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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.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.

The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.

The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

The provided FDA 510(k) clearance letter for the PENTAX Medical Video Processor (EPK-i8020c) does not contain the information requested regarding acceptance criteria and the detailed study proving the device meets those criteria.

This document primarily focuses on establishing substantial equivalence to a predicate device based on minor software modifications and changes to instructions for use. It states that "The changes to the subject device were evaluated through performance testing in design validation/verification. This testing did not raise any issues regarding the safety and effectiveness of the device, as these differences do not affect the performance, function, or general intended use of the device."

However, it does not provide any specific acceptance criteria, reported device performance metrics against those criteria, or the details of the study methodology (sample size, data provenance, expert involvement, adjudication, MRMC, standalone performance, ground truth, training set specifics).

Therefore, based on the provided text, I cannot complete the requested information. The document explicitly states:

• "NON-CLINICAL PERFORMANCE DATA" section, point iii. "System Performance": "The system performance of the subject device demonstrated the equivalence to the predicate device."
• This suggests that the performance verification for this 510(k) relied on demonstrating equivalence to an already cleared predicate, rather than a de novo clinical or rigorous standalone performance study with specific acceptance criteria that would then be detailed.

Without access to the actual design validation/verification reports that were submitted to the FDA detailing the performance testing, it's impossible to answer the specific questions about acceptance criteria and the study that proves the device meets them.

The sections for acceptance criteria, study details, and related information would be empty or marked as "Not Provided in Document" if I were to adhere strictly to the given text.

In summary, the provided FDA 510(k) clearance letter does not describe the acceptance criteria or a dedicated study proving device performance against those criteria in the level of detail requested.

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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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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 C2 CryoBalloon™ Ablation System is intended to be used as a cryosurgical tool in the field of general surgery. specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia and treatment and management of Gastric Antral Vascular Ectasia (GAVE).

The subject device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working chamel 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 system also includes NitroClip as an accessory that is intended to reduce the nitrous oxide exposure in the room.

The subject 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 by adjusting the endoscope and Controller. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

The provided document is a 510(k) Premarket Notification from the FDA for the C2 CryoBalloon Ablation System. It outlines the device's indications for use, technological characteristics, and performance data. However, it does not contain specific acceptance criteria with quantifiable metrics, nor does it detail a study explicitly designed to prove the device meets pre-defined acceptance criteria for an AI/CADe device.

The document describes clinical testing to support the device's safety and effectiveness for new indications (GAVE) and a new treatment dose for Barrett's Esophagus. This is different from the type of study typically performed to validate an AI/CADe system against specific performance metrics for diagnostic accuracy.

Therefore, I cannot fulfill all parts of your request as the provided text does not describe an AI/CADe system or a study proving its acceptance criteria in the manner you've requested. The device described, the C2 CryoBalloon Ablation System, is a cryosurgical tool and not an AI or CADe system.

However, I can extract and structure the information available regarding the performance studies that were conducted for this surgical device.

Based on the provided document, here's an analysis of the performance data for the C2 CryoBalloon Ablation System, interpreted in the context of what was evaluated, rather than specific AI/CADe acceptance criteria:

The performance data presented in the document pertains to the surgical effectiveness and safety of the C2 CryoBalloon Ablation System for its stated indications, not the diagnostic performance of an AI system.

Summary of Device Performance and Related Studies:

The document describes:

• Bench Testing: To verify temperature profiling, spray radius, and spray uniformity of the 180 Standard catheter at different speeds (1.0 mm/s and 1.2 mm/s).
• Clinical Testing:
  • Gastric Antral Vascular Ectasia (GAVE): A multi-center retrospective study.
  • 180° Catheter Treatment Dose (Barrett's Esophagus): Two studies, one dose-finding (1.0mm/s) and one multi-center (1.2mm/s).

As there are no specific "acceptance criteria" provided in a table format for an AI/CADe device, nor a study proving meeting those, I will present the key outcomes and performance metrics reported for the clinical studies.

Simulated Table of "Acceptance Criteria" and Reported Device Performance (based on clinical outcomes, not AI/CADe metrics):

Breakdown of Information as per Request (adapted to the available data for a surgical device):

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

   • See the simulated table above. The "acceptance criteria" are inferred from the outcomes measured and deemed acceptable by the manufacturer and FDA for substantial equivalence. These are not AI/CADe specific accuracy metrics.

