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The ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patent Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

The ELITATM Femtosecond Laser System is an ophthalmic laser for corneal surgical operation. The system accurately cuts cornea tissue through a high pulse repetition rate and ultra-fast scanner to place pulses tightly next to each other, generating a continuous cutting surface. The system is controlled by the graphical user interface and software real-time controls. The optical delivery system determines a 3-dimensional position in the cornea at which the laser focuses. When the laser is emitted, the energy delivered is sufficient to photo-disrupt a small volume of tissue. The process of cutting involves repetitively setting a focus point and translating the laser cutting line generated by the resonant scanner. The ELITATM Femtosecond Laser System is a CDRH Class IV laser per 21 CFR 1040.10 and 1040.11 due to intentional laser exposure of the eye.

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface.

Instead, it is a 510(k) summary for a medical device seeking substantial equivalence to existing predicate devices. The core argument for acceptance is based on demonstrating that the new device is as safe and effective as the predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

Therefore, I cannot populate a table of acceptance criteria and reported device performance, nor can I provide details on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not discussed in the document in the context of specific quantitative criteria for this device.

Key points from the document regarding acceptance and studies:

• Acceptance Criteria: The primary acceptance criterion for the 510(k) submission is demonstrating substantial equivalence to predicate devices. This is achieved by showing that the ELITA™ system has:
  • Similar intended use.
  • Similar indications for use.
  • Similar fundamental scientific technology.
  • No new harms or unacceptable risks.
• Study That Proves the Device Meets Acceptance Criteria:
  • Type of Study: Non-clinical studies were performed, including:
    • Bench testing.
    • Electromagnetic Compatibility (EMC) testing.
    • Software verification and validation testing.
    • Design verification and validation testing.
  • Conclusion: These tests "demonstrate the system's ability to meet all intended design specifications" and provide "reasonable assurance that the system remains safe and effective for its intended use" and "is substantially equivalent to the iFS predicate device."
  • Clinical Data: "Clinical Data was deemed not necessary for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface" because the device does not introduce new indications/intended use or new harms/unacceptable risks.
  • Comparison to Predicates: A detailed comparison (Table 1) of the subject device (ELITA™) with a primary predicate (FEMTO LDV™ Z8) and a secondary predicate (iFS Advanced Femtosecond Laser System) was used to highlight similarities in:
    • Technological characteristics (e.g., femtosecond pulsed laser, operating principle, resection method, patient interface).
    • Indications for Use (with a note that ELITA™'s indications are "similar, more concise").
    • Laser type, wavelength, repetition rate, pulse duration, and spot size.

In summary, the document states that the device was accepted based on non-clinical testing demonstrating its performance against design specifications, and a detailed comparison showing substantial equivalence in functionality, safety, and effectiveness to legally marketed predicate devices, negating the need for clinical studies. Specific quantitative acceptance criteria or detailed results of these non-clinical tests are not provided in this 510(k) summary.

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ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are nearsighted (hyperopic) and may have 1.00D or less of astigmatism that does not interfere with visual acuity.

ACUVUE® OASYS MAX 1-DAY Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism.

ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and may have 0.75D or less of astigmatism that does not interfere with visual acuity.

ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism.

The lenses are to be prescribed for daily disposable wear. Therefore, no cleaning or disinfection is required. Lenses should be discarded upon removal.

The subject device is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date a 2-year shelf-life has been established.

The subject device is made of a silicone hydrogel material containing an internal wetting agent. The lens is tinted using Reactive Blue 247. A benzotriazole UV absorbing monomer is used to block UV radiation in combination with a novel fused tricyclic chromophore that also blocks UV radiation and reduces transmittance in the range from 380 nm to 450 mm.

The provided document is a 510(k) Premarket Notification for ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A). It focuses on demonstrating substantial equivalence to predicate and reference devices, primarily through technological characteristics and non-clinical performance data, rather than new clinical performance data for the subject device.

