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The CENTURION® Vision system (Active Sentry™) is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert IOL Injector Handpiece is intended to deliver qualified ACRYSOF intraocular lenses into the eye following cataract removal.

The AutoSert IOL Injector Handpiece achieves the function of intraocular lenses. The AutoSert IOL Injector Handpiece is indicated for use with the ACRYSOF lenses SN6OWF. SNWAD1. 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.

Alcon's CENTURION ® Vision System is an ophthalmic surgical instrument designed for use in cataract extraction using the CENTURION® OZil® handpiece, the CENTURION® Active Sentry® handpiece, and the INFINITI® OZil® handpiece.

The CENTURION® Vision System is intended for use in small incision cataract lens extraction and IOL injection surgical procedures. This system allows the surgeon to emulsify and aspirate the lens in the eye, while replacing aspirated fluid and lens material with balanced salt solution. This process maintains a stable (inflated) eye chamber volume. Using system controls, the surgeon regulates the amount of power applied to the handpiece tip, the rate of aspiration, vacuum, and the flow of BSS® irrigating solution. The system includes a footswitch to enable the surgeon to control flow of fluidics, aspiration rate, phaco power, vitrectomy cut rate, IOL injection rate, and coagulation power.

This document describes the Centurion Vision System (Active Sentry™), a phacofragmentation system for cataract surgery. The submission to the FDA is for a modified version of an existing device, emphasizing its substantial equivalence to the predicate device. Therefore, the "acceptance criteria" and "device performance" are primarily focused on demonstrating safety and performance comparison to the predicate, rather than establishing de novo clinical performance metrics against a defined acceptance criteria for a novel device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a modified device, the "acceptance criteria" are implicitly met by demonstrating equivalence to the predicate device's established safety and performance. The performance data presented primarily focuses on non-clinical testing.

• Cytotoxicity (ISO Elution Method 1X MEM, ISO MTT Method)
• Sensitization (ISO Maximization Sensitization Study)
• Acute Systemic Toxicity (ISO Acute Systemic Toxicity Study)
• Ocular Irritation (ISO Intraocular Injection Method)
• Material Characterization (Leachables) |
  | Electromagnetic Compatibility (EMC): Device operates without causing or being susceptible to electromagnetic interference. | PASS in all conducted electromagnetic compatibility and electrical safety tests, including:
• EN 60601-1 (General requirements for basic safety and essential performance)
• EN 60601-1-2 (Electromagnetic compatibility)
• EN 60601-2-2 (Safety of high frequency surgical equipment)
• EN 60601-1-8 (Alarm systems)
• EN 80601-2-58 (Lens removal and vitrectomy devices)
• IEC 60601-1-6 (Usability)
• IEC 62366 (Usability engineering) |
  | Electrical Safety: Device meets electrical safety standards. | PASS in all conducted electrical safety tests (as part of EN 60601-1, EN 60601-2-2, etc.). |
  | Functional Equivalence: Device performs its intended functions similarly to the predicate. | Demonstrated through comparison of technological characteristics (same intended use, operating principle, basic phaco handpiece, consumables, technology, design, materials, shelf life, packaging, and sterilization). No specific quantitative functional performance metrics are provided in this summary, implying functional equivalence was accepted based on design and non-clinical testing. |

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

• Test Set Sample Size: Not applicable in the context of this submission. The "test set" here refers to non-clinical laboratory testing, not human clinical trials with a defined patient sample size. The biocompatibility tests used cell lines (L-929 Mouse), guinea pigs, and rabbits. Electrical and EMC tests were performed on the device itself.
• Data Provenance: The data provenance is from laboratory testing performed by Alcon Research, Ltd. or its contracted labs. The country of origin of the data is not explicitly stated but is implicitly where Alcon conducted its R&D and testing. The data is prospective in the sense that these tests were conducted specifically for this submission, but they are not clinical prospective studies.

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

• This question is not applicable to this type of submission. "Ground truth" in the context of expert consensus or clinical outcomes is relevant for diagnostic or AI-driven systems. For device safety and performance testing like biocompatibility, EMC, and electrical safety, the "ground truth" is established by adherence to recognized international standards (e.g., ISO, EN, IEC) and the expertise of certified laboratory personnel. No clinical experts were involved in establishing the "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among multiple human readers or experts, typically in clinical studies or image interpretation tasks. The tests described here are laboratory-based and follow standardized protocols, yielding objective pass/fail results.

