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The device is designed to be used with an Endoscope to deliver a Ligation Loop designed to control bleeding following polypectomy of pedunculated polyps.

Device Description

The Ligation Device is sterile and single-use, which consists of two main components, ligation loop and delivery system. And these two components provided in different sizes to consist different specifications of ligation device.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device called "Ligation Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or diagnostic accuracy through extensive clinical trials. Therefore, much of the requested information regarding clinical study setup, acceptance criteria, multi-reader multi-case studies, and ground truth establishment, which are typical for AI/ML-driven diagnostic devices, is not applicable or not present in this regulatory submission.

However, I can extract information related to non-clinical testing and performance comparisons.

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

The submission does not specify numerical "acceptance criteria" for the non-clinical tests in the usual sense (e.g., a specific threshold for release force). Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The "reported device performance" is implicitly that it passed these tests and was comparable to the predicate device.

Test Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Performance	Comparable to predicate in release force, tensile strength, clamping strength	Meets design specifications for release force, tensile strength, clamping strength, similar to predicate.
Biocompatibility (general)	No adverse biological reactions	Complies with ISO 10993 requirements.
Cytotoxicity	No cytotoxicity	No cytotoxicity.
Sensitization	No sensitization	No sensitization.
Irritation	No irritation	No irritation.
Acute Systemic Toxicity	No acute systemic toxicity	No acute systemic toxicity.
Subchronic Systemic Toxicity	No subchronic systemic toxicity	No subchronic systemic toxicity.
Subcutaneous Implantation	Histological responses similar to control sample	Histological responses around the test sample were similar to the control sample.
Pyrogenicity	No pyrogenicity	No pyrogenicity.
Sterilization	EO sterilized, SAL 10^-6^	EO sterilized, SAL 10^-6^ (validated per ISO 11135).
Shelf life	Two years	Two years.
Labeling	Conform to 21 CFR part 801	Conform to 21 CFR part 801.

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

The document explicitly states: "No clinical study is included in this submission." Therefore, there is no clinical test set, sample size, or data provenance information provided in this regulatory document. The evaluations were non-clinical (benchtop and biocompatibility).

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

Not applicable. No clinical test set or ground truth established by experts is mentioned in this non-clinical submission.

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

Not applicable. No clinical test set or adjudication process is mentioned.

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 device is a mechanical ligation device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a mechanical ligation device, not an algorithm.

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

Not applicable. For the non-clinical tests, "ground truth" would be the direct measurement results (e.g., force values, cytotoxicity assays) compared against predefined specifications or predicate device performance.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML model requiring a training set.

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

Not applicable. This is a mechanical device, not an AI/ML model requiring a training set and associated ground truth.

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K Number

K001744

Device Name

OLYMPUS ENDOSCOPIC LIGATION DEVICE

Manufacturer

OLYMPUS AMERICA, INC.