Therefore, the document does not contain the following information typically associated with a study proving a device meets acceptance criteria:

• A table of acceptance criteria and reported device performance based on a new clinical study.
• Sample sizes used for a new clinical test set.
• Number of experts used to establish ground truth or qualifications of those experts.
• Adjudication methods for a new clinical test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance data.
• Type of ground truth used (as no new clinical ground truth development is described).
• Sample size for a training set (as this is not an AI/ML device with a training phase).
• How ground truth for a training set was established.

Instead, the document states:

"Demonstration of the physical, chemical and sphere/toric optical design equivalency of the subject device to the predicate device and multifocal design equivalency to the reference device supports the safety and effectiveness of the subject device. Therefore, in accordance with FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 12, 1994, clinical performance data to demonstrate substantial equivalence are not required."

This indicates that the acceptance criteria for this device's approval were primarily based on its technological similarity and non-clinical performance data being equivalent to already approved devices, rather than a new clinical trial proving performance against defined clinical acceptance criteria.

However, the document does list non-clinical performance data (in-vitro and in-vivo tests) that were performed to assess properties, safety, and effectiveness. While not a "clinical study" in the sense of patient outcomes for acceptance criteria, these tests serve a similar purpose for demonstrating safety and performance.

Here's an attempt to extract relevant information based on the provided text, interpreting "acceptance criteria" as meeting the standards set by the predicate/reference devices and safety tests, since a traditional clinical study with defined performance metrics isn't presented:

Acceptance Criteria and Device Performance (Based on Non-Clinical Data and Substantial Equivalence)

The approval of the ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) was primarily based on demonstrating substantial equivalence to predicate and reference devices through:

1. Comparison of technological characteristics.
2. Non-clinical performance data (in-vitro and in-vivo tests) to assess properties and safety.

The acceptance criteria are implicitly met by demonstrating that the subject device's properties and safety profile are comparable to or within acceptable ranges of previously cleared devices and established safety standards.

1. Table of Acceptance Criteria (Implied by Predicate/Reference Equivalence and Non-Clinical Tests)

2. Sample Sizes and Data Provenance (for Non-Clinical Tests)

• Sample Sizes: Not explicitly stated for each specific non-clinical test (e.g., number of lenses tested for oxygen permeability, number of animals in biocompatibility studies). The document mentions "a series of in-vitro and in-vivo tests."
• Data Provenance: The tests were conducted following the 1994 FDA Guidance Document for Daily Wear Contact Lenses. Biocompatibility tests were conducted in accordance with GLP regulation (21 CFR Part 58). Other testing was conducted according to valid scientific protocols. The location of these tests (e.g., country of origin) is not specified. The data is retrospective in the sense that it was collected prior to this submission but not from a new clinical patient study.

3. Number of Experts and Qualifications for Ground Truth

• This information is not applicable as the submission relies on non-clinical tests and substantial equivalence to previously approved devices, not a new clinical study requiring human expert consensus for ground truth on patient data.

4. Adjudication Method for the Test Set

• Not applicable, as there was no clinical test set requiring human adjudication for ground truth.

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

• Not applicable. This is not an AI/ML device that assists human readers, nor is it a device that measures improved diagnostic accuracy over human readers. Its approval is based on safety, physical properties, and equivalence to existing contact lenses.

6. Standalone Performance

• Not applicable in the context of AI/ML or diagnostic devices. The "standalone performance" of the device refers to its inherent physical, chemical, and optical characteristics and biocompatibility, as detailed in the non-clinical performance data.

7. Type of Ground Truth Used

• For the purpose of substantial equivalence and safety, the "ground truth" is derived from:
  • Established industry standards and material properties: Such as ISO standards (e.g., ISO 18369-1:2017) for material classification and physicochemical test methods (e.g., Fatt method for Dk).
  • Regulatory safety guidelines: FDA Guidance Document for Daily Wear Contact Lenses (1994) and GLP regulations (21 CFR Part 58).
  • Prior approval for predicate/reference devices: The performance and safety profiles of the VISTAKON (senofilcon A) Soft Contact Lens (K042275) and ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia (K141670) serve as the "ground truth" for equivalence.

8. Sample Size for the Training Set

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

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

• Not applicable, as there is no AI/ML training set.