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 a diagnostic imaging device or an AI-driven system requiring human-in-the-loop performance evaluation. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

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

• Not applicable. This is a hardware and software medical device for surgical procedures, not a standalone algorithm.

7. The Type of Ground Truth Used

• For biocompatibility: The "ground truth" is established by the accepted physiological responses and safety profiles defined in the ISO standards for biological evaluation of medical devices.
• For electrical safety and EMC: The "ground truth" is established by the specifications and limits defined in the international electrical safety and EMC standards (e.g., IEC 60601 series).
• For functional aspects: The "ground truth" for functional equivalence is the performance and operating characteristics of the predicate device.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. The development and verification process involves engineering design, prototyping, and testing, not algorithmic training on large datasets.

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

• Not applicable, as there is no "training set" for an AI algorithm.

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HyperVit™ Vitrectomy Probe (23, 25 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended to be used to remove vitreous and dissect tissue in the eye.

HyperVit™ Vitrectomy Probe (27 gauge)
The HyperVit™ Vitrectomy Probe is designed for use with the Constellation® Vision System and is intended for use as follows:

• Vitreous aspiration & cutting
• Membrane cutting & aspiration
• Lens removal
• Dissect tissue in the eye

The HyperVit" Vitrectomy Probe is an accessory to the Constellation® Vision System (K141065, K101285 and K063583). The HyperVit™ Vitrectomy Probe is a sterile, single-use pneumatically actuated device which supports aspiration and guillotine style cutting functions for the purpose of vitreous cutting and aspiration, as well as tissue dissection, in the eye during vitreoretinal or cataract surgery. The HyperVit™ Vitrectomy Probe is comprised of a pre-assembled hand piece and tubing. The tubing assembly interfaces with a Constellation® Vision System console by means of RFID tags at the proximal end of the probe. The HyperVit" Vitrectomy Probe is offered in three different sizes: 23, 25 and 27 gauge.

The HyperVit" Vitrectomy Probe is a modification of the existing UltraVit® Vitrectomy Probes currently used with the Constellation® Vision System. A port opening has been added to the cutter tip to create a second cutting edge. Thus, two cuts are made during a single operating cycle, compared to one cut for the existing UltraVit® Vitrectomy Probes. With an operating actuation speed of 10,000 cycles per minutes, the HyperVit™ Vitrectomy Probe can achieve 20,000 cuts per minute.

This document describes the HyperVit™ Vitrectomy Probe, a device designed for vitreous aspiration and cutting, membrane cutting and aspiration, lens removal, and tissue dissection in the eye during vitreoretinal or cataract surgery.

Here's the breakdown of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set for each mechanical test. For the metal particulates test, the experiment describes "The probe was actuated at the maximum 10,000 cycles per minute in a water container" and "After running the test continuously for 20 minutes." This implies a single probe was tested for this specific criterion during the specified duration.

The data provenance is from mechanical testing conducted by Alcon Research, Ltd. This is an internal developmental and validation study, not data collected from patient populations. Therefore, country of origin of data or retrospective/prospective nature is not applicable in the patient-data sense.

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

Not applicable. The tests conducted are mechanical and objective (e.g., measuring flow, temperature, presence of particulates, and comparing cut quality to a defined standard), not relying on expert interpretation of ambiguous data to establish ground truth.

4. Adjudication method for the test set:

Not applicable. The tests are objective mechanical performance evaluations, not diagnostic/interpretive tasks requiring 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:

Not applicable. This device is a surgical instrument (vitrectomy probe), not an AI-assisted diagnostic or interpretive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not relevant.

7. The type of ground truth used:

The ground truth used for these tests is based on:

• Predicate device performance: The HyperVit™ Probe's performance (cut quality, aspiration flow) was compared to the performance of the legally marketed predicate devices (Enhanced UltraVit® Probe K093305, 27+ UltraVit® Probe K110951).
• Established engineering specifications and safety limits: For heat generation, a maximum allowed temperature increase of 10°C was derived from literature (Wu et al., 2006). For metal particulates, the absence of particulates on microscopy served as the ground truth for meeting the acceptance criteria.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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The WaveLight FS200 Laser System is an ophthalmic surgical laser indicated for use:

· In the creation of a corneal flap in patients undergoing LASIK surgery or treatment reguiring initial lamellar resection of the cornea.

