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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

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:

• Appearance
• Rotation performance
• Release force
• Clamping strength
• Relocation
• Tensile strength
• Dimension
• Mechanical integrity of clip assembly
• Scope compatibility/usability
• Endoscope damage
• Torque
• Clip approach
• Three ring handle strength

Specifically noted that the three-ring model's tension tests showed results similar to the predicate device, able to withstand clinical use forces. |

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 , 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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The Disposable Hemostatic Clips 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 Hemostatic Clips consist of one pre-loaded clip and delivery system for single patient use only. It 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 five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, 13mm and 16mm, and the device effective length is available in 1650mm, 1950mm and 2300mm.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for a medical imaging or AI-driven diagnostic device.

The document is an FDA 510(k) clearance letter for a Disposable Hemostatic Clips device (K232450) manufactured by Zhejiang Soudon Medical Technology Co.,Ltd. It primarily discusses the device's substantial equivalence to a predicate device, its indications for use, and manufacturing/regulatory compliance.

Here's why the requested information cannot be extracted:

• Device Type: The device is a physical medical instrument (hemostatic clips), not an AI algorithm, medical imaging device, or diagnostic tool that would typically have performance criteria like sensitivity, specificity, or AUC based on a test set and ground truth established by experts.
• Study Type: The document explicitly states under "6. Clinical Test Data" that "No Clinical Study is included in this submission." The non-clinical performance data section ("5. Non-clinical Performance Data") lists bench tests (e.g., appearance, dimensional verification, force tests) which are relevant to the physical and mechanical properties of the clips, not their diagnostic accuracy or performance in a clinical setting compared to human readers.
• Absence of AI/Diagnostic Metrics: There is no mention of sensitivity, specificity, accuracy, expert readers, ground truth establishment, or any other metrics common to the type of studies you're asking about for AI or imaging devices.

Therefore, I cannot populate the requested table or answer the questions related to acceptance criteria, AI performance, test set details, expert qualifications, or adjudication methods based on the provided text.

Ask a specific question about this device