(260 days)
The device is designed to be used with an Endoscope to deliver a Ligation Loop designed to control bleeding following polypectomy of pedunculated polyps.
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.
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.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.