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

   • GAVE Study:
     • Sample Size: 28 subjects (retrospective study).
     • Data Provenance: Not explicitly stated, but compared to a published study of 33 GAVE patients from "three tertiary referral centers in the United States." This suggests the retrospective data for the C2 CryoBalloon system were likely from similar clinical settings, though the specific country of origin is not given. It was a retrospective study.
   • BE Study (1.0mm/s dose):
     • Sample Size: 25 patients.
     • Data Provenance: Not explicitly stated regarding country, but described as a "dose-finding phase."
   • BE Study (1.2mm/s dose):
     • Sample Size: 25 patients.
     • Data Provenance: Described as a "multicenter study." Not explicitly stated regarding country.

3. 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 this surgical device. The "ground truth" for GAVE or BE treatment success/eradication would be based on endoscopic findings, histological analysis, and clinical outcomes (e.g., hemoglobin levels, transfusion independence) as determined by treating physicians, not expert readers establishing a consensus for image interpretation. No specific number of experts or their qualifications for "ground truth establishment" are mentioned.

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

   • Not applicable as this is not an image-based diagnostic AI/CADe study requiring adjudication of interpretations. Clinical outcomes were measured directly.

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 MRMC study was done, as this is not an AI/CADe device. The comparisons are between the C2 CryoBalloon system and "other modalities" (e.g., APC, RFA) for GAVE treatment, or different doses/catheters for BE treatment.

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

   • Not applicable; this is a human-operated surgical device, not a standalone algorithm.

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

   • The "ground truth" for these clinical studies relied on:
     • Clinical Outcomes Data: Mean number of packed red blood cells (PRBC) transfused, transfusion independence, blood hemoglobin levels for GAVE.
     • Endoscopic Findings: GAVE eradication, BE surface regression.
     • Adverse Events: Occurrence and severity of complications like strictures, bleeding.
     • These are direct clinical and procedural outcomes, not interpretations of diagnostic images.

8. The sample size for the training set:

   • Not applicable. This is a medical device, not a machine learning model that undergoes "training." The described studies are clinical evaluation studies, akin to validation/test sets for demonstrating safety and efficacy.

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

   • Not applicable, as no machine learning training set is involved.

Conclusion based on the provided document:

The provided document refers to the FDA's 510(k) clearance for the C2 CryoBalloon Ablation System, a surgical device. The performance data presented focuses on the safety and effectiveness of the surgical intervention for specific indications (Barrett's Esophagus with dysplasia and Gastric Antral Vascular Ectasia). It outlines clinical study results (retrospective and multi-center studies) and bench testing results. The information requested regarding AI/CADe acceptance criteria, MRMC studies, AI training/test sets, and expert consensus/adjudication for diagnostic ground truth is not applicable to this type of device and the studies described.

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The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors ancillary equipment for gastrontestinal 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.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.

The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.

The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

The provided text describes the 510(k) submission for the PENTAX Medical Video Processor EPK-i8020c. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with a defined ground truth.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly provided in the document, as the submission relies on non-clinical performance data and a comparison to an already cleared predicate device.

However, I can extract information related to the device's performance testing and the nature of the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test set sample size: Not specified. The document refers to "performance testing" and an "animal image capture study" but does not quantify the number of cases or animals involved.
• Data provenance: For the "animal image capture study," the data provenance is from an animal study. The country of origin is not specified but implicitly assumed to be from within PENTAX Medical's research and development. This was a non-clinical study.

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

• Not applicable/Not specified. The animal study evaluated the device's ability to "visualize vascularity and mucosal surface," implying an objective assessment rather than a diagnostic interpretation requiring expert ground truth establishment for a specific medical condition. The study aimed to assess optical and color performance.

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

• Not applicable/Not specified. Given the nature of the "animal image capture study" for optical and color performance, an adjudication method for diagnostic agreement with a ground truth is not described as the primary objective was visualization capability comparison.

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 MRMC study was done. The device (PENTAX Medical Video Processor EPK-i8020c) includes "digital post-processing imaging enhancement technology (PENTAX i-Scan™)" and "optical imaging enhancement technology (OE)." However, the submission does not describe a human-in-the-loop study to evaluate the effectiveness of these enhancements or how human readers' performance improves with or without these features. The statement is that these technologies are "intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling."

