(194 days)
The Miru 1day UpSide (midafilcon A) SPHERICAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myperopia) in aphakic and non-aphakic people with disease free eyes who may have 1.50 diopter (D) or less of astigmatism.
The Miru 1day UpSide (midafilcon A) TORIC Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic people with disease free eyes with 3.00 diopter (D) or less of refractive astigmatism.
The Miru 1day UpSide (midafilcon A) MULTIFOCAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic people with disease free eyes who may require a reading addition of 3.00 diopter (D) or less and who may have 1.50 diopter (D) or less of astigmatism.
The Miru 1day UpSide (midafilcon A) should only be worn once and then discarded at the end of each wearing period on a daily basis. The patient should start the next wearing period with fresh lenses should not be cleaned or disinfected and should be discarded after a single use.
The Miru 1day UpSide (midafilcon A) is a hydrophilic contact lens which is available as a spherical, toric and multifocal lens. The lens is indicated for daily wear disposable single use.
The non-ionic lens material (midafilcon A) is a random co-polymer containing polydimethyl siloxane macromonomer. It consists of 46% midafilcon A and 54% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility handling tint.
The lens contains a benzotriazole UV absorbing monomer which is used to block UV radiation. The transmittance characteristics for the lens (-3.00D) are less than 5% of UVB radiation and less than 50% of UVA radiation.
This document, K193399, is a 510(k) Premarket Notification for the Miru 1day UpSide (midafilcon A) contact lens. It describes the device, its indications for use, and the data supporting its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in a tabular format for an AI/ML device. Instead, it presents the results of non-clinical and clinical studies to demonstrate the safety and effectiveness of the contact lens, comparing it to predicate devices. The implicit acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device.
For a contact lens, performance is typically assessed based on:
- Material Properties: Water content, refractive index, oxygen permeability (Dk), UV blocking.
- Physical Characteristics: Powers, diameter, base curve, manufacturing method, sterilization, packaging.
- Clinical Performance: Visual acuity, comfort, adverse event rates, biocompatibility.
Here's an inferred table based on the "Comparison of Characteristics" and "Performance Data" sections:
| Feature/Metric | Acceptance Criteria (Implied by Predicate/Standards) | Miru 1day UpSide (midafilcon A) Performance | Notes |
|---|---|---|---|
| Non-Clinical Data | |||
| Biocompatibility | Non-toxic, non-irritating, non-sensitizing | Non-toxic, non-irritating, non-sensitizing | "The results of the non-clinical testing and evaluation demonstrate that the lens material/extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions." |
| Material Properties | Consistent with predicate lenses | Consistent with predicate lenses | "and the material properties are consistent with the predicate lens." (The specific material properties are detailed in the comparison table below). |
| UV Blocking Transmittance | 92-96%) | > 92 % | Compared to Visco Si-Hy (94%) and MyDay (96%). |
| Water Content | Similar to predicate (47-54%) | 54% | Compared to Visco Si-Hy (47%) and MyDay (54%). |
| Refractive Index | Similar to predicate (1.401-1.410) | 1.403 | Compared to Visco Si-Hy (1.410) and MyDay (1.401). |
| Dk (Oxygen Permeability) | Similar to predicate (80-120) | 64 | This is lower than the predicates (Visco Si-Hy: 120, MyDay: 80), but the overall conclusion is still "as safe, as effective and performs as well as the predicate devices," implying this Dk value is acceptable for the intended daily wear, single-use modality. The FDA's determination of substantial equivalence takes into account all factors. |
| Clinical Data | |||
| Efficacy | Lens visual acuity comparable to control lenses | Substantially equivalent to control | "The efficacy outcome measures were lens visual acuity comparisons between the test and the control contact lenses." This suggests the visual performance was not inferior to the control. |
| Safety | Acceptable adverse event rates, biomicroscopy, subjective acceptance | Substantially equivalent to control | "The safety outcome measures included adverse event rates, biomicroscopy and subjective acceptance." This implies that the rates of adverse events, ocular health assessments (biomicroscopy), and patient comfort/satisfaction were comparable to the control. |
| Overall Conclusion | As safe, as effective, performs as well as predicates | "as safe, as effective and performs as well as the predicate devices." | This is the ultimate acceptance criterion for a 510(k) submission. |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: 148 subjects (male and female) were randomized and dispensed lenses. This implies a test set of approximately 74 subjects for the investigational device (assuming a 1:1 ratio into test and control groups).
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "three-month randomized controlled clinical study." Since the applicant is Menicon Co., Ltd. in Japan, and the submission is to the U.S. FDA, the study could have been conducted in Japan, the US, or other regions. It was a prospective clinical study.
3. Number of Experts and Qualifications for Ground Truth:
- This is a medical device (contact lens) safety and efficacy study, not an AI/ML algorithm study requiring expert consensus for image annotation or diagnosis. Therefore, the concept of "experts establishing ground truth" in the same way as for AI image analysis (e.g., radiologists interpreting images) is not directly applicable.
- Clinical Efficacy/Safety Assessment: The evaluations were likely performed by ophthalmologists or optometrists who are qualified to assess visual acuity, conduct biomicroscopy examinations, and monitor adverse events related to contact lens wear. Their qualifications are not specified beyond being "qualified investigators."
4. Adjudication Method for the Test Set:
- Not applicable in the context of an AI/ML algorithm's ground truth establishment.
- For clinical trials, independent data monitoring committees (DMCS) or clinical event committees (CECs) might be used to adjudicate serious adverse events, but the document doesn't detail this for the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This was a clinical trial comparing a new contact lens to a control contact lens, not an AI-assisted diagnostic system. Therefore, MRMC studies and the concept of "human readers improving with AI vs. without AI assistance" are irrelevant to this submission.
6. Standalone (Algorithm Only) Performance:
- No. This is a physical medical device (contact lens), not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used:
- The "ground truth" for this study was established through direct clinical measurements and observations in human subjects, compared against a control (predicate) lens. This includes:
- Objective measures: Visual acuity measurements (e.g., Snellen chart, other standardized tests), biomicroscopy findings (e.g., assessing corneal health, conjunctiva).
- Subjective measures: Patient-reported acceptance and comfort, reporting of symptoms and adverse events.
- Biomaterial properties: In-vitro lab testing of Dk, water content, UV blocking, etc.
- In essence, the "ground truth" for a contact lens is its direct impact on a patient's vision, ocular health, and comfort during wear, as assessed by clinical professionals and the patients themselves.
8. Sample Size for the Training Set:
- This is a clinical study for a physical device, not an AI/ML algorithm. Therefore, there is no discrete "training set" in the AI/ML sense. Data for device development and optimization (analogous to a training set) would come from extensive R&D, material science experiments, and possibly earlier pilot clinical studies, none of which are explicitly detailed as a 'training set' sample size in this regulatory summary.
9. How Ground Truth for the Training Set Was Established:
- As there is no "training set" in the AI/ML sense, this question is not applicable. The development of the contact lens material and design would have been based on established optometric and material science principles, biocompatibility testing, and iterative design processes.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.