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The VERITAS(TM) Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the user to configure the system to meet their surgical requirements.

The VERITAS(TM) Advanced Infusion Pack or VERITAS(TM) Advanced Fluidics Pack contains the manifold (cassette) and Tubing Assembly and is intended to perform irrigation during anterior segment cataract surgery. It is used with the VERITAS(TM) Vision System. The VERITAS(TM) Pack is sterilized using ethylene oxide and is designed for single use only.

The VERITAS™ Vision System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) ophthalmic surgery. The device uses ultrasonic energy via finely modulated pulses of energy, interrupted by brief cooling periods, to emulsify and extractous lens. This allows the system to achieve full ultrasound cutting efficiency while introducing less energy to the eye, which reduces risk of thermal damage. The VERITAS™ System performs phacoemulsification, diathermy, irrigation/aspiration, and vitrectomy functions, and is a peristaltic system with a graphic user interface that has updated technology and hardware to meet current electrical and material safety standards.

The VERITAS™ Vision System consists of components that are used to perform cataract surgery, which include the 1) System Console, 2) Wireless Remote Control, 3) Advanced Foot Pedal and 4) Single-Use Fluidics Pack or Single-Use Infusion Pack 5) Swivel Handpiece 6) Hardware 7) Software.

The VERITAS™ Advanced Infusion Pack or VERITAS™ Advanced Fluidics Pack contains the manifold (cassette) and Tubing Assembly and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the VERITAS™ Vision System. The VERITAS™ Pack is sterilized using ethylene oxide and is designed for single use only.

This report describes the acceptance criteria and the study that proves the device meets those criteria for the VERITAS™ Vision System.

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not present a formal table detailing specific, quantifiable acceptance criteria and directly corresponding reported device performance metrics in a side-by-side format. Instead, it states that the device "passed the acceptance criteria" and "all tests passed and all acceptance criteria were met" for various functional aspects.

The performance testing primarily focuses on demonstrating substantial equivalence to predicate devices (WHITESTAR SIGNATURE® PRO Phacoemulsification System and OPO73 Dual Pump Fluidics Pack) rather than meeting predefined numerical acceptance thresholds for novel performance claims.

Based on the text, the acceptance criteria are implicitly tied to the performance and safety profiles of the predicate devices and compliance with relevant standards.

Implicit Acceptance Criteria and Reported Performance (derived from text):

The overall reported performance is that all required acceptance criteria were met, and the device is substantially equivalent to the predicate devices.

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

The document indicates that "bench testing" was performed for design verification and validation. However, it does not specify the sample size (e.g., number of devices, number of tests, volume of data) used in these tests. The provenance of this test data is implied to be internal testing conducted by Johnson & Johnson Surgical Vision, Inc. The document does not specify a country of origin for the data or whether the tests were retrospective or prospective, though design verification and validation testing are typically prospective.

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

The document makes no mention of experts being used to establish ground truth for a test set. The validation relies on meeting technical specifications, safety standards, and functional equivalence to predicate devices, rather than expert interpretation of medical images or diagnostic outputs. Human factors studies were conducted, but these are for usability and risk, not for establishing diagnostic ground truth.

4. Adjudication method for the test set

No adjudication method is described, as the testing performed does not involve subjective assessments requiring adjudication. The device validation relies on objective physical measurements, functional tests, and compliance with 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 MRMC comparative effectiveness study was done. This device is a phacoemulsification system and not an AI-assisted diagnostic or imaging device, so such a study would not be applicable. The document explicitly states: "No animal or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology when compared to the primary and secondary predicate devices."

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

The device is a medical system for surgical procedures, not an algorithm, so a "standalone" algorithm-only performance assessment as typical for AI/ML devices is not applicable. Its performance is assessed through its mechanical and electrical functionality, and its interaction with a surgeon (human-in-the-loop) is the inherent design.

7. The type of ground truth used

The "ground truth" for the device's performance is established by:

• Compliance with recognized international standards (e.g., IEC 60601 for electrical safety, ISO 11135 and 11137 for sterilization, ISO 10993 for biocompatibility, ISO 14971 for risk management).
• Demonstrating functional equivalence to legally marketed predicate devices through bench testing.
• Meeting design specifications and requirements for each component and the system as a whole.

