(63 days)
The RxSight Contact Lens is indication and treatment in the anterior segment of the eye.
The RxSight Contact Lens is a reusable diagnostic contact lens intended for intraocular visualization and therapy. The RxSight Contact Lens is used to maintain optical quality of the corneal surface and will provide lid stabilization to prevent blinking during therapeutic procedures that require magnification of the eye.
The RxSight Contact Lens is designed around the classic diagnostic contact lens with similar design including an optical element with a specific magnification to provide excellent visualization.
The optical component of the RxSight Contact Lens is made from polymethylmethacrylate (PMMA). The anodized aluminum cone houses the PMMA contact lens.
The provided document is a 510(k) summary for the RxSight Contact Lens, which seeks to establish substantial equivalence to a predicate device. It is not a study that proves the device meets specific acceptance criteria based on performance metrics that would typically be described with sensitivity, specificity, or similar statistical measures. Instead, the "acceptance criteria" here refer to conformance with regulatory requirements and equivalence to a predicate device, demonstrated through a comparison of physical characteristics and specific types of testing.
Therefore, many of the requested fields are not applicable because this is not a performance study in the traditional sense of evaluating an algorithm or diagnostic tool against a ground truth.
Here's the information that can be extracted and synthesized based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Product Code | HJK | HJK |
| Device Classification | 21 CFR 886.1385 | 21 CFR 886.1385 |
| Intended Use | Intended to aid in visualization and/or therapy in the anterior segment of the eye | Intended to aid in visualization and/or therapy in the anterior segment of the eye |
| Contact Material | PMMA | PMMA |
| Field of View | Wide angle | Wide angle |
| Image Magnification | 1.40x (of predicate device) | 1.30x |
| Laser Spot Magnification | 0.710x (of predicate device) | 0.766x |
| Contact Diameter | 15.5 mm (of predicate device) | 15.0 mm |
| Lens Height | 16.5 mm | 16.5 mm |
| How Supplied (Reusable/Single Use) | Single lens packaging, Non-sterile, Reusable | Single lens packaging, Non-sterile, Reusable |
| Biocompatibility | In accordance with ISO 10993-1, including: Cytotoxicity (per ISO10993-5), Sensitization (per ISO10993-10), and Ocular Irritation (per ISO10993-10) | Successfully performed and met acceptance criteria. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Sterilization Validation | Recommended sterilization parameters achieve a Sterility Assurance Level of 10^-6, in accordance with ISO 10993-7 | Performed to confirm criteria met. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Finished Product Performance Testing | General acceptance criteria for finished product performance (not explicitly detailed, but implied to be standard for this device type). | Met all acceptance criteria. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Substantial Equivalence to Predicate Device | Match or demonstrate equivalent safety and effectiveness to Ocular Instruments 12.5 mm Peyman Wide Field YAG Laser Lens (K872136) in terms of materials, technological characteristics, and principles of operation, with any minor variations not impacting safety or effectiveness. | The RxSight Contact Lens is substantially equivalent to the predicate device. It is manufactured from the same materials (PMMA), has the same technological characteristics (e.g., wide angle field of view, reusability), and principles of operation. Minor variations in specifications (Image Magnification, Laser Spot Magnification, Contact Diameter) do not impact safety or effectiveness. The descriptive characteristics of the RxSight Contact Lens are well-defined and adequate to ensure equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of a clinical performance study with a "test set" for accuracy metrics like sensitivity/specificity. The testing performed was for biocompatibility, sterilization, and general finished product performance, not a diagnostic accuracy study. The document does not specify the number of individual devices or materials tested for these purposes.
- Data Provenance: Not applicable. The testing described is laboratory-based (biocompatibility, sterilization, physical performance) rather than clinical data from human subjects from a specific country or collected retrospectively/prospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. "Ground truth" in the sense of expert-established diagnostic labels is not relevant for this type of device (a diagnostic contact lens) and the types of testing described (biocompatibility, sterilization, physical characteristics).
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring expert adjudication of diagnoses.
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 diagnostic contact lens, not an AI-powered diagnostic system. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical diagnostic contact lens, not an algorithm.
7. The Type of Ground Truth Used
- Ground Truth: For biocompatibility and sterilization, the "ground truth" would be established by the relevant ISO standards (ISO 10993-1, ISO10993-5, ISO10993-10, ISO 10993-7) and their specified testing methodologies and acceptance limits. For physical characteristics and intended use, the "ground truth" is typically defined by engineering specifications and direct comparison to the predicate device's established characteristics. It is not an expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device, so there is no training set in that context.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set.
§ 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.