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The 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 <3cm
• Bleeding ulcers
• Arteries<2mm
• Polyps<1.5cm in diameter
• Diverticula in the colon
• Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection

3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.
4. As a supplementary method, closure of GI tract luminal perforations<20mm that can be treated conservatively.

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Plastic Coated Spring Tube / Spring Tube and Handle. EO Sterilization and use for single use only.
For 510 family, the grooves on the frap tube allow the released clip could be removed by snare loops. If the clip has been deployed, but its position is not satisfactory, or it affects the field of vision, we can remove it.

The provided text is a 510(k) summary for a medical device called "Hemoclip." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way an AI/ML device submission might.

Therefore, many of the requested elements for an AI/ML device study (like sample size for test/training, number of experts, adjudication methods, MRMC studies, and detailed ground truth establishment) are not applicable or not present in this document. This document describes a traditional medical device clearance, not an AI/ML product.

However, I can extract information related to the acceptance criteria and performance data that is provided for this traditional device.

Here's an attempt to answer your request based on the provided text, while noting where information is not available due to the nature of the submission (traditional medical device vs. AI/ML):

Device: Hemoclip (Endoscope Clipping Device)
Type of Device: Traditional Medical Device (Class II)

1. Table of Acceptance Criteria and the Reported Device Performance

The submission states, "The Hemoclip meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device."

While specific numeric acceptance criteria values are not provided in this summary, the document does list the performance tests conducted, implying these tests were used to demonstrate adherence to design specifications and substantial equivalence.

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

• Sample Size: Not specified in the provided summary. Performance testing was "non-clinical bench test."
• Data Provenance: Bench test data. No country of origin or retrospective/prospective distinction is relevant for these types of bench tests.

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

• Not Applicable. For mechanical and biocompatibility testing of a physical medical device, "experts" in the sense of medical professionals establishing ground truth for diagnostic purposes are not relevant. Testing is primarily objective and based on engineering and material science standards.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication is typically for resolving discrepancies in human expert labeling or diagnosis in AI studies. For physical device performance testing, adjudication methods are not typically used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• Not Applicable. This is a traditional medical device, not an AI-assisted diagnostic device. No human-in-the-loop study involving medical image readers was conducted or is relevant for this type of device.

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

• Not Applicable. This is a physical medical device (a Hemoclip), not a software algorithm.

7. The Type of Ground Truth Used

• For the performance data, the "ground truth" is defined by the design specifications and international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterility, and implied engineering specifications for mechanical properties). There is no "true positive/negative" ground truth as would be established for a diagnostic device.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable. As there is no training set, there's no ground truth to establish for it.

Summary for the Hemoclip K211787 Submission:

This 510(k) submission for the Hemoclip is for a traditional physical medical device used for endoscopic clip placement. The "acceptance criteria" revolve around established engineering design specifications, biocompatibility standards (ISO 10993), and sterility standards (ISO 11135). The "study" proving it meets these criteria consisted of non-clinical bench testing. The data presented demonstrates substantial equivalence to a legally marketed predicate device (K172727) by showing that differences do not raise new questions of safety or effectiveness. The concept of "ground truth" as applied to AI/ML diagnostics (expert consensus, pathology, outcomes) does not apply here; rather, the device's performance is objectively measured against predetermined engineering and material standards.

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