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The INFINITI® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The INTREPID® AutoSert® IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

• Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
• AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells.
• The INTREPID® AutoSert® IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The INTREPID® AutoSert® IOL Injector Handpiece is indicated for use with AcrySof® lenses SN60WF, SN6AD1, and SN6AT3 through SN6AT9, as well as approved AcrySof® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

The INFINITI® Vision System is unchanged from the INFINITI® Vision System (Evergreen II - K112425) and maintains the modular design and incorporated features that include: Power Watch feature, UltraChopper tip, the AquaLase Capsule Wash Tip, the INTREPID® AutoSert™ IOL Injector Handpiece, and the system's associated software.

This 510(k) premarket notification for the INFINITI® Vision System (K120912) is a submission for a device that is largely unchanged from a previously cleared device (K112425). The primary "new" aspect is the expansion of the indications for use of the INTREPID® AutoSert® IOL Injector Handpiece to include additional AcrySof® intraocular lenses (SN6AT3 through SN6AT9). As such, the "study" demonstrating performance is focused on confirming the compatibility of the device with these new lenses, rather than a full de novo study of the entire system's performance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of tested lenses. The text indicates "Each AcrySoft lens was tested," implying that at least one of each newly added lens type (SN6AT3 through SN6AT9) was tested.
• Data Provenance: Not specified within the provided document (e.g., country of origin, retrospective or prospective). This information is typically found in the full test report, not usually summarized in the 510(k) itself. The testing would have been prospective to demonstrate compatibility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This type of testing involves mechanical performance standards for medical device components (i.e., whether the IOL injector can successfully inject specific lenses), not interpretation of clinical data where expert consensus for ground truth would be required. The "ground truth" here is compliance with a specified engineering standard.

4. Adjudication Method for the Test Set

Not applicable. See point 3. This was a mechanical engineering performance test against a standard, not a clinical trial with human observers requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. The submission is for a surgical instrument and a specific component's compatibility (an IOL injector with new lenses), not for an AI-powered diagnostic or assistive tool where human reader performance would be the primary outcome. Therefore, there's no discussion of AI assistance or effect size.

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

No. This device is not an algorithm or AI system. It's a surgical system with a mechanical IOL injector.

7. The Type of Ground Truth Used

The ground truth used was compliance with an established international standard for ophthalmic implants (EN ISO 11979-3:2006, Section 5). This standard outlines mechanical properties and test methods.

8. The Sample Size for the Training Set

Not applicable. There is no mention or indication of a "training set" as this device does not involve machine learning or algorithmic development requiring such a set.

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

Not applicable. See point 8.

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The Infinit® Vision System is indicated for emulsification, separation, and removal of cataracts, the removal of residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intra-ocular lens injection. The AutoSert™ IOL Injector Handpiece is intended to deliver qualified AcrySof® intraocular lenses into the eye following cataract removal.

The following system modalities additionally support the described indications:

• Ultrasound with UltraChopper Tip achieves the functionality of cataract separation.
• AquaLase achieves the functionality for removal of residual cortical material and lens epithelial cells
• The AutoSert ™ IOL Injector Handpiece achieves the functionality of injection of intraocular lenses. The AutoSert™ is indicated for use with ACRYSOF lenses SN60WF and SN6AD1, as well as approved AcrySof lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

The Infinit® Vision System is an enhanced version of the Infinit® Vision System with OZil® IP (K082845) that is modular in design and incorporates the Power Watch feature, along with the Alcon UltraChopper Tip, the AquaLase Capsule Wash Tip, the AutoSert™ IOL Injector, and its associated software.

This is a 510(k) premarket notification for the Infiniti® Vision System. As such, it reports on non-clinical testing to demonstrate substantial equivalence to previously cleared predicate devices, rather than a clinical study with acceptance criteria for a new device's performance.

