Search Results

Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.

Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear colorless aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 6.30 to 7.80 and Osmolality of 280 to 320 mOsmol/kg The Sterile Saline Solution is packed in 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.

The provided text describes the 510(k) Premarket Notification for Aqua Naina Sterile Saline Solution and its substantial equivalence to predicate devices. It focuses on the chemical composition, intended use, and various safety tests (sterility, biocompatibility, ocular irritation, cytotoxicity).

However, this document does not describe acceptance criteria, performance data, or study details relevant to a machine learning or AI device. The device in question is a sterile saline solution, which is a chemical product, not a medical imaging or AI diagnostic device. Therefore, the requested information about test sets, data provenance, expert consensus, MRMC studies, or training sets is not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to a series of chemical and biological tests conducted on the saline solution to demonstrate its safety and performance, as outlined in section (7) "PERFORMANCE STSTANDARDS APPLIED".

Here's a breakdown of what is provided and why it doesn't fit the typical AI/ML device study format:

• Device: Aqua Naina Sterile Saline Solution (a chemical product for contact lens care).

• Acceptance Criteria & Reported Performance: These are presented implicitly through the successful completion of various tests against established standards for saline solutions.

  • Sterility: USP
  • Bacteriostasis: USP
  • Ocular irritation: Tested per ISO 10993-10:2010
  • Cytotoxicity (Direct contact test & MEM Elution test): Tested per ISO 10993-5:2009
  • Biocompatibility: Tested per ISO 10993-1:2009
  • pH: 6.30 to 7.80 (reported in description)
  • Osmolality: 280 to 320 mOsmol/kg (reported in description)
    The document states: "Results of all testing demonstrate the solution is non-toxic, is comparable to other currently marketed soft contact lens solution and is substantially equivalent to legally marketed predicates." This is the reported device performance meeting the acceptance criteria set by these standards.

• Sample Size for Test Set and Data Provenance: Not applicable. This refers to chemical and biological samples, not image datasets. The tests are laboratory-based, not based on patient data in the sense of AI/ML.

• Number of Experts, Qualifications, Adjudication Method: Not applicable. These relate to human interpretation of diagnostic data, which is not relevant for testing a saline solution.

• MRMC Comparative Effectiveness Study: Not applicable. This is for evaluating AI assistance in diagnostic tasks.

• Standalone Performance (algorithm only): Not applicable, as there is no algorithm.

• Type of Ground Truth: Not applicable in the AI/ML sense. Ground truth here is established by laboratory measurements and biological assays, comparing results against defined pass/fail criteria from recognized standards (e.g., USP, ISO).

• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. There is no machine learning model involved, therefore no training set. The "training" of the product is its formulation and manufacturing process, and its "ground truth" is its chemical and physical properties verified through standard laboratory testing.

In summary, the provided document details the regulatory clearance of a contact lens saline solution, not an AI/ML-based medical device. Therefore, the questions posed regarding AI/ML device acceptance criteria and study methodology cannot be answered from this information.

Ask a specific question about this device

PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

The PuriLens Plus Preservative Free Saline is a sterile, buffered saline solution for rinsing and storing contact lenses. The solution is buffered to roughly physiological pH and has an osmolarity similar to that of human tears. The product is sold over-the-counter in various packaging configurations.

The current generation of the product, Purilens Saline Solution, was cleared under K002319 in 2000, and has been legally marketed in the US since that time. This 510(k) application is to expand the indications for use to include use with rigid gas permeable lenses. There is no change in the device design, formulation, or manufacturing. The labeling will be revised with the new indications.

This submission describes a 510(k) for a contact lens solution, PuriLens Plus Preservative Free Saline, and argues for its substantial equivalence to a predicate device based on similar formulation, manufacturing, and packaging, and expands its indications for use.

Since this is a submission for substantial equivalence based on a predicate device and there have been no changes to the device design, formulation, or manufacturing, no performance data or studies are presented. Therefore, I cannot provide information on acceptance criteria, specific study details, sample sizes, ground truth establishment, or expert involvement as these were not required or reported in this 510(k) summary.

The summary states: "Because the subject is identical to the predicate in terms of formulation, manufacturing, and packaging, no bench-testing is required to demonstrate substantial equivalence." (Page 5)

As such, for all the requested points regarding acceptance criteria, performance data, sample sizes, ground truth, expert involvement, and comparative effectiveness studies, the answer is that this information is not applicable or not provided in this 510(k) summary due to the nature of the submission (substantial equivalence based on an identical product with expanded indications, requiring no new bench testing).

Ask a specific question about this device