VNL15-J10 only, therapeutic access to, nasal, pharyngeal and the upper airway anatomy.

PENTAX Medical EPK-3000 Video Imaging System is used for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation.

The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the buttons on the system's control panel. The light from a xenon lamp at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor.

The primary components of the system include the following:

• PENTAX Medical Video Processor EPK-3000
• PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL-J10 Series)

The PENTAX Medical EPK-3000 Video Imaging System is provided with the following accessories:

• . Keyboard - input device for the video processor.
• Foot Switch - used to remotely control processor functions.
• White Balance Adjuster - used as the object of white balance feature.
• Condenser Earth Cable - used to reduce high-frequency noise generated during high-frequency electro cautery device use with Pentax endoscopes.
• . Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During the reprocessing, it seals the instrument Channel Inlet in order to full the chemical solution inside the channel.
• . Bite Block - prevents patients from biting the endoscope insertion tube during an endoscopic examination.
• Suction Control Valve - intended to control suction.

Additional accessories for reprocessing are provided with the device. These include Cleaning Adapter, Soaking Cap, Ventilation Cap, Cleaning Brush Kits, Endoscope Cleaning Brush Kits, and replacement O- Rings.

The PENTAX Medical Video Processor EPK-3000 is intended to be used with the PENTAX compatible endoscopes, light sources (including strobe), vide monitors and other ancillary equipment for ENT endoscopic observation and nasopharyngo-laryngoscopic (ENT) diagnosis, treatment, and video observation.

PENTAX Medical Video Processor EPK-3000 functions with the PENTAX i-Scan technology, a digital filter-based image enhancement technique with three modes, i-Scan 1, 2, and 3. PENTAX i-Scan™ is intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels.

White light is captured from a 150-Watt xenon lamp housed in the EPK-3000 Video Processor. All visualization is done with the white light mode first. White light illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician. The modification of the combination of red, green, blue (RGB) components for each pixel occurs when the i-Scan function is turned on in the EPK-3000 Video Processor. The resulting i- Scan image is then displayed on the observation monitor.

The PENTAX Medical Video Processor EPK-3000 is compatible with PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series. The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series are intended to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy. Three scopes are included in the VNL-J10 Series of scopes that is the subject of this submission: VNL8-J10, VNL11-J10, and VNL15-J10.

The VNL-J10 Series endoscopes are inserted transorally or transnasally to visualize subjects under illumination transmitted from a video processor with a solid-state image sensor located at the distal end of the endoscope, and provide images of the target anatomy on the video monitor. The endoscopes are flexible which allows the insertion portion to shape according to the body cavity. They are also composed of an Insertion Portion, Control Body, PVE Connector, and Light Guide Plug.

The VNL15-J10 can be used with endoscopic devices, each of which is introduced from the instrument channel inlet of the control body. Additionally, suctioning from the instrument channel at the distal end of the endoscope by pressing the suction control valve is available with this model. The VNL8-110 and the VNL11-J10 do not have an instrument channel.

The provided text describes the PENTAX Medical EPK-3000 Video Imaging System, a medical device for ENT endoscopic observation. The document is a 510(k) summary, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness on its own. Therefore, much of the information requested, particularly regarding acceptance criteria and detailed study results that prove the device meets specific performance criteria for new features, is not explicitly present in the provided text in the way one might expect for a de novo submission.

However, I can extract information related to the device's technical specifications and the comparison with a predicate device, which forms the basis for its clearance. The "acceptance criteria" here are largely implied by the successful comparison to the predicate device and compliance with various recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary focused on substantial equivalence to a predicate device (PENTAX Medical ENT Video Imaging System (K162151)), the "acceptance criteria" are implicitly met by demonstrating that the new device is either identical or equivalent in performance to the predicate and complies with relevant standards. Specific quantitative acceptance criteria for novel image enhancement features like i-Scan are not detailed with numerical thresholds but are instead assessed against the predicate's overall visualization capabilities.

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

• Test Set Sample Size: Not explicitly stated. The text mentions "A library of images was captured" for the clinical usability test and "side-by-side bench and clinical usability tests." The number of images or cases in the "library" is not quantified.
• Data Provenance: The clinical usability study was performed by PENTAX Medical, implying the data was generated specifically for this submission. The country of origin is not specified, but the submission is to the U.S. FDA by PENTAX of America, Inc. It was a "non-significant risk clinical study with IRB approval," which indicates it was a prospective study.

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

• Number of Experts: Not explicitly stated, but referred to as "experienced ENT physicians."
• Qualifications of Experts: "Experienced ENT physicians." Specific details like years of experience or board certification are not provided in this summary.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not specified. The text merely states that "These images were evaluated by experienced ENT physicians." It doesn't describe how consensus or a definitive ground truth was reached from multiple readers' evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• MRMC Comparative Effectiveness Study: A clinical usability test was performed which compares the subject device's performance to a predicate device, and physicians evaluated images from both. This technically involves multiple readers (experienced ENT physicians) evaluating multiple cases (images from the subject and predicate devices). However, it's not described as a formal "MRMC comparative effectiveness study" in the sense of a rigorous statistical design to quantify human reader improvement with AI vs. without AI assistance.
• Effect Size: No specific effect size is reported for how much human readers improve with AI (i-Scan) vs. without AI assistance (white light). The study concluded that the subject device's ability to visualize vascular structure and/or mucosal surface (both with white light and i-Scan) was equivalent to the predicate device. The i-Scan feature itself is positioned as an "optional adjunct" for enhanced viewing, not as a tool to improve human diagnosis over white light in quantified terms within this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• The i-Scan technology is a "digital, post-processing imaging enhancement technology." While it operates as an algorithm, its performance is described in the context of human evaluation of the resulting images ("i-Scan is intended to give the user an enhanced view..."). The clinical usability study involved human readers evaluating the images enhanced by i-Scan, demonstrating its utility as an adjunct. There is no mention of a standalone diagnostic accuracy study of the i-Scan algorithm without a human reader interpreting the enhanced image against a diagnostic ground truth.

