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PENTAX Medical Video Duodenoscope ED34-i10T2s: The PENTAX Medical Video Duodenoscope ED34-i10T2s 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 the biliary tract via the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems of the: esophagus, stomach, duodenum, common bile duct, hepatic ducts, cystic duct, and pancreatic duct. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.

PENTAX Gas/Water Feeding Valve OF-B194: Gas/water feeding valve is attached in place of air/water feeding valve to the gastrointestinal endoscope, in order to prevent the leaking of the nonflammable gas into the room, and feed the gas or water into the gastrointestinal tract or abdominal cavity. It also prevents back flow/splashing of body fluids.

PENTAX Medical Video Processor EPK-i8020c: The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal and pulmonary endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.

PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63: The PENTAX Medical Single Use, Sterile Distal End Cap with Elevator OE-A63 fully integrates a movable elevator, whose function it is to guide endoscopic devices. The OE-A63 is controlled by the PENTAX Medical Video Duodenoscopes and is necessary to meet the intended use of the duodenoscope.

PENTAX Medical Video Duodenoscope ED34-i10T2s is designed to be used with a PENTAX Medical Video Processor, documentation equipment, video monitor, endoscopic devices such as biopsy forceps and other ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to the biliary tract via the upper gastrointestinal tract. The PENTAX Medical Video Duodenoscope ED34-i10T2s is compatible with the hydrogen peroxide gas plasma sterilizer STERRAD 100NX.

The provided document is a 510(k) summary for a medical device (PENTAX Medical Video Duodenoscope ED34-i10T2s and accessories). It outlines the device's characteristics, intended use, and comparison to predicate devices, along with non-clinical performance data.

However, the document does not contain information related to a study proving that an AI device meets acceptance criteria, nor does it provide details about human reader studies (MRMC), standalone algorithm performance, or the establishment of ground truth for training or test sets related to AI.

The document primarily focuses on demonstrating substantial equivalence of a medical endoscope and its accessories to previously cleared predicate devices through engineering and functional performance testing, reprocessing validation, biocompatibility, electrical safety, and software validation (for a video processor which includes an image enhancement technology, but not an AI diagnostic algorithm in the sense of the prompt's request).

Therefore, I cannot extract the requested information about acceptance criteria for an AI device and related studies from this document. The information you are asking for (e.g., acceptance criteria for AI performance, sample sizes for AI test sets, number of experts for AI ground truth, MRMC studies for AI, standalone AI performance) is not present in this regulatory submission for an endoscope.

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The PENTAX Medical Video Duodenoscope ED34-i10T2 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.

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 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-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 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 ED34-i10T2.

The provided text describes the PENTAX Medical Video Duodenoscope ED34-i10T2 and its clearance via a 510(k) submission. Acceptance criteria and performance data are discussed across several categories, but it primarily focuses on device safety and functionality rather than AI performance.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a traditional medical device (endoscope), not an AI/ML device, the performance data presented is focused on safety and functional aspects, not AI accuracy metrics like sensitivity, specificity, or AUC. The "acceptance criteria" are implied by successful completion of validation studies against established standards.

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

The document does not specify a "test set" in the context of an AI/ML device with data samples. Instead, it refers to validation studies for various aspects of the device.

• Reprocessing Validation: "Simulated use testing, cleaning and rinsing... and high level disinfection were conducted at all of evaluation sites." The specific number of devices or cycles is not provided.
• Sterilization and Shelf Life (Distal End Cap): Irradiated products were tested at different storage times. The number of products per test point is not specified.
• O-Ring Analysis, Biocompatibility, Electrical Safety & EMC, Optical Testing, Distal End Cap Performance Testing, Human Factors Testing: These studies were conducted but the sample sizes (e.g., number of O-rings, number of devices tested for electrical safety, number of participants in human factors) are not explicitly stated.
• Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin, retrospective/prospective). These are device performance validation studies performed by the manufacturer or contracted labs.

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

This information is not applicable. The device is an endoscope, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation. The performance data relates to direct device functionality and safety.

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

Not applicable for a non-AI medical device validation. Decisions are based on meeting predefined engineering and safety standards, not on expert adjudication of diagnostic outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a traditional medical device (endoscope), not an AI diagnostic product. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed and is not relevant to this submission.

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

No. This device is an endoscope, which is directly operated by a human user (physician) for visualization and therapeutic access. There is no standalone algorithm performance to evaluate.

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

The concept of "ground truth" as typically defined for AI/ML performance (e.g., pathology, expert labels) is not directly applicable here. For the various validation studies:

• Reprocessing Validation: Ground truth is defined by objective analytical measurements of residual soil and microorganism reduction, compared against established industry standards (AAMI TIR 30:2011) and FDA guidance.
• Human Factors Testing: Ground truth is the observation of user performance of reprocessing steps against the manufacturer's Instructions For Use (IFU) and identification of critical errors, as evaluated by human factors experts.
• Other tests (e.g., O-ring, biocompatibility, electrical safety, optical performance) rely on engineering specifications, material science standards, and established laboratory testing protocols as their form of "ground truth."

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable, as there is no training set for an AI/ML model.

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