(255 days)
Tangible Boost is a monthly treatment to restore the Tangible Hydra-PEG coating and maintain the wettability of Tangible Hydra-PEG treated fluorosilicone acrylate rigid gas permeable lenses. Tangible Boost is intended for prescription (Rx) use only.
Tangible Boost is a monthly treatment specifically for RGP CLs made from fluorosilicone acrylate and manufactured with a Hydra-PEG coating. Tangible Boost is intended for prescription (Rx) use only, and for home use. Tangible Boost is not intended for lens disinfection and must be used in conjunction with a compatible multipurpose solution, as described in the labeling.
Tangible Boost restores the Tangible Hydra-PEG coating and maintains the wettability of Tangible Hydra-PEG treated fluorosilicone acrylate lenses. The device consists of two sterile, preservative-free, unit dose solutions to be combined in the single use, disposable Tangible Boost barrel style lens case (included in the device packaging). Patients who are allergic to any ingredient (e.g. Tangible Hydra-PEG) should not use this device.
The provided text describes a De Novo classification request for the Tangible Boost device, a hydrophilic re-coating solution for RGP contact lenses. The acceptance criteria and the study proving the device meets these criteria are primarily outlined through biocompatibility testing, shelf-life/sterility assessments, performance (bench) testing, and a single clinical study.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by the "Acceptance Criteria" column in the tables for biocompatibility testing and implicitly by the successful "Results" obtained in bench and clinical studies.
Table of Acceptance Criteria and Reported Device Performance (Synthesized from text)
| Test/Evaluation Area | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Biocompatibility (Solutions) | Evaluate potential for cellular toxicity, sensitization, ocular irritation, acute oral toxicity, and ocular biocompatibility. | Non-cytotoxic, Non-sensitizer, Non-irritant, Non-toxic (for acute oral and ocular biocompatibility). | Pass for all tests (Cytotoxicity, Sensitization, Ocular irritation, Acute Oral Toxicity, Ocular Biocompatibility). Results demonstrated acceptable performance. |
| Biocompatibility (Packaging) | Evaluate potential for cellular toxicity, ocular irritation, and acute systemic toxicity. | Non-cytotoxic, Non-irritant, Non-toxic (for acute systemic toxicity). | Pass for all tests (Cytotoxicity, Ocular irritation, Acute Systemic Toxicity). Results demonstrated acceptable performance. |
| Shelf-life/Sterility | Demonstrate sterility, maintain packaging integrity, and ensure device functionality over proposed shelf-life; ensure Boost does not hinder disinfection. | Sterility maintained throughout shelf-life; packaging integrity maintained; bacteriostatic and fungistatic within 30-minute treatment; does not hinder ability of compatible daily cleaning solutions to disinfect. | Sterilized by filtration and aseptically filled; sterilizing filtration, SIP, environmental monitoring, and aseptic filling were validated. Disinfection efficacy testing demonstrated Boost does not hinder daily cleaning solutions. Demonstrated to be bacteriostatic and fungistatic within 30 minutes. Shelf life of sterile barrier packaging established for 2 years (accelerated) and 12 months (real-time). Transit testing performed. |
| Performance - Bench | Lens/solution compatibility: Demonstrate compatibility with RGP contact lenses and care products. | ||
| Contact angle/wettability: Demonstrate ability to maintain wettability. | |||
| Thin film Ellipsometry/coating thickness: Demonstrate ability to restore Hydra-PEG coating. | |||
| Shelf-life stability: Evaluate functional performance (wettability, coating thickness) and solution parameters. | Compatibility demonstrated per ISO 11981:2009. | ||
| Reduced contact angle compared to untreated control. | |||
| Increased coating thickness to close to original value, effective over 12 months. | |||
| Functional performance and solution parameters maintained through proposed shelf-life. | Lens/solution compatibility per ISO 11981:2009 was performed. | ||
| Data indicates Boost treatment reduces contact angle of lenses compared to untreated control (over 12 months). | |||
| Data demonstrates Boost treatment increased coating thickness to close to original value and continued to be effective over 12 monthly treatments. | |||
| Shelf-life stability testing was performed for functional performance and solution parameters. | |||
| Human Factors/Usability (HF/U) | Assess patient's ability to properly use the device and identify unforeseen use errors. | No unforeseen use errors or unacceptable residual risks identified. Users understand key instructions (usage frequency, disinfection, no direct eye contact), confirmed by reference material assessment. | No unforeseen use errors or unacceptable residual risks identified. All participants understood they needed to disinfect lenses after Boost treatment and not place Boost solution directly in eyes. All knew treatment is monthly. |
| Clinical Study (Safety) | Evaluate adverse events, slit lamp findings (e.g., corneal staining), and contact lens discontinuations. Demonstrate no increase in adverse events compared to control, no increase in corneal staining, and no discontinuations due to device. | No serious adverse events (SAEs). | |
| Similar overall AE incidence to control. | |||
| No increase in corneal staining for Boost group vs. placebo. | |||
| No discontinuations. | No reported SAEs. | ||
| Similar overall AE incidence (19% Boost, 20% control); 2 AEs possibly related (1 mild allergic-type, 1 asymptomatic keratitis). | |||
| No increase in corneal staining for Boost group compared to placebo group. | |||
| No subjects discontinued from the study. | |||
| Clinical Study (Effectiveness) | Evaluate lens performance (visual acuity (VA), RGP lens fit) and secondary endpoints (non-invasive tear break-up time (TBUT), subjective symptoms, preference). Demonstrate no reduction in VA, no decline in lens fit, maintained baseline TBUT. | No statistically significant change/reduction in VA. | |
| No decline in lens fit; changes consistent with day-to-day wear. | |||
| Maintained baseline TBUT (no worsening). | |||
| Subjective patient-reported outcomes (CLDEQ, VAS, preference) did not show clinically/statistically significant reduction in discomfort or greater preference vs. placebo. | No statistically significant change in VA for test and control groups. | ||
| No decline in Lens Fit observed; changes not at higher rate for Boost group compared to placebo. | |||
| Maintained baseline TBUT for both groups. | |||
| CLDEQ, VAS, and preference results did not demonstrate clinically significant meaningful reduction in discomfort nor greater patient preference compared to placebo. |
Study Details for Device Performance Evaluation:
This section addresses specific questions regarding the studies. Based on the provided text, the primary study demonstrating performance is the Clinical Performance Study, supplemented by various non-clinical/bench studies.