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

• A standalone performance assessment was done for various system components, including software and optical performance. The "animal image capture study" can be considered a standalone assessment of the device's imaging capabilities (optical and color performance) in a biological setting, comparing it to predicate/reference devices. This was an evaluation of device capability itself, not an algorithm's diagnostic output.

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

• For the "animal image capture study," the "ground truth" was the objective presence of vascularity and mucosal surface in the animal model. The assessment was likely based on the visual quality and clarity of these features as captured by the device, compared to the predicate and reference devices. It was not a ground truth for a diagnostic condition established by pathology or expert consensus.

8. The sample size for the training set:

• Not applicable/Not specified. This submission does not describe a machine learning algorithm that would require a distinct training set. The device contains "digital post-processing imaging enhancement technology (PENTAX i-Scan™)," which might involve algorithms, but the development and training of these are not detailed as part of this 510(k) submission.

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

• Not applicable/Not specified, as no training set is discussed in this context.

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PENTAX Medical Single Use Video Bronchoscope EB-S01 are sterible endoscopes intended for use with PENTAX Medical mobile processor, therapeutic accessories, and other ancillary equipment for endoscopy and endotherapeutic procedures within the airways and tracheobronchial tree.

PENTAX Medical Mobile Processor ONE-M is intended to be used with PENTAX Medical endoscopes and other peripheral devices for endoscopic diagnosis, treatment and video observation.

PENTAX Medical Mobile Processor Plug-in ONE-Dock is intended to the PENTAX Medical Mobile Processor to provide additional ports for hardware interface.

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is intended to provide the optical visualization of the airways and tracheobronchial tree for diagnostics and therapeutic applications. The PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System consist of the following three component devices:

• . PENTAX Medical Single Use Video Bronchoscope EB11-S01 / EB15-S01
• . PENTAX Medical Mobile Processor ONE-M
• PENTAX Medical Mobile Processor Plug-in ONE-Dock

The EB11-S01 / EB15-S01 endoscopes are connected to the ONE-M and video images captured with the bronchoscope are displayed on the touch screen of the ONE-M. The ONE-M is also connected to the Plug-in ONE-Dock, which has several interfaces, such as an external monitor to display captured images by the bronchoscope and a connection with an external network.

The provided text is a 510(k) summary for the PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System. It details the device, its intended use, and a comparison to a predicate device. However, it does not contain a detailed study report with specific acceptance criteria and device performance results in the format requested.

Here's an analysis of what can be extracted and what information is missing:

The document states that the subject device (post-modification) is substantially equivalent to the predicate device (pre-modification PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System, K213235). This implies that the acceptance criteria for the subject device are implicitly met by demonstrating equivalence to the predicate, which presumably had its own acceptance criteria met previously.

The document discusses performance data in the "NON-CLINICAL PERFORMANCE DATA" section, but these are general statements about successful testing rather than a table of specific criteria and quantitative results.

Here's what can be inferred or explicitly stated from the provided text, and what remains unknown based on the prompt's requirements:

1. Table of Acceptance Criteria and Reported Device Performance

• Software function for maximum light intensity (XLUM) added.
• Shelf life extended to 3 years. |
  | Other Shared Characteristics (Implied Criteria met via Predicate Equivalence) | - Scope working length
• Scope field of view
• Scope depth of field
• Scope tip angulation
• Software requirements |

Missing Information:

• Specific numerical acceptance criteria (e.g., "signal-to-noise ratio > X dB").
• Specific quantitative results from the tests (e.g., "Measured signal-to-noise ratio was Y dB").
• Detailed reports of the "equivalence" demonstrated in system and optical performance.

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

• Sample Size: Not specified for any of the performance tests. The document mentions "test sets" or "bench testing" but does not give numbers of devices tested.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given that it's a 510(k) for a medical device manufacturer, it's highly likely to be internal validation data, but the specifics are not provided.

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

• Not applicable / Not specified. The reported tests are primarily non-clinical bench and engineering tests (e.g., electrical safety, mechanical durability, optical measurements, software V&V, biocompatibility). These types of tests typically do not involve human expert adjudication for ground truth in the way a diagnostic AI algorithm would.

4. Adjudication Method for the Test Set

• Not applicable / Not specified. As noted above, the reported tests are non-clinical and do not involve human adjudication of results in the context of establishing a "ground truth" for a diagnostic outcome.

