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510(k) Data Aggregation
(141 days)
The BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.
The BOSTON ES® (enflufocon A) and BOSTON EO® (enflufocon B) are Rigid Gas Permeable Contact Lens materials composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer with an ultraviolet absorber.
BOSTON® XO (hexafocon A) is a rigid gas permeable contact lens material, composed of siloxanyl fluoromethacrylate copolymer containing an ultraviolet absorber.
The color additives conform to 21 CFR Part 74 and/or 21 CFR Part 73. The lens may also be supplied clear (no tint).
Here's an analysis of the provided text regarding the acceptance criteria and study for the BOSTON ES®, BOSTON EO®, and BOSTON® XO Rigid Gas Permeable Contact Lenses.
It's important to note that this document is a 510(k) summary, which often points to prior submissions and substantial equivalence rather than detailing a new comprehensive clinical study for the specific device being cleared.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are primarily based on demonstrating substantial equivalence to a predicate device (BOSTON® II itafocon A). This means that the new devices are considered safe and effective because they are as safe and effective as a legally marketed device.
The "performance" for these new devices is presented not as a comparison against specific numerical targets, but as their fundamental physical and optical properties, which are then implicitly considered acceptable because they fall within the parameters of what is deemed safe and effective for rigid gas permeable contact lenses, similar to the predicate.
| Acceptance Criteria Category (Implicit) | Specific Criteria (from predicate/general RGP lens standards) | Reported Device Performance (BOSTON ES, EO, XO) |
|---|---|---|
| Substantial Equivalence to Predicate Device | Safety and efficacy equivalent to BOSTON® II (itafocon A) lens. | Achieved through similarity in materials, indications for use, and general design. |
| Material Composition | Appropriate for RGP contact lenses, including UV absorber. | BOSTON ES/EO: aliphatic fluoroitaconate siloxanyl methacrylate copolymer with UV absorber. BOSTON XO: siloxanyl fluoromethacrylate copolymer with UV absorber. Color additives conform to 21 CFR Part 74/73. |
| Physical/Optical Properties | Within acceptable ranges for RGP lenses (specific gravity, refractive index, light transmittance, water content, oxygen permeability). | BOSTON ES: Specific Gravity: 1.22 Refractive Index: 1.443 Light Transmittance: C.I.E. Y value - at least % |
| Indications for Use | Correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia and keratoconus) in aphakic and non-aphakic persons with non-diseased eyes; chemical disinfection only. | Matched to predicate device's indications, as stated in the submission. |
Notes:
- Specific numerical acceptance criteria for each physical/optical property are not explicitly stated in this 510(k) summary, but are implied to be acceptable based on the predicate and general RGP lens standards.
- The "at least %" for Light Transmittance in BOSTON ES and EO is an incomplete entry in the original document.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The safety and efficacy of BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON® XO (hexafocon A) Rigid Gas PermeableContact Lenses was demonstrated in 510(k) Premarket Notifications: K943177 cleared on August 25, 1994; K980741 cleared on May 11, 1998; and K000795 cleared on May 25, 2000, respectively."
This means that the current 510(k) (K013762) is leveraging previous clearances. The specific details of the test sets (sample sizes, prospective/retrospective, country of origin) for those earlier 510(k)s are not provided in this summary document. This 510(k) relies on the fact that those previous submissions adequately demonstrated safety and efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. For 510(k) submissions, particularly for devices with a clear predicate, detailed expert adjudication for ground truth (as might be seen in AI/diagnostic device studies) is generally not required unless there's a novel aspect requiring new clinical data. The primary "ground truth" here is the established safety and efficacy of the predicate device.
4. Adjudication Method for the Test Set
This information is not provided in the summary.
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
No MRMC study was done or is mentioned. This type of study is specifically relevant for AI-powered diagnostic devices where human interpretation interacts with AI output. These contact lenses are a medical device, not an AI diagnostic tool.
