(104 days)
Boston® Enhanced Original Formula Conditioning Solution is indicated for use in wetting, disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses.
The modified Boston® Enhanced Original Formula Conditioning Solution is a sterile conditioning solution used in the care of rigid gas permeable contact lenses and is indicated for the wetting, disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate and silicone acrylate contact lenses. This product is a sterile, buffered solution, preserved with chlorhexidine gluconate and edetate disodium.
The provided document describes a 510(k) premarket notification for the "Boston® Enhanced Original Formula Conditioning Solution". This is a contact lens care product, not a medical device in the typical sense of providing diagnostic or therapeutic measurements based on algorithms. Therefore, many of the requested sections related to AI/algorithm performance (e.g., test set, training set, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable to this type of submission.
The acceptance criteria and study information provided focuses on demonstrating the safety and effectiveness of the conditioning solution for contact lenses, primarily through preclinical (toxicology, microbiology, solution compatibility, wetting angle) and clinical equivalence testing against a predicate device.
Here's the information that can be extracted from the provided text, structured according to your request, with a clear indication of non-applicable sections:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Acceptance Standard | Reported Device Performance |
|---|---|---|---|
| Toxicology | In-Vitro Cytotoxicity (USP Agar Diffusion) | Meets requirements of USP XXII for Agar Diffusion Test. | "The test article meets the requirements of the Agar Diffusion Test." |
| Acute Ocular Irritation | No significant ocular irritation to laboratory animal tissues. | "Acute Ocular Irritation test was performed and produced no ocular irritation. The solution did not cause any significant irritation to the ocular tissues of the laboratory animals." | |
| Microbiology | Preservative Effectiveness | Meets requirements of the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997, and the ISO Draft Standard. | "The results of these tests demonstrate that the modified Boston® Enhanced Original Formula Conditioning Solution meets the requirements of the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. May 1, 1997 and the ISO Draft Standard." |
| Disinfection Efficacy | Meets FDA performance criteria for regimen evaluation as described in the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997, and the Draft Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, April 1, 1996. | "The results of this evaluation demonstrate that the product meets the FDA performance criteria for regimen evaluation as described in the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997, and the Draft Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, April 1, 1996." | |
| Shelf Life | Expiration Dating | Established in accordance with the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997, and the Draft Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, April 1, 1996. | "Expiration dating will be established based on the Shelf-life Protocol in accordance with the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997, and the Draft Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, April 1, 1996." (Note: This is a protocol statement, implies that the protocol will ensure compliance to criteria, rather than stating measured performance.) |
| Solution Compatibility | Physical/Lens Parameters after Repeated Cycles | All physical and lens parameters tested within ISO specifications for rigid corneal and scleral contact lenses; no change in cosmetic appearance. | "After thirty repeated cycles with Boston Cleaner and the modified Boston® Enhanced Original Formula Conditioning Solution, all of the physical and lens parameters tested for BOSTON IV and BOSTON ES rigid gas permeable tinted contact lenses were within ISO specifications for rigid corneal and scleral contact lenses. There was no change in the cosmetic appearance." |
| Wetting Angle | Wettability Maintenance (Dynamic Contact Angle Analysis) | Modified solution should maintain wettability of the surface better than the currently marketed Boston Conditioning Solution. | "The results of the DCA testing indicate that the modified Boston® Enhanced Original Formula Conditioning Solution maintains the wettability of the surface better than the currently marketed Boston Conditioning Solution." |
| Clinical Equivalence | Safety and Efficacy compared to Predicate Device | No clinically significant differences between the Test (modified) and Control (predicate) groups. Substantially equivalent in safety and efficacy. | "Analysis of all data from this study showed no clinically significant differences between the Test and Control Groups. Based on these data, the Sponsor concludes that the modified Boston Enhanced Original Formula Conditioning Solution is substantially equivalent in safety and efficacy to the currently marketed Boston Original Conditioning Solution." |
2. Sample size used for the test set and the data provenance
- Sample Size (Clinical Study): 212 eyes (106 patients). 36 eyes (18 patients) were non-dispensed.
- Data Provenance: The document does not explicitly state the country of origin, but the submission is to the U.S. FDA, and it mentions "laboratory animals" for acute ocular irritation, implying controlled laboratory and clinical studies rather than retrospective review of existing data. The clinical study was performed by "7 Investigators", which suggests a multi-site clinical trial. It is a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission is for a contact lens care solution, which does not involve "ground truth" derived from expert image interpretation or similar diagnostic tasks. The "ground truth" for preclinical and clinical studies is based on established laboratory testing methodologies and clinical observations by investigators (e.g., absence of irritation, meeting microbial reduction standards, no clinically significant differences).
4. Adjudication method for the test set
- Not Applicable. As there is no "ground truth" established by experts in the sense of diagnostic interpretation, there is no need for an adjudication method. Clinical data was analyzed using "descriptive statistics, tests for normality, analysis of variance and/or t-tests where appropriate."
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 type of study relates to AI in diagnostic imaging or similar scenarios requiring human reader interpretation, which is not relevant for a contact lens conditioning solution.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no AI algorithm being evaluated in this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Preclinical Studies: The "ground truth" for the preclinical tests (cytotoxicity, ocular irritation, preservative effectiveness, disinfection efficacy, solution compatibility, wetting angle) is derived from the results of standardized laboratory tests and measurements against predefined regulatory or international standards (e.g., USP XXII, 510(k) Guidance Document for Contact Lens Care Products, ISO Draft Standard, ISO specifications for RGP lenses).
- Clinical Study: The "ground truth" (or outcome measure for equivalence) for the clinical study was based on observed clinical safety and efficacy parameters in human subjects, evaluated against the performance of the predicate device, with the goal of demonstrating 'no clinically significant differences'.
8. The sample size for the training set
- Not Applicable. There is no AI algorithm and therefore no "training set" in the context of this submission. The "training" for the product refers to its formulation and testing to meet intended performance.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI algorithm, this question is not applicable.
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”