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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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This device is used to enter human gastrointestinal tract (stomach or duodenum) via endoscope to collect cells.

The main component of the proposed device is Brush Head, Outer Sheath, Sliding Handle, Thumb ring, Catheter and Steel Wire. The device is expected to use via endoscope to obtain cellular material from the human body. The main operation is move the Finger Ring back and forth to achieve the movement of Brush Head, and then the Brush Head can collect cells from the target site.

The proposed device has twenty-one (21) specifications, the main differences of these specifications are Diameter of Brush Head, Brush Length, Outer Sheath OD and Effective Length.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided document is a 510(k) premarket notification letter and summary for a medical device called "Single Use Cytology Brush." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials.

As such, the document does not describe a study proving the device meets acceptance criteria in the manner requested by your prompt (i.e., for an AI/ML-based medical device with performance metrics, ground truth, expert adjudication, etc.). Instead, it focuses on bench testing and an assessment of substantial equivalence.

Therefore, I cannot extract the information to fill your requested categories for acceptance criteria and a study that proves the device meets them in the context of an AI/ML device. However, I can explain what is presented in the document regarding the acceptance of this specific device.

Based on the provided text, here's what can be inferred about the acceptance process for the Single Use Cytology Brush:

The "acceptance criteria" here are fundamentally about demonstrating substantial equivalence to a predicate device (K172663). This is a regulatory pathway, not a performance study of an AI model.

No study proving device meets acceptance criteria in the AI/ML context was performed or described. Instead, the manufacturer performed bench tests to ensure the physical and operational characteristics of the device were comparable to the predicate.

Here's a breakdown of the information from the document related to "acceptance" of this device:

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

The document does not present a formal table of quantitative acceptance criteria for device performance with specific numerical targets like sensitivity/specificity for an AI model. Instead, it refers to regulatory and bench testing requirements.

• Appearance
• Dimension
• Operational performance |
  | Substantial Equivalence | Demonstrated to be "Substantially Equivalent (SE)" to the currently cleared predicate device (K172663) based on indications for use, technological characteristics (materials, design, configuration, packaging, fundamental technology, sterilization process), and safety and performance testing. |

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

The document does not specify sample sizes for the bench tests. It refers to general passing results without providing the number of units tested. This is not a data provenance in the sense of patient data; it's product testing.

• No mention of a "test set" in the context of patient data for an AI model.
• Sample size: Not specified for bench tests.
• Data provenance: Not applicable in the context of clinical data. The tests are performed on the device itself by the manufacturer.

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

Not applicable. This device is a physical medical instrument (cyto brush), not an AI algorithm. Ground truth (e.g., disease presence) is not established by experts for its performance in the way it would be for a diagnostic AI. Its "performance" refers to its physical capabilities and safety.

4. Adjudication method for the test set

Not applicable. There is no "adjudication" necessary for the physical properties and functional tests of a cytology brush.

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 not an AI-assisted device.

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

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

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

Not applicable. The "ground truth" for this device's acceptance is its ability to meet engineering specifications, adhere to ISO standards, and be substantially equivalent to a predicate physical device. There are no clinical "ground truth" labels like pathology for its clearance.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model, so there is no training set.

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

Not applicable. There is no training set or clinical ground truth in the context of this 510(k) submission for a physical device.

Summary relevant to the document:

The provided 510(k) submission for the "Single Use Cytology Brush" demonstrates that the device is substantially equivalent to a predicate device (K172663). This equivalence is based on:

• Similar intended use (collecting cells from the GI tract via endoscope).
• Similar technological characteristics (materials, design, configuration, packaging, sterilization).
• Successful completion of non-clinical bench testing for appearance, dimension, and operational performance, which all yielded "passing" results.
• Compliance with relevant ISO standards for biological evaluation and sterilization.
• Crucially, Section 9 states: "Clinical Test is not applicable for the proposed device. No clinical study is included in this submission." This confirms that no human clinical performance study was conducted or required for this 510(k) clearance, and therefore, no data related to AI/ML performance on patient data, expert ground truth, or MRMC studies would be present.

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The Single Use Hemoclip Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: (1) endoscopic marking, (2) hemostasis for (a) mucosal / sub-mucosal defects

The proposed device Single Use Hemoclip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

The provided text describes a 510(k) premarket notification for a medical device (Single Use Hemoclip) and demonstrates its substantial equivalence to predicate devices. However, the document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device, which the provided prompt seems to be specifically asking for.

