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The AUXILIARY WATER TUBE MAJ-855 is intended to be used to provide sterile water, detergent solution, disinfectant solution, water, and alcohol for irrigation through the auxiliary water channel of compatible endoscopes.

The Auxiliary Water Tube MAJ-855 is used in endoscopic procedures to flush sterile water through the auxiliary water channel to wash the endoscopic field of view. Sterile water for washing the mucosa can be provided either manually by use of a syringe or automatically via a flushing pump. The MAJ-855 can be used both during an endoscopic procedure and reprocessing (i.e. pre-cleaning, manual cleaning and manual disinfection).

The Auxiliary Water Tube MAJ-855 is a reusable device, provided to the user in a non-sterile condition and must be reprocessed prior to first use and following each use (i.e., after each patient exam).

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The SINGLE USE BIOPSY VALVE MAJ-1555 has been designed to be attached to the instrument channel port of the endoscopes and to provide access for endoscopic device passage and exchange, help maintain insufflation, minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provide access for irrigation.

The Olympus Single Use Biopsy Valve MAJ-1555 is a sterile, disposable device designed to attach to the instrument channel port of Olympus endoscopes. It facilitates the passage and exchange of endoscopic devices, helps maintain insufflation, minimizes leakage of biomaterial, and prevents reflux of body fluids. The device consists of a cap and inner rubber made of silicone rubber, and a housing made of polyethylene. A lever mechanism prevents reuse after detachment.

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The ArgoCap has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy.

The ArgoCap is intended for the following:

• Gastrointestinal endoscopic mucosal resection and coagulation
• Keeping the suitable depth of the endoscope's view field

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the ArgoCap (200.52) does not contain any information regarding the acceptance criteria or the study that proves the device meets the acceptance criteria.

This document is a formal notification of substantial equivalence for a medical device, outlining regulatory information such as:

• Device name and product codes
• Regulation numbers and regulatory class
• Indications for Use
• General controls provisions of the Act
• Links to FDA guidance documents
• Requirements for Quality System (QS) regulation, UDI rule, and medical device reporting

It does not include details about:

• Specific performance metrics or acceptance criteria for the device itself
• Clinical or non-clinical study design, results, or statistical analyses
• Sample sizes, data provenance, ground truth establishment, or expert qualifications
• Adjudication methods or MRMC studies

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported performance, nor can I provide information on the various aspects of the study mentioned in your prompt, as none of that data is present in the document.

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The Endoscopic Water Pump is a peristaltic pump intended to supply fluid to compatible endoscopes or endotherapy devices for irrigation of the gastric and colonic mucosa during endoscopic or endotherapeutic procedures, allowing to aid in visualisation, diagnosis and treatment.

AGS's Endoscopic Water Pump comprises:

• A host machine (including drive system, peristaltic pump head, housing, etc.); -
• Operating component (Rotatable Knob and Footswitch); -
• -Hanger assembly(optional);
• -An irrigation tube (optional)
  The Endoscopic Water Pump is a motorized pump designed to transfer water from a bottle, via a tube, to an endoscope or EndoTherapy devices, and the pump is operated by a footswitch. It uses a peristaltic pump head to move the water through the tube. The speed of the rotation of the pump head is adjustable by the user, using flow control knob on the front of the pump.

The provided text is a 510(k) summary for the Endoscopic Water Pump. It details the device's characteristics and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria, a study that proves the device meets acceptance criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.

The document explicitly states:

• "No Clinical test is included in this submission." (CH2.03.9)
• And for Performance Data: "The Endoscopic Water Pump meets all design specifications and medical device standards for electrical safety and EMC (IEC 60601), and the Irrigation tube meet the standard for sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." (CH2.03.8)

This indicates that the submission relies on adherence to design specifications and recognized standards, along with non-clinical performance (which is not detailed as a specific study with acceptance criteria in the requested format), rather than a clinical study or a study directly comparing algorithm performance against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's a summary of what can be inferred or directly stated from the provided text, along with the information that is not present:

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

• Not present in the requested format. The document states the device "meets all design specifications and medical device standards" and "non-clinical performance meets the design specification." It also provides a comparison of technical characteristics and performance with the predicate device (Table CH2.03.6), primarily focusing on maximum output flow for different endoscope types. However, explicit acceptance criteria with corresponding performance metrics are not presented in a table.