This is a form of technical and regulatory compliance ground truth, rather than a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

The document does not mention a training set. This device is a hardware/software medical system, not a machine learning or AI model that typically requires a training set.

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

Not applicable, as no training set is mentioned or relevant for this type of device.

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The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may need up to 4.00 of ADD power and have 0.75D or less of astigmatism.

The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.

Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional.

When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2 weeks (14 days).

The subject device is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells.

The subject device is made of a silicone hydrogel material containing an internal wetting agent. The lens is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 315 nm to 380 nm for the entire power range.

This document is a 510(k) summary for the ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL and ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC. It discusses the substantial equivalence of the new device to previously cleared predicate and reference devices.

Here's an analysis of the provided text in the context of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a study endpoint. Instead, it presents physicochemical properties and parameters of the subject device, which are implicitly the performance characteristics that need to be within an acceptable range to demonstrate equivalence to the predicate and reference devices.

In this case, the "device performance" is the reported property/parameter values.

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

The document explicitly states: "clinical performance data to demonstrate substantial equivalence are not required."
Therefore, there is no "test set" in the context of clinical performance data described in this document. The non-clinical performance data involved "finished product testing for verification of the modified design," but no specific sample sizes or data provenance are provided for these tests.

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, as no clinical performance data requiring expert ground truth for a test set was conducted or reported in this document.

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

Not applicable, as no clinical performance data requiring adjudication was conducted or reported in this document.

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 contact lens, not an AI-powered diagnostic device. No MRMC study was conducted.

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

Not applicable. This device is a contact lens, not an AI-powered algorithm. No standalone algorithm performance was assessed.

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

Not applicable, as no clinical performance data requiring ground truth was conducted or reported in this document. The "ground truth" for the non-clinical tests would be the established specifications and measurement standards for the material and design properties.

8. The sample size for the training set

Not applicable, as no AI/machine learning model was developed for this device. Therefore, 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 an AI/ML model for this device.

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The UNFOLDER Vitan™ Inserter, Model DK9000, is used in combination with the SmartLOAD™ Delivery Technology to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, ONLY into the capsular bag.

The UNFOLDER Vitan™ Inserter, Model DK9000, is an autoclavable, reusable titanium intraocular lens (IOL) inserter or handpiece that is designed for use in combination with the SmartLOAD™ Delivery Technology (P980040/S095) to fold and assist in the insertion of a J&J Vision acrylic one-piece IOL into the eye following cataract extraction. The IOL is provided preloaded in the disposable polypropylene cartridge and is snapped into the inserter. The screw plunger advances the IOL through the cartridge, which folds the IOL and advances it into the eye. The SmartLOAD™ Delivery Technology cartidge is designed to eliminate the need for the IOL to be loaded into the cartridge to provide a sterile, controlled, and convenient method of efficiently delivering J&J Vision acrylic onepiece lenses into the eye during cataract surgery.

The provided document describes the UNFOLDER Vitan™ Inserter, Model DK9000, which is an intraocular lens (IOL) inserter. It is a Class I device used to fold and assist in inserting Johnson & Johnson Surgical Vision, Inc. Acrylic 1-piece intraocular lenses, in combination with the SmartLOAD™ Delivery Technology. The document does not describe an AI/ML device per se but a medical device in general. Therefore, some of the requested information, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," and specifics about AI/ML algorithm training, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table detailing numerical acceptance criteria and reported device performance for specific metrics. Instead, it generally states that the device "complies with applicable standards" and "passed all acceptance criteria" during functional testing.

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

• Sample Size for Test Set:
  • Reprocessing Study: The study involved processing a sufficient number of UNFOLDER Vitan™ Inserters to verify that they can withstand 500 clinical reprocessing cycles. The exact number of inserters tested is not specified but it states "the inserters" implying multiple units.
  • Functional Delivery Testing: "All tested IOLs" were evaluated. The exact number of IOLs tested is not specified, but the phrase implies a representative sample.
• Data Provenance: The studies were non-clinical tests conducted by Johnson & Johnson Surgical Vision, Inc. There is no information about the country of origin of the data as it's not patient-specific data, but rather device performance data. The studies are described as verification and validation testing, which are typically prospective in nature to assess product performance against design specifications.

