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The Haemoband Multi-Ligator includes suction and ligation capabilities. The ligator is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. It is for use only by trained medical personnel.

Device Description

The Haemoband Multi-Ligator is a simple handheld device which allows the user to hold the hemorrhoid tissue with an applied suction while slipping a ligation band around the tissue. The Haemoband Multi-Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with 4 preloaded non-latex rubber bands.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Haemoband Multi-Ligator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on proving device performance against specific acceptance criteria through a clinical study. Therefore, the document does not contain the detailed information requested regarding acceptance criteria, a specific study proving device performance, sample sizes for test/training sets, expert consensus details, or MRMC studies.

The document primarily details the device description, indications for use, comparison with predicate devices to establish substantial equivalence in terms of technology, materials, and intended use.

Here's a breakdown of what can be extracted and what is missing based on the provided text:

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

Missing. The 510(k) summary does not define specific performance acceptance criteria or report device performance against them. It focuses on establishing substantial equivalence to predicate devices, implying that if it is equivalent, its performance is acceptable.

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

Missing. No specific test set or clinical study data is mentioned in this 510(k) summary. The submission relies on a comparison to predicate devices.

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)

Missing. Ground truth establishment is not relevant as no test set or clinical study is described.

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

Missing. Not applicable; no test set is described.

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

Missing. This device is a mechanical ligator, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related effects are not applicable.

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

Missing. Not applicable; this is a mechanical device, not an algorithm.

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

Missing. Not applicable; no ground truth is established for device performance in the context of this 510(k) submission.

8. The sample size for the training set

Missing. Not applicable; no training set for an algorithm is mentioned.

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

Missing. Not applicable; no training set is mentioned.

Summary based on available information:

The Haemoband Multi-Ligator obtained 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (K0000297 - Erchinger Medizintechnik - Ligator and K070881 - SAPI MED S.p.a. - LEM ligator). The "study" for this submission is implicitly the comparison presented in the "Summary of substantial equivalence" table.

Table of Acceptance Criteria and Reported Device Performance:

Feature/Criterion (Implied by Substantial Equivalence Claim)	Haemoband Multi-Ligator Performance (Claimed)	Basis for Claim	Actual Acceptance Criterion from Study	Specific Reported Performance Data
Intended Use	Cut off blood flow to hemorrhoidal tissue by means of a ligature/ring.	Identical to predicate K070881 SAPI Med LEM.	Not explicitly defined, relies on predicate's established use.	Not quantifiable in this document.
Technology / Principle of Operation	Apply ligature, suction to hold tissue, pre-loaded bands, pistol handgrip.	Similar to K000297 Erchinger and K070881 SAPI Med.	Not explicitly defined, relies on predicate's established mechanism.	Not quantifiable in this document.
Materials (Patient Contact)	Standard materials tested/certified to ISO 10993; bands identical to K000297.	Identical to predicate device or ISO 10993 certified.	Biocompatibility standards (ISO 10993).	Compliance with ISO 10993 (certification mentioned).
Environment of Use	Hospitals, clinics, doctors' offices.	Identical to predicate K000297 Erchinger.	Not explicitly defined, relies on predicate's established use environment.	Not quantifiable in this document.
Safety and Effectiveness	No significant differences affecting safety or effectiveness compared to predicates.	Conclusion drawn from substantial equivalence comparison (technology, materials, intended use).	No specific quantitative safety/effectiveness criteria are provided in the 510(k) summary for this device as part of a formal study.	No specific reported performance data from a dedicated study is included.

Key takeaway: This 510(k) submission does not include a clinical study with acceptance criteria and measured performance in the way a robust device performance study or AI algorithm validation would. Instead, it demonstrates that the Haemoband Multi-Ligator is "substantially equivalent" to already legally marketed devices, implying that its safety and effectiveness are comparable.

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