7. The Type of Ground Truth Used:

• For the clinical usability test, there isn't an explicit "ground truth" (e.g., pathology report) against which the device's diagnostic accuracy is measured. Instead, the "ground truth" for the comparison was the expert evaluation/consensus of "experienced ENT physicians" who assessed the ability to visualize vascular structure and/or mucosal surface in images from both the subject and predicate devices. The study aimed to show equivalence in visualization capabilities, not diagnostic accuracy against a definitive disease state.

8. The Sample Size for the Training Set:

• Training Set Sample Size: The document does not mention a training set for the i-Scan algorithm or any other machine learning component in the traditional sense, as it focuses on demonstrating substantial equivalence of a video imaging system. The i-Scan is described as a "digital filter-based image enhancement technique," implying it might use pre-defined filters and algorithms rather than requiring ongoing machine learning with a specific training set.

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

• As no training set is mentioned for an AI/ML algorithm requiring ground truth, this information is not applicable and therefore not provided in the document.

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: Esophagus, 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 PENTAX compatible 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 lightcarrying bundles to illuminate the body cavity and a charge couple device (CCD) to collectimage data. The instrumentcontains a working channel through which biopsy devices or other devices may be introduced. The Video Processor contains a 300 watt short Arc Xenon lamp which provides white light that is focused at the connected video endoscope 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.

This document is a 510(k) premarket notification for the PENTAX Medical ED-3490TK, Video Duodenoscope. The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI or diagnostic performance claim.

Therefore, many of the requested sections regarding AI/algorithm performance studies, such as specific acceptance criteria for diagnostic metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this submission. This is a medical device clearance for an endoscope, not an AI-powered diagnostic tool.

The document highlights changes to the device (distal end design, reprocessing procedures) and discusses non-clinical tests conducted to support safety and effectiveness.

Here's a breakdown based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for an AI-driven diagnostic device. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and showing that design changes do not raise new questions of safety or effectiveness.
• Reported Device Performance:
  • Safety and Performance Data (Non-clinical tests): "PENTAX Medical has conducted performance testing and design analysis to demonstrate the safety and effectiveness of the elevator wire channel seal, as well as the distal end cap seal strength and integrity."
  • Biocompatibility: "Biocompatibility of the ED-3490TK was evaluated in accordance with ISO 10993-1."
  • Software: "Software changes were made to enhance functionality and do not raise new or different questions of safety and effectiveness. Changes were validated in accordance with FDA's 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'."
  • Reprocessing Validation: "Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'. The following Technical Information Reports (TIRs) were referenced: AAMI TIR 12:2010, AAMI TIR30:2011."
  • EMC and Electrical Safety: "No changes have been made to the EMC or electrical safety as compared to prior submission (K092710)."

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

• Not applicable for diagnostic performance. The document mentions "performance testing and design analysis" for mechanical and reprocessing aspects, but does not specify sample sizes in the context of a "test set" for a diagnostic algorithm because one is not being evaluated.
• The studies conducted are internal engineering and validation tests, not clinical studies with patient data for diagnostic evaluation.

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

• Not applicable. This information is relevant for AI/diagnostic performance studies where ground truth is established by medical experts for image interpretation. This document pertains to an endoscope's mechanical and sterilization properties.

4. Adjudication Method for the Test Set:

• Not applicable. This applies to clinical diagnostic studies, not device engineering or reprocessing validation.

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, an MRMC study was NOT done. This device is an endoscope, not an AI-assisted diagnostic tool.

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

• No, a standalone algorithm performance study was NOT done. This device is an endoscope, not an AI algorithm.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" would be established through engineering specifications, direct measurements, and established industry standards (e.g., ISO 10993-1 for biocompatibility, AAMI TIRs for reprocessing). It's not clinical "ground truth" like pathology or outcomes data.

8. The Sample Size for the Training Set:

• Not applicable. There is no AI algorithm being trained for this device notification.

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

• Not applicable. There is no AI algorithm being trained for this device notification.

In summary, this 510(k) submission for the PENTAX Medical ED-3490TK Video Duodenoscope focuses on non-clinical testing (biocompatibility, reprocessing, mechanical integrity, software validation for functionality, EMC/electrical safety) to demonstrate substantial equivalence to a predicate device. It does not involve AI or diagnostic performance studies, and therefore, most of the requested fields regarding acceptance criteria and studies for AI performance are not relevant to this document.

Ask a specific question about this device

The PENTAX Duodenoscope ED34-i10T is intended to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. These instruments are introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

The ED34-i10T, Video Duodenoscope is used with a compatible Video Processor. The ED34-i10T 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, cannula/forceps elevator, and air/water 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, cannula/forceps elevator control lever, air/water cylinder, suction cylinder, remote button, 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 connected to the video processor via 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 cannula/forceps elevator mechanism is used to control for position of cannula which is inserted through the Instrument Channel. The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator. 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 detachable and disposable distal cap of ED34-i10T is intended for single use, and is processed with steam sterilization prior to use. It is discarded after use. Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel. 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 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 body cavity is displayed on the monitor.

This document is a 510(k) summary for the PENTAX Medical ED34-i10T Video Duodenoscope, which is a medical device and not an AI or software-only product. Therefore, much of the requested information regarding AI-specific criteria (like training set size, ground truth for training data, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.

However, I can extract and describe the acceptance criteria and performance data provided for the device as a whole.

1. Table of Acceptance Criteria and Reported Device Performance

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 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