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

• Not present. No test set or data provenance is mentioned as a clinical study was not performed. The performance evaluation seems to be based on engineering tests and adherence to standards.

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

• Not applicable / Not present. Since no clinical test or test set requiring ground truth was conducted, this information is not available.

4. Adjudication method for the test set

• Not applicable / Not present. Since no clinical test or test set requiring ground truth was conducted, this information is not available.

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 / Not present. This device is an Endoscopic Water Pump, a hardware device, not an AI or software device that assists human readers. No MRMC study was conducted.

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

• Not applicable / Not present. This is a hardware device; the concept of "standalone algorithm performance" does not apply.

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

• Not applicable / Not present. As no clinical study or test set requiring ground truth was performed, this information is not relevant.

8. The sample size for the training set

• Not applicable / Not present. This is a hardware device, not a machine learning model, so there is no training set in the typical sense.

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

• Not applicable / Not present. This is a hardware device, not a machine learning model, so there is no training set or ground truth for it.

Information provided in the document related to performance:

• Performance Comparison (from Table CH2.03.6, "Performance" row):

  • Proposed device (AGS):
    • Maximum output flow is generally higher than the predicate device.
    • For endoscopes with an auxiliary water channel and using irrigation tube AG-5247-3.2: approx. 240~248ml/min at flow setting 10 (maximum) with a new pump head. Recommended flow settings: 1-10.
    • For instrument channel flushing (GIF-Q260, 2.8mm diameter channel): approx. 240~258ml/min at flow setting 10 (maximum) with a new pump head. Recommended flow settings: 1-10.
  • Predicate device (Olympus OFP-2):
    • Water feed controlled by footswitch. Flow rate variable, controlled from front panel.
    • For endoscopes with an auxiliary water channel and using tube MAJ-1608/MAJ-1651 (CF-Q180AL): approx. 230ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 1-6.
    • For instrument channel flushing (1) (CF-Q260AL/DL, 3.2mm diameter channel): approx. 785ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 5-9.
    • For instrument channel flushing (2) (GIF-Q260, 2.8mm diameter channel with 2.5mm ultrasound probe): approx. 100ml/min at flow setting 9 (maximum) with a new pump head. Recommended flow settings: 5-9.
  • Comparison Note: The proposed device's maximum output flow is higher than the predicate. The submission states that "we confirmed that the proposed device can meet the clinical requirements through simulate the clinical use of proposed device," and that "the simulation test in Section 12 demonstrates the substantial equivalence of the Endoscopic Water Pump." (Section 12 is not provided in the excerpt).

• Shelf Life:

  • Proposed device: 5 years for host machine, 3 years for irrigation tubes.
  • Predicate device: Unknown.
  • Comparison Note: "we conducted the shelf life validation in Section 14 which can prove that the difference of shelf life doesn't raise different questions regarding its safety and effectiveness." (Section 14 is not provided in the excerpt).

• Sterility/Single Use:

  • Proposed device irrigation tube: Sterile supplied, Single use.
  • Predicate device irrigation tube: MAJ-1608, MAJ-1651 is single day use item; MAJ-1607, MAJ-1681, MAJ-1682 is single use. MAJ-1651, MAJ-1681 and MAJ-1682 supplied sterile.

• Biocompatibility:

  • Proposed device materials contacting human body: ABS, PVC, PC. Biocompatibility tested to ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021.
  • Predicate device: Biological information unknown.
  • Comparison Note: "biological risks are acceptable, please refer to Section 15." (Section 15 is not provided in the excerpt).

In conclusion, the document emphasizes compliance with standards and non-clinical performance assessments rather than a detailed study with specific acceptance criteria and ground truth in the context of diagnostic accuracy, which would be typical for an AI/CADe device.

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The water container MAJ-901 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.

Do not use this instrument for any purpose other than its intended use.

The water container MAJ-902 has been designed to be used with endoscopes to allow gas insufflation and water feeding from the endoscope.

Do not use this instrument for any purpose other than its intended use.