The acceptance criteria typically outlined in AI/ML medical device submissions (as per the prompt's structure) would include metrics like sensitivity, specificity, AUC, and performance targets against "ground truth" established by experts. The provided document instead focuses on equivalence testing for a physical medical device (a hemoclip), detailing mechanical and biological testing to ensure its safety and performance.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and reported device performance: Because the document does not define such criteria or report AI/ML performance metrics.
2. Sample size and data provenance for the test set: Not applicable for a physical device.
3. Number of experts and qualifications for ground truth: Not applicable for a physical device.
4. Adjudication method for the test set: Not applicable for a physical device.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for a physical device.
6. Standalone (algorithm-only) performance: Not applicable as there is no algorithm.
7. Type of ground truth used: Not applicable.
8. Training set sample size: Not applicable.
9. How ground truth for training set was established: Not applicable.

The "Performance data" section in the document (Page 8, Item 7) lists bench tests conducted on the Single Use Hemoclip, which are relevant for a physical device, but not for an AI/ML driven one:

• Dimensional verification
• Mechanical Integrity of Clip Assembly
• Clamping Strength Testing
• Tensile Strength Testing
• Release Force Testing
• Rotation Testing

The conclusion states that "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent." This is the "proof" for this specific device, based on physical and material properties, not AI/ML performance.

In summary, the provided document relates to the 510(k) clearance of a physical medical device and thus does not contain the information requested about AI/ML device acceptance criteria and performance studies.

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The device is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.

The Single Use Ureteral Access Sheath is a single use sterile device, provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. The Ureteral Access Sheath is comprised of five components: outer sheath base, outer sheath, dilator tube, locking clip and joint. The outer surface of the sheath has a hydrophilic coating. When activated, the hydrophilic feature allows for easier insertion and removal of the sheath. The sheath is offered in three French sizes: 10Fr, 12Fr and 14Fr, and range in effective length of sheath from 10.0cm (shortest) to 55cm (longest). The device is packaged in a peel-open pouch with a two-year shelf life.

The request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided FDA 510(k) summary.

However, the provided document does not contain information related to an AI/ML device or its performance criteria, expert review, MRMC studies, or training/test set details. The product described is a "Single Use Ureteral Access Sheath," which is a physical medical device. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through bench testing, material biocompatibility, and sterilization validation, not AI/ML model performance.

Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and related study details, as these are not present in the provided text.

Based on the document, here's what can be inferred about the criteria for this specific device:

Device: Single Use Ureteral Access Sheath (A physical medical device, not an AI/ML diagnostic tool)

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

The document describes the performance data through bench testing and compliance with various standards. It does not present specific quantitative acceptance criteria in a table format with corresponding performance results for each criterion, but rather states that tests were "passing" and standards were "met."

Sections that cannot be addressed due to the nature of the device and information in the document:

• 2. Sample sizes used for the test set and the data provenance: Not applicable to a physical device evaluated by bench testing; no "test set" of patient data is mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth in the context of AI/ML diagnostics is not relevant for this physical device.
• 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: Not applicable, as this is not an AI/ML device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable; the "truth" is based on material properties, mechanical performance, and compliance with recognized standards.
• 8. The sample size for the training set: Not applicable; no AI/ML model training is described.
• 9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document describes a 510(k) submission for a physical medical device. The "acceptance criteria" discussed relate to engineering, material, and sterilization standards for medical devices, rather than the performance of an AI/ML algorithm.

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The device is used for endoscopic injection into gastrointestinal mucosa, or to endoscopically introduce a sclerosing agent into selected sites to control actual or potential bleeding lesions in the digestive system.

The Sclerotherapy Needle device consists of Luer connector, handle, sheath, infusion tube, fixed button connection tube and needle. EO sterilization and use for single use only. The Sclerotherapy Needle device is designed to pass through the channel of endoscope to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1200mm,1800mm, 2000mm, 2300mm, and the minimum working channel is ф 2.8 mm.

This document describes the premarket notification (510(k)) for the Sclerotherapy Needle by Zhejiang Chuangxiang Medical Technology Co., LTD., which has been determined substantially equivalent to the predicate device. However, this document does not contain the specific acceptance criteria or a detailed study outlining device performance against such criteria for the Sclerotherapy Needle.

