(85 days)
Boston Advance ® Cleaner is indicated for use to clean fluoro silicone and silicone acrylate rigid gas permeable contact lenses after each removal and before conditioning (wetting, soaking, and disinfecting).
Boston Advance® Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alky ether sulfate, ether sulfate, ethoxylated alkyl phenol, triquaternary cocoabased phospholipid, silica gel as cleaning agents; with titanium dioxide.
This 510(k) summary describes a submission for a contact lens cleaner, Boston Advance® Cleaner. The primary goal of the submission is to demonstrate substantial equivalence to a previously marketed device. Therefore, the study focuses on showing comparable safety and efficacy rather than establishing novel performance criteria as might be expected for a new, unique device.
Here's an analysis of the provided information, structured around your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state distinct "acceptance criteria" with numerical thresholds for performance endpoints in the way you might see for an AI algorithm's accuracy or sensitivity. Instead, the "acceptance criteria" were implied by demonstrating substantial equivalence to the predicate device across various safety and efficacy parameters.
The "reported device performance" is a conclusion of "substantial equivalence" based on these tests.
| Category | Implied "Acceptance Criteria" (Demonstrate Substantial Equivalence to Predicate) | Reported Device Performance (Summary) |
|---|---|---|
| Toxicology | No toxic effects when used with specified RGP contact lenses | "The results of these tests demonstrate that the product is not toxic." |
| Sterility | Product remains sterile according to USP standards. | Studies performed according to USP 23, 1995, Chapter 95, 1689 demonstrated sterility. |
| Antimicrobial Activity (Biostatic Efficacy) | Acceptable antimicrobial activity against USP-designated microorganisms over specified timeframes. | Samples inoculated with USP-designated microorganisms. Test samples assayed at 7 and 14 days, then continually every 7 days through 42 days, and every 2-3 weeks up to at least 98 days. The results imply acceptable biostatic efficacy. |
| Antimicrobial Activity (Preservative Efficacy) | Meets requirements for multi-dose preserved contact lens care products after storage. | "Results demonstrate that the modified Boston Advance® Cleaner meets the requirements for multi-dose preserved contact lens care products." "The results from these tests support that the product has acceptable antimicrobial activity." |
| Shelf Life | Product remains safe and effective over its stated shelf life. | Expiration dating established based on the Shelf-life Protocol testing in accordance with relevant Guidance Documents. The results support the claimed shelf life. |
| Lens/Solution Compatibility | Compatible with silicone acrylate and fluoro silicone acrylate RGP contact lenses. | "The results of these tests demonstrate the compatibility of the proposed regimens with silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses." |
| In-Vitro Cleaning | Cleaning efficacy equivalent to the predicate device, specifically demonstrated by surfactants being above critical micelle concentrations. | Critical micelle concentrations (CMC) of surfactants evaluated; found to be above CMC. "The results of these tests demonstrate that the cleaning efficacy of the product is equivalent to the predicate device." |
| Clinical Safety & Efficacy | Substantially equivalent in safety and efficacy to the currently marketed Boston Advance® Cleaner when used with RGP lens materials on a daily wear basis (no statistically significant difference). | "Based on these data, it is concluded that the modified Boston Advance® Cleaner (Test), is substantially equivalent in safety and efficacy to the currently marketed Boston Advance® Cleaner (Control)." (Detailed statistical findings for equivalence are not provided in this summary but are implied by the conclusion). |
2. Sample Size Used for the Test Set and Data Provenance
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Clinical Study (In-vivo):
- Total Patients: 170 patients (340 eyes)
- Test Group (modified Boston Advance® Cleaner): 114 patients (228 eyes)
- Control Group (marketed Boston Advance® Cleaner): 54 patients (108 eyes)
- Completed Study: 151 patients
- Discontinued: 17 patients (none for safety or efficacy reasons)
- Data Provenance: The study involved 12 investigational sites. The document doesn't explicitly state the country of origin, but given the submission is to the U.S. FDA, it is highly likely that the investigational sites were in the United States. The study started in April 1997 and concluded in November 1997, making it a prospective clinical study.
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In-vitro, Toxicology, Microbiology, Shelf Life, Lens/Solution Compatibility, In-Vitro Cleaning: These studies were conducted in laboratory settings as "pre-clinical" or in-vitro tests, not on human subjects. Sample sizes and provenance vary by test (e.g., "separate samples of three lots" for Biostatic Efficacy, unspecified numbers of lenses for compatibility). The provenance would be the testing laboratories, likely within the manufacturer's or contracted facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of submission (for a contact lens care product) does not typically involve "experts establishing ground truth" in the way an AI diagnostic device would.
- For the clinical study, the "ground truth" would be established through standard clinical examinations and patient reporting of symptoms by licensed eye care professionals (e.g., ophthalmologists, optometrists) at the 12 investigational sites. Their qualifications are not explicitly stated but are assumed to be appropriate for clinical trials involving contact lenses.
- For the laboratory tests (toxicology, microbiology, cleaning efficacy, etc.), ground truth is established by following validated, standardized testing protocols (e.g., USP standards) and performing objective measurements. The "experts" would be the laboratory personnel qualified to conduct and interpret these specific assays, but they wouldn't be forming consensus "diagnoses" as for medical imaging.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method (like 2+1 or 3+1 consensus) for the clinical test set. In clinical trials for equivalence, outcomes (e.g., adverse events, visual acuity, comfort levels) are typically assessed individually by the investigators at each site and then aggregated for statistical comparison between the test and control groups. It's not a diagnostic scenario requiring a consensus "ground truth" in the same way.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the performance of diagnostic devices or AI algorithms where multiple human readers interpret cases, often with and without AI assistance. This submission is for a contact lens cleaning solution and does not involve such an evaluation methodology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a contact lens cleaning solution, not an algorithm or AI product. There is no algorithm to assess in a standalone manner.
7. The Type of Ground Truth Used
- Clinical Study: The "ground truth" for the clinical study would be a combination of:
- Clinical Assessments: Objective findings from eye examinations (e.g., corneal staining, lens deposits) performed by eye care professionals.
- Patient-Reported Outcomes: Subjective feedback from patients regarding comfort, vision, and adverse events.
- Comparison against the predicate device's established safety and efficacy profile. The ultimate ground truth is "substantial equivalence" to the predicate.
- Toxicology: Absence of biological reactivity (cell viability/response to extracts).
- Microbiology: Absence of microbial growth (sterility) and reduction in microbial concentration (antimicrobial efficacy) based on standardized culture methods.
- Shelf Life: Stability of the product's chemical and microbiological properties over time.
- Lens/Solution Compatibility: Physical integrity and optical properties of lenses after exposure to the solution.
- In-Vitro Cleaning: Objective measurement of surfactant properties (critical micelle concentration) and implied cleaning efficacy.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device (contact lens cleaner) and does not involve an AI algorithm that requires a "training set." The clinical study performed functions as the "test set" to demonstrate equivalence.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI algorithm, there is no training set and hence no ground truth establishment for a training set.
§ 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.”