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

• No. The document explicitly states: "Animal Image Capture Study: This change does not affect the image quality. As the subject and predicate scopes are identical, animal performance testing was not conducted." This indicates that no comparative effectiveness study involving human or animal subjects (which would be necessary for MRMC) was performed for this specific 510(k) submission.

6. Standalone (Algorithm Only) Performance Study

• Not applicable / Not specified. This device is hardware (bronchoscopes, mobile processor, dock) with associated software (for image display, controls, etc.), not a standalone diagnostic algorithm. The software verification and validation are for the functionality of the device, not a diagnostic algorithm's standalone performance.

7. Type of Ground Truth Used

• Technical Specifications / Engineering Standards / Regulatory Guidance. For the non-clinical tests conducted, the "ground truth" refers to meeting predefined technical specifications, industry standards (e.g., IEC 60601 series), and regulatory guidance from the FDA. For example, for "Optical Performance," the ground truth would be that the measured values for signal-to-noise, sharpness, etc., fall within an acceptable range defined by engineering specifications or are equivalent to the predicate device's performance.

8. Sample Size for the Training Set

• Not applicable / Not specified. This is not an AI/ML diagnostic algorithm that would have a "training set" in the conventional sense. The software functions (e.g., brightness control, exposure control, color adjustment, i-scan image processing) are likely deterministic or rule-based, or if they involve ML, the training data for such embedded features are not disclosed or are aggregated within the predicate device's prior development.

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

• Not applicable / Not specified. As above, a specific training set ground truth process is not relevant or described for this device's submission.

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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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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 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.

The PENTAX Medical Video Upper Gl Scope EG29-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.

The PENTAX Medical Video Colonoscope EC38-120cL 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 20 kg of body weight.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.

The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.

The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is supposed to be found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

The PENTAX Medical Video Upper GI Scope EG29-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.

The PENTAX Medical Video Colonoscope EC38-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 device is equipped with stiffness setting mechanism for the insertion tube. This feature enables the physician to choose the stiffness of the insertion tube, depending on the preferred level.

The document provides information on the PENTAX Medical EPK-i8020c Video Imaging System, including its components (Video Processor EPK-i8020c, Video Upper GI Scope EG29-i20c, and Video Colonoscope EC38-i20cL) and their intended uses. It also details the non-clinical performance data used to support the substantial equivalence determination to predicate devices.

However, the document does not contain the specific details required to answer all parts of your request, particularly regarding detailed acceptance criteria, reported device performance metrics in a table, an AI component, and the specifics of a study proving the device meets acceptance criteria in the way you've outlined.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through various technical and performance tests, rather than setting and meeting a specific set of quantitative acceptance criteria for a new clinical performance claim or an AI algorithm.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance Study (Based on provided document)

The document describes various non-clinical performance tests to demonstrate substantial equivalence, rather than a single study with specific acceptance criteria for a novel AI feature. The "acceptance criteria" here are generally compliance with recognized standards or demonstration of equivalence to predicate devices.

1. A table of acceptance criteria and the 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 images or patient data for an algorithm. The non-clinical tests mentioned rely on physical devices, simulated use, and animal models.

• For Reprocessing Validation: Simulated use testing. Sample size not specified.
• For Biocompatibility: Materials assessed in accordance with ISO standards. Sample size not specified.
• For Animal Image Capture Study: Animal model used. Sample size not specified.

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

Not applicable as there is no mention of a human-expert-annotated "test set" for an AI algorithm or clinical performance study. The ground truth for the non-clinical tests is based on objective measurements, standards, or comparison to established predicate devices/methods.

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

Not applicable.

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

No MRMC study or AI assistance claim is described in the provided document. The device includes "digital post-processing imaging enhancement technology (PENTAX i-Scan™)" and "optical imaging enhancement technology (OE)", but this is described as an "optional adjunct following traditional white light endoscopy" and "not intended to replace histopathological sampling." It is not presented as an AI-assisted diagnostic tool that would typically undergo an MRMC study to compare human performance with and without AI.

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

This document does not describe the performance of a standalone algorithm for diagnostic purposes. The imaging enhancements (i-Scan, OE) are adjuncts for visual inspection by a clinician.

