Search Results

The inx Medical Nexus™ Hemorrhoid 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 in hospitals, clinics, and doctors' offices.

The inx Medical Nexus™ Hemorrhoid 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 inx Medical Nexus™ Hemorrhoid Ligator is a disposable device for the rubber band ligation of hemorrhoids. It is for single use only and is supplied with preloaded non-latex rubber bands.

The provided document is a 510(k) Premarket Notification for the Nexus™ Hemorrhoid Ligator. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and statistical endpoints as might be found for a PMA device.

Therefore, the study design and acceptance criteria information as typically requested for performance evaluation of a novel medical device (especially AI/ML-driven) are not available in this document. The provided text outlines non-clinical performance testing against the predicate devices for features like drop resistance, environmental exposure, and suction generation, and asserts substantial equivalence rather than reporting on specific clinical performance metrics.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes.
• Information on sample sizes for test sets, data provenance, or ground truth establishment by experts for clinical performance.
• Adjudication methods or multi-reader multi-case comparative effectiveness studies.
• Details on standalone algorithm performance for an AI component.
• Training set details.

The focus is on demonstrating that the Nexus™ Hemorrhoid Ligator is substantially equivalent to existing predicate devices (Haemoband Multi-Ligator and O'Regan Ligator) in terms of indications for use, technology, mode of operation, materials, and environment of use, and that no new safety or efficacy considerations are raised.

However, here's an overview of the non-clinical testing conducted to support substantial equivalence, presented in a format that aligns with parts of your request for "acceptance criteria" where applicable to non-clinical tests:

Non-Clinical Performance Testing and Reported Device Performance

The "acceptance criteria" here are framed as pass/fail criteria for non-clinical engineering and material tests, demonstrating that the device functions as intended and is comparable to predicates.

Further Details (as per request, but information is limited/not applicable to clinical performance)

2. Sample size used for the test set and the data provenance: Not applicable. This was non-clinical engineering and material testing, not a clinical study involving patients or data sets. The "test set" would be the specific units of the device subjected to the environmental, drop, and suction tests. The document doesn't specify the number of units tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to engineering specifications and comparison to predicate device characteristics, not expert clinical interpretation.
4. Adjudication method for the test set: Not applicable. This was engineering testing, not a study requiring adjudication of expert interpretations.
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 ligator, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm-driven device.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" was based on established engineering standards (e.g., ISO, MIL-STD) for performance and direct comparison of material identity and functional equivalence (suction strength) to legally marketed predicate devices.
8. The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device