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The Single Use Reloadable Clip Applicators HX-810 Series, Long Clip HX-610 Series, Short Clip HX-610 Series and Super Short Clip HX-610-135XS have been designed to be used with an Olympus endoscope for endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:

(1) Endoscopic marking,

(2) Hemostasis for

(a) Mucosal/sub-mucosal defects

The instruments (AKA EZClip) have been designed to be used with an Olympus endoscopic Clip placement within the gastrointestinal (GI) tract in adult patients only for the purpose of:

(1) Endoscopic marking,

(2) Hemostasis for

(a) Mucosal/sub-mucosal defects

The provided text is a 510(k) summary for a medical device cleared by the FDA. It does not include information about a study based on analyzing medical images/data, establishing ground truth using experts, or evaluating AI performance. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets those criteria for such a system.

The document describes pre-clinical (bench) testing performed on a physical medical device (endoscopic clip applicator) and its components to demonstrate substantial equivalence to a predicate device.

Here's an analysis of what is available in the document, which primarily focuses on engineering and performance characteristics of the physical device:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests conducted, but it does not provide a table detailing specific acceptance criteria values and the quantitative reported performance for each criterion. It only states that "The subject Single Use Reloadable Clip Applicators (HX-810 Series) have satisfied the pre-defined acceptance criteria for each test item described in the test plan."

The tests performed were:

• Insertability
• Clip opening width
• Clip rotatability
• Clip capability
• Withdrawal from Endoscope
• Mechanical integrity of clip assembly
• Tensile Strength/coil to handle strength
• Applicator repetition

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text. The tests were performed on "finished devices, prior to and after simulated distribution and accelerated aging." This indicates bench testing rather than clinical data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of device and testing described. Ground truth established by medical experts is typically for diagnostic or prognostic systems that interpret medical data. The tests here are physical performance tests of a medical instrument.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for expert review of data/images, which is not what was performed for this device. These were bench tests against engineering specifications.

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 for an AI-powered diagnostic/interpretive system, not a physical medical instrument.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the physical device, the "ground truth" would be the engineering specifications and performance standards against which the device was tested (e.g., a clip's opening width must be X mm, a tensile strength must be Y Newtons). These are not established by expert consensus or pathology in the medical sense, but rather by engineering design and regulatory requirements.

8. The sample size for the training set

Not applicable. This is not a data-driven model that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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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.

Ask a specific question about this device