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. Its performance is inherent in its physical and material properties, and its interaction is directly with the human eye, not through an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The primary "ground truth" for these contact lenses, as presented in this 510(k) summary, is:
- Substantial Equivalence to a Predicate Device: The established safety and efficacy of the BOSTON II (itafocon A) Rigid Gas Permeable Contact Lens, which was approved under a Premarket Application (PMA P820065). This implies that the predicate device underwent comprehensive clinical trials and demonstrated safety and efficacy through clinical outcomes data, which then serves as the benchmark.
- Physical and Optical Property Characterization: The physical properties of the new lenses (e.g., oxygen permeability, refractive index) are measured and implicitly compared against accepted standards for RGP lenses, which are themselves derived from years of clinical experience and outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI algorithm.
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(83 days)
BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) RGP Contact Lenses are 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.
BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) Contact Lenses are composed of fluoro silicone acrylate copolymers wet shipped in Boston Advance Comfort Formula Conditioning Solution and stored for up to 30 days.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BOSTON® EQUALENS® and BOSTON® EQUALENS® II RGP Contact Lenses:
The information provided is a 510(k) summary for RGP contact lenses, focusing on the stability of the lenses when wet-shipped and stored in a specific conditioning solution. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the studies described are primarily performance and safety tests, not clinical efficacy trials in the typical sense for a new drug or high-risk device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Stability/Compatibility (Physical) | Average changes for diameter, base curve, and power compared to DRAFT ISO/CD 8321-2: Optics and Optical Instruments – Contact Lenses - Part 1: Specifications for rigid corneal and scleral contact lenses. | After soaking for thirty days, the silicone acrylate and fluoro silicone acrylate rigid gas permeable contact lenses were determined to be physically compatible with Boston Advance Comfort Formula Conditioning Solution. |
| Microbiology (Bioburden) | 100 Colony Forming Units (CFU) per lens | Less than 10 Colony Forming Units (CFU) per lens (for both control and stored lenses). |
2. Sample Size Used for the Test Set and Data Provenance
- Stability/Compatibility Test Set: The sample size is not explicitly stated. The text refers to "Silicone acrylate (SA) and fluorosilicone acrylate (FSA) tinted rigid gas permeable contact lenses" being subjected to the test.
- Microbiology Test Set: The sample size is not explicitly stated, but it refers to "a set of test lenses" and "two sets of lenses" (one control, one stored).
- Data Provenance: The studies were performed by "The applicant," Polymer Technology. The location of the testing is not specified, nor is whether the data is retrospective or prospective. Given the nature of a 510(k) submission for device approval, these would be prospective tests conducted specifically for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For these types of physical and microbiological performance tests, the "ground truth" is typically established by laboratory measurements against defined standards or protocols, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The tests described are objective laboratory measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the goal is to assess the impact of an AI algorithm on human reading performance. The described studies are physical and microbiological performance tests for contact lenses.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable in the context of this device. A standalone algorithm performance study refers to the evaluation of an AI algorithm's performance without any human intervention. The device in question is a contact lens, and the studies performed are physical and microbiological tests, not AI algorithm evaluations.
7. The Type of Ground Truth Used
- Stability/Compatibility: The ground truth for physical compatibility (diameter, base curve, power changes) was established by comparison to the DRAFT ISO/CD 8321-2: Optics and Optical Instruments – Contact Lenses - Part 1: Specifications for rigid corneal and scleral contact lenses. This is a recognized international standard for contact lens specifications.
- Microbiology (Bioburden): The ground truth for microbial contamination was established by quantitative measurement of Colony Forming Units (CFU) per lens against a defined numerical acceptance criterion.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of this device and study. Training sets are relevant for machine learning or AI models, which are not involved here.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device.
