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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 Hemoclip is indicated for endoscopic clip placement within the digestive tract for the purpose of:

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

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Spring hose near clip end, Connect end, Plastic Coated Spring Tube / Spring Tube and Handle part. EO Sterilization and use for single use only. For our proposed Hemoclip, the release part could connect and release the clips repeatedly.

We include 5 series for this submission, 55501series, 55502 series, 55504 series and 55505 series. 55501 series and 55502 series are models consist of release part and clip part, and the release part and clip part are already combined, no additional separate clips include, 55501series and 55502 series are reloadable, the release part could connect and release clips repeatedly. 55503 series are models only consist of separate clip part, and the release part of 55501, 55502, 55503 and 55504 series can connect with the separate clip (55503 series) repeatedly. 55504 and 55505 series are models consist of one preloaded Hemoclip (consist of release part and clip part, and the release part and clip part are already combined) and additional separate clips, 55504 series and 55505 series are reloadable, the release part can connect separate clips and release clips repeatedly.

The provided text describes a 510(k) summary for a medical device called Hemoclip. This document does not pertain to an AI/ML device, therefore, the requested information regarding acceptance criteria and study details for such a device is not applicable. The Hemoclip is a medical device for endoscopic clip placement and its clearance is based on substantial equivalence to a predicate device, not on AI/ML performance metrics.

Specifically, the document states:

• No Clinical test is included in this submission. (Section 5.9)
• The performance data provided relates to non-clinical performance (shelf life validation, packaging validation, biocompatibility, and sterility) to meet design specifications and show substantial equivalence to the predicate device (Section 5.8).

As such, I cannot extract the acceptance criteria, study details, human reader performance, standalone algorithm performance, or ground truth information relevant to an AI/ML device from this document.

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

Endoscopic marking,

Hemostasis for

·Mucosal/sub-mucosal defects

The proposed device Disposable Dual Action Tissue Clip is a sterile, single-use endoscopic clipping device, intended to be used in flexible endoscopy for the compression 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 10 ° and placed in a sterility maintenance package to ensure a shelf life of 1 year.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, along with the requested details, because the provided text is a 510(k) summary for a medical device (Disposable Dual Action Tissue Clip) and does not contain detailed information about specific acceptance criteria or a dedicated study report with performance data.

The document states that "Performance testing was conducted to demonstrate the essential performance of the proposed device... and confirmed that the proposed device works as intended with the compatible devices." It then lists various bench tests performed (Dimension, Release Force, Clamping Strength, Tensile Strength, etc.) and mentions that these were "tested and evaluated as substantially equivalent to the predicate device."

However, it does not provide:

• A table of specific acceptance criteria (e.g., "Clamping Strength must be > X N") and corresponding reported device performance values.
• Sample sizes for test sets (beyond implying "bench tests").
• Data provenance for any performance data.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies, as it explicitly states "No animal study is included in this submission" and "No clinical study is included in this submission."
• Details about the training set or its ground truth, as this is a mechanical device subject to bench testing, not an AI/ML algorithm.

Therefore, I cannot fulfill your request for the specific comparative performance data, sample sizes, and expert details as they are not present in the provided FDA 510(k) summary.

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