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device (Hangzhou AGS's Disposable Sclerotherapy Needle, K190032) based on similarities in design, configuration, intended use, and fundamental technology.

Here's an analysis of the information provided and what is missing in relation to your request:

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

• Missing. The document explicitly states: "The following bench tests were performed on Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing." However, it does not provide a table detailing specific acceptance criteria (e.g., maximum force for needle deployment, flow rate through the infusion tube, specific dimensions, etc.) or the measured performance values for these tests. It only states that the tests "were passing," which indicates compliance with internal or regulatory requirements but lacks the specific data requested.

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

• Missing. The document mentions "bench tests," but it does not specify the sample size for these tests or the provenance of the data.

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 / Missing. This device is a physical medical instrument (sclerotherapy needle), not an AI/imaging device requiring expert interpretation for ground truth establishment. The "bench tests" would typically be evaluated against engineering specifications, not expert consensus on diagnostic images.

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

• Not Applicable / Missing. As above, this concept typically applies to diagnostic studies with multiple readers, not bench testing of a physical medical device.

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 physical medical device, not an AI diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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):

• Not Applicable. For the bench tests performed ("Appearance, Physical properties"), the "ground truth" would be the device's adherence to engineering drawings, material specifications, and functional requirements, as validated by standard measurement techniques and test methods. It's not a diagnostic "ground truth" in the clinical sense.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

• Not Applicable. As above, no training set.

Summary based on the provided text:

The document confirms that the Sclerotherapy Needle underwent "bench tests" for "Appearance, Physical properties" and that the results "were passing." It also notes compliance with biocompatibility (ISO 10993), sterilization (ISO 11135), and ethylene oxide residuals standards (ISO 10993-7). However, the detailed acceptance criteria (what constitutes "passing" for each specific test of appearance and physical properties) and the actual performance data are not disclosed in this summary. The entire premise of this 510(k) summary is to demonstrate substantial equivalence to an existing predicate device rather than to provide a comprehensive performance study with explicit acceptance criteria and results.

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Single Use Grasping Forceps are indicated for use in gastrointestinal tract of the patient to grasp, clip, drag, and remove tissue or foreign particle during endoscopic procedures.

The proposed device Single Use Grasping Forceps is a sterile, single-use device, designed to pass through a 2.0mm and 2.8mm or greater working channel of an endoscope. The main components of Single Use Grasping Forceps are jaws, spring sheath and handle. This device can be used to grasping tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close. The Single Use Grasping Forceps has three models, the differences of these models are type of jaws, OD of the device and working length. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided document describes the acceptance criteria and the study that proves the performance of the Single Use Grasping Forceps (K191900).

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "performance test bench" and "Non clinical tests were conducted," indicating laboratory-based testing rather than clinical data from human subjects. As such, the concept of a "test set" in the context of clinical data provenance (country, retrospective/prospective) and sample size of human subjects doesn't directly apply here. The tests were performed on the device itself.

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

This information is not applicable. The study involves non-clinical bench testing and compliance with established standards for device performance, sterilization, and biocompatibility. There is no "ground truth" established by human experts in this context.

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

This information is not applicable, as the study is not based on expert adjudication of clinical findings.

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:

This information is not applicable. This is a 510(k) submission for a medical device (grasping forceps), not an AI-powered diagnostic or assistive technology.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" in this context is the fulfillment of established engineering specifications, performance standards (e.g., tensile strength, clamping strength, jaws opening/closing), and regulatory compliance as defined by international standards (ISO, ASTM, EN, USP) and FDA guidance for medical devices.

8. The sample size for the training set:

This information is not applicable. There is no concept of a "training set" as this is not an AI/machine learning model. The devices are manufactured and tested against predefined specifications.

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

This information is not applicable for the same reason as point 8.

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Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve.

Disposable Air/Water Valve: This device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow during a GI Endoscopic procedure.

Disposable Suction Valve: The device intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air during a GI Endoscopic procedure.

Disposable Biopsy Valve: This device is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of bio material during an endoscopic procedure.

Disposable Valve Sets includes either one air/water and suction valve or one air/water, suction and biopsy valve. So we divided into two models for these devices. One suction valve, air/water valve and biopsy valve means model B, one suction valve and air/water valve means model A. These devices are supplied sterile. These valves easily incorporate into infection prevention policies as a single use item, and these valves are suitable for Olympus 140/160/190/240/260 series endoscopes.

