Search Results

Type

Panel

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

Reference & Predicate Devices

K201098,K143153,K230332

Intended Use

The aScope™ Duodeno 2 is designed to be used with the aBox™2, endoscopic accessories (e.g., biopsy forceps) and other ancillary equipment (e.g., medical grade video monitor) for endoscopic surgery within the duodenum.

The aBox ™2 is intended to display live imaging data from compatible Ambu visualization devices.

Device Description

The Ambu® aScope™ Duodeno 2 Endoscopy System is a combination of the duodenoscope, Ambu® aScope™ Duodeno 2 and the compatible displaying unit, Ambu® aBox™ 2.

The Ambu® aScope™ Duodeno 2, is a sterile and single-use medical device for endoscopic surgery within the duodenum.

The Ambu® aScope™ Duodeno 2 is a flexible endoscope) with side viewing optics, deflectable tip and an elevator to control the position of inserted accessories. The angulation of the endoscope tip is wheels, whereby the angulation can be locked via levers. The elevator (Albarran lever) is also controlled via a lever. Insufflation, suction and rinsing functions are activated via user controls. The product contains remote switches / programmable buttons of the connected Displaying Unit (Ambu® aBox™ 2). The Ambu® aScope™ Duodeno 2 must be connected to the Ambu® aBox™ 2 to be able to work.

The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8" LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.

The Ambu® aBox™ 2 has the following physical and performance characteristics:

· Can process and display live imaging data from Ambu® aScope™ Duodeno 2 to a monitor
· Can record, store and transport image data from Ambu® aScope™ Duodeno 2
Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

AI/ML Overview

The provided text describes the regulatory clearance of a medical device (Ambu® aScope™ Duodeno 2 and Ambu® aBox™ 2), but it does not contain information about an AI-powered device or a study validating its performance against specific acceptance criteria for AI.

Therefore, I cannot extract the detailed information requested in your prompt (acceptance criteria table, sample size for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, etc.) because these elements are not present in the provided FDA 510(k) summary for the Ambu® aScope™ Duodeno 2 Endoscopy System.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing (e.g., geometrical characteristics, functional performance, optical performance, biocompatibility, electrical safety), not on the performance of a software algorithm against a specific clinical task with AI-defined acceptance criteria.

The information regarding acceptance criteria and performance in the document is general, stating: "In all instances, the Ambu® aScope™ Duodeno 2 Endoscopy System performed as expected and met the set test specifications." It lists types of tests performed (e.g., optical performance, image quality, electrical safety) but does not provide quantitative acceptance criteria or detailed study results for each.

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K Number

K220587

Device Name

Manufacturer

Olympus Medical Systems Corp.

Date Cleared

2022-05-11

(71 days)

Product Code

FDT,NWB

Regulation Number

Type

Panel

PENTAX Medical Video Duedenoscope ED34-i10T2

Reference & Predicate Devices

K112680,K193182,K202661

Intended Use

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTberapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Device Description

The EVIS EXERA III DUODENOSCOPE TJF-Q190V has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. The TJF-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)."

The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (CCD) chip which delivers images.

The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal.

There is an instrument channel located inside of the flexible insertion section. EndoTherapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion to elevate EndoTherapy accessories for endoscopic treatment.

A sterile, single-use Distal Cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182 and K202661.

AI/ML Overview

This document K220587 is a 510(k) Premarket Notification from Olympus Medical Systems Corp. regarding the EVIS EXERA III Duodenovideoscope Olympus TJF-Q190V.

Based on the provided document, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of device performance metrics often associated with AI/ML devices (e.g., sensitivity, specificity, AUC). This document primarily addresses the substantial equivalence of device modifications to an existing predicate device, focusing on bench testing, sterilization, biocompatibility, and human factors.

The document explicitly states: "No clinical data were collected."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it does not exist within this document for this specific device clearance.

Here's a breakdown of why each requested point cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: Not available. The document discusses "performance testing bench," "sterilization validation," "shelf-life testing," "biocompatibility evaluation," and "human factors evaluation" as verification activities, but it does not specify quantitative acceptance criteria or reported performance metrics (like sensitivity, specificity, etc.) for the duodenoscope's diagnostic or therapeutic function.
Sample sizes used for the test set and the data provenance: Not applicable in the context of a clinical performance study. The tests mentioned are engineering and safety validations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with "ground truth" (e.g., disease presence) was performed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 pertains to a medical imaging device (endoscope), not an AI/ML-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study was performed.
The sample size for the training set: Not applicable, as no AI/ML component is discussed.
How the ground truth for the training set was established: Not applicable.