The MAJ-901 and MAJ-902 have been designed to be used with Olympus light sources and endoscopes to allow gas insufflation and water feeding from the endoscope.
MAJ-901 and MAJ-902 are both comprised of a Lid, Container, O-ring, and Container Protector. Other than Lid, the devices are the same.
MAJ-902 also includes a "gas tube connector" in the lid for carbon dioxide gas delivery. Additionally, MAJ-902 includes a Caution tag that the MAJ-901 does not.

This is a 510(k) summary for a medical device (Water Container MAJ-901 and MAJ-902), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new therapeutic might.

Based on the provided document, here's what can be extracted regarding acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:

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

The document mentions that all subject devices met design specifications and performed as intended in the non-clinical tests. However, it does not provide a table with specific quantitative acceptance criteria or the numerical performance results of these tests. Instead, it offers a high-level summary of the types of tests conducted:

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

The document does not provide details on the sample sizes used for each of the non-clinical tests (e.g., how many water containers were tested for flow rate, durability, etc.). Similarly, it does not specify the country of origin of the data or whether the tests were retrospective or prospective. It is implied these were prospective bench tests conducted by the manufacturer.

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 is not applicable to this type of 510(k) submission. The "ground truth" for non-clinical bench testing often refers to established engineering standards or internal design specifications, verified through objective measurements, rather than expert consensus on medical images or clinical outcomes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters where there's a need to resolve discrepancies in expert opinions. This document describes bench testing where performance against technical specifications is directly measured.

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 medical device for water and gas feeding in endoscopes, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

Not applicable. This device is a water container, not an algorithm.

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

For the non-clinical tests mentioned, the "ground truth" would be the engineering design specifications and recognized industry standards for flow rate, durability, biocompatibility, and reprocessing effectiveness. Performance was measured against these predefined technical parameters.

8. The sample size for the training set

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

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

Not applicable, as there is no training set for this device.

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To be utilized by a trained physician through a flexible endoscope for the collection of duodenal or jejunal fluids for diagnostic analysis.

The Hobbs Medical Aspiration Catheter is a sheath within a sheath design. The inner sheath is actuated using a proximal handle. The inner sheath is protected by an elastomeric membrane that has a slit at the distal end to allow for the inner sheath to advance. The inner sheath has three side holes at the distal tip for collection of aspirate. Once the sample is collected the inner sheath is retracted to protect the sample from contamination as it is withdrawn from the endoscope.

The provided text describes a 510(k) premarket notification for an Aspiration Catheter, which is a medical device for collecting duodenal or jejunal fluids. However, the document does not contain information about a study involving an AI/Machine Learning component, nor does it provide the detailed specifics required to answer your questions about acceptance criteria, study design, ground truth, or expert involvement in the context of an AI-based device.

The document primarily focuses on demonstrating the substantial equivalence of the new Aspiration Catheter to a legally marketed predicate device (Hobbs Medical/Jayco Aspiration Catheter K844550) through physical performance testing, rather than a clinical study evaluating an AI algorithm's performance.

Therefore, I cannot provide the requested information based on the provided text, as it does not pertain to the development or validation of an AI/ML medical device.

Here's a breakdown of why I cannot answer each question based on the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions "Joint integrity testing," "Deployment force testing," "Endoscope compatibility testing," "Design verification and validation," "Protection of sample from contamination," and "Shelf life testing." However, specific numerical acceptance criteria (e.g., "deployment force must be less than X N") and the quantitative results for these tests are not provided. These are engineering/device performance tests, not AI performance metrics.
2. Sample sized used for the test set and the data provenance: No information on sample sizes for clinical or AI-specific testing is available. The provenance of any data (country of origin, retrospective/prospective) is also not mentioned, as it's not a data-driven AI study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert annotation or ground truth establishment for an AI algorithm.
4. Adjudication method: Not applicable. There's no AI algorithm requiring adjudication.
5. MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted human reader study.
6. Standalone (algorithm only without human-in-the loop performance) study: Not applicable. This device is not an algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" for this device would relate to its physical performance meeting specifications, not clinical diagnoses or classifications.
8. The sample size for the training set: Not applicable. No AI training was conducted.
9. How the ground truth for the training set was established: Not applicable. No AI training was conducted.