Therefore, many of the requested categories regarding clinical study design and performance metrics (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable in the context of this 510(k) summary.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-clinical submission focused on substantial equivalence to existing predicate devices, the "acceptance criteria" are compliance with established medical device standards and demonstrating that the new features do not negatively impact safety or effectiveness. The "reported device performance" is essentially that the device meets these standards and maintains equivalent functionality.

• ISO 11135-1:2007 (Sterilization)
• BS EN ISO 11979-3:2006 (Intraocular Lenses Mechanical Properties)
• EN ISO 14971:2007 (Risk Management)
• IEC 60601-1 (General Safety of Medical Electrical Equipment)
• IEC 60601 series (Collateral and Particular Requirements for Medical Electrical Equipment and Ophthalmic Devices)
• BioCompatibility Standards (ISO 10993 series) |
  | Material Biocompatibility | Biocompatibility evaluations of patient fluid path materials performed to ISO 10993 standards (Parts 1, 5, 10, 11, 12). |
  | Sterilization Efficacy | EtO sterilization process for sterile accessories validated per ISO 11135-1:2007. |
  | Reprocessing Instructions | Validated reprocessing instructions (cleaning, sterilization, re-use) provided for reusable handpieces. |
  | Manufacturing and Design Control | Developed and manufactured in compliance with 21 CFR 820 (Quality System Regulation) and ISO 14971:2007 (Risk Management). |
  | Functional Equivalence | Non-clinical testing demonstrated that the functional requirements have been met and that the modified device is equivalent to the predicate device. Technological characteristics affecting clinical performance are similar to predicate devices. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. This 510(k) relies on non-clinical testing against established standards and comparison to predicate devices, not on a clinical test set with human patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. Ground truth, in the sense of expert consensus on patient data, is not part of this type of submission. The "ground truth" for non-clinical testing relates to objective measurements against standard specifications.

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

• Not Applicable. No clinical test set requiring adjudication of findings is described.

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 device is a surgical system, not an AI-assisted diagnostic tool for human readers.

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

• Not Applicable. This is a hardware/software medical device used by a human surgeon, not a standalone algorithm.

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

• For non-clinical testing, the "ground truth" is defined by engineering specifications, recognized national and international standards (e.g., ISO, IEC), and established predicate device performance. For biocompatibility, it's the results of standardized biological tests. For sterilization, it's the validation against the specified sterilization cycle.

8. The sample size for the training set:

• Not Applicable. This is a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The development likely involved iterative design and testing, but not a dataset for training an AI model.

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

• Not Applicable. As above, no training set for an AI model is described.

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This MONARCH® III P Cartridge IOL insertion device is indicated to fold/hold and insert Alcon IOLs that have the use of this inserter in their approved labeling.

The Monarch® III IOL Delivery System (P Cartridge), hereafter referred to as the Monarch® III P Cartridge, is a modification to the previously cleared Alcon Monarch® III IOL Delivery System (D Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III P Cartridge features nozzle tip sizing like the currently marketed Monarch® III D Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the anterior chamber of the eye. It is designed to work with the currently marketed Monarch® III handpiece.

The provided document describes the predicate device and the new device (Monarch® III IOL Delivery System (P Cartridge)) and concludes with an assessment of substantial equivalence. The document does not contain the acceptance criteria and performance data in the format requested. It states: "The Monarch® III P Cartridge, in conjunction with the currently marketed Monarch® III handpiece, has been tested and found to deliver Alcon IOL in conformance with the requirements set forth in ISO 11979-3, section 5." However, the specific acceptance criteria from ISO 11979-3, section 5, and the detailed results of the testing (actual performance metrics) are not provided in the document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the text. I also cannot fulfill the requests for sample size, data provenance, number or qualifications of experts, adjudication method, MRMC study details, standalone performance, training set details, or ground truth establishment, as this information is not present in the provided 510(k) summary.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and conformity to a standard (ISO 11979-3, section 5) rather than a detailed report of clinical study results against specific criteria.

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The Constellation® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser.

