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The PENTAX Medical Video Colonoscope EC38-i20cWL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.

This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 20kg of body weight.

The PENTAX Medical Video Colonoscope EC38-i20cWL is designed to be used with a PENTAX Medical Video Processor, 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 lower digestive tract.

The provided text is a 510(k) summary for the PENTAX Medical Video Colonoscope (EC38-i20cWL). It describes the device, its intended use, comparison to predicate devices, and non-clinical performance data supporting its substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of an AI-powered device or a study involving human readers and AI assistance (MRMC).

The document specifically states: "The subject device is functionally equivalent to the predicate/reference devices, and the differences between the devices are minor technological changes such as the application of wide field of view for the new endoscope. There is no new technological feature in the subject device in comparison to the reference device, K231249." This indicates that the device is a refined version of an existing product, not a novel AI-powered diagnostic or assistive tool.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, training set details) from the provided text, as this type of information is generally specific to the validation of AI/ML-based medical devices or comparative studies of diagnostic performance against established benchmarks, which are not described in this 510(k) summary. The summary focuses on engineering and safety validation, not on diagnostic performance or AI integration.

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PENTAX Medical Video Upper GI Scope EG27-i20c:
The PENTAX Medical Video Upper GI Scope EG27-i20c is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs; tissues; and subsystems: esophagus, stomach, and duodenum. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in patient populations with greater than 20 kg of body weight.

PENTAX Medical Video Colonoscope EC34-i20cL:
The PENTAX Medical Video Colonoscope EC34-i20cL is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the lower gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems: Large Bowel to the cecum, terminal ileum of the small bowel.
This endoscope is introduced via the rectum, as decided by the physician, when indications consistent with the need for the procedure are observed in patient populations with greater than 5kg of body weight.

PETNAX Medical Video Upper GI Scope EG27-i20c
The PENTAX Medical Video Upper GI Scope EG27-i20c is designed to be used with a PENTAX Medical Video Processor, 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 upper gastrointestinal tract.

PENTAX Medical Video Colonoscope EC34-i20cL
The PENTAX Medical Video Colonoscope EC34-i20cL is designed to be used with a PENTAX Medical Video Processor, 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 lower digestive tract.

The provided document describes the clearance of two PENTAX Medical Video Scopes, the Upper GI Scope (EG27-i20c) and the Colonoscope (EC34-i20cL), and does not contain acceptance criteria for specific device performance metrics in the format of a table with reported performance. The document focuses on showing substantial equivalence to predicate devices through various non-clinical performance data categories.

Therefore, I cannot fulfill your request for "A table of acceptance criteria and the reported device performance".

However, I can extract information related to the studies conducted to support the substantial equivalence:

Non-Clinical Performance Data / Studies Conducted:

The document mentions several non-clinical performance tests but does not define specific acceptance criteria or report numerical performance results against those criteria. Instead, it generally states that "All acceptance criteria were satisfied" or that the devices demonstrated equivalence.

Here's a breakdown of the studies mentioned and related information:

• Sample size used for the test set and the data provenance: Not specified for any of the tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified for any of the tests. The document does not mention the use of experts to establish ground truth for testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned. The document primarily focuses on technical and safety equivalence.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The devices are endoscopes, which are human-in-the-loop devices. The document does not describe any standalone algorithm performance testing.
• The type of ground truth used: Not explicitly stated for any test. For the "Animal Image Capture Study," it compares "visualizations of vascularity and mucosal surfaces" to predicate devices, implying a qualitative assessment.
• The sample size for the training set: Not applicable, as these are hardware medical devices (endoscopes) and not AI/machine learning algorithms that require training sets in the typical sense.
• How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

Detailed Information from the Document Regarding Studies:

1. Reprocessing Validation:

   • Study: Simulated use testing, cleaning, high-level disinfecting, and rinsing validation studies for EG27-i20c and EC34-i20cL.
   • Purpose: Confirmed effectiveness of reprocessing procedures.
   • Acceptance Criteria: Established in accordance with AAMI TIR 30:2011 for amount of residual soil accumulation and extraction efficiency.
   • Results: "All acceptance criteria were satisfied."

2. Sterilization and Shelf Life:

   • Study: Validation of System 1E liquid chemical sterilization with STERIS Corporation.
   • Purpose: Confirmed suitable sterilization method.
   • Results: Devices are not provided sterile, shelf-life not applicable.

3. Biocompatibility:

   • Study: Assessment of cytotoxicity, sensitization, and intracutaneous reactivity for direct and indirect contact materials.
   • Standard: In accordance with ISO 10993-1:2018.
   • Results: Risk levels of local toxicity determined as "Acceptable."

