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The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorber.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:

The following table depicts the physical properties of the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses:

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are supplied dry (without storage solution) and non-sterile in a screw top case and must be cleaned and conditioned prior to use.

This is an FDA 510(k) summary for a rigid gas permeable contact lens. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against predefined acceptance criteria for a novel device through clinical trials. Therefore, much of the information you requested regarding acceptance criteria and study details (like sample size for test sets, expert ground truth, MRMC studies, training set details) is not applicable to this type of submission.

Here's a breakdown of what is available in the document related to acceptance criteria and performance, and why other elements are absent:

Context: This 510(k) submission is for the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses. The manufacturer is not introducing a new type of device or technology but is demonstrating that their product is "substantially equivalent" to existing, legally marketed predicate devices. For this type of submission, extensive clinical studies and a complex acceptance criteria framework (as would be seen for a novel AI device, for example) are generally not required. The focus is on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate devices.

Acceptance Criteria and Device Performance (as evident from the document):

The acceptance criteria are implicitly based on demonstrating that the device's physical properties and manufacturing quality fall within acceptable ranges and meet the standards set by the predicate devices and relevant industry standards (like ANSI Z80.20 for lens specifications).

Regarding the specific questions you asked:

1. A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" for a 510(k) are often implied by compliance with recognized standards and substantial equivalence to predicates, rather than a strict, numerical performance target for a novel feature.

2. Sample size used for the test set and the data provenance:

   • The document does not specify exact sample sizes for bench testing (manufacturing verification, bioburden) or biocompatibility tests. It mentions "finished lenses" and "a variety of prescribed parameters."
   • Data Provenance: The manufacturing facility is Tianjin MasterVision Technology Co., Ltd. in Tianjin, P.R. China. The testing was conducted "at the Tianjin MasterVision Technology Co., Ltd. facility" for bioburden and biocompatibility, or implied to be internal for bench testing. The data is non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a contact lens 510(k), ground truth isn't established by expert consensus on, for example, diagnostic image interpretations. Performance is measured against physical and biological compatibility standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is typically used in clinical studies involving subjective assessments or interpretation by multiple readers/experts.

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 contact lens, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is compliance with established physical standards (e.g., ANSI Z80.20 tolerances for lens parameters), and recognized international standards for biocompatibility (ISO 10993 series). For bioburden, it's a quantitative microbiological test.

8. The sample size for the training set: Not applicable. This describes the manufacturing of physical medical devices, not the development of an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of Study Type:

The studies conducted were non-clinical bench testing and biocompatibility testing. The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices based on:

• Identical or similar intended use and indications for use.
• Highly similar technological characteristics (material, production method, physical properties).
• Demonstrating safety and performance through standard bench and biocompatibility testing, showing the device meets established manufacturing and biological compatibility standards for its class and material.

The FDA explicitly states: "Based on recommendations in the FDA guidance titled Class II Daily Wear Contact Lenses - Premarket Notification [510(k)] Guidance Document, clinical studies are not required for this 510(k) premarket notification." This clarifies why the document lacks the detailed clinical study information often associated with AI/diagnostic device approvals.

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