· In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.

· In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.

· In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.

· In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea.

· In patients undergoing ophthalmic surgery or other treatment requiring pocket cuts/incisions in the cornea.

The WaveLight® FS200 is a stationary scanning-spot femtosecond laser system used to support refractive surgery of the cornea as specified in the indications for use statement.

The provided text is a 510(k) summary for the WaveLight FS200 Laser System, which is an ophthalmic laser. It focuses on demonstrating substantial equivalence to predicate devices for new indications for use related to arcuate and pocket cuts/incisions in the cornea. It is not a study proving device meeting specific acceptance criteria in the context of an AI/algorithm-driven device with performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested categories for a study proving device acceptance criteria (e.g., sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission. This document describes a traditional medical device's non-clinical performance and a comparison to predicate devices, not an AI/ML device study.

However, I can extract the relevant information regarding performance testing and a high-level "acceptance criteria" through the lens of what this document does provide.

Here's the breakdown based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document states "Performance testing on pig eyes." It does not specify the number of pig eyes used.
• Data Provenance: The data is from "pig eyes," indicating an ex vivo or in vivo animal study, not human data. The country of origin is not specified. It is a non-clinical study, presumably prospective in design for the purpose of testing the device.

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

• Experts: Not applicable. This document describes non-clinical performance testing on animal tissue (pig eyes) to demonstrate the physical properties of the cuts. The "ground truth" would be objective measurements of the cuts themselves, not expert interpretation of images or clinical outcomes.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. As this is non-clinical testing of physical device output on animal tissue, an adjudication method for human interpretation is not relevant.

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:

• MRMC Study: No, an MRMC study was not done. This device is an ophthalmic surgical laser, not an AI/ML-powered diagnostic or assistive tool for human interpretation.

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

• Standalone Performance: Not applicable in the context of an AI algorithm. The device is a standalone surgical laser. Its performance (accuracy, precision, quality of cuts) was assessed directly from its physical output.

7. The type of ground truth used:

• Ground Truth: For the non-clinical performance testing, the ground truth would be objective measurements of the arcuate and pocket cuts/incisions (e.g., dimensions, morphology, depth, width, curvature) produced by the laser on the pig eyes. The document states "accuracy, precision, and quality" were addressed, implying quantitative measurement of these physical parameters.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This summary describes a physical medical device, not an AI/ML algorithm that requires a training set. The device itself is "trained" through its engineering design and manufacturing processes.

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

• Training Set Ground Truth: Not applicable. As there is no AI/ML algorithm involved, there is no training set and therefore no ground truth establishment for a training set.

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The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e. phacoemulsification, removal of cataracts, and intraocular lens injection) and posterior segment (i.e., vitreoretinal) ophthalmic surgery in addition to the indications included with the optional Next Generation laser. The AutoSert® IOL Injector Handpiece is intended to deliver qualified ACRYSOF® intraocular lenses into the eye following cataract removal.

The AutoSert® IOL Injector Handpiece achieves the functionality of intraocular lenses. The AutoSert® is indicated for use with ACRYSOF lenses SN60WF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySoft® lenses that are specifically indicated for use with this inserter, as indicated in the approved labeling of those lenses.

Flex-Tip Laser Probes
· Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
o Proliferative and nonproliferative retinopathy (including diabetic);
o Choroidal neovascularization secondary to age-related macular degeneration;
o Retinal tears and detachments;
o Macular edema;
o Retinopathy of prematurity;
o Choroidal neovascularization;
o Leaking microaneurysms.
Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma.
· Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma.
· And other laser treatments including:
o Internal sclerostomy;
o Lattice degeneration;
o Central and Branch Retinal Vein Occlusion;
o Suturelysis;
o Vascular and pigmented skin lesions.

UltraVit Probes
· Vitreous aspiration & cutting.
Membrane cutting & aspiration.
· Lens removal.

Endoilluminator Probes
· Endoillumination
Valved Entry Systems
Scleral incision
· Canulae for posterior segment instrument access
· Venting (of valved cannulae)

Infusion Cannulas
Posterior segment infusion (liquid or gas)

The CONSTELLATION® Vision System is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, and illumination as well as irrigation, lens emulsification and fragmentation, cautery, diathermy, and IOL Insertion.

