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Alcon 27GA Chandelier
The 27GA Chandelier is indicated for use during posterior segment ophthalmic surgery.

Alcon 27+ DS Wide Angle Endoilluminator
The 27+DS Wide-Angle Endoilluminator is indicated for use during posterior segment ophthalmic surgery.

Alcon 27+ DS Endoilluminator
The 27 + DS Endoilluminator is indicated for use during posterior segment ophthalmic surgery.

As part of this premarket notification Alcon presents three new endoilluminators, compatible with the UNITY VCS device cleared in K233876 (clearance date: June 21, 2024).

Alcon 27GA Chandelier: The Alcon 27GA Chandelier provides a hands-free wide field of illumination for vitreoretinal procedures. The distal end of the device incorporates a short, tapered fiber optic to provide wide angle illumination projected from a pars plana position of the eye. The distal end consists of a tapered fiber, which is inserted into the eye through the Alcon 27GA entry system. The fiber is malleable so the physician can shape it to form a stable service loop, position the tip, and minimize interference with the lid speculum.

Alcon 27+ DS Wide Angle Endoilluminator: The Alcon 27+ DS WA Endoilluminator offers wide-angle illumination, featuring a sapphire lens at the distal end of the probe. This design ensures consistent, low-glare illumination across a broad field of view. Additionally, it incorporates a Dynamic Stiffener (DS) element-a retractable stiffener designed to minimize needle deflection at the proximal end of the stainless steel cannula. as opposed to the fixed stiffener used in previous models.

Alcon 27+ DS Endoilluminator: The Alcon 27+ DS Endoilluminator transmits light energy into the eye and incorporates a DS element at the proximal end of the stainless-steel cannula.

This FDA 510(k) summary does not contain the specific acceptance criteria or performance data in a format that directly matches the requested table. This document is a "Substantial Equivalence" submission, which focuses on demonstrating that new devices (Alcon 27GA Chandelier, Alcon 27+ DS Wide Angle Endoilluminator, Alcon 27+ DS Endoilluminator) are as safe and effective as previously cleared predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria for a novel device.

The document primarily relies on non-clinical testing to demonstrate substantial equivalence. Here's a breakdown of the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding performance results in a quantitative manner for specific clinical metrics. Instead, it states that the devices "met ISO 10993" for biocompatibility, "passed the predetermined acceptance criteria" for sterilization and shelf life, and that "safety tests demonstrated the compliance of the subject devices to the appropriate standards" for performance testing. For light hazard testing, it states the devices "meet aphakic and thermal safety standards comparable to the predicate devices."

The comparisons in Tables 1-3 highlight similarities in technological characteristics between the subject devices and their predicates, rather than presenting numeric acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Non-Clinical Testing: The document refers to "tested devices" for sterilization, "tested units" for packaging integrity, and "three subject devices" for light hazard testing. However, specific sample sizes (e.g., number of units tested for biocompatibility, number of sterilization cycles validated) are not provided.
• Data Provenance: All testing described is non-clinical. There is no mention of human subject data, therefore no information on country of origin or retrospective/prospective nature.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable, as this submission concerns non-clinical testing of medical devices (endoilluminators and a chandelier) for surgical use, not AI/diagnostic devices requiring expert adjudication for ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as this submission concerns non-clinical testing of medical devices (endoilluminators and a chandelier), not AI/diagnostic devices requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This submission is for physical medical devices, not AI software where such studies are typically performed.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Not applicable. This is not an AI device. The "performance testing" referenced is for the physical attributes and safety of the endoilluminators (e.g., light transmission, mechanical integrity, biocompatibility), which are inherently "standalone" in their assessment as device components.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by:

• Biocompatibility: ISO 10993 standards.
• Sterilization: ISO 11135 and ISO 10993-7 standards; achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
• Shelf Life/Packaging: ASTM D4169, ASTM F1980, and ISO 11607-1 standards.
• Performance (General): ISO 14971, ISO 15004-1, ISO 15752, and ANSI Z80.36 standards.
• Light Hazard: ANSI Z80.36 and ISO 15752 standards, and comparability to predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device; therefore, there is no training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set.