Summary from the document:

The 510(k) submission for the Olympus TJF-Q190V Duodenovideoscope focuses on design modifications to a sterile, single-use Distal Cover (MAJ-2315) used with the duodenoscope and labeling updates. The core duodenoscope device itself (TJF-Q190V) and the distal cover were previously cleared under K193182 and K202661. This submission aims to demonstrate that these specific modifications do not adversely affect device performance and that the device remains substantially equivalent to its predicate.

The non-clinical performance data summarized includes:

Performance Testing Bench
Sterilization Validation and Shelf-Life Testing
Biocompatibility Evaluation
Human Factors Evaluation

The conclusion is that the modified Distal Cover MAJ-2315 raises no new issues of safety and effectiveness and the device is substantially equivalent to the predicate device.

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K Number

K210710

Device Name

Manufacturer

PENTAX of America, Inc.

Date Cleared

2021-04-09

(30 days)

Product Code

FDT

Regulation Number

Type

Special

Panel

Pentax Medical Video Duodenoscope ED32-i10

Reference & Predicate Devices

K192245

Intended Use

The PENTAX Medical Video Duodenoscope ED34-110T2 is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Billary 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.

This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

Device Description

The PENTAX Medical Video Duodenoscope ED34-i10T2 is intended to be used with a PENTAX Video Processor, documentation equipment, video monitor, endoscopic device ancillary equipment for optical visualization (via a video monitor) of, and/or 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.

The ED34-i10T2 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 portion includes the distal end and bending section. The objective lens, light guide, instrument channel, elevator link, 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 connector is connected to the video processor via electrical contacts.

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 cannula/forceps elevator mechanism is used to control the position of the cannula which is inserted through the Instrument Channel.

The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator of the Distal End Cap with Elevator (OE-A63). 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 functions of the video processor and any external device from the control body, as necessary.

The single use, Distal End Cap with elevator (OE-A63) is provided as a sterile product. OE-A63 is attached to the elevator link of the distal end of ED34-i10T2. 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 image inside the body cavity is displayed on the monitor.

The PENTAX Medical Video Processors EPK-i5010 and EPK-i7010 are compatible with PENTAX Medical Video Duodenoscope ED34-i10T2.

The primary components of the system include the following:

The PENTAX Medical ED34-i10T2 Video Imaging System is provided with the following accessories:

Keyboard input device for the video processor.
White Balance Adjuster – controls the 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 reprocessing, it seals the instrument Channel Inlet in order to fill 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.
Air/Water Valve - intended to control air and waterfeeding.
Distal End Cap with Elevator intended to guide the endoscopicdevice.

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

AI/ML Overview

The provided FDA 510(k) summary for the PENTAX Medical Video Duodenoscope ED34-i10T2 does not include information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The submission is a Special 510(k), which typically addresses minor modifications to an already cleared device. In this specific case, the primary purpose of the submission is to obtain clearance for "updated instructions that enhance awareness of Distal End Cap attachment process" and a minor software change due to component obsolescence.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement for clinical performance evaluation are not present in this document, as they would have been assessed during the original clearance of the predicate device (K192245).

Here's a breakdown of what can be extracted from the document regarding "performance data," which in this context refers to engineering and software validation rather than clinical efficacy:

Acceptance Criteria and Study for PENTAX Medical Video Duodenoscope ED34-i10T2 (Special 510(k) Submission K210710)

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) for minor changes (updated instructions and software component change), the "acceptance criteria" and "reported device performance" referenced relate to software and cybersecurity testing, rather than clinical performance metrics like sensitivity, specificity, or reader agreement. The document explicitly states: "Functions realized by these two software are identical, and the difference of the software versions does not affect safety or effectiveness for the device, or any hardware performance such as CPU processing speed."

