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The Disposable Dual Action Tissue Closure Device is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only.

The Disposable Dual Action Tissue Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of:

1. Endoscopic marking:

2. Hemostasis for:

a.Mucosal/sub-mucosal defects < 5 cm,

b.Bleeding ulcers,

c.Polyps < 1.5 cm in diameter,

d.Diverticula in the colon,

e. Arteries < 2 mm,

3. As a supplementary method. closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

The proposed device Disposable Dual Action Tissue Closure Device is a sterile, single-use endoscopic clipping device, intended to be used in flexible endoscopy for the compression, manipulation of tissue in the gastrointestinal tract. It consists of two main components, delivery system and clip assembly. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

This document outlines the acceptance criteria and supporting studies for the Micro-Tech (Nanjing) Co., Ltd. Disposable Dual Action Tissue Closure Device (K233772).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device as substantially equivalent to a predicate device (K212748) except for one indication and shelf-life, and therefore, directly stated acceptance criteria are not explicitly presented as separate quantitative values for each performance test. Instead, the document relies on demonstrating that the proposed device performs the same or better than the predicate device for all shared characteristics, and that the changes in indications and shelf-life are supported by additional testing or literature.

Below is a table summarizing the performance data presented, emphasizing the comparison to the predicate device.

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

• Mechanical and Functional Performance Tests (Dimension, Open/Close, Compatibility, Forces, Strength, etc.): The document states that "The bench performance testing that was previously conducted on the predicate device and not re-conducted on the proposed device." This implies that the sample sizes for these tests were those used for the K212748 predicate device. The specific sample sizes for these tests are not provided in this summary. The data provenance would be from the original studies for K212748, likely prospective bench testing. The country of origin of this data is not specified, but given the manufacturer's location (China), it's highly probable the testing was conducted there or by affiliated labs.
• Shelf-life Testing: "Three-years accelerated aging tests were performed." The sample size for these accelerated aging tests is not specified. This would be prospective testing. The country of origin is not specified.
• Sterilization Validation: "The sterilization testing that was previously conducted on the predicate device and not re-conducted on the proposed device." The sample size for this is not provided but would refer to the tests for K212748.
• Biocompatibility Testing: "The biocompatibility performance testing that was previously conducted on the predicate device and not re-conducted on the proposed device." The sample size for this is not provided but would refer to the tests for K212748.
• MRI Compatibility Testing: "The MR compatibility performance testing that was previously conducted on the predicate device and not re-conducted on the proposed device." The sample size for this is not provided but would refer to the tests for K212748.
• Indication Change (Mucosal/sub-mucosal defects < 5 cm): "clinical literature was used to support changing the IFU." This suggests the test set for this particular change relied on retrospective data from published clinical studies, not new testing by the manufacturer. The specific sample sizes and provenance of these literature studies are not detailed in this summary.

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

• For all mechanical, functional, and material tests (including shelf-life, sterilization, biocompatibility, MRI compatibility), the "ground truth" is established by adherence to engineering specifications, regulatory standards (e.g., ISO, ASTM), and comparison to the predicate device's established performance. There is no mention of external human experts establishing ground truth for these technical tests in the sense of clinical interpretation.
• For the indication change regarding mucosal/sub-mucosal defects, the "ground truth" was established by clinical literature. The document does not specify the number of experts in these literature studies or their qualifications, as it references existing publications rather than new expert review panels for this submission.

4. Adjudication Method for the Test Set

• For the technical and performance testing (mechanical, functional, material, shelf-life, sterilization, MRI compatibility), no specific adjudication method is mentioned. Adherence to established test protocols and comparison to predicate device performance would be the primary method.
• For supporting the indication change with clinical literature, no adjudication method is described for the selection or interpretation of the literature. It's implicitly assumed that the referenced literature itself has undergone peer review and scientific scrutiny.

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. The submission explicitly states "No animal study is included in this submission. No clinical study is included in this submission."

Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance, as this device is a physical medical instrument, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical tissue closure device and does not involve an algorithm or human-in-the-loop performance in the sense of AI-driven medical imaging or diagnostics. The performance described is purely mechanical and functional.

7. The Type of Ground Truth Used

The ground truth used depends on the aspect being evaluated:

• Mechanical, Functional, Material, Sterilization, MRI Compatibility Performance: Established through objective physical measurements against specifications and regulatory standards (e.g., ISO 11135, ISO 10993-1, ASTM standards) and direct comparison to the predicate device's previously established performance.
• Shelf-life: Established through accelerated aging test data (ASTM F1980-16).
• Expanded Indication (Mucosal/Sub-mucosal defects < 5 cm): Established through clinical literature.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this device.

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