7. The type of ground truth used

For the non-clinical performance tests:

• Reprocessing Validation: AAMI TIR 30:2011 for residual soil accumulation and extraction efficiency.
• Biocompatibility: ISO 10993-1:2018 (toxicity, sensitization, intracutaneous reactivity).
• Electrical Safety and EMC: IEC and ISO standards.
• Optical Performance/Animal Image Capture Study: Comparison against predicate and reference devices' images and visualization capabilities.

No histological pathology or specific clinical outcomes data are mentioned as ground truth for a diagnostic performance study.

8. The sample size for the training set

Not applicable. There is no mention of an AI algorithm requiring a training set in this submission. The imaging enhancement technologies are likely rule-based image processing or optical filtering techniques rather than deep learning AI.

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

Not applicable.

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PENTAX Medical Single Use Video Bronchoscope EB-S01 is sterile single use flexible endoscopes intended for use with PENTAX Medical mobile processor, therapeutic accessories, and other ancillary equipment for endoscopy and endo-therapeutic procedures within the airways and tracheobronchial tree.

PENTAX Medical Mobile Processor ONE-M is intended to be used with PENTAX Medical endoscopes and other peripheral devices for endoscopic diagnosis, treatment and video observation.

PENTAX Medical Mobile Processor Plug-in ONE-Dock is intended to be attached to the PENTAX Medical Mobile Processor to provide additional ports for hardware interface.

PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System is intended to provide the optical visualization of the airways and tracheobronchial tree for diagnostics and therapeutic applications. The PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System consist of the following three component devices:

• . PENTAX Medical Single Use Video Bronchoscope EB11-S01 / EB15-S01
• . PENTAX Medical Mobile Processor ONE-M
• . PENTAX Medical Mobile Processor Plug-in ONE-Dock

The EB11-S01 / EB15-S01 endoscopes are connected to the ONE-M and video images captured with the bronchoscope are displayed on the touch screen of the ONE-M. The ONE-M is also connected to the Plug-in ONE-Dock, which has several interfaces, such as an external monitor to display captured images by the bronchoscope and a connection with an external network.

Based on the provided text, the document is a 510(k) Premarket Notification for the PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving clinical effectiveness through extensive clinical trials for new indications or technologies. Therefore, the information provided focuses on demonstrating equivalence through non-clinical performance data and technological comparisons, rather than a clinical study with detailed acceptance criteria and a human-in-the-loop performance study as might typically be found for AI/ML device submissions.

The document does not describe a study that proves the device meets specific acceptance criteria related to an AI/ML algorithm's diagnostic performance, as it is a bronchoscope system, not an AI/ML diagnostic aid. It lists various non-clinical performance tests to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI/ML, human expert involvement, and ground truth establishment are not applicable or not detailed in this submission because it is not an AI/ML device submission for diagnostic accuracy.

However, I can extract the relevant information that is present and explain why other requested information is not available:

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

The document describes general performance equivalency rather than specific quantitative acceptance criteria for image analysis or diagnostic performance of an AI system. The key "acceptance criteria" here relate to demonstrating equivalence to a predicate device and meeting recognized standards for safety and performance (e.g., electrical safety, biocompatibility).

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

• Test Set: Not applicable in the context of an AI/ML "test set" for diagnostic performance. Performance testing involved various engineering and animal studies. For the "Animal Image Capture Study," an animal model was used, but the specific number of animals is not provided. The data provenance is implied to be from internal testing by PENTAX Medical.
• Data Provenance: Implied to be from internal testing and validation studies conducted by PENTAX Medical (e.g., "PENTAX Medical coordinated with HA2 Medizintechnik GmbH (German company) to validate the use of EO sterilization"). The animal study location and specifics are 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 applicable and not provided. The ground truth for this device's performance does not involve human expert adjudication of images for diagnostic purposes in the way it would for an AI/ML algorithm. The performance evaluation focused on physical, electrical, and optical properties as well as safety and biocompatibility.

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

Not applicable, as this is not an AI/ML diagnostic device requiring expert adjudication of results.

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 a bronchoscope system, not an AI-assisted diagnostic tool for image interpretation. No MRMC study was conducted or required for this type of submission.

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

Not applicable, as this is a medical device for direct visualization and not an AI algorithm.

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

Not applicable in the AI/ML sense. The "ground truth" for this submission are the established performance specifications for medical devices, relevant ISO standards, and the performance of the predicate device, against which the subject device's non-clinical performance was compared (e.g., electrical safety standards, biocompatibility testing results, optical measurements, and visualization capabilities in an animal model).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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