Acceptance Criteria Category	Specific Criteria (Implicit for Special 510(k))	Reported Device Performance (Summary)
Software Functional Equivalence	Software update does not alter device functions.	Functions of two software versions are identical.
Software Safety & Effectiveness	Software update does not affect device safety or effectiveness.	No effect on safety or effectiveness.
Software Hardware Performance	Software update does not affect hardware performance.	No effect on hardware performance (e.g., CPU processing speed).
Software Verification & Validation	Compliance with relevant standards and guidances.	Conducted according to IEC 62304: 2006 + A1: 2015.
Cybersecurity Assessments	Compliance with relevant FDA cybersecruity guidances.	Conducted according to FDA guidances for cybersecurity management.

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

Test set for software changes: Not explicitly stated as a number of cases or patients. The "test set" would refer to the software verification and validation protocols and test cases derived from software requirements. These are internal engineering tests, not a clinical study.
Data provenance: Not applicable in the context of clinical study data for this submission. The software changes are internal to the device and its manufacturing process.

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

Not applicable as this is a software/engineering verification and validation, not a clinical study requiring expert diagnosis for ground truth. Software testing typically involves software engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not applicable for this type of software verification and validation described.

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

No, a MRMC comparative effectiveness study was not done as part of this Special 510(k) submission. This type of study would evaluate human reader performance with and without AI assistance, which is not relevant to the minor software and instruction changes addressed here.

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

No, a standalone performance study in the context of clinical diagnostic accuracy or image analysis was not done for this submission. The "algorithm" here refers to the device's operational software, not an AI for interpretation. Software verification and validation address the algorithm's functional correctness.

7. The Type of Ground Truth Used

For the software verification and validation mentioned, the "ground truth" would be the expected behavior or specified requirements of the software and hardware, as defined by engineering specifications and design documents. It is not clinical ground truth (e.g., pathology, expert consensus).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a machine learning algorithm that requires a "training set" in the typical sense for clinical applications. The software changes are due to component obsolescence, not model retraining.

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

Not applicable, as there is no "training set" for a clinical algorithm in this submission.

Summary of the K210710 Submission:

This 510(k) is a Special 510(k) for the PENTAX Medical Video Duodenoscope ED34-i10T2. It concerns two minor modifications:

Updated Instructions: Enhancing awareness of the Distal End Cap attachment process.
Minor Software Change: Due to obsolescence of electronic components. The submission asserts that the new software versions are functionally identical to the previous one and do not affect the device's safety, effectiveness, or hardware performance.

The "performance data" provided relates specifically to the software and cybersecurity aspects of these minor changes. The submission confirms that software verification and validation, including cybersecurity assessments, were conducted according to relevant standards (IEC 62304) and FDA guidances. The conclusion is that the updated device remains substantially equivalent to its predicate.

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K Number

K202365

Device Name

Manufacturer

Pentax of America, Inc.

Date Cleared

2021-04-01

(225 days)

Product Code

FDT

Regulation Number

Type

Panel

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

Reference & Predicate Devices

N/A

Intended Use

The PENTAX Medical Video Duodenoscope ED32-i10 is intended to be used with endoscopic devices and other ancillary equipment 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.

This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

Device Description

The PENTAX Medical Video Duodenoscope ED32-i10 is intended to be used with a PENTAX Video Processor, documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and/or 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.

The PENTAX Medical Video Duodenoscope ED32-i10 has a smaller insertion portion width (32 French size) compared to the predicate device, ED34-i10T2, (34 French size) and is expected to provide better access to patients for whom that the ED34-i10T2 may have had difficulties accessing, for example in patients with narrowed lumens and in pediatric patients.

The ED32-i10 is composed of the following main parts: 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 objective lens, light guide, instrument channel, elevator link, 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 connector is 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 the position of the cannula which is inserted through the Instrument Channel.

The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator of the Distal End Cap with Elevator (OE-A65). 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 functions of the video processor and any external device from the control body, as necessary.

The single use, Distal End Cap with elevator (OE-A65) is provided as a sterile product. OE-A65 is attached to the elevator link of the distal end of ED32-i10. 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 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.

The PENTAX Medical Video Processors EPK-i5010 and EPK-i7010 are compatible with PENTAX Medical Video Duodenoscope ED32-i10.

The PENTAX Medical ED32-i10 Video Imaging System is provided with the following accessories:

Inlet Seal - prevents suctioned fluid from coming out of the instrument Channel Inlet during the use of suction function. During reprocessing, it seals the instrument Channel Inlet in order to fill 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.
Air/Water Valve - intended to control air and water feeding.
Distal End Cap with Elevator - intended to guide the endoscopic device.

