(112 days)
Boston XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed 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 lenses may be disinfected using a chemical disinfection system only.
Boston XO (hexafocon A) is a rigid gas permeable material, composed of siloxanyl fluoromethacrylate copolymer available with or without an ultraviolet absorber.
The Boston XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) are rigid gas permeable contact lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer available with or without an ultraviolet absorber.
Boston XO, Boston EO, and Boston ES Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in aphakic and non-aphakic persons with non-diseased eyes. Additionally, these lenses may be prescribed for non-diseased eyes requiring a rigid contact lens for managing irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery (e.g., LASIK). Disinfection must be done using a chemical disinfection system only.
The safety and efficacy of these devices were established in prior 510(k) clearances (K000795, K013762, and K053124). For the current submission (K071043), the primary change was the addition of a UV blocker to the BOSTON XO material. Preclinical testing, as required by the "Pre-Market Notification Guidance for Daily Wear Contact Lenses, May 12, 1994," demonstrated the safety of this change. Since BOSTON EO and BOSTON ES already incorporate the same UV blocker, clinical studies were deemed unnecessary.
A table of acceptance criteria and reported device performance cannot be extracted as the provided text refers to "preclinical testing" for the UV blocker addition but does not detail specific acceptance criteria or performance metrics in a tabular format for this aspect, nor does it provide new clinical study data. The original clearances relied on historical data which is not provided in detail.
1. A table of acceptance criteria and the reported device performance:
Specific acceptance criteria and device performance metrics, particularly for the addition of the UV blocker, are not provided in the document in a comparative table format. The submission primarily relies on the safety and efficacy established in previous 510(k) clearances and states that preclinical testing for the UV blocker was performed as required by guidance.
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable for a new clinical test set. The submission states that "Clinical studies for the BOSTON XO... materials have been deemed as not necessary."
- Data provenance: Not applicable, as no new clinical studies were conducted for this 510(k) submission. The safety data for the UV blocker was generated through preclinical testing, but the specifics (e.g., country of origin, retrospective/prospective) are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no new clinical studies were conducted and thus no expert-established ground truth for a new test set was required.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no new clinical studies were conducted.
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, as this device is a contact lens and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this device is a contact lens and not an algorithm.
7. The type of ground truth used:
For the original safety and efficacy of the contact lenses (from the predicate devices), the ground truth would have been based on clinical examinations by ophthalmologists/optometrists assessing visual acuity, ocular health, comfort, and adverse events. For the current submission, the ground truth for the safety of the UV blocker was established through preclinical testing (e.g., biocompatibility, toxicology), as evidenced by the mention of "preclinical testing as required in current Pre-Market Notification Guidance for Daily Wear Contact Lenses, May 12, 1994."
8. The sample size for the training set:
Not applicable for this context, as this is a contact lens approval, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable for this context.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.