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

This information is not applicable as the described tests are non-clinical device performance tests. Ground truth in the context of expert consensus is typically associated with clinical studies or AI/ML evaluations where human experts label or interpret data. For device performance testing, "ground truth" is typically defined by engineering specifications and objective measurements against those specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI/ML evaluations when there's a need for consensus among multiple human readers/experts to establish a definitive "ground truth" for ambiguous cases. For device performance testing, results are typically determined by objective measurements and passing/failing predefined specification limits.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses the performance of human readers, often with and without AI assistance, which is not relevant for a standalone medical device like an IOL inserter that doesn't involve interpretation by human readers in the same way.

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

This information is not applicable. The device described is a physical instrument (IOL inserter), not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this device.

7. The Type of Ground Truth Used

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

• Engineering Specifications and Functional Requirements: For the reprocessing study, the ground truth was the device's ability to maintain its "functional properties," remain "intact," and "successfully deliver IOLs per the Directions for Use," ultimately meeting its predefined design and performance specifications.
• Established ISO Standards (ISO 11979-3: 2012): For functional delivery testing, the "ground truth" was defined by the acceptance criteria mentioned in Section 5 of ISO 11979-3: 2012, specifically for post-delivery dioptric power, image quality, overall diameter, sagitta, and surface and bulk homogeneity. These standards provide objective, measurable criteria for IOL delivery performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, 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 (as explained in point 8).

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The COMPACT INTUITIV™ System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

The COMPACT INTUITIV™ System is a modular ophthalmic microsurgical system that is intended for use in anterior segment (cataract) surgery. The device is used to emulsify and extract a cataractous lens. The COMPACT INTUITIV™ is a mid-tier peristaltic system with a graphic-user that has updated technology and hardware to meet current electrical and material safety standards. The currently cleared COMPACT INTUITIV™ consists of the System Console, the Wireless Remote Control, the Open-Toe Foot Pedal, and the Single-Use Fluidics Pack, Model OPO80.

The closed-toe foot pedal is equivalent to the currently cleared open-toe foot pedal for use with the COMPACT INTUITIV" system. The closed-toe foot pedal provides similar functionality as the opentoe foot pedal. Both open-toe and closed-toe foot pedals contain three-programmable switches, and the closed-toe device incorporates a programmable treadle. Both open and closed toe foot pedals provide tactile feedback to the user. The switches and treadle on the foot pedal can be programmed to access features on the COMPACT INTUITIV™ System Console based on the surgeon's preference.

The provided text does not describe acceptance criteria for an AI/ML device in the traditional sense, nor does it detail a study proving such a device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device (a phacofragmentation system and its foot pedal) that does not incorporate AI/ML.

The document explicitly states: "No animal or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology when compared to the predicate device." This clearly indicates that the device being reviewed is not an AI/ML device requiring complex performance studies.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the product described in the input document.

The "Performance Data" section (Page 3) discusses:

• Design verification and validation testing, including electromagnetic compatibility testing: This ensures the physical device (foot pedal) works as intended and is compatible with the system.
• Software validation: This was performed on a proposed software version with minor changes to accommodate the new foot pedal, ensuring the software functions correctly with the new component.
• Acceptance criteria for these engineering and software tests were met. Without further details, these acceptance criteria are likely related to electrical safety, functional performance (e.g., foot pedal response time, correct input recognition), and electromagnetic compatibility limits.

The document concludes that the new closed-toe foot pedal is substantially equivalent to the predicate open-toe foot pedal based on these non-clinical bench tests and software validation.

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The Neutrogena Light Therapy Aging Mask+ is an over the counter device that is indicated for the treatment of full face wrinkles.

The Neutrogena Light Therapy Aging Mask+ uses known LED light therapy technology for the treatment of facial wrinkles. The device emits a combination of red light and infrared light. Users place the lightweight mask over the face and press the "On" button on the controller module to start treatment. The device will automatically turn off after each 10-minute treatment.