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PENTAX Medical Video Duodenoscope ED32-i10, asserting its substantial equivalence to a predicate device, the PENTAX Medical Video Duodenoscope ED34-i10T2 (K192245). This is a medical device clearance, not an AI/ML device, so many of the requested sections related to AI/ML studies are not applicable.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a single table directly comparing acceptance criteria with reported performance in a quantitative manner for most tests. Instead, it states that "All acceptance criteria were satisfied" for most tests.

Test Category	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Reprocessing Validation	Effectiveness of reprocessing procedures for cleaning, high-level disinfection, and rinsing in accordance with FDA's 2015 Reprocessing Guidance. Acceptance criteria established per AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency.	Validation studies confirmed the effectiveness of reprocessing procedures at the distal end, instrument/suction channel, and air/water channel. "All acceptance criteria were satisfied."
Sterilization & Shelf Life	For Distal End Cap with Elevator (OE-A65): Sterilization using electron beam and a shelf-life of 2 years after sterilization.	The Distal End Cap with Elevator (OE-A65) is provided as a single-use, sterile product. Electron beam sterilization was conducted and a shelf-life of 2 years after sterilization was verified. (The main device is not sterile, so shelf-life is not applicable for it).
O-ring Sealing Performance	Same dimensions and sealing performance as the predicate device's O-ring.	The O-ring on the elevator link has "the same dimensions and sealing performance as the predicate device."
Software	Equivalent to predicate device software.	The subject device "utilizes the same software as the predicate device."
EMC and Electrical Safety	Acceptable levels per IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; and IEC 60601-2-18:2009.	Conformed to the specified standards.
System Performance	Equivalence to the predicate device. A service life of six years.	Demonstrated equivalence to the predicate device. Test results also demonstrated "six years of the service life for the ED32i10."
Optical Performance	Equivalence in optical characteristics (signal to noise, color, limiting spatial resolution (LSR), modulation transfer function (MTF), distortion, image intensity uniformity (IIU), and photobiological safety) to the predicate device when used with EPK-i7010 and EPK-i5010 Video Processors.	"All results show that the optical characteristics of the subject device is equivalent to those of the predicate device."
Distal End Cap (OE-A65) Performance Testing	OE-A65 attachment performance.	Verification studies for attachment performance tests were conducted on the Distal End Cap with Elevator, OE-A65, and "all test items satisfied the acceptance criteria and were determined to be acceptable."
Human Factors Testing	Acceptable user performance for reprocessing procedures and critical tasks.	Human Factors validation testing from the ED34-i10T2 (predicate) was leveraged for the ED32-i10 because the proposed manual reprocessing procedures and all critical tasks are identical, and the user-interface is the same.

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

The document does not specify exact sample sizes for each individual test in the non-clinical performance data section. It generally refers to "validation studies," "verification studies," and "test results" without numerical detail for the number of devices or data points used.

Provenance: The studies were conducted by PENTAX Medical and STERIS Corporation. The document doesn't explicitly state the country of origin for the data, but it's part of a submission to the U.S. FDA by PENTAX Medical HOYA Corporation located in Montvale, New Jersey, USA. All studies mentioned appear to be prospective testing for device verification and validation.

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

This information is not provided in the document. Given this is a non-AI/ML device, the concept of "ground truth" established by experts as typically understood in AI/ML performance evaluation doesn't directly apply in the same way. The performance is assessed against engineering specifications, recognized standards, and equivalence to a predicate device.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device clearance. Adjudication methods are typically used in clinical studies or AI/ML studies where multiple human readers' interpretations of data need to be resolved to establish ground truth or evaluate diagnostic performance. This document focuses on engineering and performance testing.

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. This document describes a medical device (endoscope) and not an AI/ML software device. No MRMC study or AI assistance evaluation is mentioned.

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

This is not applicable. This is a hardware medical device; it does not have a standalone algorithm for performance evaluation in the context of AI/ML. Its performance is assessed as an integrated system with compatible video processors.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established engineering specifications, performance standards (e.g., AAMI TIR 30:2011, IEC 60601 series), and the performance of the legally marketed predicate device (PENTAX Medical Video Duodenoscope ED34-i10T2). For reprocessing, laboratory tests were used to measure residual soil and extraction efficiency against pre-defined limits.