4. Software and Cybersecurity:

   • Study: Software verification and validation, including cybersecurity assessments.
   • Standards/Guidance: IEC 62304:2006 + A1:2015 and FDA Guidance for Industry and Staff.

5. Electrical Safety and EMC:

   • Study: Testing to confirm acceptable levels of electrical safety (ES) and electromagnetic compatibility (EMC).
   • Standards: IEC 60601-1-2:2014 + A1:2020; IEC 60601-1:2005 + A1:2012 + A2:2020; IEC 60601-1-6:2010 + A1:2013 +A2:2020; and IEC 60601-2-18:2009.

6. System Performance:

   • Results: "The system performance of the subject device demonstrated the equivalence to the predicate/reference devices."

7. Optical Performance:

   • Study: Measurement of optical properties of imaging and illumination performances.
   • Results: "All results show that the optical characteristics of the subject devices are equivalent to those of the predicate devices."

8. Animal Image Capture Study:

   • Study: Used as part of optical and color performance testing.
   • Purpose: To demonstrate visualization capabilities.
   • Results: "The findings demonstrate that the subject devices provide visualizations of vascularity and mucosal surfaces for each anatomical area comparable to those achieved by the predicate devices."

In summary, the document provides evidence of various non-clinical performance studies demonstrating that the new PENTAX Medical Video Scopes meet established safety and performance standards and are substantially equivalent to predicate devices. However, it does not present this information in the specific structured format requested for acceptance criteria and reported numerical performance values.

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The Gas/Water Feeding Valve OE-B14 is intended to be attached in place of Air/Water Feeding Valve (OE-B12) to PENTAX Medical GI endoscopes and used to feed the gas/water to the body (via the air/water channel).

The Gas/Water Feeding Valve OE-B14 is intended to be attached in place of Air/Water Feeding Valve (OE-B12) to PENTAX Medical GI endoscopes and used to feed the gas/water to the body (via the air/water channel).

The OE-B14 is attached onto the air/water feeding cylinder of the control body of PENTAX Medical endoscope. The endoscope is linked to non-flammable gas cylinder and the water bottle assembly via air/water feeding circuit.

The device descriptions for the PENTAX Medical EPK-i8020c Video Imaging System remain unchanged from K231249. They include the PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, and PENTAX Medical Video Colonoscope EC38-i20cL.

The provided text describes the regulatory clearance of the PENTAX Medical Gas/Water Feeding Valve OE-B14, an accessory for GI endoscopes. The device's clearance is based on its substantial equivalence to a predicate device. The information provided focuses on non-clinical performance data rather than a clinical study evaluating diagnostic or therapeutic efficacy with human subjects.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an accessory device and the review focuses on substantial equivalence based on non-clinical performance, the "acceptance criteria" here refer to meeting standards for reprocessing, sterilization, biocompatibility, and system/mechanical performance. There are no specific quantifiable clinical performance metrics like sensitivity/specificity for a diagnostic device.

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

The document describes non-clinical bench testing and validation studies, not a clinical trial with human subjects. Therefore, the concept of a "test set" in the context of clinical data or patient samples, sample size, or data provenance (country of origin, retrospective/prospective) is not applicable here as it would be for a diagnostic or therapeutic device. The "test set" would refer to the physical devices subjected to the various non-clinical tests (reprocessing, mechanical, etc.), for which specific numerical sample sizes are not provided in this summary.

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

This information is not applicable. The device underwent non-clinical performance testing and validation against recognized standards and internal criteria. There was no "ground truth" derived from expert clinical opinion on patient data as would be for an AI/diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable. There was no clinical test set requiring expert adjudication for ground truth.

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

No, an MRMC comparative effectiveness study was not done. The device is an accessory that feeds gas/water, not a diagnostic or AI-assisted tool that would involve human readers interpreting cases.

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 an algorithm or AI was not done. The device is a physical accessory.

7. The Type of Ground Truth Used

For this device, the "ground truth" for proving its safety and effectiveness was established through:

• Compliance with recognized consensus standards: (e.g., AAMI TIR 30: 2011/(R)2016 for reprocessing, ISO 10993-1: 2018 for biocompatibility).
• Achievement of pre-defined acceptance criteria for bench testing of functions, performance, and safety (e.g., residual soil levels, successful steam sterilization, acceptable toxicity levels, sufficient gas/water feeding performance, verified mechanical performance).
• Comparison to a legally marketed predicate device (PENTAX Gas/Water Feeding Valve OF-B194) to demonstrate substantial equivalence, particularly regarding intended use and technological characteristics.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical accessory, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable as there was no training set for an AI/ML algorithm.

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