The document describes the acceptance criteria and study to demonstrate substantial equivalence for the Disposable Valve Sets (intended for use with endoscopes) by Zhejiang Chuangxiang Medical Technology Co., LTD. against the predicate device Endorate™ Valve Sets (K181509) by Smardata Suzhou Co., Ltd.

Here's the detailed breakdown as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner (e.g., specific thresholds and measured values). Instead, it states that "In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." and "The testing successfully demonstrated essential performance is achieved before and after the shelf life test."

The following tests were performed and implicitly form the basis of the acceptance criteria by ensuring the device meets required specifications:

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 exact sample sizes used for each of the in-vitro performance tests. It generally states that "In-vitro Testing has been performed" on "components, subassemblies, and/or full devices."

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, given that "Zhejiang Chuangxiang Medical Technology Co., LTD." is located in Hangzhou, Zhejiang, China, it is highly probable that the testing was conducted in China. These would be considered prospective laboratory tests using newly manufactured device samples.

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 device is a physical medical instrument (valve sets), not an AI algorithm or diagnostic tool that relies on expert interpretation of data or images to establish a "ground truth." Therefore, the concept of "number of experts used to establish the ground truth" is not applicable in this context. The "ground truth" for this device's performance is established by objective engineering and safety standards (e.g., flow rates, leak resistance, mechanical force, biocompatibility standards).

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 for establishing ground truth in studies involving human interpretation (e.g., radiology reads), especially for AI clinical trials. The performance of these physical valves is assessed against predefined engineering and material standards through objective laboratory measurements.

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 (endoscope valve sets), not an artificial intelligence-powered diagnostic or assistive tool. MRMC studies are used to evaluate AI's impact on human reader performance.

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

Not applicable. This is a physical medical device. The concept of "standalone algorithm performance" does not apply. The performance tests evaluate the device itself.

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

The "ground truth" for the performance tests of the Disposable Valve Sets is based on objective engineering and safety specifications and recognized international standards. This includes:

• Physical performance criteria: Such as vacuum leak rates, flow rates (water and air), depression force, and leak resistance (squeegee leak test). These are quantifiable measurements.
• Sterilization standards: Meeting criteria defined in ISO 10993-7 for EO residual and achieving a SAL of 10⁻⁶.
• Shelf-life standards: Compliance with ASTM F1980-16 for accelerated aging and ISO 11607-1/2 for packaging.
• Biocompatibility standards: Compliance with FDA Guidance and ISO 10993-1 for cytotoxicity, sensitization, and intracutaneous irritation.

There is no "expert consensus" or "pathology" involved in determining if a valve leaks or if it's biocompatible beyond interpreting the results of the objective tests against established thresholds.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing processes are validated through engineering principles and testing.

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

Not applicable, as there is no training set for a physical medical device.

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The Disposable Biopsy Valve is used to cover the biopsy/suction channel of Olympus® and Fujinon® or Pentax® gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

The Disposable Biopsy Valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Disposable Biopsy Valve provides sealable access via the working channel port of an endoscope for surgical instruments. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free. The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve. The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.

The provided document is a 510(k) premarket notification for a medical device: the Disposable Biopsy Valve. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.

However, the document does not contain any information regarding the acceptance criteria for a study proving the device meets those criteria, nor details of such a study.

Specifically, the document states under "7. Non-Clinical Testing":
"The device has undergone both bench testing of performance and laboratory biocompatibility testing for cytotoxicity, sensitization, intracutaneous injection test, and system injection test, in accordance with 21 CFR, Part 58. The Single Use Biopsy Valve results in no safety or efficacy concerns regarding biocompatibility or performance. Likewise, in conformance with 21 CFR 807.92(b)(3), the device performs as well as the predicate in all testing performed."

And under "Performance testing" in the comparison table (pages 7 and 8):
"Design verification Pressure test with valve closed - the device holds pressure for 1 Min at 10 PSI"
"Design verification Pressure test with instrument inserted - the device holds pressure for 1 Min at 10 PSI"
"Design verification Pressure test: Following removal of instrument the device holds pressure for 1 Min at 10 PSI"

While these are performance tests, they are described as "Design verification" and do not provide:

