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The Disposable Circular Stapler has application throughout the alimentary tract for end-to-side and side-to-side anastomoses.

The Disposable Circular Staplers, can anastomose organs by firing into the tissues of alimentary canal two staggered (interior and exterior) rings of titanium staples and cutting off inside tissue with the circular blades simultaneously. The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. The instrument is activated by squeezing the handles firmly as far as they will go. Immediately after staple formation, the knife blade resects the excess tissue, creating a circular anastomosis.

The provided text is a 510(k) Summary for a medical device (Disposable Circular Stapler), which focuses on establishing substantial equivalence to a predicate device based on technical characteristics and performance testing. This document does not describe a study involving an AI/human reader in the loop, or the use of expert consensus/pathology for establishing ground truth as would be relevant for an AI/ML device. Therefore, much of the requested information cannot be extracted from this document.

However, based on the provided text, here's what can be extracted regarding acceptance criteria and the study:

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

The document mentions several performance tests were conducted. While specific acceptance criteria values are not explicitly stated, the implication is that the device met the criteria for each test to claim substantial equivalence.

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

• Sample size: Not specified in the document. The document only states that "the same testing submitted for the predicate was repeated."
• Data provenance: The testing was conducted by Changzhou Kangdi Medical Stapler Co., Ltd. The document does not specify the country of origin of the data beyond the company's location in China. The testing appears to be for the device itself rather than patient data, and thus is an in vitro/benchtop study.

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 stapler, and the "ground truth" for its performance is established through engineering and sterility testing, not expert interpretation of medical images or data.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements (e.g., dimensions, hardness, force, pressure resistance) or pass/fail criteria (e.g., visual inspection, sterility). There is no "adjudication" in the sense of resolving differences between expert opinions.

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 document describes a medical stapler, not an AI-powered diagnostic device.

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

Not applicable. This document describes a medical stapler, not an AI algorithm.

7. The type of ground truth used

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

• Engineering specifications and standards: For dimensions, sharpness, operational/cutting performance, staple formation, hardness, firing force, energy testing.
• Material standards: For implantable staple material (Standard for Unalloyed Titanium for Surgical Implant Applications).
• Biological evaluation standards: For biocompatibility (Biological Evaluation of Medical Devices, parts 1,3,5,6, 10 and 11).
• Packaging and sterility standards: USP standards for sterility and packaging verification.
• Corrosion resistance tests.

8. The sample size for the training set

Not applicable. This document describes a medical stapler, not an AI/ML device that requires a training set.

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

Not applicable.

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The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side anastomoses in both open and laparoscopic surgeries.

The Disposable Linear Stapler has application in the resection of tissue for abdominal. gynecological, pediatric and thoracic surgical procedures.

The Disposable Endoscopic Linear Cutter Stapler and Cartridge has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance and biliary structures.

The Disposable Linear Cutter Stapler Cartridge has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.

The Disposable Circular Stapler for Hemorrhoids has application for general treatment of hemorrhoids.

The Disposable Linear Stapler places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm and 90mm staple line length for use in various applications. Two staple sizes (3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure.

Disposable Circular stapler place a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. It is available in 20, 22, 24, 26, 29, 32mm six specifications. Two staple sizes (4.7mm and 5.6mm) are available to accommodate various tissue thicknesses.

Disposable Endoscopic Linear Cutter Stapler and Cartridge places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. It is available in 30mm, 45mm, 60mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 2 times for a total 3 firing in a single procedure.

Disposable Linear Cutter Stapler Cartridge places a two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.5mm. It may be reloaded and fired up to 5 times for a total 6 firings in a single procedure.

Disposable Circular Stapler for Hemorrhoids is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The device is available in 34mm with 4.6mm staple.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance in the format you specified.

The document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to predicate devices, not on presenting a detailed study proving the device meets specific acceptance criteria in the way you've outlined.

Here's what the document does provide and why it doesn't fit your request:

• Non-Clinical Test Conclusion: It mentions that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It lists several ISO and ASTM standards that the device complies with, in areas such as biological evaluation, sterilization residuals, irritation/hypersensitivity, bacterial endotoxins, and seal strength of packaging.
• No Clinical Study: It explicitly states, "No clinical study is included in this submission."
• Comparison Tables (Tables 1-5): These tables compare the proposed devices (various staplers) with predicate devices on technical characteristics like product code, regulation number, intended use, cutting mechanism, operation principle, safety mechanism, closed staple height, closed staple form, patient-contact material, sterilization method, endotoxin limit, and labeling. This comparison is to establish "substantial equivalence," not to detail acceptance criteria and performance against those criteria as a standalone study.