The provided text describes a 510(k) premarket notification for the CONSTELLATION® Vision System, focusing on its substantial equivalence to predicate devices and adherence to various safety and performance standards. However, it does not include the detailed breakdown of acceptance criteria, device performance, or specific study information (like sample sizes, ground truth establishment, or expert qualifications) that you've requested.

The document primarily outlines:

• Indications for Use: The system is for anterior (phacoemulsification, cataract removal, IOL injection) and posterior (vitreoretinal) ophthalmic surgery. Specific probes and systems within CONSTELLATION® (e.g., Flex-Tip Laser Probes, UltraVit Probes, AutoSert® IOL Injector Handpiece) have their own detailed indications.
• Predicate Devices: Several previously cleared Alcon devices (e.g., K101285 CONSTELLATION® Vision System, K121555 CENTURION® Vision System) are listed as predicates.
• Nonclinical Tests and Results: The device's compliance with numerous international and industry standards for sterilization, risk management, electrical safety, electromagnetic compatibility, usability, and biocompatibility is stated.

Therefore, based solely on the provided text, I cannot complete your requested table and study details. The document focuses on regulatory compliance through adherence to standards and substantial equivalence, rather than presenting a performance study with specific acceptance criteria and outcome metrics for the device itself.

The information requested, such as specific performance metrics (e.g., sensitivity, specificity for a diagnostic device), sample sizes for test sets, details about ground truth, expert qualifications, or MRMC study results, are typical for AI/ML device submissions, but this document predates broad AI/ML medical device regulation and describes a surgical hardware system with accessories.

Here's a summary of what could be extracted and what is missing, based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as performance metrics. The closest are adherence to various safety, sterilization, and biocompatibility standards (e.g., EN ISO 11135-1 for sterilization, UL 60601-1 for electrical safety, ISO 10993-1 for biocompatibility). These are pass/fail criteria for compliance.
• Reported Device Performance: Not provided in terms of quantitative clinical performance (e.g., success rates, complication rates, or diagnostic accuracy). The document states "Safety tests... have demonstrated its compliance with applicable requirements of the following standards" and "Non-clinical testing... has demonstrated that the functional requirements have been met and that the modified device is equivalent to the 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 provided. The document refers to non-clinical testing for compliance with standards, not a specific clinical test set with human subject 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/Not provided. No "ground truth" in the diagnostic sense is established in this document, as it's not a diagnostic AI/ML device study.

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

• Not applicable/Not provided. No human adjudication of a test set 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

• No. This is not an AI/ML device. No MRMC study is mentioned.

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

• No. This is not an AI/ML device.

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

• Not applicable/Not provided. "Ground truth" as a diagnostic reference standard is not relevant to the compliance testing described for this surgical system. The "truth" in this context is whether the device meets engineering specifications and safety standards.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device that requires a training set.

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

• Not applicable/Not provided. This is not an AI/ML device.

In conclusion: The provided document is a 510(k) summary for a surgical system, detailing its intended use and compliance with general medical device standards. It does not contain the specific study design, performance metrics, or "ground truth" information typically associated with the evaluation of AI/ML diagnostic or assistive devices, which is what your questions suggest.

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The WaveLight® FS200 Patient Interface 1505 is indicated to be used with the WaveLight® FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.

The WaveLight® FS200 Patient Interface 1505 is a patient contact consumable (disposable) consisting of a Tubing System with integrated Suction Ring and an Applanation Cone. The flat bottom of the cone is used as an applanation plate for the patient's cornea.

The provided 510(k) summary for the WaveLight® FS200 Patient Interface 1505 describes a device that is essentially a consumable component (patient interface) for an existing laser surgical system (WaveLight® FS200 Laser System). The focus of the submission is to demonstrate substantial equivalence to a predicate device (WaveLight® FS200 Patient Interface 1504), rather than proving the performance of a novel diagnostic or therapeutic algorithm.

Therefore, the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable to this submission. This device does not involve an AI algorithm, a diagnostic output, or a performance metric like accuracy that would require human expert adjudication of ground truth or a comparative effectiveness study with human readers.

Instead, the acceptance criteria and supporting studies for this device relate to its safety and functional equivalence as a consumable physical component.

