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The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.

• Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.

• Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.

• Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.

• Disposable Water Jet Adapter: This unit is designed to prevent backflow and intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

The Disposable Endoscopy Valve Set is a collection of several sterile units. It is intended to be fitted to different endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.

This FDA 510(k) clearance letter pertains to a Disposable Endoscopy Valve Set, which is a Class II device. The document explicitly states that no clinical study was conducted for this submission (K250732) and that no clinical test data is included. Instead, the clearance is based on the device being "substantially equivalent" to a predicate device (Disposable Endoscopy Adapter Set, K220210) through non-clinical performance data, primarily bench testing.

Therefore, many of the requested criteria related to clinical studies, human readers, ground truth, and training sets are not applicable to this specific clearance. I will extract the information that is present in the document regarding the acceptance criteria and the study (bench testing) that supports it.

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

Acceptance Criteria and Device Performance for Disposable Endoscopy Valve Set (K250732)

1. Table of acceptance criteria and the reported device performance:

The document details extensive performance characteristics for each component of the Disposable Endoscopy Valve Set. Since the submission relies on substantial equivalence through bench testing, the reported device performance is indicated as "Substantially equivalent supported by bench testing" for each characteristic compared to the predicate device.

Disposable Air/Water Valve:

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The Disposable Hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

1. Endoscopic marking
2. Hemostasis for
   • Mucosal/sub-mucosal defects

The Disposable Hemoclip consists of one pre-loaded clip and delivery system for single patient use only. Disposable Hemoclip is provided in sterile. The clip is made of stainless steel with good superelasticity performance. The clip is pre-loaded in end of the Spring tube part through its deformation and it is deployed from the delivery system during use.The clip is engineered such that they can be opened and closed up to many times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. The delivery system consists of a handle and delivery catheter. The delivery system will allow for the device to rotate at the distal end.

The provided text describes a 510(k) premarket notification for a medical device, the Disposable Hemoclip. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a detailed clinical study demonstrating improved patient outcomes or diagnostic accuracy.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria for software or AI-driven diagnostic devices.

Specifically, the document states:

• "No Clinical Study is included in this submission." This means there is no study that evaluates the device's performance in a clinical setting against specific metrics like sensitivity, specificity, or reader improvement with AI assistance.
• The "acceptance criteria" listed for the device relate to non-clinical performance data (e.g., appearance, size, hardness, open/close performance, rotation performance, releasing force, clipping force, peeling force, connection firmness, dimensional verification, and MR safety testing), and compliance with ISO standards (ISO 10993, ISO 11135-1, ISO 10993-7). These are engineering and material specifications, not performance metrics for diagnostic accuracy or clinical effectiveness in the way an AI/software device would have acceptance criteria.
• The device being discussed is a physical medical instrument (a disposable hemoclip), not a software or AI device. Hence, there are no concepts like "ground truth for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," or "training/test set sample sizes" in the context of an AI/diagnostic algorithm.

In summary, this document is not relevant for describing the acceptance criteria and study proving a device meets those criteria for an AI/software-driven diagnostic device. It details a substantial equivalence claim for a physical medical instrument.

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The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials.

• Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
• Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
• Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
• Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

The Pentax Medical Valve Set is a collection of several sterile units. It is intended to be fitted to Pentax endoscopes' working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.

The provided document is a 510(k) Premarket Notification summary for the Pentax Medical Valve Set. This document is a regulatory submission for a medical device, which seeks to establish substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a rigorous scientific study (like for AI/ML devices).

Therefore, the information required to answer the question about acceptance criteria and a study proving a device meets these criteria (especially in the context of AI/ML performance metrics like accuracy, sensitivity, specificity, or MRMC studies) is not present in this document.

Here's why and what information is present:

• Device Type: The Pentax Medical Valve Set is an endoscope accessory, a physical medical device. It is not an AI/ML software device.
• Regulatory Pathway: A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market. This involves comparing technological characteristics, intended use, and assessing any performance differences through bench testing, biocompatibility testing, and sterilization validation. It does not typically involve clinical performance studies in the way an AI/ML device would need to demonstrate its diagnostic or predictive accuracy.
• Non-clinical Performance Data: The document mentions "bench tests were performed on Pentax Medical Valve Set: Appearance, Physical properties. The results of all testing were passing." This implies the device met its internal design specifications for those physical attributes. However, these are not "acceptance criteria" for a diagnostic or predictive performance study as would be seen for AI/ML.
• Clinical Test Data: The document explicitly states: "No Clinical Study is included in this submission." This confirms that no study was conducted to demonstrate clinical performance (e.g., diagnostic accuracy, reader improvement).

In summary, this document does not contain the information required to fill out the table and answer the questions about AI/ML device performance and testing.

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The Clean Connecting Tube (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via sterile water and to supply air(via an air pump) or CO2(Via a CO2 pump) along with sterile water during GI endoscopic procedures when used in conjunction pump or electrosurgical unit.

