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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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Disposable Linear Stapler, Model KYFB-30 / 60 / 90: The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues.
Disposable Linear Cutter, Model KYQII-60 / 80 / 100: The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

General Disposable Linear Stapler: The Disposable Linear Stapler delivers two staggered rows of titanium staples to approximate internal tissues. The instrument is available in three sizes to accommodate different tissues. Staple height is adjustable to compensate for various tissue thickness .The 30 mm instruments create a 30 mm staple line, the 60 mm instruments create a 60 mm staple line, the 90 mm instruments create a 90 mm staple line.
Disposable Linear Cutter: The disposable linear cutter and the cartridge for disposable linear cutter have applications in abdominal gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

The provided text is a 510(k) Summary for a medical device (Disposable Linear Stapler and Disposable Linear Cutter). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device through clinical studies in the way an AI/ML device submission would.

Therefore, the requested information in the prompt, such as acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, is not applicable to this document, as it describes a traditional medical device submission for a stapler/cutter, not an AI/ML device.

The study described is a set of bench tests and biocompatibility tests to demonstrate substantial equivalence to existing predicate devices, not to establish novel performance criteria for an AI/ML system.

Here's a breakdown of the "studies" mentioned, as they relate to a traditional device submission:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of submission. The performance is assessed against the predicate device through bench tests.

   • Bench Testing:
     • Acceptance Criteria (Implied): Energy to deliver staples and energy to remove staples should be consistent with the predicate device.
     • Reported Performance: "Bench testing was performed to demonstrate the energy to deliver staples and also to remove staples was consistent with the predicate device."
   • Biocompatibility Testing:
     • Acceptance Criteria (Implied): Construction material passes ISO 10993 benchmarks.
     • Reported Performance: "The devices successfully passed tests for ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11."
   • Sterility Testing:
     • Acceptance Criteria (Implied): Sterilization methodology is sufficient and packaging maintains sterility for 3-year shelf life.
     • Reported Performance: "Testing was performed to ISO 11137-1:2006, ISO 11137-2:2006, ISO 11737-1:2006 and ISO 11737-2:2009, ISO 11607-1:2006, ASTM F1929-98 (2004), ASTM F1980-01 and ASTM D3078-02 (2008) with the products successfully passing all tests."

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device. For a physical device, samples would refer to the number of devices tested in bench studies. The document does not specify the number of individual staplers/cutters tested, only that "bench testing was performed." Data provenance is from internal testing 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. Ground truth for a physical device's performance often comes from engineering specifications and testing against established standards, not expert adjudication in the clinical sense.

4. Adjudication method: 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. This device is a surgical stapler/cutter, not an imaging or diagnostic AI tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used: For the bench and biocompatibility tests, the "ground truth" is defined by the requirements of the international and ASTM standards cited (e.g., ISO 5832-2:1999, ASTM F67-06, ISO 10993 series, ISO 11137 series, ISO 11737 series, ISO 11607-1:2006, ASTM F1929-98, ASTM F1980-01, ASTM D3078-02). These standards establish mechanical properties, material safety, and sterility assurance levels.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

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

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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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