(78 days)
For magnification during vitreoretinal surgery.
The Endoview™ Sapphire Contact Lens Set consists of one sterilization container, one lens ring (either infusion or non-infusion), and one each of the following lenses: Plano Concave, Symmetric Concave-Concave, Asymmetric Concave, Prism 15° - Concave, Prism 30° Concave, and a Prism Concave-Concave Lens. The lenses, rings and sterilization container may be sold separately or as a set. During vitreoretinal surgery, the surgeon requires the aid of a contact lens in order to visualize the posterior segment of the eye. First, the ring is sewn onto the sclera to hold the lens in place on the cornea. The customer has the option of choosing a ring with an infusion port, which eliminates the need for the surgeon to constantly place irrigant on the corneal. Once the ring is in place, the surgeon places one of the lenses in the ring in order to visualize the posterior segment of the eye. The surgeon changes the lenses during the case depending on where visualization is required.
The provided text is a Premarket Notification [510(k)] Summary for the "Endoview™ Sapphire Lens Set" by American Medical Devices, Inc. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria for device performance in the way a clinical trial or AI/software validation would.
Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/software device.
The study presented here is a comparison to predicate devices to demonstrate that the Endoview™ Sapphire Lens Set is as safe and effective as existing products.
Here's a breakdown of why many of your categories cannot be filled from this document:
- Acceptance Criteria and Reported Device Performance: Not applicable in the context of this 510(k) submission. The "performance" being assessed is substantial equivalence to predicate devices, not meeting specific quantitative clinical performance metrics.
- Sample size for the test set and data provenance: No test set in the sense of clinical data is described. The comparison is feature-based against existing devices.
- 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. "Ground truth" in this context would refer to the characteristics and performance of the predicate devices, which are established by their prior marketing clearance.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical contact lens, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for substantial equivalence is the established safety and effectiveness of the identified predicate devices.
- The sample size for the training set: Not applicable. There is no "training set" for a physical medical device in this context.
- How the ground truth for the training set was established: Not applicable.
However, I can extract the substantial equivalence comparison, which serves as the "study" for this type of submission:
1. Table of Acceptance Criteria and the Reported Device Performance
In a 510(k) submission, "acceptance criteria" relate to demonstrating that the new device shares characteristics with legally marketed predicate devices, thereby establishing "substantial equivalence." The "performance" is the new device's features matching or being comparable to the predicate devices.
| Feature / Criteria (for Substantial Equivalence) | Predicate Devices (DORC, Grieshaber, Ocular Instruments) | Endoview™ Sapphire Lens Set (Reported Performance) |
|---|---|---|
| Flat Lens for Central viewing | X | X |
| 15 degree lens for mid-Peripheral viewing | X | X |
| 30 degree lens for wide field viewing | X | X |
| Bi-concave lens For air filled phakik Patients | X | X |
| Shipped Non Sterile | X | X |
| Sterilize with either ETO Or steam | X | X |
| Sterilization Container | X | X |
| Infusion Lens Ring | X | X (Also explicitly mentions Ocular Instruments has this) |
| Lens Ring | X | X |
| Materials: Lenses | Quartz, high refractive index plastic (for comparison) | Single Crystal Sapphire (stated as ideal and previously approved for ophthalmic use via 510(k)s K853129, K860852, K861744) |
| Materials: Sterilization Container | High temperature plastic | High temperature plastic |
| Materials: Lens Ring | Aluminum | Aluminum |
| Sterility Status | N/A (Predicates are assumed to be similar) | Shipped Non-Sterile |
| Sterilization Instructions | N/A (Predicates are assumed to be similar) | ETO or steam sterilize according to AAMI or USP Standards |
| Indications for Use | For magnification during vitreoretinal surgery | For magnification during vitreoretinal surgery |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not applicable. This is a comparison of design features and materials, not a clinical data set. The "sample" can be considered the set of predicate devices identified by the manufacturer (DORC, Grieshaber, Ocular Instruments).
- Data Provenance: The "data" pertains to the specifications and characteristics of the Endoview™ Sapphire Lens Set and those of the predicate devices. This information is derived from the manufacturer's design specifications and existing market information for predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth is established by the known characteristics and approved status of the predicate devices as legally marketed medical devices. The FDA regulatory staff (like the Director of the Division of Ophthalmic Devices) assess the submission.
4. Adjudication method for the test set:
- Not applicable. The assessment is a regulatory review for substantial equivalence, not a clinical adjudication.
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 is a physical surgical device, not an AI/software diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical device.
7. The type of ground truth used:
- Substantial Equivalence: The "ground truth" is the established safety, effectiveness, and intended use of the legally marketed predicate devices (DORC, Grieshaber, Ocular Instruments). The new device is compared feature-by-feature to these predicates to demonstrate that it raises no new questions of safety or effectiveness. Additionally, the use of Sapphire as a material had prior FDA clearance in other ophthalmic devices (K853129, K860852, K861744).
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of a physical device's 510(k) submission.
9. How the ground truth for the training set was established:
- Not applicable.
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.