Summary of Device Acceptance:

The acceptance of these devices is based on demonstrating substantial equivalence to existing predicate devices (cleared under K875005 and K110951) through a battery of non-clinical tests. The tests confirm they meet established safety and performance standards (ISO, ASTM, ANSI) and have comparable technological characteristics and risk profiles to their predicates, making them safe and effective for their intended use in posterior segment ophthalmic surgery.

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UNITY VCS:
The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery.

In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures.

UNITY CS:
The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.

The UNITY VCS is a multifunctional surgical instrument for use in anterior and posterior segment ophthalmic surgeries. The capabilities of the UNITY VCS include driving a variety of handpieces that provide the ability to cut vitreous and tissues, emulsify the crystalline lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding. Flow-controlled or vacuumcontrolled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven. The operator provides inputs using the touchscreen panel, the remote control, and the foot controllers.

An optional, fully integrated laser module is available that can be installed in the base of the UNITY VCS configuration for vitreoretinal surgery. The laser delivers the same visible 532-nm green treatment beam designed for ophthalmic use as in the predicate device.

When used with compatible components and accessories, the system will perform anterior and posterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, diathermy coagulation, intraocular illumination, photocoagulation, viscous fluid control, tissue grabbing and cutting.

The UNITY CS is a multifunctional surgical instrument for use in anterior segment ophthalmic surgeries. The capabilities of the UNITY CS include driving a variety of handpieces that provide the ability to cut anterior vitreous and tissues, emulsify the crystalline lens, and apply diathermy to stop bleeding. Flow-controlled or pressure-controlled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven, and the operator provides inputs using the touchscreen panel, the remote control, and the foot controllers.

When used with compatible components and accessories, the system will perform anterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, and diathermy coagulation.

The UNITY VCS and UNITY CS are intended to be used within a clinic(s)/hospital(s)/surgical practice network.

Both devices are for prescription use only.

The provided text does not contain information about studies involving AI/ML components or their acceptance criteria. The document is an FDA 510(k) premarket notification for two ophthalmic surgical systems, UNITY VCS and UNITY CS, demonstrating their substantial equivalence to predicate devices. The studies summarized are non-clinical testing for biocompatibility, sterilization and shelf life, electromagnetic compatibility/wireless/electrical safety, software, and performance testing, all of which are standard for medical device clearance and do not involve AI/ML performance metrics, expert consensus, or MRMC studies.

Therefore, I cannot provide the requested table and information as it is not present in the given text.

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TOTAL30™ (lehfilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

TOTAL30™ Asphere (lehfilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.

TOTAL30™ for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism.

TOTAL30™ Multifocal (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

TOTAL30™ Multifocal Toric (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and byperopia) in phakic persons with non-diseased eves who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism.

The lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eve care professional. Lenses should be discarded with a new pair each month, or more often, if recommended by the eye care professional.

The subject device, TOTAL30™ (lehfilcon A) soft contact lenses, are made from a surface treated, silicone containing hydrogel lens material that is approximately 55% water and 45% lehfilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue-green edgeto-edge color to make it easier to see when handling. The lenses contain two benzotriazole monomers to block UVA and UVB radiation and, additionally, reduce transmittance in the range from 380 nm to 450 nm.

Lehfilcon A represents a Group 5B silicone hydrogel contact lens material ("enhanced oxygen permeable materials') according to ISO 18369-1:2017, Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications, as follows:

Group Suffix: 5B
Hydrogel Material: High water subgroup
Description: A subgroup of Group 5 which contains more than 50 % water and no ionic monomer or oligomer at pH 6 to pH 8

Lehfilcon A lens designs include spherical, asphere, toric, multifocal toric contact lenses in the following parameter ranges:
Diameter Range: 13.0 to 15.0 mm
Base Curve Range: 8.0 to 9.2 mm
Power Range: -20.00 D to +20.00 D
Center Thickness: varies with design and power (Example: 0.08 mm for -3.00 D spherical)
Cylinder Power (Toric) -0.25 D to -10.00 D
ADD Power (Multifocal) LO, MED, HI

Lenses have the following properties:
Refractive index: 1.40 (hydrated)
Water content: 55% by weight in normal saline
Surface water content: ≥ 90%
Oxygen permeability: 123 x 10 -11 [(cm2/sec)(ml O2 /ml.mmHg)] measured at 35 °C (normalized Dk-Polarographic method)
Light transmittance: >85%
UV Transmittance: The transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 315 to 380 nm for the entire power range.