The Constellation® Vision System is a combined anterior and posterior procedure ophthalmic system that is modular in design and serves as an enhanced version of the Alcon Vision System. The Constellation® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, and illumination as well as irrigation, lens emulsification and fragmentation, cautery and diathermy. The system was developed with a dual purpose: to make it simple to operate, and to allow the surgeon control and flexibility.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Alcon Constellation® Vision System:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, there are no specific quantitative acceptance criteria or reported device performance metrics listed in the document for clinical or diagnostic efficacy. The submission focuses on substantial equivalence to predicate devices and adherence to standards.

The document primarily states:

• "Technological characteristics affecting clinical performance are similar to that of other ophthalmic devices."
• "Test data and documents were submitted that demonstrated that the functional requirements had been met and that the system specifications have been met prior to commercial product release."

This implies that the acceptance criteria are related to the successful completion of functional tests, compliance with electrical safety and EMC standards, and similarity to predicate device performance, rather than specific numerical efficacy targets.

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

The document does not describe a test set in the context of clinical or diagnostic performance evaluation. The testing mentioned is for:

• "regression testing for the Electromagnetic Compatibility (EMC) standard"
• "functional requirements" and "system specifications"

Therefore, sample size and data provenance (country of origin, retrospective/prospective) are not applicable or mentioned in the context of clinical efficacy for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as there is no mention of a human-read test set or a clinical study for diagnostic or clinical performance that would require establishing ground truth by experts. The submission relies on technical testing and substantial equivalence.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a clinical test set requiring expert adjudication.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an ophthalmic microsurgical system, not an AI-powered diagnostic or assistive tool for human readers that would necessitate such a study.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable as the Constellation® Vision System is a surgical device, not a standalone algorithm. Its "performance" is primarily defined by its functionality, safety, and operational characteristics in a surgical context, rather than a diagnostic output.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the type of technical and functional testing described, the "ground truth" would be established by engineering specifications, regulatory standards compliance, and predefined functional outputs expected from the system. It would not be based on clinical outcomes data or expert medical consensus in the way a diagnostic device's ground truth is established.

8. The Sample Size for the Training Set

This information is not applicable. The device is a surgical system, not a machine learning or AI algorithm that requires a training set of data.

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

This information is not applicable as there is no training set for this type of device.

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The AquaLase® Capsule Wash Tip is indicated to assist in the removal of residual cortical material and lens epithelial cells.

The AquaLase® Capsule Wash Tip is a sterile, single-use product. It is an accessory to the AquaLase® Handpiece (K980292), which produces the heated intraocular irrigating solution (Balanced Salt Solution or equivalent fluid) that washes the capsular surface. The AquaLase® Capsule Wash Tip and the AquaLase® Handpiece are accessories to the INFINITI® Vision System (K021566). The AquaLase® Capsule Wash Tip utilizes existing packaging configurations and has the same shelf life as existing AquaLase® tips.

To use the AquaLase® Capsule Wash Tip as intended, no modification to the existing INFINITI® System is required.

The document describes the acceptance criteria and performance testing for the AquaLase® Capsule Wash Tip, an accessory to a phacoemulsification device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a distinct "test set" in terms of a clinical study with human patients. The performance testing appears to be primarily non-clinical bench testing of the device itself. Therefore, sample sizes would refer to the number of tips or tests conducted on the device components. This information (e.g., number of tips tested for each criterion) is not provided in the summary.

Data provenance is not explicitly stated as country of origin, but given the submission is to the FDA, it's implied that the testing was conducted to meet US regulatory requirements. The testing is retrospective in the sense that it's conducted on the manufactured device prior to market introduction, but not in the context of analyzing previously collected patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the "ground truth" for the non-clinical performance testing of this medical device is based on predefined engineering specifications, regulatory standards, and comparison to predicate devices, not on expert consensus from clinical cases. There is no mention of experts establishing ground truth for the device's functional performance.

