(170 days)
The Nunchaku stents are intended for use for nasolacrimal intubation in patients 12 months and older. Indications for nasolacrimal intubation performed with the Nunchaku are:
- Canalicular pathologies (e.g., congenital or acquired stenosis, laceration)
- During dacryocystorhinostomy
- Congenital lacrimal duct obstruction
The Nunchaku is a bicanalicular intubation device for the treatment of epiphora in patients 12 months and older. The device consists of two lateral silicone tubes connected to a silicone body that is delivered pre-mounted on two guides facilitate insertion of the Nunchaku and are completely removed once insertion of the device is complete. The Nunchaku comes in two different model lengths (90 or 105 mm depending on length of tube required) and is provided as a sterilized product.
Based on the provided text, the device in question (Nunchaku) is a bicanalicular intubation device. The document describes non-clinical (bench-top) tests and results, but does not describe a study involving human readers or an AI algorithm, nor does it establish ground truth through expert consensus, pathology, or outcomes data for clinical performance. Therefore, I am unable to provide information on the following points:
- Acceptance criteria related to clinical performance or human reader studies.
- Sample sizes for test sets in a clinical study.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of clinical ground truth used.
- Sample size for a training set (as no AI algorithm is mentioned).
- How ground truth for a training set was established.
The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, intended use, and non-clinical testing.
Here's a summary of the provided information relevant to acceptance criteria and "studies" (non-clinical tests) that "prove" the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document lists several non-clinical tests conducted to validate the device's mechanical characteristics and biocompatibility. The "acceptance criteria" are implied by the statement "All non-clinical test results met the established specifications for the device" and "The biocompatibility test results met the required specifications for all tests."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Manufacturing process validated | Capacity to manufacture Nunchaku demonstrated |
| Mechanical integrity during guide detachment | Met established specifications |
| Mechanical integrity during guide insertion and removal | Met established specifications |
| Tensile strength of silicone tube (resistance to breakage/pull-out) | Met established specifications; demonstrated sufficient tensile strength |
| Biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity, muscular implantation, endotoxins) | Met required specifications for all tests |
| Sterilization effectiveness | Studies performed according to applicable standards; results support shelf-life |
| Shipping and package integrity | Studies performed according to applicable standards; results support storage |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document states "Bench top testing was performed on samples before and after sterilization." The exact number of samples tested for each non-clinical test is not specified in the provided text.
- Data Provenance: Not applicable as these are bench-top tests, not a clinical study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for these non-clinical tests is based on measurable physical properties and established ISO/USP standards, not expert clinical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for non-clinical testing.
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:
- No MRMC study was mentioned or performed. The device is a physical medical device (stent) for intubation, not an AI-powered diagnostic tool for image interpretation or a device requiring human reader assistance with AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical medical device. There is no mention of an algorithm involved.
7. The type of ground truth used:
- For non-clinical tests, the "ground truth" is defined by established engineering specifications, mechanical properties standards, and biocompatibility standards (e.g., ISO standards, USP standards for endotoxins).
8. The sample size for the training set:
- Not applicable. These are non-clinical engineering and materials tests, not an AI model.
9. How the ground truth for the training set was established:
- Not applicable.
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