8. The Sample Size for the Training Set

This is not applicable. This is a hardware medical device, not an AI/ML device that requires a "training set."

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

This is not applicable. As it's not an AI/ML device, there is no "training set" or ground truth established for one.

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K Number

K202661

Device Name

Manufacturer

Olympus Medical Systems Corp.

Date Cleared

2020-12-08

(85 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K112680,K193182

Intended Use

This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Device Description

The TJF-Q190V has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. The TJF-0190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)".

The subject device consists of flexible insertion section, control section and endoscope connector section with equipped CCD chip which delivers images.

The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both the white light for the normal observation and the narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces electrical signal to video signal.

There is an instrument channel entirely inside of the flexible insertion section. Endo Therapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion to elevate EndoTherapy accessories for endoscopic treatment.

The TJF-Q190V consists of a single-use distal cover, MAJ-2315 which has been designed to be attached to OLYMPUS TJF-O190V to cover the distal end of the insertion tube and around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously 510(k) cleared via premarket notification, K193182.

The following new reprocessing accessory has also been designed for use with TJF-O190V:

CONNECTING TUBE MAJ-2358

The MAJ-2358 has been designed to be used when reprocessing TJF-Q190V using the Olympus endoscope reprocessor.

The MAJ-2358 is a connecting tube to connect Olympus endoscope reprocessor and TJF-O190V. The endoscope side connector is attached to the distal end of the endoscope to directly deliver fluid to the elevator area.

AI/ML Overview

This document (K202661) is a 510(k) premarket notification for a medical device, the Evis Exera III Duodenovideoscope Olympus TJF-Q190V, and its associated reprocessing accessory, the Connecting Tube MAJ-2358. The core of the submission is to demonstrate that the redesigned duodenoscope and new reprocessing accessory are substantially equivalent to a previously cleared predicate device.

The provided text does not contain information about a study that proves the device meets specific performance acceptance criteria in terms of clinical performance (e.g., diagnostic accuracy, sensitivity, specificity, or human expert performance improvement with AI). Instead, the performance data provided focuses on:

Reprocessing validation testing: Ensuring the device can be properly reprocessed for safe reuse.
Bench testing: Verifying the device and its accessories meet design specifications and perform as intended.
Risk analysis: Assessing potential risks associated with the new connecting tube.

Therefore, many of the requested details, particularly those related to AI/human reader performance studies, ground truth establishment for clinical data, and effect sizes of AI assistance, are not applicable to this document as it describes a conventional medical device rather than an AI-powered one.

However, based on the provided text, I can extract information related to the device's technical acceptance criteria and the type of studies performed for regulatory clearance.

Acceptance Criteria and Device Performance (Based on provided text)

Since this is not an AI/diagnostic device, the acceptance criteria are related to cleaning, functionality, and safety.

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Reprocessing Validation	Reprocessing instructions and validation testing for TJF-Q190V using OER-Pro and MAJ-2358 were conducted as recommended by FDA guidance ("Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling").
Bench Testing	Bench testing for TJF-Q190V and accessories (including MAJ-2358) was conducted to ensure the device performs as intended and meets design specifications. This included process verification, design verification, and design validation.
Connecting Tube MAJ-2358 Functionality	The MAJ-2358 is designed to connect the endoscope reprocessor to the TJF-Q190V to deliver fluid directly to the elevator area during reprocessing. Bench testing supports this functionality.
Risk Analysis	Risk analysis for MAJ-2358 when used with TJF-Q190V was conducted in accordance with ISO 14971:2007 established in-house acceptance criteria.
Human Factors Validation	Human factors validation for the MAJ-2358 and TJF-Q190V was conducted in accordance with FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices."
Substantial Equivalence	Based on indications for use, technological characteristics, performance testing, and technological comparison to predicate devices, the TJF-Q190V makes "no new issue of safety and effectiveness" and is "substantially equivalent" to predicate devices in terms of safety, efficacy, and performance. This is the overarching "acceptance criterion" for 510(k) clearance.

