(119 days)
The scleral plugs are provided as part of single- and multiple-use surgical component kits/packs, or as kit replacements, in order to maintain patency of a previously made incision in the sclera of the eye, during ophthalmic surgical procedures, performed by a certified clinician in a clinical setting.
Scleral plugs, 19 and 20 ga., for use in ophthalmic surgical procedures. Both as stainless steel, with the 19 ga. plugs gold plated, and the 20 ga. plugs silver plated.
This 510(k) submission for the Scleral Plug does not include a study demonstrating how the device meets acceptance criteria. Instead, it relies on demonstrating substantial equivalence to pre-existing predicate devices. Therefore, much of the requested information regarding a specific study and its methodology is not available in this document.
Here's a breakdown of the available information and a notation where information is not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: No substantive change in materials, basic components, or method of manufacture compared to predicates. Raw materials/components used have a history of safe use in similar products. | "No substantitive change in materials, basic components, or method of manufacture between this device and the predicate(s); the raw materials/components used have been used in the medical industry on similiar/identical products and for similiar/ identical uses since pre-amendment, without any record of patient problems or adverse reactions." |
| Configuration/Construction Equivalence: No change in basic configuration or construction compared to predicates. | "No change in basic configuration or construction;" |
| Biocompatibility: Device components must be biocompatible. | "These devices and their components have been tested by an indevendent lab for biocompatability (cyctotoxicity, hemolysis)..." No specific acceptance criteria (e.g., passing a specific ISO standard or threshold for cytotoxicity/hemolysis) or detailed test results are provided in this summary. |
| Function and Use Equivalence: Function and use should be no different than predicate devices. | "The function and use of this product will be no different than that of the predicate devices, and countless other similiar devices in the marketplace since pre-amendment." |
| Manufacturing Quality: Subject to inspection/testing at IQC and during/after manufacture. | "...and will be subjected to inspection/ testing at IQC, and during/after manufacture and prior to release to the field." No specific acceptance criteria for these inspections/tests are provided. |
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 / Not provided. This submission relies on substantial equivalence to predicate devices, not a clinical study with a test set of data. The biocompatibility testing likely used laboratory samples, but details are not included.
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 / Not provided. No test set or ground truth in the context of clinical performance evaluation is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set requiring adjudication is described.
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. This is a medical device (scleral plug), not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a medical device (scleral plug), not an algorithm. Standalone performance as typically understood for AI algorithms is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. No ground truth in the context of clinical performance evaluation is described. The "ground truth" for this device's approval is its substantial equivalence to other legally marketed predicate devices, meaning it is considered safe and effective because similar products have been proven so.
8. The sample size for the training set
- Not applicable / Not provided. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As above, no training set for an AI model is involved.
§ 886.4155 Scleral plug.
(a)
Identification. A scleral plug is a prescription device intended to provide temporary closure of a scleral incision during an ophthalmic surgical procedure. These plugs prevent intraocular fluid and pressure loss when instruments are withdrawn from the eye. Scleral plugs include a head portion remaining above the sclera, which can be gripped for insertion and removal, and a shaft that fits inside the scleral incision. Scleral plugs are removed before completing the surgery.(b)
Classification. Class II (special controls). The special controls for the scleral plug are as follows:(1) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9 if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are:
(i) The device must be demonstrated to be sterile during the labeled shelf life;
(ii) The device must be demonstrated to be biocompatible; and
(iii) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.
(2) The device is not exempt from premarket notification procedures if it is composed of a material other than surgical grade stainless steel (with or without a gold, silver, or titanium coating). The special controls for scleral plugs made of other materials are:
(i) The device must be demonstrated to be sterile during the labeled shelf life;
(ii) The device must be demonstrated to be biocompatible;
(iii) Characterization of the device materials must be performed;
(iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device;
(v) Performance data must demonstrate adequately low levels of the extractables or residues from manufacturing (or processing) of the device; and
(vi) Labeling must include all information required for the safe and effective use of the device, including specific instructions regarding the proper sizing, placement, and removal of the device.