The Clean Connecting Tube is intended for 24 hour multiple-patient use and then discarded. The Clean Connecting Tube design minimizes infection control risks that are associated with manual cleaning and sterilization.The maximum number of patient is up to 15 in 24 hours , and maximum duration of us shall not exceed 15h. The check valve attached to the irrigation tubing shall be replaced after every patient use. The Clean Connecting Tube is manufactured for use in conjunction with sterile water bottle, and together with irrigation pump. The Clean Connecting Tube 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 pump to provide irrigation through the auxiliary water channel to the distal end of endoscope.

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and study proving a device meets these criteria. The document is a 510(k) premarket notification letter from the FDA regarding a "Clean Connecting Tube" device and its substantial equivalence to a predicate device.

It primarily discusses:

• The FDA's review and determination of substantial equivalence.
• Regulatory classifications and requirements for the device.
• A comparison of the proposed device ("Clean Connecting Tube") with a predicate device ("Universal Irrigation Solution Hybird™").
• Non-clinical performance data (bench tests, compliance with ISO standards), stating "The results of all testing were passing."
• A clear statement that "No Clinical Study is included in this submission."

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (beyond "passing" for bench tests).
2. Sample sizes for a test set or data provenance.
3. Number/qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document indicates that substantial equivalence was primarily established through a comparison of technological characteristics and non-clinical bench testing, rather than human-in-the-loop or standalone AI performance studies typically associated with the type of acceptance criteria you are asking about.

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The Disposable Endoscope Injection Needle is used for endoscopic injection into gastrointestinal mucosa and submucosa to:
• introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system;
• aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures;
• control non-variceal hemorrhage.

The Disposable Endoscope Injection Needle consists of Sheath, Handle buckle, Handle, Booster tube, Handle end cap, Outer tube, Inner tube, Metal end cap and injection needle tip. It is available in a variety of configurations with varying needle lengths, gauges and working lengths.

The provided text is a 510(k) summary for a medical device called the "Disposable Endoscope Injection Needle." It describes the device, its intended use, comparison to a predicate device, and non-clinical performance data. However, it explicitly states that "No Clinical Study is included in this submission."

Therefore, I cannot provide information about acceptance criteria and a study that proves the device meets clinical performance acceptance criteria, as no such clinical study was conducted or presented in this document. The submission relies solely on non-clinical (bench) testing and substantial equivalence to a predicate device.

Here's what I can extract regarding acceptance criteria and performance based only on the non-clinical data provided:

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

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 specify the sample sizes used for the non-clinical (bench) tests. The data provenance is implied to be from Yangzhou Fartley Medical Instrument Technology Co., Ltd. in China, where the device is manufactured. These are all prospective bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These were non-clinical, objective bench tests, not clinical evaluations requiring expert interpretation of results or establishment of ground truth in a medical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as these were objective bench tests, not subjective interpretations requiring adjudication.

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 physical medical instrument (an injection needle), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests, the "ground truth" was defined by engineering specifications, industrial standards (like ISO 10993, ISO 11135), and the physical properties required for safe and effective function of such a device.

8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:
Not applicable.

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Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Disposable Polypectomy Snare shall be used with monopolar diathermic energy. Disposable Polypectomy Hybrid Snare shall be used with or without monopolar diathermic energy.

The Disposable Polypectomy Snare is available in two different types with rotating snare and non-rotating snare. The cutting wire diameter of the snares is 0.4mm. The catheter diameters are 1.8mm and 2.4mm the depending on the version. The snares are available in different forms, lengths and openings depending on the type.

• Non-rotating snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm, 25mm,30mm, 35mm. Working lengths 1800mm and 2300mm.
• Rotatable snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm.25mm. 30mm. 35mm. Working lengths 1800mm and 2300mm.

The Disposable Polypectomy Hybrid Snare is available in two different types with rotating snare and non-rotating snare. Only one available loop shape is Hybrid. The cutting wire diameter of the snares is 0.4mm. The catheter diameters is 2.4mm. The snares are available in different forms, lengths and openings depending on the type.

• Non-rotating snares: available in the opening widths 10mm, 15mm. Working lengths 1800mm and 2300mm.
• Rotatable snares: available 10mm, 15mm. Working lengths 1800mm and 2300mm.

The provided text is a 510(k) summary for a Disposable Polypectomy Snare and Hybrid Snare. This document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical performance data, rather than presenting a study to prove a device meets specific clinical acceptance criteria for a new AI or diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable or not provided in this type of submission.