Here's a breakdown based on the provided text, addressing the points where applicable and explaining why others are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility: No specific sample size provided, but tests were "evaluations of materials coming into contact with the patient or fluid path."
• Sterility: Validated for the "product." No specific sample size mentioned, but validation typically involves multiple batches/units for statistical confidence.
• Packaging & Shelf-life: Validated for the "product." No specific sample size mentioned.
• Function and Performance (Flap cutting tests): No specific sample size (number of cuts or units tested) is provided in the summary. Data provenance is implied to be laboratory testing conducted by the manufacturer, not patient data from a specific country or retrospective/prospective collection.

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

• Not Applicable. This device is a physical consumable component for a surgical laser, not a diagnostic or AI-powered device requiring expert-established ground truth. The "ground truth" here is objective physical and chemical properties and functional equivalence to the predicate device.

4. Adjudication method for the test set

• Not Applicable. As this is not a diagnostic device requiring interpretation, no adjudication method (e.g., 2+1, 3+1) was used. Testing relies on objective measurements and established standards.

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. An MRMC study is not relevant as this device is a physical consumable for a surgical laser, not an AI-assisted diagnostic or therapeutic tool that involves human readers interpreting output.

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

• Not Applicable. This device does not contain an algorithm or AI component; it is a passive, sterile, disposable physical interface.

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

• Objective Measurements and Predicate Equivalence: The "ground truth" for this device's performance relies on:
  • Compliance with recognized international standards (ISO 10993 for biocompatibility, AAMJ/ISO 11135 for sterility, ISO 11607-1 for packaging) which define acceptable limits for parameters.
  • Functional comparison to the legally marketed predicate device (WaveLight® FS200 Patient Interface 1504) for "flap cutting results," demonstrating equivalence rather than an absolute ideal "ground truth."
  • System validation against internal development and risk management procedures (21 CFR 820, ISO 14971).

8. The sample size for the training set

• Not Applicable. This product does not involve an AI/ML algorithm that requires a training set.

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

• Not Applicable. This product does not involve an AI/ML algorithm that requires a training set or its associated ground truth establishment.

In summary, this 510(k) submission successfully demonstrated substantial equivalence of a consumable device based on rigorous non-clinical testing (biocompatibility, sterility, packaging, functional performance, and system validation) against established standards and direct comparison to a predicate device, rather than patient-level clinical performance data or AI algorithm validation.

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This Monarch® III C 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 (C Cartridge), hereafter referred to as the Monarch® III C Cartridge, is a modification to the previously cleared Alcon Monarch® II IOL Delivery System (C Cartridge) consisting of a disposable polypropylene cartridge and reusable titanium handpiece. The Monarch® III C Cartridge features nozzle tip sizing like the currently marketed Monarch® II C Cartridge and is intended to fold and deliver Alcon AcrySof® intraocular lenses into the posterior chamber of the eye. The width of the loading zone has been increased to ease loading of 6 mm lenses. The exterior body has been modified, similar to Monarch® III D cartridge to improve manufacturability. It is designed to work with the currently marketed Monarch® III handpiece, and has been qualified for use with Alcon's AcrySof® Intraocular Lens models.

The provided text describes a 510(k) premarket notification for a medical device, the Monarch® III IOL Delivery System (C Cartridge). It focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's what can be inferred or stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device "has been tested and found to deliver the AcrySof® Intraocular Lens in conformance with the requirements set forth in ISO 11979-3, ISO 10993, ISO 11135, and ISO 14971." However, the specific acceptance criteria (e.g., maximum force, minimum delivery success rate) from these ISO standards and the reported device performance against those criteria are not detailed in the summary.

Since specific criteria and numerical performance are not provided, a table cannot be constructed with this information.

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

The document mentions "tested," but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This was likely part of the detailed test reports submitted with the 510(k), but not included in this summary.

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

This information is not applicable as the testing described relates to the physical performance of an intraocular lens delivery system against industrial standards (ISO), not the interpretation of medical images or diagnostic outputs requiring expert ground truth establishment.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as #3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted and is not applicable. This device is a delivery system, not a diagnostic or interpretive tool that would involve human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This information is not applicable. The device is not an algorithm; it is a physical medical device. The "performance" described relates to its ability to deliver an IOL in conformance with ISO standards, which is inherently a standalone physical test.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is compliance with international ISO standards (ISO 11979-3, ISO 10993, ISO 11135, and ISO 14971) which dictate requirements for intraocular lenses and their delivery systems, biocompatibility, sterilization, and risk management.

