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The Disposable Hemostatic Clips is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations only via a straight or side viewing flexible endoscope for the purpose of : 1) Endoscopic marking; 2) Hemostasis for: A) Mucosal/sub-mucosal defects < 3cm. B) Bleeding ulcers. C) Polyps < 1.5cm in diameter. D) Diverticula in the colon. E) Arteries < 2 mm. F) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. 3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively 4) Anchoring to affix jejunal feeding tubes to the wall of the small bowel

The proposed device is consisted of a clip section. The delivery section. The delivery section include: slide bar, slip ring, protective sleeve, rotation head, coated spring tube, slip ring holder, traction assembly, connecting tube, decoupled piece, decoupled shrapnel, rotation sleeve. And the clip section include: clip, sliding block, shaft and rocker arm. The clip is made of stainless steel. The clip can be opened and closed more than five times prior to deployment, aiding in repositioning of the lesion site. The proposed device is available in single ring and three ring models, and each case is divided into rotatable and non-rotatable clip. The effective length of the proposed device includes 1250mm, 1650mm, 2350mm and the opening width is 9mm, 11mm. 13mm and 16mm. The proposed devices are provided in sterile and single use.

The provided text describes the 510(k) submission for a medical device, the "Disposable Hemostatic Clips." This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Crucially, the document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide information regarding:

• Acceptance Criteria and Reported Device Performance (Table): There are no clinical performance metrics of the device against "acceptance criteria" presented from a clinical study. The document details non-clinical tests and their pass/fail status, indicating they met product requirements, but not against specific acceptance criteria for clinical performance.
• Sample size and data provenance (test set): No clinical test set.
• Number of experts and qualifications (ground truth for test set): Not applicable for a clinical test set.
• Adjudication method (test set): Not applicable.
• MRMC comparative effectiveness study: Not conducted.
• Standalone (algorithm only) performance: Not applicable as this is a mechanical device, not an AI algorithm.
• Type of ground truth used (clinical): No clinical data to establish ground truth.
• Sample size for training set: No clinical training set.
• How ground truth for training set was established: No clinical training set.

However, I can provide information based on the non-clinical testing summarized in the document, framed as how the device "meets the acceptance criteria" for functional and safety performance, as demonstrated by bench testing and biocompatibility assessments.

Non-Clinical Acceptance Criteria and Reported Device Performance

The device's performance was evaluated through a series of non-clinical tests to verify it met design specifications and standards, demonstrating substantial equivalence to the predicate device. The "acceptance criteria" for these tests are implicitly that the device passes the specified tests and complies with the relevant ISO and ASTM standards.

Here's a summary of the non-clinical tests and their outcomes:

Study Proving the Device Meets Acceptance Criteria (Non-Clinical)

The "study" proving the device meets its non-clinical acceptance criteria consists of the comprehensive set of Non-Clinical Tests and Biocompatibility Testing.

1. Sample sizes used for the test set and the data provenance:

   • The document does not specify the exact sample sizes for each non-clinical test (e.g., number of units tested for tensile strength or rotation performance). It states "all tests were passed."
   • Data Provenance: The tests were performed by Ningbo Xinwell Medical Technology Co., Ltd. (China) or their designated testing facilities, as per the submission. This is internal testing data for the 510(k) submission.

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

   • Not applicable in the context of non-clinical, bench testing. The "ground truth" for these tests is defined by the established industry standards (ISO, ASTM, USP) and the device's design specifications. Conformance to these standards and specifications is evaluated through laboratory testing.

3. Adjudication method for the test set:

   • Not applicable as this refers to human review of clinical data. Non-clinical tests have pass/fail criteria based on objective measurements against defined standards.

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

   • No, a MRMC comparative effectiveness study was not done. The submission states: "No clinical study is included in this submission." This implies no clinical performance data involving human readers or patients, only bench and biocompatibility testing. The comparison to the predicate device is based on functional equivalence and meeting, or not raising new questions about, safety and effectiveness through non-clinical data.

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

   • Not applicable. This device is a mechanical hemostatic clip and delivery system, not an algorithm or AI-powered device.

6. The type of ground truth used:

   • For non-clinical performance and safety: The ground truth is defined by established international and national standards (ISO 10993, ISO 11135, ASTM F1929, ASTM F88/F88M, ASTM F1886/F1886M, USP <85>, ASTM D4169, ASTM F1980) and the device's internal design specifications and requirements. The "truth" is whether the device's physical properties and performance characteristics meet these objective, measurable standards.

7. The sample size for the training set:

   • Not applicable as there is no clinical study data, training set, or machine learning component cited.

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

   • Not applicable as there is no clinical study data, training set, or machine learning component cited.

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