1. Sample sizes used for the test set and the data provenance:
-
Clinical Performance Study:
- Sample Size: 30 subjects (20 test group, 10 control group).
- Data Provenance: Not explicitly stated as to the country of origin, but implied to be a single-site study. It was a prospective, randomized, subject and investigator masked, placebo-controlled study conducted for 3 months.
-
Human Factors/Usability (HF/U) Study:
- Sample Size: 15 laypersons.
- Data Provenance: Not explicitly stated (retrospective/prospective or geographical origin). Implied to be prospective.
-
Bench and Biocompatibility Studies: Specific sample sizes for these tests (e.g., number of lenses, cells, animals) are generally not provided in the summary, other than "representative RGP contact lenses" for bench testing. The provenance is likely lab-based (pre-clinical).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Clinical Study:
- The study mentions "in the opinion of the investigator" for inclusion criteria and "investigator" for assessing conditions. The qualifications of the investigator(s) are not specified beyond their role.
- For slit lamp findings, VA measurement, and lens fit assessment, these would be medically trained professionals (e.g., ophthalmologists, optometrists), but the exact number of experts, their specific qualifications, or their role in establishing "ground truth" (e.g., independent adjudication) is not detailed.
- Bench and Biocompatibility Studies: These are laboratory tests with defined protocols (e.g., ISO standards), so "expert" interpretation in the sense of human readers for medical imaging is less applicable. The "ground truth" is derived directly from the test results against established criteria.
- HF/U Study: "Reference material assessment" was used, suggesting observation and participant feedback. No specific "experts" for ground truth establishment are noted beyond the study conductors.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The text does not explicitly mention an adjudication method for the clinical study's primary or secondary endpoints (VA, lens fit, TBUT, subjective symptoms, AEs, corneal staining).
- For the AEs, it provides a summary table and qualitative assessment (e.g., "possibly related"), but not a formal adjudication process by independent experts.
4. 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, an MRMC comparative effectiveness study was NOT done. This device is a re-coating solution, not an AI or imaging diagnostic device. Therefore, the concept of "human readers improving with AI assistance" does not apply.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI algorithm. This question is not applicable to the Tangible Boost device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Study:
- Direct Clinical Observation/Measurement: Visual acuity (measured), RGP lens fit (assessed by investigator), non-invasive tear break-up time (TBUT) (measured), corneal staining (scored).
- Patient-Reported Outcomes (PROs): CLDEQ (questionnaire), VAS for comfort, preference questions.
- Adverse Event Reporting: Based on subject reports and investigator assessment.
- There is no mention of "expert consensus" or "pathology" in the context of ground truth establishment for clinical endpoints. The outcomes data (e.g., VA, lens fit) are considered the ground truth for evaluating the device's clinical performance.
- Bench/Biocompatibility Studies: The ground truth is established by the defined methodologies and acceptance criteria of the ISO/ASTM standards being followed (e.g., cytotoxicity determined by cell viability, contact angle by measurement).
7. The sample size for the training set:
- This question is not applicable as the device is not an AI/machine learning product and therefore does not have a "training set" in that sense.
8. How the ground truth for the training set was established:
- This question is not applicable as there is no "training set" for this device.
§ 886.5919 Hydrophilic re-coating solution.
(a)
Identification. A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate device safety as assessed by adverse events, slit lamp findings, and maintenance of visual acuity.
(2) The patient contacting components of the device and packaging components must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the sterility of the device.
(4) Use-related risk analysis must be performed to determine if a self-selection study and human factors validation study must be conducted to demonstrate that users can correctly use the device based solely on reading the directions for use.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Performance testing must demonstrate compatibility with each lens and solution labeled for use with the device.
(7) Performance testing must demonstrate the ability of the device to restore the coating of compatible lenses.
(8) Labeling must include the following:
(i) Instructions on how to correctly use the device, including instructions to use fresh components for each use;
(ii) Descriptions of compatible contact lenses;
(iii) Descriptions of compatible care solutions;
(iv) A warning that if patients are not sure of their lens material, they should contact their health care provider prior to use; and
(v) A precaution against use with lenses that have not been demonstrated to be compatible with the device.