1. A table of acceptance criteria and reported device performance. The document lists the tests performed (pressure tests) and states the device "holds pressure for 1 Min at 10 PSI", but it doesn't explicitly state quantitative acceptance criteria (e.g., "must hold pressure for minimum of X minutes at Y PSI") against which a reported performance would be quantitatively compared.
2. Sample size used for the test set and data provenance: Not specified.
3. Number of experts used to establish ground truth and their qualifications: Not applicable for these types of physical performance and biocompatibility bench tests.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: No such study described. The device is a physical component (biopsy valve), not an AI/imaging device that would typically involve human reader studies.
6. Standalone (algorithm only) performance: Not applicable as this is a physical device, not an algorithm.
7. Type of ground truth used: For these bench tests, ground truth would be the physical measurements and observations of the device's performance under test conditions.
8. Sample size for the training set: Not applicable; this is a physical device, not a machine learning model.
9. How ground truth for the training set was established: Not applicable.

In summary, the document refers to "bench testing of performance" and "design verification pressure tests" but does not provide the detailed study information requested, such as specific acceptance criteria tables, sample sizes, or details typically associated with clinical or AI/imaging performance studies.

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The Single Use Hemoclip device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

(1) endoscopic marking,

(2) hemostasis for
(a) mucosal / sub-mucosal defects

The proposed device Single Use Hemoclip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

The provided text is a 510(k) summary for the "Single Use Hemoclip" device. It outlines the device's characteristics, indications for use, and comparison to predicate devices, along with performance data. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study that proves the device meets them, particularly for AI/human reader performance.

This document focuses on the substantial equivalence of a medical device (a hemoclip) to previously cleared devices based on physical and mechanical properties, not on the performance of a diagnostic AI algorithm that would typically involve acceptance criteria related to sensitivity, specificity, or human reader studies.

Here's an analysis of what information is present and what is missing from the provided text:

Information Present:

• Device Name: Single Use Hemoclip
• Predicate Devices: Sterile Repositionable Hemostasis Clipping Device (K152001) and SureClipTM Repositionable Hemostasis Clip (K161463).
• Bench Tests Performed:
  • Appearance
  • Dimensional verification
  • Clamping Strength Testing
  • Release Force Testing
  • Open and Close Mechanical Integrity of Clip Assembly
  • Tensile Strength Testing
  • Rotation Testing
• Conclusion from Bench Tests: "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent."
• Clinical Study: "No clinical study is included in this submission."
• Ground Truth for Manufacturing/Bench Testing: Implied by ISO standards (ISO 10993, ISO 11135-1, ISO 10993-7) and the specific bench tests (e.g., dimensional verification would involve measuring against design specifications).

Information Missing (and why it's missing from this specific document type):

The majority of your questions are relevant to the evaluation of a diagnostic AI device or a device where human interpretation or a specific performance metric (like accuracy, sensitivity, specificity) is key to its safety and effectiveness. This document describes a physical medical device (a hemoclip) and its physical and mechanical performance. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/diagnostic algorithm are not directly applicable here.

Here's why many of your specific questions cannot be answered from this document:

1. Table of acceptance criteria and reported device performance (for AI): Not applicable. The "performance data" listed are for mechanical integrity and dimensions, not diagnostic accuracy.
2. Sample size used for the test set and data provenance (e.g. country of origin, retrospective/prospective): Not applicable for an AI test set. The "tests" were bench tests on the physical device. The relevant "sample size" would be the number of devices tested for each bench test, which is not detailed here. No patient data is involved.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. Ground truth for a physical device's mechanical properties is based on engineering specifications and measurement standards, not expert reader consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human interpretation requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, effect size: No. Clinical studies were not conducted, and this is not a diagnostic device requiring human reader evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the ground truth would be the engineering design specifications and industry standards for mechanical performance (e.g., how much force the clip should withstand, its dimensions). This is implied by the listed ISO standards.
8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

In summary:

This 510(k) pertains to a physical medical device (a hemoclip) and its substantial equivalence based on bench testing of mechanical and physical properties. The framework of acceptance criteria and study design you've described (particularly questions 2-6 and 8-9) is primarily relevant to diagnostic AI/machine learning devices or clinical studies involving diagnostic accuracy or human interpretation, which are not detailed or applicable in this specific regulatory submission for this type of device.

The "acceptance criteria" for this device would be its ability to meet the specified mechanical and dimensional requirements, demonstrating equivalence to the predicate devices, as shown by the listed bench tests. The full details of these bench tests (e.g., the number of clips tested for clamping strength, the specific force values) are not provided in this summary but would be part of the full 510(k) submission.

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