Therefore, I cannot extract:

1. A table of specific acceptance criteria and reported device performance. The document only mentions compliance with standards.
2. Sample size, data provenance, number of experts for ground truth, adjudication method, or ground truth type for a test set of a performance study.
3. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance.
4. Sample size and ground truth establishment for a training set.

The document's purpose is to demonstrate that the new devices are as safe and effective as already marketed devices, primarily through comparison of technical characteristics and adherence to general performance standards, rather than presenting a novel performance study against defined acceptance criteria.

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The Disposable Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The Disposable Linear Staplers and Reloads have application in the resection or transection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

The Disposable Hemorrhoidal Staple has application for general surgical treatment of hemorrhoids.

The Disposable Endoscopic Linear Cutter Staplers and Reloads have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.

The Disposable Linear Cutter Staplers and Reloads have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

The Disposable Curved Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.

The proposed device, Disposable Circular Stapler is a sterilized and disposable surgical instrument intended to be used throughout the alimentary tract for the creation of end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. It places a double staggered, circular row of titanium staples upon activation, which was actieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, and then a circular anastomosis is created. The staple is available in two specifications which are 4.8 mm and 5.2 mm to be used per different thickness of the tissue.

The proposed device, Disposable Linear Staplers and Reloads is a sterilized and disposable surgical instrument intended to be used in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. It places a double staggered row of titanium staples and is available in 30 mm, 45 mm, 60mm and 94 mm staple line length for use in various applications. Four staple sizes (3.8mm ,4.5 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings. The Disposable Linear Staplers and reloads have two configurations: (1) DLS serials are Disposable I he Disposable Linear Business and (2) DLR serials are reloads for Disposable Linear Staplers. Each of them has various specifications.

The proposed device, Disposable Hemorrhoidal Stapier is a sterilized and disposable surgical The "proposed" Corner and surgical treatment of hemorrhoids. It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately It is a set of insultions and photo a knowlar knife blade resects the excess of compressed mucosa. The aller the formation of supres, and them. Sets are commonly used in the procedures for prolapsed and Hemorrhoids. They are also used for sets are ochanced , and circular or semicircular stapling of anorectic tissue is required.

The proposed device, Disposable Endoscopic Linear Cutter Staplers and Reloads is a sterilized and I ile proposed unstrument, which has applications in abdominal, gynecologic, pediatic and thoracic surgery for resection, and creation of anastomoses. They may be used for thoracter bargery 200 on of liver substance, hepatic vasculature and biliary structures. It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The size of the staples is decided by selecting 3.5 mm, or 4.8 mm reload. The Endoscopic Linear Cutter can be adapted for all of the reload sizes available. The Disposable Endoscopic Linear Cutter Staplers and Reloads have two configurations: (1) DEC The Disposable Endoscopic Linear Cutter Staplers and Reloads, and (2) DER serials are sellas for Disposable Endoscopic Linear Cutter Staplers. Each of them has various specifications. Detail specifications are presented in Section 4.5 Model Description.

The proposed device, Disposable Linear Cutter Staplers and Reloads is a sterilized and disposable surgical instrument, which has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses. It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Disposable Linear Cutter Staplers and Reloads are available in 55 between the two 20 mm and 100 mm lengths. Reloads are available in four staple sizes to accommodate उन्द various tissue thicknesses: 3.8 mm, 4.0mm, 4.5mm and 4.8 mm. The Disposable Linear Cutter Staplers and Reloads has two configurations: (1) DLC serials is The Disposable Linear Cutter Staplers Disposable Linear Cutter Staplers with Reloads, and (2) DCR serials is Reloads for Disposable Linear Cutter Staplers. Each of them has various specifications.

The proposed device, Disposable Curved Cutter Stapler is a sterilized and disposable surgical instrument, which is mainly suitable for low rectal resection and anastomosis of tissues where manual anastomosis is difficult. It places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines.