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The ClearCap Distal Attachment has been designed to the distal end of the endoscope to facilitate endoscopic therapy.

The ClearCap Distal Attachment is intended for the following:

• · Gastrointestinal mucosal resection (endoscopic mucosal resection)
• · Keeping the suitable depth of the endoscope's view field

The ClearCap Distal Attachment is a sterile distal attachment intended to improve endoscopic control and to help maintain the clear view by keeping a moderate distance from the tissues during endoscopic surgical procedures.

The ClearCap Distal Attachment is comprised of three main sections: an attaching portion, a distal portion and draining holes. The attaching portion is connecting portion of the attachment to an applicable endoscope; a distal portion is the ending portion of the attachment and the 2 draining holes on the sidewall are to discharge bleeding and some foreign matter.

Applicable lesions are both lower digestive tract (=gastrointestinal (GI) tract) and upper GI tract. The model name FM-CC01, FM-CC05, FM-CC06 and FM-CC07 are for lower GI Tract, and FM-CC02, FM-CC03 and FM-CC04 are for upper GI tract.

It is available in various sizes of diameter to assure the compatibility of various endoscope outer diameters. The average contact time of the product and the mucosa of the human digestive tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or resterilized.

This document does not contain the information requested for acceptance criteria and the study proving the device meets them.

The provided text is a 510(k) summary for a medical device called "ClearCap Distal Attachment." While it discusses the device's design, intended use, and comparison to a predicate device to establish substantial equivalence, it specifically states that non-clinical tests were performed, and it does not mention any clinical study or human subject data.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Performance Data for a "Study": The document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and non-clinical performance (e.g., direct comparison testing for gap, endoscope compatibility, viewing, and suction function). It does not present acceptance criteria in the context of a clinical study or report device performance against such criteria.
• No Clinical Study Details: There is no mention of a clinical study, test set, training set, human readers, ground truth established by experts, or MRMC analysis. The device is evaluated through "non-clinical tests."

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and a study that proves the device meets those criteria, as such a study (in the sense of human performance or clinical outcomes) is not described in this document.

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The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.

The troCarWash™ system is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the distal lens of the laparoscope. Consisting of a mains powered reusable control unit, and a single use disposable trocar, obturator, and tubing set, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat, and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures providing a clear image of the surgical site. The disposable portion of the system is sterilized via irradiation and has limited (<24 hours) patient contact with abdominal tissue. The trocar and obturator are primarily made of ABS and polycarbonate, and the tubing set is made of ABS, Polycarbonate, and PVC tubing. The system is intended for use in typical hospital environments by medical professionals and is suitable for all patients approved for laparoscopic operations. The system incorporates a software that initiates a short (<250 millisecond) wash and dry mechanism to efficiently clean the lens of the laparoscope and may be initiated with a natural single-handed surgical motion of retracting the scope momentarily into the supplied trocar.

The provided document describes the troCarWash™ System, a device intended to remove visual obstructions from the distal lens of a laparoscope during surgery.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in the format requested. However, it details various validation and testing activities with implied acceptance criteria being successful completion of these tests according to specified standards.

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

• Packaging Validation: The sample sizes are not explicitly stated for each test within the packaging validation.
• Sterilization Validation: The sample sizes are not explicitly stated for each test within the sterilization validation.
• Biocompatibility Testing: The sample sizes for these tests are not explicitly stated.
• Electrical Safety & EMC: The sample sizes for these tests are not explicitly stated.
• Software V&V Testing: Not applicable for a sample size in this context.
• Bench Performance Testing:
  • Test Set Size: 29 disposable sets (preconditioned with sterilization and accelerated aging) and 8 disposable sets (preconditioned with sterilization and simulated transportation and distribution) were tested.
  • Data Provenance: The document does not specify the country of origin of the data. It is a benchtop model study, implying it was conducted in a controlled laboratory environment. The tests involved preconditioned (sterilized, aged, and simulating transport) devices, indicating a prospective testing approach on manufactured devices.

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. The ground truth for the performance of this device (e.g., wash efficacy, sterilization, biocompatibility) is established through objective physical, biological, and electrical measurements against established international and industry standards, not by expert interpretation in the sense of medical image analysis or diagnosis.

