(64 days)
Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome. "dry eye being a condition where there is insufficient lubrication in the eye and the conjunctive becomes much less moist than normal. This produces pain and discomfort in the eyes. This may occur in any condition that causes scars of the cornea, such as erythema multiforme, trachoma, or corneal burns;" ... etc. Other patients that may benefit are: cataract patients, patients with arthritis, patients medicated for hypertension, contact wearers of any age, seasonal allergy sufferers, patients who live in dry climates, or spend extended periods in air conditioning, and any others who suffer from dry eye irritation. Treatment is to stop tear outflow via a specific punctum to enhance tear contact time in certain dry eye conditions. It is also reasonable that eye drops of many kinds would be more effective if retained on the surface of the eye, rather than drained into the sinus.
This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a propritary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eye" conditions through the total occlusion of individual punctal openings.
The provided text describes a 510(k) premarket notification for a Punctal Occluder device (K972523), comparing it to a previously marketed Odyssey Punctal Occluder. The submission focuses on demonstrating substantial equivalence.
Based on the provided text, the following information regarding acceptance criteria and a study to prove it can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria with numerical performance metrics as would be seen in a clinical study for a new device. Instead, the acceptance criterion for this 510(k) submission is the demonstration of substantial equivalence to a predicate device.
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance |
|---|---|
| Material Equivalence: Made of medical grade silicone, titanium dioxide as a colorant, and proprietary surface treatment. | The new device is stated to be "made of medical grade silicone, titanium dioxide as a colorant and utilizing a propritary surface treatment made under current good manufacturing practices." This matches the description of the previous device implicitly, as the claim is substantial equivalence. |
| Design Equivalence (functional): Small, generally "plug" shaped design for total occlusion of individual punctal openings. | The description states it is a "small, generally 'plug' shaped design." While there are design differences (larger overall diameter, smaller effective nose, shorter length), these are presented as enhancements for ease of insertion, removal, and anchoring, rather than fundamental changes to the core function of occlusion. The claim is that "By material, design and intended use, the Odyssey Punctal Occluder is substantially equivalent to the previous Odyssey Punctal Occluder." |
| Intended Use Equivalence: Treatment of "dry eye" conditions through total occlusion of individual punctal openings. | The new device is intended "for the treatment of 'dry eye' conditions through the total occlusion of individual punctal openings," which is the same intended use as the predicate. |
| Biocompatibility: Surface treatment does not reduce biocompatibility. | "Testing has indicated that the surface treatment does not reduce the biocompatibility of the device." (No specific test results or metrics are provided in this summary.) |
| Safety and Reversibility: Functionally safe and fully reversible, without breaching intact tissue surfaces or risk of damage upon reversal. | "Alternative methods of punctal occlusion are either permanent or difficult to reverse. In contrast, the submitted method is both functionally safe and fully reversible. Unlike some other methods, this device does not require the breach of intact tissue surfaces nor the risk of damaging said surfaces should reversal become desirable." This highlights comparison to alternative methods, reinforcing the safety profile, but doesn't explicitly state new device performance vs. predicate on these specific metrics. |
2. Sample size used for the test set and the data provenance:
The provided text does not include information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary focuses on design and material comparisons, and a statement about biocompatibility testing, rather than a clinical performance study using a defined test set of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided document. As there's no mention of a clinical test set with patient outcomes, there's no need for experts to establish ground truth in the context of this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
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:
This information is not present in the provided document. The device is a physical punctal occluder, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided document. The device is a physical medical device and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as typically applied to diagnostic algorithms or AI models is not directly relevant here. For this 510(k) submission, the "truth" being established is the substantial equivalence of the new device to the predicate device in terms of materials, design, intended use, and safety. This is established through the manufacturer's self-declaration and substantiation, reviewed by the FDA. The biocompatibility statement suggests in vitro or in vivo testing, but the nature of the "ground truth" (e.g., specific assays, observed reactions) is not detailed.
8. The sample size for the training set:
This information is not present in the provided document. As it is a physical device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
This information is not present in the provided document, for the same reason as point 8.
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