The provided document is a 510(k) Summary for various surgical staplers. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone clinical study report with detailed acceptance criteria and performance data for a new AI/ML device.

Therefore, the requested information, particularly regarding specifics of a study proving device performance against acceptance criteria, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or specific AI algorithm performance metrics, is not present in this document.

This document outlines the intended use, technological characteristics, and comparison to predicate devices for a suite of surgical staplers. The "Non-Clinical Test Conclusion" section {4} states that tests were conducted to verify the device met all design specifications and was substantially equivalent to the predicate device. These tests primarily cover physical performance, material properties, and packaging integrity.

Here's a table summarizing the acceptance criteria and reported device performance for one of the devices (Disposable Circular Stapler) as presented in the document:

Table of Acceptance Criteria and Reported Device Performance (Disposable Circular Stapler)

Regarding the other requested information:

1. Sample size used for the test set and the data provenance: This document does not specify sample sizes for specific tests or the provenance of any "data provenance" (e.g., country of origin, retrospective/prospective clinical data) as it's a submission for a medical device (surgical staplers) based on non-clinical performance and substantial equivalence to existing predicate devices, not an AI/ML diagnostic or prognostic tool. The tests mentioned are "Performance Testing, including Physical Specification, Closed Staple Height Dimensions, Pressure Perforrnality Tisting, Mercums Tensile Strength of Staple Line Repair and Force Required to Fire Stapler" {4}.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for surgical staplers like this would typically be established through engineering specifications, material standards, and performance testing against those standards, not expert consensus on interpretations of data.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done as this is not an AI/ML-driven diagnostic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical instrument.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device would be its adherence to established engineering specifications, material standards (e.g., ASTM F 67-06 for titanium), and performance thresholds (e.g., pressure resistance, hardness) determined through non-clinical testing.
7. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission demonstrates substantial equivalence of a physical medical device (surgical staplers) to previously cleared devices based on non-clinical performance testing and design specifications, rather than clinical studies or AI/ML algorithm evaluations which would require the detailed information requested.

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The Disposable Circular Stapler has application throughout the alimentary tract for end to-end, end-to-side and side-to-side anastomoses.

The disposable circular stapler is preloaded with two staggered rows of 26mm titanium staples in both inner and outer circles. After the deploying of the instrument, the circular knife blade inside the instrument can cut off excess tissue automatically to create a circular anastomosis. The instrument is fired by squeezing the trigger handle firmly as far as it will go. The size of the anastomosis site is determined by the diameter of the selected circular knife blade.

The provided text is a 510(k) summary for a medical device (Disposable Circular Stapler, YH-26) and focuses on establishing substantial equivalence to a predicate device. It does not describe an AI/ML device or a study that evaluates its performance against acceptance criteria in the typical sense of AI model metrics (like AUC, sensitivity, specificity).

Therefore, I cannot extract the information required for an AI/ML device as per your request related to:

• A table of acceptance criteria and reported device performance (in terms of AI metrics)
• Sample sizes and data provenance for test sets
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone performance
• Type of ground truth used (for AI)
• Sample size for training set
• How ground truth for the training set was established

However, I can describe the acceptance criteria and study that proves the device meets its acceptance criteria based on the provided document, which is a regulatory submission for a traditional medical device.

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

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

The document does not explicitly state the sample sizes for the bench testing, biocompatibility testing, or sterility testing. It describes these as "bench testing," "biocompatibility testing," and "sterility testing" without detailing the number of units or samples used in each test.

The data provenance is from laboratory and bench tests conducted by or for Changzhou City Zhiye Medical Devices Institute Co., Ltd. (China). The data is prospective in the sense that these tests were performed specifically for this 510(k) submission to demonstrate compliance.

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

This is not applicable as the study did not involve human experts establishing "ground truth" in the context of diagnostic interpretation. The "ground truth" for this device focused on objective engineering, material, and biological safety standards. The "experts" would be the scientists, engineers, and microbiologists conducting and evaluating the tests against established international and ASTM standards.

4. Adjudication method for the test set

Not applicable. The tests performed are objective measurements against defined standards, not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI tools that assist human interpretation, not for mechanical surgical staplers.