8. Sample Size for the Training Set:

This information is not applicable as the device is a mechanical delivery system, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reasons as #8.

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The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses:

27+ UltraVit Probe: Vitreous aspiration & cutting. Membrane cutting & aspiration. Lens removal. Dissect tissue in the eye. (The 27+ UltraVit Probe is intended to be used with the Alcon Constellation Vision System.)

27+ Flex-Tip Laser Probe: Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); Choroidal neovascularization secondary to age-related macular degeneration; Retinal tears and detachments; Macular edema; Retinopathy of prematurity; Choroidal neovascularization; Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. And other laser treatments including: Internal sclerostomy; Lattice degeneration; Central and Branch Retinal Vein Occlusion; Suturelysis; Vascular and pigmented skin lesions. (The 27+ Flex-Tip Probe is intended to be used with 532 nm laser systems such as the Alcon Constellation Vision System, or the Alcon PurePoint Laser System.)

27+ Endoilluminator Probe: Endoillumination (The 27+ Endoilluminator Probe is intended to be used with the Alcon Constellation Vision System)

27+ Valved Entry System: Scleral incision; Canulae for posterior segment instrument access; Venting (of valved cannulae)

27+ Infusion Cannula: Posterior segment infusion (liquid or gas)

The five instruments comprising the 27+ Retina Instrument Set are modified versions of approved larger gauge CONSTELLATION accessories but with smaller diameter instrument tips for less invasive surgery. All other features are exactly the same as the respective predicate devices cleared in K093305, K062624, K063583, and K101285.

The Alcon Research, Ltd. 27+ Retina Instrument Set is a set of surgical instruments intended for ophthalmic procedures, specifically vitreoretinal surgery. The devices are modified versions of existing, larger gauge instruments with smaller diameter tips for less invasive surgery. This 510(k) summary focuses on demonstrating substantial equivalence to these predicate devices rather than providing a detailed study proving performance against defined acceptance criteria.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in the format requested. Instead, the submission demonstrates equivalence through a combination of:

• Biocompatibility Standards Compliance: The materials are evaluated against a comprehensive set of ISO 10993 standards.
• Sterilization Validation: The ethylene oxide (EO) sterilization process is validated to a Sterility Assurance Level (SAL) of 10^-6, compliant with EN ISO 11135-1:2007.
• Technological Characteristics Equivalence: The claim is that the "Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The 27+ Retina Instrument Set has been developed and will be manufactured in compliance with 21 CFR 820 and ISO 14971:2007. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified devices are equivalent to the predicate devices."

Since no specific numerical acceptance criteria or performance results are provided, a table in the requested format cannot be created. The "performance" is demonstrated by adherence to technical standards and the claim of substantial equivalence to predicate devices.

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

The document describes non-clinical testing for biocompatibility and sterilization.

• Sample Size for Test Set: Not specified. The document states that "Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed" and "EO sterilized and the process has been validated." The specific number of samples for each test (e.g., cytotoxicity, irritation, systemic toxicity) is not disclosed in this summary.
• Data Provenance: The tests are non-clinical (laboratory-based) and conducted to international standards (ISO, AAMI/ANSI, EN ISO). The country of origin for the data is not explicitly stated beyond being conducted by Alcon Research, Ltd. There is no indication of retrospective or prospective patient data, as this is a pre-market submission for a surgical instrument rather than a diagnostic AI device.

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

This information is not applicable. The "ground truth" in this context refers to established scientific and regulatory standards for biocompatibility and sterilization, which are inherently defined by consensus among scientific and medical experts who developed these international standards (ISO, AAMI/ANSI, EN ISO). There are no "experts" establishing ground truth for this specific device's test set in the way one would for annotating medical images for an AI algorithm. The device's materials and sterilization process are evaluated against predefined criteria outlined in the standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for resolving disagreements in expert labeling of ground truth data, especially in studies involving human interpretation (e.g., reading medical images). Here, the testing involves standardized laboratory methods and measurements against established criteria, not subjective expert judgment that requires 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

This is not applicable. The submission is for a surgical instrument set, not an AI or diagnostic imaging device that involves human readers or AI assistance. No MRMC study was performed or is relevant to this type of device.