Study Details (Applicable to this type of device and submission)

Sample sizes used for the test set and the data provenance:
- The document does not specify sample sizes for the reprocessing validation, bench testing, risk analysis, or human factors studies. These would typically be detailed in the full test reports referenced by the submission, not in the summary document.
- Data Provenance: Not explicitly stated for specific tests, but the manufacturing site is Aizu Olympus Co., Ltd., Japan, implying tests likely occurred within Olympus's development and testing infrastructure, which could be global. The submission is to the U.S. FDA. The design and validation studies generally reflect prospective testing of the device against its specifications and reprocessing protocols.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of clinical expert review for diagnostic accuracy. For reprocessing validation, experts would be microbiologists or reprocessing specialists. For human factors, they would be end-users (e.g., nurses, technicians, physicians) representative of the target user population. The specific number and qualifications are not disclosed in this summary but would be part of the underlying test reports.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for clinical diagnostic adjudication. For technical validation (reprocessing, bench tests), "adjudication" wouldn't be in the sense of resolving differing clinical interpretations. Pass/fail criteria are established based on engineering specifications, regulatory standards (e.g., AAMI TIR30 for reprocessing), and risk analysis results. Human factors studies would assess usability and potential for error, which might involve qualitative and quantitative data but not a clinical adjudication model.
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 a duodenoscope, an imaging and interventional tool. It is not an AI-powered diagnostic device, nor does it claim to assist human readers in image interpretation or diagnostic performance in the way an AI algorithm would.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device.
The type of ground truth used:
- Not a clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for these tests would be:
  - Reprocessing: Sterility, absence of bioburden, and functional integrity after multiple reprocessing cycles, confirmed by laboratory methods.
  - Bench Testing: Engineering specifications (e.g., dimensional accuracy, image quality parameters, durability, fluid flow rates in channels), confirmed by measurements and functional checks.
  - Risk Analysis/Human Factors: Identification of potential hazards and user errors, and confirmation that controls mitigate risks to an acceptable level.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses a "training set."
How the ground truth for the training set was established:
- Not applicable. (See point 7)

In summary: The provided document is a regulatory clearance for a medical device (a duodenoscope) and a reprocessing accessory. The acceptance criteria and supporting studies are focused on the device's physical and functional performance, reprocessing efficacy, safety, and human factors, rather than clinical diagnostic performance enhancements or AI assistance.

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K Number

K203028

Device Name

FUJIFILM Distal End Cap

Manufacturer

Fujifilm Corporation

Date Cleared

2020-10-30

(28 days)

Product Code

FDT

Regulation Number

Type

Special

Panel

Reference & Predicate Devices

K191747

Intended Use

This product is a single use distal end cap required to be attached to certain FUJIFILM endoscopes during clinical use to assist in providing atraumatic passage of the endoscope tip during endoscopic procedures.

Do not use this product for any other purposes.

Device Description

FUJIFILM Distal End Cap DC-08D is a single use device that is supplied sterile, eliminating the need for reprocessing prior to use. This distal end cap is designed to the distal tip of a FUJIFILM ED-580XT duodenoscope. After an endoscopic procedure, the DC-08D is detached to facilitate easier access to the distal elevator during reprocessing of the ED-580XT.

AI/ML Overview

The available document is a 510(k) Summary for the FUJIFILM Distal End Cap DC-08D. It details the device's characteristics and compares it to a predicate device (FUJIFILM Distal End Cap DC-07D). However, it does not contain details about a clinical study involving human readers or an AI algorithm’s standalone performance, as the device is a medical accessory, not an AI diagnostic tool.

Therefore, many of the requested sections about acceptance criteria and study details for AI performance are not applicable and cannot be extracted from this document.

Here's the information that can be extracted, along with an explanation for the unavailable sections:

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

The document mentions that "Additional performance specifications were evaluated against pre-determined acceptance criteria" and that "Bench testing was conducted to demonstrate that the subject device is attached securely such that it will not detach during use." However, it does not explicitly list the specific acceptance criteria or quantitative performance results in a table format. It only states that the device was evaluated for conformance to ISO 8600-1:2015 and other standards.

Acceptance Criteria (Not explicitly stated in detail)	Reported Device Performance (Summary)
Sterility (Based on consensus standards)	Evaluated using ASTM F1980-16, ISO 11137-1:2006, ISO 11607-1:2019, ISO 11607-2:2019. (Implies successful evaluation).
Biocompatibility (Based on international standards)	Evaluated using ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 per FDA guidance. (Implies successful evaluation).
Secure attachment during use	Bench testing conducted to demonstrate secure attachment and no detachment during use. (Implies satisfactory performance).
Conformance to ISO 8600-1:2015	Evaluated for conformance to ISO 8600-1:2015. (Implies successful conformance).
Other performance specifications	Evaluated against pre-determined acceptance criteria. (Implies satisfactory performance, but criteria not detailed).