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

Not applicable. This type of adjudication method is relevant for studies involving human interpretation of data (e.g., medical images). The studies described here are primarily objective validation and bench performance tests against predefined standards.

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 comparative effectiveness study was done. The device is a physical cleaning system for laparoscope lenses, not an AI-assisted diagnostic or interpretive tool. Therefore, the concept of human readers improving with AI assistance is not relevant here.

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

A standalone performance evaluation was indeed done for the device's functional aspects:

• Bench Performance Testing: This test specifically evaluated the "system performance" and its "wash efficacy" using various scope angles and brands in a "benchtop model." This implies an algorithm-only or device-only performance evaluation without direct human intervention in the cleaning process itself beyond initiating the cycle. The device "utilizes a light sensor to detect the position of the scope as the user pulls the scope back within the trocar to deliver a cleaning cycle," and "incorporates a software that initiates a short (<250 millisecond) wash and dry mechanism." This confirms the automated, standalone operation for its core function.

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

The ground truth for the various tests outlined is based on:

• Bench Performance Testing: The ground truth for "acceptable cleans" is implied to be visually clear lenses after the cleaning cycle, as determined by direct observation in the benchtop model. The document states "the troCarWash™ system was able to achieve acceptable cleans." While not explicitly defined as a quantified "ground truth" metric (like µg/cm² of residue), the pass/fail nature against visual clarity is the de facto ground truth.
• Packaging, Sterilization, Biocompatibility, Electrical Safety & EMC, Software V&V: The ground truth for these validations is compliance with specific international and national standards (e.g., ASTM, ISO, ANSI AAMI, IEC, FDA guidance documents). Successful completion according to the parameters and thresholds defined in these standards constitutes the ground truth.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense. Its function is mechanical cleaning and physical/chemical interaction, governed by established engineering principles and materials science. While "software" is mentioned as having undergone V&V, it is for controlling the physical cleaning mechanism.

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

Not applicable, as there is no training set for this type of device.

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The 24 hour use Endoscopy Irrigation Tubing (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via a sterile water bottle during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.

The Endoscopy Irrigation Tubing is intended for 24-hour use and then discarded. The endoscopy irrigation tubing is manufactured for use in conjunction with sterile water bottle, and together with irrigation pumps. The endoscopy irrigation tubing is individually packed in sealed package, sold as a sterile device. The endoscopy irrigation tubing is designed to be attached to the auxiliary water connector or biopsy irrigation accessory and to be inserted into pump head of the irrigation pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.

The provided text describes the 510(k) premarket notification for the "Endoscopy Irrigation Tubing" device. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance criteria through a rigorous clinical trial or AI model validation.

Therefore, many of the requested sections related to AI model validation, ground truth establishment, expert consensus, MRMC studies, and effect sizes cannot be directly extracted from this document, as the device is not an AI/ML-driven diagnostic tool. The document describes a medical device (tubing) and its physical and chemical properties and basic performance.

However, I can extract information related to the acceptance criteria and the type of study done to prove the device meets these criteria as described for this specific type of medical device submission.

Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not applicable due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (Endoscopy Irrigation Tubing), the "acceptance criteria" are related to its physical and functional equivalence to the predicate device and its compliance with relevant standards. The "performance" is demonstrated through bench testing and compliance with various material and sterilization standards.

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

• Test Set Sample Size: Not specified in the provided text. The "Performance Test" states "bench testing was performed" but does not give sample sizes for devices tested.
• Data Provenance: The tests are analytical bench tests, not clinical data from patients. The manufacturer is Zhejiang Chuangxiang Medical Technology Co., LTD., located in Hangzhou, Zhejiang Province, P.R. China. The data would originate from their internal testing or contracted labs. It is not retrospective or prospective in the clinical sense.

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

• Not Applicable. This is a medical device (tubing), not a diagnostic or AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device's performance is established by compliance with engineering standards, material properties, and functional specifications defined by recognized standards (e.g., ISO, ASTM) and internal quality control.