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

Not applicable. This device is a mechanical surgical instrument, not an algorithm or AI. Its performance is inherent to its design and manufacturing, tested objectively, and always used by a human surgeon ("human-in-the-loop" in a different sense).

7. The type of ground truth used

The "ground truth" for this device was established based on:

• Pre-defined international standards (e.g., ISO, ASTM) for materials, biocompatibility, and sterilization.
• Predicate device performance characteristics for functional aspects like staple insertion/extraction energy.
• Objective measurements and laboratory assays.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model, so there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, this question is irrelevant to the provided document.

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The Disposable Circular Stapler has application throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses.

The disposable circular stapler is preloaded with two staggered rows of titanium staples in both inner and outer circles. After the deploying of the instrument, the circular knife blade inside the instrument can cut off excess tissue automatically to create a circular anastomosis. The instrument is fired by squeezing the trigger handle firmly as far as it will go. The size of the anastomosis site is determined by the diameter of the selected circular knife blade.

The provided 510(k) summary (K100723) describes the Changzhou Kangdi Medical Stapler Co., Ltd. Disposable Circular Stapler. However, it does not contain information related to acceptance criteria or a study proving that an AI-driven device meets such criteria.

The document describes a medical device, a surgical stapler, and its equivalence to a predicate device. The performance testing section focuses on biocompatibility, general device performance standards (for implanted titanium), and package integrity/shelf-life assessments. These are all related to the physical and functional aspects of the hardware device, not an AI or software component.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or AI-related effectiveness studies, as these details are not present in the given text.

In summary, the provided text describes a traditional hardware medical device and its predicate equivalence, not an AI-driven device.

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The Disposable Circular Stapler is intended to be used throughout the alimentary tract for the creation of end-to-end and end-to-side anastomosis.

The Disposable Circular Stapler places a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. It is applicable to end-to-end and end-to-side anastomosis. The proposed device is provided EO sterilized.

The provided text is a 510(k) Summary for a medical device (Disposable Circular Stapler) and the FDA's response. It does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the way typically expected for an AI/CADe device. The "Testing Conclusion" section states: "Performance testing was conducted to validate and verify that the proposed device, Disposable Circular Stapler met all design specifications and was substantially equivalent to the predicate device." However, it does not provide details about what those design specifications (acceptance criteria) were, nor does it describe the study that was conducted.

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

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document states "Performance testing was conducted to validate and verify that the proposed device... met all design specifications," but it does not list these specific design specifications (acceptance criteria) or the quantitative results of the device's performance against them.

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

• Cannot be provided. The document states "Performance testing was conducted," but it does not specify any test set size, data provenance, or the nature of the data (e.g., in-vitro, ex-vivo, in-vivo animal, or human clinical 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):

• Cannot be provided. There is no mention of ground truth establishment by experts for a test set, as this is not a study of diagnostic accuracy or similar performance for which expert consensus would typically be required. The device is a surgical stapler, and its performance evaluation would likely involve mechanical and functional testing, not expert interpretation of outputs.

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

• Cannot be provided. As there's no mention of a test set or expert involvement, adjudication methods are not applicable and not discussed.

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:

• Cannot be provided. This is not an AI/CADe device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed or reported.

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

• Cannot be provided. This is a physical surgical device, not an algorithm. Standalone algorithm performance is not applicable.

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

• Cannot be provided. The concept of "ground truth" as typically applied in AI/CADe studies (e.g., for diagnostic accuracy) does not directly apply to the performance testing of a mechanical surgical stapler. Its "ground truth" would likely be defined by engineering specifications, material properties, and functional tests (e.g., staple formation, burst pressure, tissue compression, leak tests). The document does not detail these.

8. The sample size for the training set:

• Cannot be provided. The device is a physical stapler, not a machine learning model, so there is no training set in the context of AI.

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

• Cannot be provided. As above, there is no training set for this type of device.

In summary: The provided document is a 510(k) summary for a physical surgical device. It states that performance testing was conducted to verify that the device met design specifications and was substantially equivalent to a predicate device. However, it does not provide the specific details of these design specifications (acceptance criteria) or the methodology, sample sizes, or results of the performance testing in the manner typically expected for a detailed study report of an AI/CADe device. The questions posed are primarily relevant to AI/CADe device evaluation, which is not what this document addresses.

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