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 applicable as the document describes the regulatory submission for a physical medical device (an end cap), not an AI algorithm requiring a test set of data. The "testing" mentioned refers to bench testing, sterility testing, and biocompatibility testing of the physical product, not data analysis.

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 applicable. Ground truth for data analysis is not relevant for this physical device submission. The "ground truth" for this device would be established by validated engineering and scientific methods and standards (e.g., successful sterilization, material safety, secure attachment), not by expert consensus on data interpretation.

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

This information is not applicable for the reasons stated above.

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 applicable. The device is an end cap for an endoscope, not an AI system designed to assist human readers.

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

This information is not applicable. The device is a physical medical accessory, not an algorithm.

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

As mentioned, the concept of "ground truth" for data analysis is not applicable here. The verification of the device's properties relies on scientific and engineering testing methods, such as:

Sterility verification: Based on biological indicators and established sterilization cycles.
Biocompatibility verification: Based on in-vitro and/or in-vivo tests according to ISO standards.
Mechanical integrity: Based on bench testing to ensure secure attachment and durability during use.

8. The sample size for the training set

This information is not applicable as there is no AI algorithm and therefore no training set for data.

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

This information is not applicable as there is no AI algorithm and therefore no training set.

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K Number

K201098

Device Name

Ambu Duodeno System

Manufacturer

Ambu Innovation GmbH

Date Cleared

2020-07-17

(84 days)

Product Code

FDT,FET

Regulation Number

Type

Panel

Evis Exera III Duodenovideoscope Olympus TJF-Q190V

Reference & Predicate Devices

K143153,K100584

Intended Use

The aScope Duodeno is designed to be used with the aBox Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. video monitor) for endoscopy and endoscopic surgery within the duodenum.

The aBox Duodeno is designed to be used with the aScope Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade video monitor) for endoscopy and endoscopic surgery within the duodenum.

Device Description

The Ambu Duodeno System consists of a sterile single-use endoscope, the aScope Duodeno, and a processing unit, the aBox Duodeno.

The sterile single use duodenoscope aScope Duodeno consists of a flexible insertion tube with bendable tip, a control body and an umbilicus cord. The insertion tube has a bendable tip which is equipped with a camera to collect image data and a LED light source to illuminate the body cavity. The device contains a working channel through which additional instruments as biopsy devices may be introduced. The aScope Duodeno provides functions for lens washing, insufflation and suction.

The aBox Duodeno is an endoscopic video imaging system that receives video signals from the connected endoscope, controls the light at the endoscope tip and outputs this signal including a graphical user interface (GUI) to a connected external video monitor. It also provides signals to capture images by a connected external image capturing system. The aBox Duodeno also contains a peristaltic pump to provide water for the endoscope lens washing function. The peristaltic pump is controlled by the operator via the endoscope.

AI/ML Overview

The provided text describes the Ambu Duodeno System, a sterile single-use duodenoscope, and its associated processing unit, the aBox Duodeno. The document outlines its intended use, device description, comparison to predicate devices, and performance testing, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The document details non-clinical and animal testing to demonstrate substantial equivalence to predicate devices (Olympus TJF-Q180V and EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180). This type of testing focuses on functional performance, safety, and physical characteristics of the duodenoscope itself, not on the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets acceptance criteria, as the provided text relates to the regulatory clearance of a traditional medical device (a duodenoscope) and not an AI/ML-powered device.

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K Number

K193182

Device Name

Manufacturer

Olympus Medical Systems Corp.

Date Cleared

2020-01-17

(60 days)

Product Code

FDT,NWB,OCX

Regulation Number

Type

Panel

EXALT Model D Single-Use Duodenoscope, EXALT Controller

Reference & Predicate Devices

K112680,K143153

Intended Use

Device Description

The TJF-Q190V has been designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. The TJF-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)".

The subject device consists of flexible insertion section, control section and endoscope connector section with equipped CCD chip which delivers images.

