(284 days)
The STENTube lacrimal intubation device is a sterile, single-use, prescription device intended for use as an in situ (up to 11 months) device for various ophthalmic procedures.
The STENTube lacrimal intubation device is indicated for use for the following:
- Maintenance of lacrimal outflow post-primary DCR surgical procedure
- Maintenance of lacrimal outflow post-failed open DCR surgical procedures with complete obstruction
- Reconstruction of the canaliculi
The Quest Medical, Inc. STENTube is a sterile, hand held, ophthalmic surgical device. The STENTube is a large diameter lacrimal intubation set consisting of two malleable stainless steel probes (to facilitate insertion) securely attached to a flexible silicone tube. The STENTube intubation set is single-use, biocompatible, and non-pyrogenic. The STENTube is packaged with 1 device per pouch, and 2 pouches per carton. It is available by prescription only. The STENTube is used following a procedure in the lacrimal system, such as a Dacryocystorhinostomy (DCR), to clear any blockage to the lacrimal passage. The tubes are inserted with the purpose of keeping the passages open for a period of time during the healing process.
Here's an analysis of the provided text regarding the STENTube Lacrimal Intubation Set:
This document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It is not a study proving the device meets acceptance criteria based on clinical performance. Instead, it argues that the new device (STENTube) is as safe and effective as its predicate (Ryder International Lacrimal Intubation Set, K962151) primarily due to technological characteristics and non-clinical performance data.
Therefore, most of the requested information regarding clinical studies, acceptance criteria, sample sizes, ground truth, and expert adjudication is not applicable or not provided in this type of submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable as this is a 510(k) for substantial equivalence, not a clinical performance study. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to the predicate device through technological characteristics and non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance (STENTube) |
|---|---|
| Safety: Biocompatibility, non-pyrogenic | "single-use, biocompatible, and non-pyrogenic" (Section D) |
| Effectiveness: Maintaining lacrimal outflow, reconstruction of canaliculi (same as predicate) | Indications for Use are identical to the predicate device: 1. Maintenance of lacrimal outflow post-primary DCR surgical procedure 2. Maintenance of lacrimal outflow post-failed open DCR surgical procedures with complete obstruction 3. Reconstruction of the canaliculi (Section E & Indications for Use document). The document claims the device "performed as well or better than the predicate device" based on bench testing and "demonstrates it is as safe and as effective as the predicate device." (Section G) |
| Technological Characteristics: Materials, design | "The STENTube has the same technological characteristics compared to the predicate device. It has the same design and materials." (Section F). Minor modifications: "Only the length of some of the components has been modified, and a shrink tube component was added." (Section F) |
| Sterilization Method | "Sterilization method has been updated" (Section F) - implicitly meets new or updated criteria. |
| Shelf Life | "shelf life extended to 3 years" (Section F) - implicitly implying it meets new criteria for this extended shelf life. |
| Physical Specifications | "Verification and Validation tests were performed to ensure the modified STENTube continued to meet or exceed specification in accordance to the Design Requirements." (Section G) - These specifications are stated to be "the same as for the predicate device." |
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set data is described. The non-clinical performance data refers to "Verification and Validation tests" and "benchtesting," but no sample sizes or data provenance (country of origin, retrospective/prospective) are mentioned for these engineering tests.
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 was used, and therefore no ground truth was established by experts in the context of clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was used, and therefore no adjudication method was employed.
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 physical medical device (lacrimal intubation set), not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the clinical sense. For the non-clinical performance data, the "ground truth" would be the engineering specifications and performance characteristics derived from the predicate device and internal design requirements.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device. The "training set" for the design and specifications would be the knowledge and data from the predicate device's design and performance.
9. How the ground truth for the training set was established
Not applicable. As above, no training set in the AI sense. The "ground truth" for the design was established by the predicate device's established safety and effectiveness and by the medical community's understanding of the requirements for lacrimal intubation sets.
N/A