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The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/ lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

The Custom Stable™ Rigid Gas Permeable (roflufocon D, roflufocon E) Scleral Contact Lens for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Custom Stable™ Rigid Gas Permeable (rofflufocon D, roflufocon E) Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluorosilicone acrylate materials: roflufocon D (supplied by Contamac Ltd.) or roflufocon E (supplied by Contamac Ltd.).

This document is a 510(k) premarket notification for a medical device, specifically a type of contact lens. It outlines the manufacturer's claim that their new device is substantially equivalent to a previously cleared predicate device. This type of FDA submission does not involve the rigorous clinical study design typically associated with proving a device meets specific acceptance criteria for AI/ML-based medical devices.

Therefore, I cannot extract the information requested about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement as these concepts are not applicable to this particular 510(k) submission for a physical contact lens.

This document focuses on demonstrating substantial equivalence based on comparable:

• Intended Use
• Indications for Use
• Technological Characteristics (materials, design, production method, physical properties)
• Performance Data (which here refers to non-clinical bench testing for manufacturing verification and reference to previously cleared 510(k)s for material clinical safety/effectiveness, not new clinical trials for this specific device).

The "performance data" sections (VII. PERFORMANCE DATA) specifically state that "Non-clinical testing to validate safety and effectiveness for finished contact lenses manufactured from roflufocon D and roflufocon E blanks has been addressed by reference to previously cleared 510(k) premarket notifications" and "Clinical performance data to validate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to previously cleared 510(k) premarket notifications." This confirms that no new standalone clinical studies were performed for this specific submission to define and meet new acceptance criteria.

In summary, the provided document does not contain the information needed to answer the questions regarding acceptance criteria, study design, sample sizes, ground truth, or expert involvement, as it pertains to a traditional medical device (contact lens) seeking 510(k) clearance based on substantial equivalence, not an AI/ML-based medical device requiring such validation.

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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)

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.

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