(204 days)
The Riverpoint Medical Absorbable Canalicular Plugs are intended to temporarily block tear drainage by the obstruction of the canaliculus in the lacrimal drainage system. The Absorbable Canalicular Plugs are used for the temporary treatment of dry eye syndrome, and the dry eye components of various ocular surface diseases including contact lens intolerance secondary to dry eye. The Absorbable Canalicular Plugs can be used in the treatment of dry eye following ocular surgery or to enhance the efficacy of topical medicines and/or ocular lubricants. The Riverpoint Medical Absorbable Canalicular Plugs may also be used to determine the potential effectiveness of a non-absorbable punctal occlusion device.
The Riverpoint Medical PDO Absorbable Canalicular Plug is a monofilament synthetic absorbable device prepared from poly(p-dioxanone). PDO Absorbable Canalicular Plugs are available undyed or violet. When dyed, only FDA-approved color additives such as D&C Violet No. 2 are used. PDO Absorbable Canalicular Plugs are used to temporarily block tear drainage by the occlusion of the lacrimal canaliculi for approximately 180 days.
The provided document is a 510(k) summary for a medical device (PDO Absorbable Canalicular Plug) seeking substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating equivalence rather than comprehensive clinical studies with detailed acceptance criteria and performance reports in the format requested.
Therefore, the document does not contain specific acceptance criteria, detailed study results proving a device meets these criteria, sample sizes for test sets or training sets, information on expert numbers/qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily states that the device is substantially equivalent to a predicate and that "All acceptance criteria were met" for specific non-clinical performance tests. However, it does not define those acceptance criteria or report the device performance against them in a measurable way that could be tabulated as requested.
Here's what can be extracted based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "All acceptance criteria were met, and the Riverpoint Medical Absorbable Canalicular Plug performed as intended."
However, the specific acceptance criteria and the quantitative or qualitative device performance against those criteria are not detailed in this document. The document lists the types of tests performed (sterilization validation, biocompatibility, stability, usability validation) but does not provide the pass/fail thresholds or the actual results.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the performance tests mentioned.
- Data Provenance: The tests are non-clinical (laboratory/simulated use). Country of origin is not specified.
- Retrospective/Prospective: Not applicable as these are non-clinical performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. These were non-clinical performance tests (sterilization, biocompatibility, stability, usability validation). No "ground truth" established by experts in a clinical context is described for these tests.
4. Adjudication method for the test set:
- Not applicable. This relates to clinical studies and expert review, which are not detailed for the performance tests described.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- No, a MRMC comparative effectiveness study was not done according to this document. The document focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison of technological characteristics.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:
- Not applicable. This device is a physical medical implant (canalicular plug), not a software algorithm.
7. Type of ground truth used:
- Not applicable. The performance tests mentioned (sterilization, biocompatibility, stability, usability validation) are evaluated against established standards (e.g., ISO guidelines) and engineering specifications, not clinical "ground truth" like pathology or outcomes data.
8. Sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is a physical device, not an AI/machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
In summary, the provided FDA 510(k) summary focuses on demonstrating that a new device is "substantially equivalent" to an existing predicate device through a comparison of technological characteristics and non-clinical performance testing (e.g., sterilization, biocompatibility). It does not include the detailed clinical study information—with specific acceptance criteria, reader performances, and ground truth establishment—that would be expected for a product requiring such extensive evaluation for its primary performance claims.
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