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(120 days)
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(62 days)
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(74 days)
BOSTON XO (hexafocon A) Contact Lens Material is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and nresbyopia) in aphakic and not-aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
The BOSTON XO Contact Lens Material, hexafocon A, is composed of aliphatic fluoroitaconate siloxanyl methacrylate copolymer. The color additives conform to 21 CFR part 74.3206. The hexafocon A material has an oxygen permeability, DK of 100, a specific gravity of 1.26, and the lens visible light transmittance of at least 70%. The hexafocon A name has been adopted by the United States Adopted Names Council (USAN).
The provided text describes the BOSTON XO (hexafocon A) Contact Lens Material, and its submission for 510(k) clearance, asserting substantial equivalence to the predicate device, BOSTON ES (enflufocon A). The document focuses on preclinical and clinical studies conducted to support this claim.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the clinical study in the format of a target value to be met. Instead, it concludes equivalence to the predicate device. The preclinical tests had requirements that were met.
| Test Category | Acceptance Criteria/Requirement | Reported Device Performance |
|---|---|---|
| Preclinical Testing | ||
| In-Vitro Cytotoxicity | Meets requirements of USP XXII for Agar Diffusion Test | "The test article meets the requirements of the Agar Diffusion Test." |
| Acute Ocular Irritation | No ocular irritation produced | "produced no ocular irritation." |
| Systemic Injection | Meets requirements of Systemic Injection Test; considered non-toxic | "The lens material meets the requirements of the Systemic Injection Test and is considered non-toxic." |
| Shelf Life | Not required for clearance (due to <1% water content and dry shipping) | "shelf-life studies are not required for clearance of this material." |
| Solution Compatibility | No significant changes to lens parameters after 30 cycles of cleaning and conditioning | "There were no significant changes to lens parameters after 30 complete cycles." |
| Clinical Testing | ||
| Overall Safety & Efficacy | Equivalent to predicate device (Boston ES) | "The sponsor concludes that BOSTON XO (hexafocon A) contact lens material is equivalent in safety and efficacy to the predicate device, Boston ES (enflufocon A)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study):
- Enrolled: 128 eyes (64 patients)
- Completed Study: 102 eyes (51 patients)
- Data Provenance: The document does not explicitly state the country of origin. It does state that "3 Investigators" were involved, which often implies a multi-site study, but specific locations are not provided. The study was prospective, as patients were "entered into the study" and followed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number of experts or their qualifications used to establish "ground truth" for the clinical study in the way one might assess an AI diagnostic device. Instead, the "safety and efficacy measures" were assessed by the clinical investigators. The document mentions "3 Investigators" who entered patients into the study. Their specific qualifications are not detailed beyond "Investigators."
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the clinical study's safety and efficacy measures. The results are presented as conclusions from the study, without mentioning independent adjudication or consensus review of specific findings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not conducted. This document describes the evaluation of a contact lens material, not an AI-assisted diagnostic system. Therefore, assessing how much human readers improve with AI vs. without AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study
No, a standalone performance study in the context of an "algorithm only" or AI system was not conducted. This document describes the evaluation of a contact lens material, which does not involve an algorithm or AI.
7. Type of Ground Truth Used
For the preclinical tests, the "ground truth" was based on established standard testing methodologies (e.g., USP XXII, Systemic Injection Test requirements) and observable physical changes.
For the clinical study, the "ground truth" for safety and efficacy was established through clinical observations and measurements by the investigators. These included:
- Adverse Events (self-reported and observed)
- Positive Slit Lamp Findings
- Symptoms/Complaints (patient-reported)
- Keratometry Changes (objective measurement)
- Refractive Changes (objective measurement)
- Lens Visual Acuity (objective measurement)
- Lens VA Line Changes (objective measurement)
- Lens Deposits (objective observation/grading)
- Lens Wettability (objective observation/grading)
This constitutes a form of expert assessment and objective measurement in a clinical setting.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This is a medical device (contact lens material) and its evaluation methods do not involve AI training. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI system, this question is not applicable.
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(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.
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