4. Adjudication Method for the Test Set:

This information is not applicable as the testing described is objective, non-clinical performance testing against pre-defined specifications. There is no mention of subjective assessments 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. The document focuses on the non-clinical performance of the device itself and its equivalence to predicate devices, not on the clinical effectiveness or improvement of human readers with or without AI assistance. The device is a surgical accessory, not an AI software.

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

This question is not applicable as the device is a physical surgical accessory (Capsule Wash Tip), not an algorithm or AI software. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance testing is based on:

• Engineering specifications and requirements: Such as minimum retention strength, passive flow requirements, collimation of fluid output profile, maximum temperature, and leak-free operation.
• Regulatory standards: Adherence to standards like ISO 10993 (biocompatibility) and ISO 11135-1 (sterilization).
• Comparison to predicate devices: "Salient tip performance characteristics such as fluid output volume and fluid output temperature are analogous to the 1.1mm Liquefaction Tip."

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI or software algorithm that requires a "training set."

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

This information is not applicable as there is no "training set" for this type of medical device.

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The MONARCH® III IOL Delivery System is used for implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.

The Monarch© III IOL Delivery System is a modification to the previously cleared Alcon Monarch(r) II IOL Delivery System (K003768) consisting of a disposable cartridge and reusable handpiece. The Monarch II cartridges are designated as A, B, and C, and feature various nozzle tip sizes that correspond to the various AcrySof® IOL models. As with the cleared cartridges, the Monarch© III IOL Delivery System presented in this submission utilizes a one-piece disposable cartridge (designated as D) with progressive folding in combination with a reusable handpiece (H4). This new cartridge possesses the same basic inner lumen design and lens guiding mechanisms as the existing Monarch*) II A, B, and C cartridges, but differs in nozzle tip sizing.

The document provided is a 510(k) summary for the Alcon Monarch® III IOL Delivery System. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously marketed devices. The summary outlines the device description, indications for use, and a brief summary of nonclinical tests. However, it does not contain detailed acceptance criteria, specific study results proving device performance against those criteria, or the other specific information requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details).

This document is a regulatory submission, not a detailed scientific study report. It states that Alcon will conform to requirements but doesn't provide the test results or the specific acceptance criteria themselves.

Therefore, I cannot provide the requested table and detailed study information based on this document.

Here's an explanation of why the requested information is absent:

• Acceptance Criteria & Reported Performance: The document states that the device "will conform in all respects with the requirements set forth in the FDA Intraocular Lens Guidance Document (Draft released 10/14/1999) Section C. Mechanical Testing, 5. Folding and Injection Testing prior to marketing the product." This is a statement of intent to conform to guidance, not a set of specific, quantified acceptance criteria or a report of the device's performance against them.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): This type of detailed information would typically be found in a comprehensive test report or clinical study report, which is usually part of the full 510(k) submission but not typically included in the public 510(k) summary. For a device like an IOL delivery system, the "ground truth" often relates to mechanical integrity, successful delivery without damage to the IOL or ocular structures, and consistent performance, rather than expert consensus on images.
• Training Set Information: This device is a mechanical delivery system, not an AI or image-based diagnostic tool. Therefore, concepts like "training set," "ground truth for the training set," "experts," and "MRMC studies" are generally not applicable in the context of this type of medical device submission.

In summary, the provided text confirms:

• Device Name: Monarch® III IOL Delivery System (D Cartridge and H4 Handpiece)
• Indication for Use: Implantation of ALCON® qualified ACRYSOF® intraocular lenses into the eye following cataract removal.
• Regulatory Clearance: K063155, cleared March 27, 2007.
• Nonclinical Test Summary: "Alcon has provided a Statement of Conformance... that the Monarch® III IOL Delivery System... will conform in all respects with the requirements set forth in the FDA Intraocular Lens Guidance Document (Draft released 10/14/1999) Section C. Mechanical Testing, 5. Folding and Injection Testing prior to marketing the product."

No further details regarding specific acceptance criteria, study methodologies, statistical results, or expert involvement are present in this 510(k) summary.

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