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The Disposable Hemoclip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

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

The Disposable Hemoclip is the key and common accessory in the diagnosis and treatment procedure of digestive endoscope. As a single use instrument, the disposable hemoclip does not allow to be used by twice, and cannot be separated by components except to be used as well. It is also a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle and tube. The delivery system is constructed using stainless steel and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1600mm, 1800mm, 2100mm and 2300mm working lengths.
The clip is made of stainless-steel material and deployed from the delivery system during use. The clip jaws are designed that they can be opened and closed up to five 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 provided text is a 510(k) Summary for a medical device called "Disposable Hemoclip (AF series)". It describes the device, its intended use, a comparison with a predicate device, and the non-clinical data used to demonstrate substantial equivalence.

However, the document does not contain information about:

• A table of acceptance criteria and the reported device performance in the sense of predefined thresholds for clinical efficacy or accuracy. Instead, it lists various non-clinical tests performed.
• Sample sizes used for a "test set" in a clinical study because no clinical studies were performed.
• Data provenance, number of experts, adjudication methods, or MRMC studies, as these relate to clinical data which is explicitly stated as N/A.
• Standalone algorithm performance or details about ground truth for training data, as this is a physical medical device, not an AI/software device.

Therefore, many of the requested items cannot be provided from the given input.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present "acceptance criteria" in the format of specific thresholds for clinical performance (e.g., sensitivity, specificity, accuracy) because it relies on non-clinical testing for substantial equivalence. Instead, it lists various non-clinical tests performed to demonstrate that the subject device performs similarly to the predicate device. The "reported device performance" is essentially that the device "met all design specifications" and that "test results demonstrate substantial equivalence between the subject device and the predicate device" for each test.

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

• Test Set Sample Size: Not applicable. The submission relies on non-clinical (bench) testing, not clinical studies with patients or human data to form a "test set" in the context of clinical performance.
• Data Provenance: The non-clinical tests were conducted internally or by contract labs following recognized standards.

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

• Not applicable. No clinical studies were conducted, and therefore no ground truth was established by medical experts for a test set.

4. Adjudication method for the test set

• Not applicable. No clinical studies requiring adjudication were performed.

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 (hemoclip), not an AI/software device, and no MRMC studies were performed.

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

• The "ground truth" for the non-clinical tests was established by adhering to recognized international and FDA standards (e.g., ISO, ASTM, USP) for biocompatibility, sterilization, shelf life, and mechanical properties. The performance of the predicate device also served as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

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

• Not applicable, for the same reason as above.

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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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Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking, 2 ) Hemostasis for: Mucosal/sub-mucosal defects

The clip is pre-installed at the front of the chuck releaser, the chuck releaser is delivered by the conveyor duct through the endoscope to the Gastrointestinal (GI) tract system finds the bleeding site, thumb ring releases the chuck, so that the clip clamps the bleeding site to stop the bleeding.

The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the HC series. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed no more than five times prior to deployment, aiding in repositioning of the clip at the lesion site.

There are 30 models of Disposable Hemoclip.The main structure and material of each specification model are completely consistent. The outer tube of the plastic wrap type has one more layer of plastic than that of the ordinary type. The material is PE, but the other is the same.

This document describes the premarket notification for the "Disposable Hemoclip" (K213217) and its substantial equivalence to a predicate device. The information details non-clinical tests conducted to demonstrate the device meets acceptance criteria.

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

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

   • Sample size: The document does not explicitly state the numerical sample size for each performance test. It refers to "a piece of 10cm*10cm isolated pig stomach tissue" for certain tests (e.g., Release the performance, Clamping force, Repositionability, Hemoclip assembly mechanical integrity) and "sample block comparison" for surface roughness. For other tests like reducing substances, extractable metal content, pH, evaporation residue, and UV absorbance, it references using specific volumes of test solutions (e.g., "0.2g sample", "1ml of water", "10mL of the test solution", "25mL of the test solution", "50 mL of the test solution"). The biological tests (cytotoxicity, skin sensitization, acute systemic toxicity, pyrogens, sub-acute systemic toxicity) would have their own sample sizes as per the ISO standards cited, but these are not provided in this summary.
   • Data provenance: The data is based on non-clinical testing conducted by the manufacturer, Beijing ZKSK Technology Co., Ltd., in China. The tissue model used in several tests is "isolated pig stomach tissue," indicating an ex-vivo or in-vitro animal tissue model. All results are from laboratory tests performed on the device itself or its materials, not human clinical trials. Thus, the data provenance is retrospective (tests already performed) and from the manufacturer's facility in China.

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

   • Not applicable. This submission is for a medical device (hemoclip) and relies on objective, quantifiable performance and biocompatibility testing against established standards, not on expert-adjudicated ground truth like in diagnostic imaging with AI. The "ground truth" here is derived directly from the physical properties of the device and its interaction with test materials, measured according to recognized test methodologies and standards.

4. Adjudication method for the test set:

   • Not applicable. As described above, the evaluation is based on objective measurements and adherence to specific numerical or qualitative criteria (e.g., "Meet the requirements", specific values for chemical tests, visual observation of functionality), not on human expert 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 manual endoscopic tool, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

   • Not applicable. This is not an algorithm-only device. It is a physical medical device. The "standalone" performance testing refers to the device's inherent mechanical, material, and functional properties as evaluated in the non-clinical tests.

7. The type of ground truth used:

   • The "ground truth" for the non-clinical tests is established by:
     • Standardized measurement methodologies: Testing performed according to recognized international and national standards (ISO, ASTM, USP).
     • Objective performance criteria: Specific quantitative thresholds (e.g., force values, concentration limits, roughness parameters) and qualitative observations (e.g., smooth rotation, no separation, no cytotoxicity) defined in the acceptance criteria.
     • Material properties and chemical analysis results: Direct measurements of material hardness, chemical residues, extractables, pH, and UV absorbance.
     • Functional demonstrations: Observing the device's ability to open, close, clamp, release, and rotate as intended with a tissue model (isolated pig stomach tissue).

8. The sample size for the training set:

   • Not applicable. This submission concerns a physical medical device, not an AI model requiring a training set.

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

   • Not applicable, as no training set was used.

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