(12 days)
The Diagnostic Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Diagnostic lenses are indicated for use during vitreoretinal surgical procedures.
Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.
The Super View Disposable BIOM Lens Set(s) consists of multiple sterile, disposable, thermoplastic lenses for both contact and non-contact use in conjunction with an operating microscope equipped with a BIOM wide-angle viewing system.
This 510(k) premarket notification for the "Super View Disposable BIOM Lens Set" from Insight Instruments, Inc. does not contain a study to prove acceptance criteria in the traditional sense of a clinical trial or performance study with defined metrics.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device. This is a common pathway for Class II medical devices, where the focus is on showing that the new device is as safe and effective as a legally marketed device, rather than proving novel efficacy.
Therefore, many of the requested elements for a study proving acceptance criteria are not explicitly present in this document. I will fill in the table and address the other points based on the information provided, highlighting where data is absent due to the nature of the 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (If Defined in this Document) | Reported Device Performance (If Defined in this Document) |
|---|---|
| Design Equivalence: The device should have equivalent design characteristics to the predicate device. | The device's "Materials" (PMMA, Polystyrene, other thermoplastics) and "Design" (Contact lens with concave surface and corneal radius, flat surface; Non-contact lenses with spheric and aspheric surfaces and thermoplastic housings) are compared to the predicate. No specific performance metrics for these design elements are provided, only a descriptive comparison. |
| Material Equivalence: The device should use materials equivalent to the predicate device. | The materials are listed as PMMA, Polystyrene, other thermoplastics, which are similar to the predicate's PMMA, Silicone, Glass, Quartz. The equivalence is descriptive, not quantitative. |
| Sterility Equivalence: The device should have equivalent sterility characteristics to the predicate device. | The device is "Sterile disposable," similar to some versions of the predicate. |
| Intended Use & Indications Equivalence: The device should have the same intended use and indications for use as the predicate device. | The device is intended "to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures" and is "indicated for use during vitreoretinal surgical procedures," which is stated to be equivalent to the predicate. |
Important Note: The concept of "acceptance criteria" in this context is implicitly about demonstrating substantial equivalence across these characteristics. There are no quantitative performance metrics (e.g., optical resolution, magnification, field of view metrics) or statistical thresholds explicitly stated as acceptance criteria for the performance of the device itself. The "performance" being reported is the similarity to the predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable. This document does not describe a performance study with a test set of data. The "test" is the comparison of characteristics against the predicate device.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. No ground truth was established by experts for a test set in this submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set was analyzed by multiple reviewers requiring 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
- MRMC Study: No. This device is a diagnostic lens, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This device is a physical diagnostic lens. It does not involve an algorithm or AI component to have a "standalone" performance in that sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the context of a performance study. The "ground truth" for this 510(k) submission is the characteristics and established safety/effectiveness of the predicate device. The new device's characteristics are compared against the predicate as the benchmark.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document does not describe the development or training of an algorithm or AI model.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: 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.