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510(k) Data Aggregation
(104 days)
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
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.
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(74 days)
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
BOSTON EO (enflufocon B) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
The BOSTON EO Gas Permeable Contact Lens Material, enflufocon B, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber (Uvinul D-49). The color additives conform with 21 CFR part 74.3206. The enflufocon B material has an oxygen permeability, DK, of 58, a specific gravity of 1.23, and the lens visible light transmittance of at least 70%. The enflufocon B name has been adopted by the United States Adopted Names Council (USAN).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Test Lens (BOSTON EO) Performance | Control Lens (BOSTON ES) Performance |
|---|---|---|
| Safety: | ||
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(15 days)
POLYMER TECHNOLOGY DIV. WILMINGTON PARTNERS, L.P.
The BOSTON Contact Lens Case is indicated for disinfection and storage of rigid gas permeable contact lenses.
The BOSTON® Contact Lens Case is plastic and double-welled with ridged screw caps on the wells. The interiors of the wells and caps contain elevated ridges to prevent the adherence of rigid gas permeable contact lenses to the surfaces.
This document is a 510(k) summary for a contact lens case, not a study presenting acceptance criteria and device performance data from a clinical trial or algorithm evaluation. Therefore, most of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, etc.) is not present in the provided text.
The document discusses toxicology testing for the contact lens case, which is a type of pre-market safety evaluation. It mentions "Systemic Injection Test," "Eye Irritation Test," and "Cytotoxicity Test." However, it does not provide the specific acceptance criteria for these tests nor the detailed results demonstrating the device meets them. Instead, it merely states that information from these tests was submitted for review.
Here's an attempt to address the request based only on the provided text, highlighting what's missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/Missing Details) | Reported Device Performance |
|---|---|
| Toxicology Testing: | |
| Systemic Injection Test: (Specific criteria for passing - e.g., no systemic toxicity observed) | Information submitted. (Specific results not provided) |
| Eye Irritation Test: (Specific criteria for passing - e.g., no significant eye irritation) | Information submitted. (Specific results not provided) |
| Cytotoxicity Test: (Specific criteria for passing - e.g., non-cytotoxic) | Information submitted. (Specific results not provided) |
| Substantial Equivalence: | |
| Device is substantially equivalent to predicate device (K951552) based on similar designs and indications for use. | Stated as equivalent to BOSTON® Contact Lens Case (K951552) |
Missing Information: The specific acceptance criteria (e.g., quantitative thresholds, qualitative outcomes) for the toxicology tests are not detailed in this summary. The actual numeric or descriptive performance results are also not provided beyond "information from the following was submitted for review."
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not mentioned. (Toxicology tests would involve animal models or in-vitro samples, but the number is not specified).
- Data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/mentioned. For toxicology tests, results are typically determined by laboratory protocols and evaluated by qualified personnel in toxicology, but this document does not specify the number or qualifications of "experts" in the context of ground truth establishment.
4. Adjudication method for the test set
- Not applicable/mentioned.
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 is a contact lens case, not an AI-powered diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a contact lens case, not an algorithm.
7. The type of ground truth used
- For the toxicology tests (Systemic Injection, Eye Irritation, Cytotoxicity), the "ground truth" would be established by the standardized methods and observations of these specific biological assays.
- For substantial equivalence, the "ground truth" is regulatory equivalence to an already marketed device.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model.
9. How the ground truth for the training set was established
- Not applicable.
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