(68 days)
The Surgidev Silicone Punctum Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex learing, itching or foreign body sensations which can be relieved by blockage of the punctum.
The Surgidev Sillcone Punctum Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as comeal ulcers, conjunctivitis, pterygium, blepharitis, keratils, red lid margins, recurrent chalazions, recurrent comeal eroston, filamentry keratitis and other external eye diseases.
When indicated the Surgidev Silicone Puncture Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing ocular dryness secondary to contact lens use may also be alded by Slicone Puncturn Plugs.
A flexible silicone ophthalmic device designed to fit and be retained in the punctum.
Here's an analysis of the provided text regarding the Surgidev Silicone Punctum Plug:
Acceptance Criteria and Device Performance
Based on the provided documents, there are no explicit acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) submission process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct performance against formal acceptance criteria through clinical studies.
The document states: "Clinical Tests: None" and "Adverse S&E Information: None". This strongly indicates that no specific performance metrics with acceptance criteria were defined or tested in a clinical setting for this device. The basis for clearance was comparison to predicate devices, which means that the device is considered substantially equivalent if its indications for use, technological characteristics, and safety and effectiveness are similar to those of a pre-existing device.
Therefore, the table below reflects that there are no specified acceptance criteria or reported performance data from a clinical study within these documents.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| No specific acceptance criteria are described in the provided document. | No specific device performance metrics from a clinical study are reported in the provided document. |
Detailed breakdown of why specific sections are unanswered based on the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical tests or test sets are mentioned. The clearance is based on comparison to predicate devices and general controls.
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)
- Not applicable. No ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is mentioned.
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 (punctum plug), not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm. Standalone performance studies are not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical studies or ground truth establishment are mentioned. The basis for clearance relies on substantial equivalence to predicate devices, which implies that the safety and effectiveness of the device type are already established.
8. The sample size for the training set
- Not applicable. No "training set" in the context of an algorithm or clinical study is mentioned.
9. How the ground truth for the training set was established
- Not applicable. No "training set" or ground truth establishment for it is mentioned.
Summary of what was done for this device's clearance:
The device (Surgidev Silicone Punctum Plug) received 510(k) clearance by demonstrating "substantial equivalence" to predicate devices (Soft Plug™, Punctum Plug (FCI Ophthalmics), and Tapered-Shaft Punctum Plug). This equivalence was established by comparing:
- Indications Claimed: The indications for the Surgidev device (Treatment of dry eye, enhance efficacy of medications, treatment of contact lens problems, adjunctive treatment aid) are similar to those of the predicate Soft Plug™ and Tapered-Shaft Punctum Plug.
- Function: All devices cause occlusion of the punctum to retain tears.
- Design (Length/Diameter): The Surgidev device's typical length (2.0 mm) and diameter (0.8 mm) are identical to the Soft Plug™ and FCI Punctum Plug, and very similar to the Tapered-Shaft Punctum Plug.
- Material: All compared devices are made from Medical Grade Silicone.
The FDA's review concluded that, based on these comparisons and subject to general controls, the device is substantially equivalent to legally marketed predicate devices, and therefore can be marketed. No new clinical safety or effectiveness data were required or submitted for this specific 510(k) clearance.
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