Lehfilcon A contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents.

The provided document is a 510(k) Premarket Notification for Alcon's TOTAL30 contact lenses. It details the steps taken to demonstrate substantial equivalence to a predicate device, CooperVision Biofinity.

Here, we will synthesize the information to describe the acceptance criteria and the study that proves the device meets them, focusing on aspects relevant to device performance and ground truth establishment.

Based on the provided document, the acceptance criteria and proof of adherence are primarily demonstrated through a comparison against a predicate device and adherence to established ISO standards and FDA guidance for contact lenses, rather than a typical AI/software device evaluation with specific performance metrics like sensitivity, specificity, etc.

However, we can infer "acceptance criteria" as meeting the safety and performance standards demonstrated by the predicate device and relevant industry standards. The "study that proves the device meets the acceptance criteria" refers to the nonclinical and clinical performance testing.

1. A table of acceptance criteria and the reported device performance:

Since this is a contact lens submission (medical device), the "acceptance criteria" are not reported as specific numerical thresholds for metrics like accuracy, sensitivity, or specificity as would be common for an AI/software device. Instead, they relate to demonstrating comparable safety, effectiveness, and performance to a legally marketed predicate device and compliance with applicable standards. The "reported device performance" is largely qualitative and comparative.

Here's an interpretation based on the document:

2. Sample size used for the test set and the data provenance:

• Sample Size (Clinical Study): 119 subjects enrolled, 118 randomized and exposed to study lenses (236 eyes).
  • 78 subjects (test group: lehfilcon A)
  • 40 subjects (control group: comfilcon A)
• Data Provenance:
  • Country of Origin: US (8 study sites in the US).
  • Retrospective or Prospective: Prospective, randomized, stratified, controlled, double-masked, parallel group study.
• Nonclinical/Bench Testing: The document does not specify exact sample sizes for each nonclinical test (e.g., number of lenses tested for oxygen permeability). It refers to "a series of" tests performed under GxP conditions and according to ISO standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable in the context of this 510(k) submission. "Ground truth" in this context is established by the accepted methods of evaluating contact lens safety and performance, which include:

• Clinical observation and objective measurements: Performed by eye care professionals at the study sites (though their qualifications and numbers are not detailed, it's implied they are qualified for conducting such clinical trials). The primary effectiveness endpoint was Snellen VA (visual acuity) at distance, which is an objective measurement. Other endpoints included manifest refraction, keratometry, and biomicroscopy findings.
• Subjective ratings: From subjects regarding vision, comfort, and handling.
• Nonclinical/Bench testing: Results from laboratory measurements according to established ISO standards.
• Adverse event reporting: Monitored throughout the study.

There isn't a "ground truth" derived from a panel of independent expert adjudicators as one might see in an imaging AI study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a clinical study for a medical device (contact lens), not a test set for an AI algorithm requiring adjudication of interpretations. The study involved direct clinical observation, objective measurements, and subject reporting.

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 submission for a contact lens, not an AI-powered diagnostic device that assists human readers/interpreters. The clinical study was a direct comparison between the new contact lens and a predicate contact lens.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. TOTAL30 is a physical medical device (contact lens), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for evaluating the contact lens's performance and safety is multifaceted and comprises:

• Objective Clinical Measurements: Snellen Visual Acuity (VA) at distance, manifest refraction, keratometry, biomicroscopy findings (e.g., assessing ocular health, tissue responses).
• Subjective Clinical Data: Patient-reported outcomes on vision, comfort, and handling.
• Nonclinical/Bench Test Results: Quantitative measurements of physical and chemical properties (e.g., oxygen permeability, water content, refractive index, transparency, mechanical properties) obtained through standardized laboratory methods.
• Biocompatibility Test Results: Laboratory and animal study data demonstrating absence of toxicity, irritation, or sensitization.
• Comparison to Predicate Device: The performance and safety profile of the new lens are benchmarked against an already legally marketed, established predicate device.

Essentially, the "ground truth" is established by comprehensive conformance to recognized standards and demonstrated equivalence to a safe and effective predicate device across multiple domains (biocompatibility, physical properties, and clinical performance).

8. The sample size for the training set:

Not applicable. This is a contact lens, not an AI algorithm. There is no concept of a "training set" for this type of device.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for a contact lens.

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