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

This is not applicable. The device is a set of physical surgical instruments, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

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

The "ground truth" for the non-clinical tests is based on:

• Established Biocompatibility Standards: The test results are compared against the acceptance criteria defined within ISO 10993 series standards, which represent expert consensus on biological evaluation of medical devices.
• Sterilization Validation Standards: The sterilization process is validated against EN ISO 11135-1:2007, a standard for ethylene oxide sterilization, representing expert consensus on achieving sterility.

There is no "pathology" or "outcomes data" in the typical sense for proving the fundamental safety aspects covered in this non-clinical testing.

8. The Sample Size for the Training Set

This is not applicable. There is no AI algorithm being developed or "trained" for this surgical instrument set.

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

This is not applicable as there is no training set for an AI algorithm.

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ClearCut™ S Incisional Instruments are sterile, single-use disposable devices intended for use during ophthalmic surgical procedures.

The ClearCut™ S family of incisional instruments are manual ophthalmic surgical instruments used by surgeons to create surgical incisions during ophthalmic surgical procedures. Incisional instruments incorporating sharps protection features provide injury prevention to those who come in contact with the device. The instruments are designed with an integral guard that can be activated to place the blade in a safe or exposed condition. The product is delivered to the user terminally sterilized by either gamma irradiation or ethylene oxide sterilization methods.

This 510(k) pertains to a manual ophthalmic surgical instrument (ClearCut™ S Incisional Instruments) that is exempt from direct performance comparison studies to establish substantial equivalence because it falls under a general control regulation (21 CFR 886.4350). Instead, the submission focuses on demonstrating compliance with safety and materials standards. Therefore, the requested information elements related to AI/algorithm performance and clinical studies are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not presented in a traditional tabular format with specific performance metrics for evaluation against a new AI algorithm. Instead, the submission focuses on meeting established standards and guidance documents related to medical devices with sharps injury prevention features and biocompatibility.

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

Not applicable. This submission does not involve a clinical test set for AI algorithm performance. The testing mentioned refers to mechanical and material compliance with standards.

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

Not applicable. This is not an AI-driven device requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable.

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 not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" in this context refers to established engineering and medical device standards for sharps injury prevention and biocompatibility. The device's compliance with these standards serves as the "ground truth" for its safety and effectiveness for its intended use.

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

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For use in the daily cleaning, reconditioning, rinsing, removing protein deposits, and reducing lipid deposition, chemical (not heat) disinfection, and storage of silicone hydrogel and soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

Alcon Multi-Purpose Disinfecting Solution (MPDS) is a sterile, buffered, aqueous solution containing sodium citrate, sodium chloride, boric acid, sorbitol, aminomethylpropanol, disodium EDTA, two wetting agents (TETRONIC® 1304) and HydraGlyde™ Moisture Matrix) with POLYQUAD® (polyquaternium-1) 0.001% and ALDOX® (myristamidopropyl dimethylamine) 0.0006% preservatives. HydraGlyde™ Moisture Matrix is a proprietary synthetic block copolymer that is primarily designed for wetting and lubricating silicone hydrogel lenses.

The provided text describes the Alcon Multi-Purpose Disinfecting Solution (MPDS) and its clearance through a 510(k) premarket notification. It outlines the safety and effectiveness studies conducted, but does not present acceptance criteria in a table format with numerical performance metrics for the device. The term "acceptance criteria" is used in a general sense, referring to compliance with guidelines.

Here's an attempt to structure the information based on the request, acknowledging the limitations of the provided text:

Acceptance Criteria and Device Performance Study for Alcon Multi-Purpose Disinfecting Solution (MPDS)

The Alcon Multi-Purpose Disinfecting Solution (MPDS) was evaluated against guidelines set forth in the FDA's May 1, 1997 Guidance for Industry; Premarket Notification 510(k) Guidance Document for Contact Lens Care Products, as well as relevant ANSI and EN ISO standards for microbiological requirements (EN ISO 14729:2001) and antimicrobial preservative efficacy (EN ISO 14730:2000).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table. Instead, it refers to meeting established guidelines and demonstrating clinical equivalence or superiority. The reported performance is qualitative.