The following new reprocessing accessory has also been designed for use with TJF-Q190V:

DISTAL END FLUSHING ADAPTER MAJ-2319

The MAJ-2319 was designed to flush the distal end of the endoscope with reprocessing fluids.

The MAJ-2319 can be attached to the distal end of the endoscope during the manual cleaning and disinfection process to flush the distal end with reprocessing fluids. The reprocessing fluid is flushed through the MAJ-2319 to the distal end using a syringe.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Evis Exera III Duodenovideoscope Olympus TJF-Q190V." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for an AI algorithm.

Therefore, the information requested in points 1-9 is largely not applicable or directly available in the provided text, as this is a submission for a traditional medical device (an endoscope), not an AI-powered diagnostic tool.

Here's why and what can be extracted:

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

Not Applicable in the traditional sense for an AI study. The document lists various performance data categories (sterilization, reprocessing, biocompatibility, software V&V, electrical safety, bench testing, risk analysis), but these are for the mechanical and electrical functionality of the endoscope itself, and its accessories, not for an AI's accuracy metrics. There are no specific "acceptance criteria" for metrics like sensitivity, specificity, accuracy, etc., for an AI algorithm, because this device does not contain one.

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

Not Applicable. There is no "test set" for an AI algorithm. The performance testing refers to physical tests on the endoscope and its accessories.

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. No ground truth establishment for an AI algorithm is mentioned.

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

Not Applicable. No test set or adjudication for an AI algorithm is mentioned.

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 is a hardware device (endoscope), not an AI-assisted diagnostic tool. No human reader studies are mentioned.

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

Not Applicable. No AI algorithm is integrated into this device.

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

Not Applicable. There is no AI algorithm that requires ground truth in this submission. The "ground truth" for the device's functionality would be adherence to engineering specifications and regulatory standards.

8. The sample size for the training set

Not Applicable. No AI training set is mentioned.

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

Not Applicable. No AI training set or ground truth establishment process is mentioned.

Summary of Relevant Performance Data from the Document (as it pertains to a non-AI device):

The document details various performance data provided in support of the substantial equivalence determination for the Olympus TJF-Q190V Duodenovideoscope. These studies demonstrate the safety and effectiveness of the traditional medical device and its accessories, not an AI component.

Here's a breakdown of the performance data categories:

1) Sterilization/Shelf life testing:
- Description: Conducted for the MAJ-2315 (Single Use Distal Cover) in accordance with FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510k) Submissions for Devices Labeled as Sterile." Accelerated aging was performed per ASTM F1980-16, with real-time aging for three years planned.
2) Reprocessing validation testing:
- Description: Reprocessing instructions and method validation for the TJF-Q190V were conducted and documented as recommended by FDA guidance "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling." This includes the MAJ-2319 (Distal End Flushing Adapter).
3) Biocompatibility testing:
- Description: Performed for the TJF-Q190V and MAJ-2315 according to FDA guidance and ISO 10993-1. Specific tests included:
  - Cytotoxicity Study Using the Colony Assay
  - Intracutaneous Study in Rabbits
  - Guinea Pig Maximization Sensitization Test
4) Software verification and validation testing:
- Description: Conducted for the TJF-Q190V software, following FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
5) Electrical safety and electromagnetic compatibility (EMC):
- Description: Tested on the TJF-Q190V. The system complies with:
  - AAMI ANSI ES60601-1: 2005/(R)2012 and A1:2012
  - IEC 60601-2-18: Edition 3.0 2009-08 (for safety)
  - IEC 60601-1-2: Edition 4: 2014-02 (for EMC)
6) Performance testing - Bench:
- Description: Conducted for the TJF-Q190V and its accessories to ensure it performs as intended and meets design specifications. This included:
  - Thermal Safety test
  - Mechanical durability test
  - Performance testing for MAJ-2315
  - Photobiological safety test
  - Accidental Physical Impact testing on distal tip
7) Performance testing - Animal:
- Description: No animal study was performed.
8) Performance testing - Clinical:
- Description: No clinical study was performed.
9) Risk analysis:
- Description: Conducted according to ISO 14971:2007 and human factors validation per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices." This risk analysis helped identify and perform design verification tests and their acceptance criteria.

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K Number

K193202

Device Name

Manufacturer

Boston Scientific Corporation

Date Cleared

2019-12-13

(23 days)

Product Code

FDT,FET

Regulation Number

Type

Panel