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510(k) Data Aggregation
(148 days)
The Acuity 58™ (en:flufocon B) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. The lens may be prescribed in spheric powers ranging from -20.00 D to +20.00 D for daily wear. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only.
The Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses:
- in the power range of -20.00 to +20.00 diopters for sphere
- with base curves of 4.0 mm to 11.50 mm
- with base curve chord of 6.0 mm to 6.5 mm
- with diameter of 7.0 to 21.0 mm
The lens material (enflufocon B) incorporates an ultraviolet light absorber and lenses are lathe cut in the following designs: spherical, toric, multifocal, and aspheric surfaces in visibility tinted material from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston EO Material and Contact Lenses (enflufocon B) described K980741.
The provided text describes the Acuity 58™ (enflufocon B) Rigid Gas Permeable Contact Lens and its substantial equivalence to a predicate device. However, it does not explicitly detail acceptance criteria in the form of specific performance metrics with numerical thresholds that the device must meet, nor does it describe a study specifically designed to prove the device meets such criteria in a comparative fashion. Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Boston EO Contact Lens, K980741) by showing that the new device has identical or highly similar material, design, and indications for use.
Here's an attempt to extract the requested information based on the provided text, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission asserts "substantial equivalence" as its primary acceptance criterion. The performance is demonstrated by comparing the new device's characteristics to those of the predicate device.
| Characteristic | Acceptance Criteria (based on predicate) | Reported Device Performance (Acuity 58™ enflufocon B) |
|---|---|---|
| Material | enflufocon B | enflufocon B (identical) |
| Production Method | Lathe Cut | Lathe Cut (identical) |
| UV Blocking | Yes | Yes (identical) |
| Base Curves | 4.0 mm to 11.5 mm | 4.0 mm to 11.5 mm (identical) |
| Base Curve Chord | 6.0 mm to 6.5 mm | 6.0 mm to 6.5 mm (identical) |
| Design | Standard & reverse geometry with anterior aspheric surface | Standard & reverse geometry with anterior aspheric surface (identical) |
| Diameters | 7.0-21.0 mm | 7.0-21.0 mm (identical) |
| Power Range | -20.00D to +20.00D | -20.00D to +20.00D (identical) |
| Astigmatism range corrected | Up to 9.00 D | Up to 9.00 D (identical) |
| Add Powers (multifocal) | +1.00 D to +4.00 D | +1.00 D to +4.00 D (identical) |
| Indications for Use | Effectively identical scope (myopia, hyperopia, presbyopia, astigmatism in aphakic/non-aphakic non-diseased eyes, irregular corneal conditions) | Effectively identical scope as predicate |
| Refractive Index | 1.429 | 1.429 (identical) |
| Oxygen Permeability | 58 | 58 (identical) |
| Specific Gravity | 1.23 | 1.24 (very close) |
| Hardness | 114 (Rockwell R) | 81 (Shore D) (Note: Different scales, not directly comparable without conversion. The document states "materials values meet minimum values required for use.") |
| Modulus | 1500 MPa | 1568 MPa (very close) |
| Tint | Visibility tints (D&C Green #6, D&C Violet #2, Solvent Yellow 18) | Visibility tints (D&C Green #6, D&C Violet #2, Solvent Yellow 18) (identical) |
| Water Content |
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(84 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, and presbyopia) in aphakic and not-aphakic persons with nondiseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. 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 absorher.
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 lenses may also be supplied clear (no tint).
The provided text describes information for the "BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) AND BOSTON XO® (hexafocon A) RIGID GAS PERMEABLE CONTACT LENSES". However, it is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the way a clinical trial would for a novel medical device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set size) are not applicable or not provided in this type of document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a pass/fail sense against pre-defined thresholds. Instead, it reports the physical/optical properties of the lenses, which are implicitly accepted given their substantial equivalence claim. The reported properties are presented below:
| Property | BOSTON ES | BOSTON EO | BOSTON XO |
|---|---|---|---|
| Specific Gravity | 1.22 | 1.23 | 1.27 |
| Refractive Index | 1.443 | 1.429 | 1.415 |
| Visible Light Transmittance | > 85% | > 85% | > 92% |
| Water Content |
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(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 % |
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