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

• Not Applicable. This is a medical device, not an AI/ML algorithm or clinical study requiring adjudication of interpretations. The "test set" involves laboratory measurements and comparisons to predicate device specifications.

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 passive medical tube. There is no AI component, and no human reader interpretation is involved or enhanced.

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

• Not Applicable. This is not an algorithm.

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

• Engineering Specifications and Standard Compliance: The "ground truth" for this device's acceptance is based on meeting pre-defined physical, chemical, and functional specifications derived from engineering standards (e.g., flow rate requirements, material biocompatibility limits, sterilization efficacy) and demonstrating substantial equivalence to a legally marketed predicate device. This is primarily a bench testing and material characterization ground truth.

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. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The Air/Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.

The CO2 Source Tubing is intended to be used with a carbon dioxide (CO2) source with the purpose of supplying CO2 to the endoscope during endoscopic procedures. This device is intended to be used for not more than 24 hours. It is a 24-hour multi-patient use device.

The proposed device includes two (2) categories:

• Air/Water Bottle Tubing
• CO2 Source Tubing

The Air/Water Bottle Tubing and CO2 Source Tubing are intended for 24-hour multi-patient use. Air/water bottle tubing is supplied in sterile and CO₂ Source Tubing is supplied in non-sterile.

6.1 The Air/Water Bottle Tubing
The Air/Water Bottle Tubing is manufactured for use in conjunction with a sterile water bottle, and together with OLYMPUS®140/240, 160/260, 180/280, 190/290 series endoscopes. The Air/Water Bottle Tubing is individually packed in sealed package, sold as a sterile device. The Air/Water Bottle Tubing is designed to be attached to the air/water port of the endoscopes to provide irrigation through the air/water channel to the distal end of endoscope.

There are two types of the device Air/Water Bottle Tubing provided by the manufacturer, such as type A and type B. Type B has an additional air extended tubing but type A does not. The clinician selects the appropriate model according to the actual clinical needs.

6.2 The CO2 Source Tubing
The CO2 Source Tubing is manufactured for use in conjunction with air/water bottle tubing and CO2 insufflator. The CO2 Source tubing is individually packed in a sealed package, and sold as a non-sterile device. The CO2 Source Tubing is designed to be attached to the air/water bottle tubing and the outlet of the CO2 insufflator to provide irrigation and CO2 insufflation through the air/water channel to the distal end of endoscope.

The provided FDA 510(k) summary (K231471) describes the Chuangxiang Medical Technology Co., LTD.'s Air/Water Bottle Tubing and CO2 Source Tubing. This submission focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving human subjects or complex AI algorithms. Therefore, many of the requested categories related to clinical studies, AI performance metrics, and expert adjudication are not applicable to this document.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document details various performance tests conducted on the devices. It claims these tests successfully demonstrated essential performance and substantial equivalence to predicate devices, implying that the devices met pre-defined acceptance criteria for these tests. However, the specific quantitative acceptance criteria or detailed numerical results for each test are not provided in this summary. Instead, the summary states that the testing "successfully demonstrated essential performance" and that the manufacturer "believes that no significant differences exist."

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

The document states that performance tests were performed on "samples from initial lots." However, the specific sample size for each test or for the overall test set is not quantified.

The data provenance is retrospective, as the testing was conducted by the manufacturer (Zhejiang Chuangxiang Medical Technology Co., LTD. in China) on their newly manufactured devices to support the 510(k) submission. The country of origin of the data is China.

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

Not Applicable. This submission relies on non-clinical, bench testing, not expert interpretation of medical images or patient data to establish ground truth. The "ground truth" for these tests would be the measurement against established engineering or performance specifications.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical bench testing, there is no need for expert adjudication of results in the way it would be applied to a clinical study involving human interpretation. The results are based on objective measurements and predefined performance parameters.

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 submission is for medical device accessories (tubing) and does not involve an AI algorithm or human readers.

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

Not Applicable. This submission does not involve an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on engineering specifications, industry standards (e.g., ISO, ASTM), and predefined performance parameters for air/water flow, leak integrity, compatibility, sterilization, shelf life, and biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. There is no AI algorithm involved, so no "training set."

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

Not Applicable. There is no AI algorithm involved, so no need to establish ground truth for a training set.

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