2. Sample Size and Data Provenance (for test set/clinical study)

• Sample Size: Not explicitly stated for the clinical study. The text only mentions "a clinical study was conducted" with "silicone hydrogel and soft (hydrophilic) contact lens wearers."
• Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "clinical study" and is prospective in nature, as it evaluates the safety and efficacy of the new Alcon MPDS in lens wearers.

3. Number of Experts and Qualifications (for ground truth)

• This information is not provided in the given text. For a medical device like a contact lens solution, ground truth regarding safety and efficacy in a clinical setting would typically be established by ophthalmologists or optometrists, but the number and qualifications of such experts are not detailed.

4. Adjudication Method (for test set)

• This information is not provided in the given text. While a clinical study was performed, the method of adjudicating outcomes (e.g., adverse events, comfort scores) is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically relevant for diagnostic imaging AI devices, not for a contact lens care solution. Therefore, there is no effect size of human readers improving with or without AI assistance.

6. Standalone Performance (Algorithm only)

• No, a standalone (algorithm only) performance study was not conducted. This device is a chemical solution, not an AI algorithm. Its performance is inherent to its chemical formulation and interaction with biological and material components.

7. Type of Ground Truth Used (for test set)

• The ground truth for the clinical study would be based on clinical assessments and patient reports of outcomes (e.g., safety events, comfort levels, visual acuity where relevant) in comparison to the control product. For microbiological studies, ground truth is established by standard laboratory culture methods. For cleaning and compatibility, it's based on laboratory analytical methods.

8. Sample Size for the Training Set

• This concept is not applicable as the device is a chemical solution, not an AI algorithm that requires a training set. The development of the solution involved chemical formulation and in-vitro testing.

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

• This concept is not applicable for a chemical solution. The "ground truth" during development would be based on scientific principles, chemical analysis, and iterative testing in vitro to optimize the formulation for its intended functions (cleaning, disinfection, compatibility).

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The WaveLight® FS200 Laser System is an ophthalmic surgical laser indicated for use:

• · In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
• · In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
• · In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.
• · In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.

The WaveLight® FS200 Laser System is a stationary scanning-spot femtosecond laser system used in refractive surgery.

The provided text describes the WaveLight® FS200 Laser System and its clearance through the 510(k) pathway. However, the document does not contain a detailed study design with specific acceptance criteria, sample sizes for test and training sets, expert qualifications, or adjudication methods in the way one would typically expect for a modern AI/ML device submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance in creating corneal cuts. The information provided is characteristic of a traditional medical device submission rather than one for an AI/ML diagnostic tool.

Here's an attempt to answer your questions based only on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for precise numerical metrics like accuracy, sensitivity, or specificity. Instead, it refers to "performance tests" that establish "equivalence" to predicate devices.

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

The document states: "Performance tests according to the FDA Guidance 'Keratome and Replacement Keratome Blades Premarket Notification [(510(k)] Submissions' were conducted to collect data on the accuracy, precision and quality of the cuts achieved with the WaveLight® FS200 Laser System."

• Test Set Sample Size: Not specified. The document does not provide a number for the test set.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not applicable/Not specified. The "ground truth" here would relate to direct measurements of the physical cuts, not expert interpretation of outputs. The document does not mention the use of experts in this context.

4. Adjudication method for the test set

Not applicable/Not specified. Given the nature of a laser system creating physical cuts, an adjudication method for expert consensus on images is not relevant to the described performance tests.

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 not an AI/ML device that assists human readers. It's a surgical instrument.

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

The device is a standalone surgical laser system. Its performance evaluation focuses on the quality of the cuts it creates.

7. The type of ground truth used

The "ground truth" would be objective measurements of the physical characteristics (accuracy, precision, quality) of the corneal cuts themselves, likely performed using metrology or other analytical techniques directly on the cut tissue, as described in the referenced FDA Guidance. The document doesn't explicitly detail the methodology, but for a keratom, ground truth typically involves physical measurements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary Limitations:

The provided 510(k) summary is for a traditional surgical laser system, not an AI/ML driven device. Therefore, many of the questions related to AI/ML specific evaluation criteria (like training sets, expert consensus, MRMC studies, etc.) are not addressed in the document and are likely not relevant to its regulatory clearance. The performance testing for this device would have focused on engineering specifications, safety, and the physical outcomes of the laser's operation compared to known predicate devices or established standards.

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