Here's an explanation based on the provided text:

• No clinical study was conducted or included in this submission. The device is being cleared based on substantial equivalence to a legally marketed predicate device, primarily through bench testing and comparison of technical specifications.
• The summary explicitly states: "No Clinical Study is included in this submission." (Section 5.8)

However, I can extract the "Non-clinical Performance Data" which serves as the basis for demonstrating safety and effectiveness for this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance (Non-clinical)

Based on the "Non-clinical Performance Data" section (5.7), the acceptance criteria are generally adherence to recognized international standards and satisfactory results from specific bench tests.

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

• Sample Size: Not specified for the bench tests. Typically, regulatory submissions for physical devices include testing on a representative number of units to ensure consistency and performance across the product line.
• Data Provenance: The tests were performed on the Disposable Polypectomy Snare and Disposable Polypectomy Hybrid Snare (the proposed device). The provenance of the raw data (e.g., country of origin, retrospective/prospective) is not detailed in this summary. These are typically controlled laboratory tests.

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

• Not applicable. This submission relies on objective physical and chemical testing standards (ISO standards, bench tests) rather than expert-derived ground truth.

4. Adjudication method for the test set

• Not applicable. This submission relies on objective physical and chemical testing 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

• Not applicable. This device is a physical medical instrument (polypectomy snare), not an AI or diagnostic device that involves human readers.

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

• Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

• For biocompatibility and sterilization, the "ground truth" is defined by adherence to internationally recognized ISO standards.
• For physical properties, the "ground truth" is adherence to pre-defined specifications and satisfactory performance in bench tests.

8. The sample size for the training set

• Not applicable. No machine learning or AI component, thus no training set.

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

• Not applicable. No machine learning or AI component, thus no training set or its associated ground truth establishment.

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The Disposable Endoscopy Adapter Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials.

• Disposable Air/Water Valve: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.

• Disposable Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.

• Disposable Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.

• Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.

The Disposable Endoscopy Adapter Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.

This document pertains to the 510(k) premarket notification for a medical device called the "Disposable Endoscopy Adapter Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. Therefore, the questions related to AI/MRMC studies, human reader improvement, and extensive clinical ground truth establishment are not applicable in this context.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Nature of the Device and Submission:

The Disposable Endoscopy Adapter Set is a collection of sterile units (Air/Water Valve, Suction Valve, Biopsy Valve, Water Jet Adapter) intended to be fitted to endoscope working channels/ports to control fluid/gas flow and prevent leakage/back-flow. This is a Class II device.

The submission is a 510(k), which aims to demonstrate that the new device is "substantially equivalent" to a predicate device already on the market (in this case, "Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B, K200769" from Wilson Instruments (SHA) Co., LTD). Substantial equivalence is primarily proven through comparison of technological characteristics and non-clinical performance data, rather than large-scale clinical trials.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (endoscopy adapters) and not an AI/software device, the "acceptance criteria" are not framed in terms of AI performance metrics (like sensitivity, specificity, AUC) but rather through adherence to recognized standards and successful completion of pre-defined non-clinical tests to demonstrate equivalence to the predicate.

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

• Sample Size: The document does not specify exact sample sizes for the "bench tests" performed. For physical device testing, sample sizes are typically determined by statistical methods for device validation (e.g., AQL sampling plans) or by industry standards for specific tests, but these details are not provided in this high-level summary.
• Data Provenance: The testing was performed as part of the submission by Yangzhou Fartley Medical Instrument Technology Co., Ltd. and their consultant Shanghai Thinkwell Consulting Co., Ltd. The country of origin for the manufacturing and testing would be China. The data would be considered prospective with respect to the regulatory submission, meaning the tests were specifically conducted to support this 510(k).

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

This question is not applicable to this 510(k) submission. "Ground truth" for physical device performance (like fluid flow, material properties, sterility) is established through standardized laboratory testing, rather than expert consensus on medical images or clinical outcomes. The "experts" would be the engineers, microbiologists, and other technical personnel who conducted and validated the bench tests, adhering to established international standards (ISO). Their specific number or qualifications are not typically detailed in the public 510(k) summary, as their expertise is presumed in conducting validated tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are for interpreting subjective data, typically in diagnostic imaging studies where multiple readers might interpret the same case. For physical device performance, tests have objective pass/fail criteria based on measured parameters and adherence to 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 is a 510(k) for a physical medical device, not an AI-assisted diagnostic tool. No AI component is mentioned, and therefore, no MRMC study or AI-related effectiveness claim was made or required.

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

Not applicable. There is no algorithm or software component mentioned for this device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Bench Testing: Objective measurements of physical properties, appearance, and functional performance (e.g., flow control, prevention of back-flow/leakage, compatibility with endoscopes).
• Biocompatibility Testing: Laboratory tests to ensure the materials are non-toxic and compatible with biological systems.
• Sterilization Validation: Microbiological testing to confirm sterility assurance level (SAL) and ethylene oxide residuals meet standards.
• Adherence to Standards: Compliance with recognized international standards (ISO 10993, ISO 11135-1) serves as the "ground truth" for safety and performance in these areas.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI algorithm requiring a training set.

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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