Search Results

The BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D for daily wear.

The BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D for daily wear.

The Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens and the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens are soft hydrophilic contact lens. The lenses are made from the balafilcon A material, a copolymer of a silicone vinyl carbamate, N-vinyl-pyrrolidone, a siloxane crosslinker and a vinyl alanine wetting monomer, tinted blue with Reactive Blue Dye 246.

The provided 510(k) summary for the Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens does not describe any new studies or acceptance criteria.

Instead, the submission hinges on demonstrating substantial equivalence to a previously cleared predicate device (OxyCor (balafilcon A) Visibility Tinted Contact Lens, K972454). The core argument is that there has been no change made to the device itself. The submission clarifies the indications for use within the already cleared range, providing more specific guidance for eye care practitioners regarding prescribing for frequent/planned replacement wear or disposable wear, and limiting astigmatism indications to within previously cleared levels.

Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance are not applicable to this 510(k) submission.

Here's a breakdown based on the provided document:

1. Table of acceptance criteria and the reported device performance:

   • Not Applicable. No new acceptance criteria were established, and no new performance data was generated or reported for this submission. The device is considered to meet the performance of the predicate device due to being identical.

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

   • Not Applicable. No new test set or associated data was used. The submission relies on the data that supported the clearance of the predicate device (K972454).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. No new ground truth establishment was conducted for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Applicable. No new test set required adjudication.

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 diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This device is a contact lens, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not Applicable. No new ground truth was established for this submission. The safety and effectiveness of the device were established by demonstrating its identical nature to a previously cleared device.

8. The sample size for the training set:

   • Not Applicable. This is a medical device, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established:

   • Not Applicable. No training set ground truth was established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or rather, the basis for clearance, is a comparative analysis demonstrating substantial equivalence to a predicate device (OxyCor (balafilcon A) Visibility Tinted Contact Lens, K972454).

• Rationale: The submission explicitly states: "There has been no change made to this device" (Section 7.0 Non-Clinical Testing and Section 8.0 Clinical Testing) and "The subject devices are identical to the predicate device cleared under K972454" (Section 6.0 Technological Characteristics).
• Methodology: The sponsor provided a side-by-side comparison of the technological characteristics (material, water content, physical/optical properties, oxygen permeability, color additive, manufacturing method, lens design, replacement, base curve, diameter, sphere powers, cylinder powers, axis, center thickness) of the subject device to the predicate device. This comparison confirmed their identical nature, with a minor difference noted in the "Indications for Use" which was explained as being "within currently cleared indications" for the predicate.
• Conclusion: Because the device is identical to the legally marketed predicate device, and the stated indications for use are within the scope of the predicate, the device is considered substantially equivalent, thus meeting the relevant regulatory acceptance criteria for market clearance without requiring new performance data or clinical trials.

Ask a specific question about this device