The provided document focuses on the FDA's 510(k) clearance for the Neutrogena Light Therapy Aging Mask+ and primarily uses substantial equivalence to predicate devices, rather than establishing new acceptance criteria and proving the device meets them through clinical studies with specific performance metrics.

Therefore, the information required to answer your questions regarding acceptance criteria, study details, expert involvement, and ground truth establishment (as typically found in clinical trials for new efficacy claims) is not present in this document.

The document states: "Performance testing performed on the Neutrogena Light Therapy Aging Mask+ is sufficient to demonstrate that the subject device is as safe and effective as the legally marketed predicate devices." This indicates that the primary method for demonstrating effectiveness was through comparison to existing devices with established safety and efficacy profiles, rather than establishing new, quantitative performance criteria for wrinkle reduction itself.

However, I can extract the following information that is available:

1. Table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria for wrinkle reduction performance or report the device's performance against such criteria. Instead, it compares the technological characteristics and indications for use of the subject device to predicate devices to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance: Not provided in the document for efficacy testing. The performance and safety testing mentioned are:
* Performance verification
* Human Factors Evaluation
* Biocompatibility testing
* Electrical Safety and Electromagnetic Compatibility testing

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. This type of information would typically be relevant for studies involving qualitative assessments (e.g., by dermatologists for wrinkle severity), which are not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.

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 not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a light therapy device, not an algorithm.

7. The type of ground truth used: Not explicitly stated for performance/efficacy, as the primary basis for clearance is substantial equivalence. For safety assessments, recognized standards (biocompatibility, electrical safety) serve as the "ground truth" or reference.

8. The sample size for the training set: Not applicable, as this refers to a medical device's clearance based on technological characteristics and comparison to predicates, not an AI model's training.

9. How the ground truth for the training set was established: Not applicable.

In summary, the FDA 510(k) clearance process for this device relies heavily on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than presenting a novel clinical study with new, specific performance acceptance criteria for wrinkle reduction. The provided document details the technological characteristics and safety testing (bench, human factors, biocompatibility, electrical safety) that support this substantial equivalence claim.

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The Neutrogena Light Therapy Acne Mask+ is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne on the face.

The Light Therapy Acne Mask + uses a known light emitting diode (LED) therapy, noncoherent light, in the red and blue range to treat mild to moderate acne bearing similar methods of operation, treatment regimen, and the ability to be recharged as the predicate K170111. The reference device bears the same technological characteristics including anatomical design and biocompatible materials as the Light Therapy Acne Mask +. Consistent with the intended use of the predicate and reference device, the Light Therapy Acne Mask + uses blue light to kill acne causing bacteria and the red light to decrease inflammation. The user wears the mask over their face, like a pair of glasses, and presses the button on the integrated module - holding for one second - to initiate the treatment. The device has a continuous working time of 10 minutes and shuts off automatically. Each use counts as a single dose. The module contains rechargeable batteries. The module is then recharged prior to the next treatment via a micro USB cable.

The provided text describes the Johnson & Johnson Neutrogena Light Therapy Acne Mask+ and its substantially equivalent determination by the FDA. However, the document does not contain specific acceptance criteria, performance metrics, or study details in the format required by your request (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details).

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial results with specific performance criteria and statistical analysis. The "Performance Data" section primarily lists compliance with various electrical, safety, and biocompatibility standards, and a Human Factors evaluation, not clinical efficacy data in the typical sense of measuring device performance against defined clinical acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a summary of what can be extracted and what is missing:

Neutrogena Light Therapy Acne Mask+

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not specified. The document mentions "bench performance tests" and a "Human Factors (HF) evaluation" but does not detail a clinical test set with sample sizes or data provenance (country of origin, retrospective/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 document does not describe a clinical study for which experts would establish ground truth on a test set.

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

• Not applicable / Not specified.

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 light therapy mask, not an AI diagnostic/assistance tool for human readers.

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

• Not applicable. This device is a light therapy mask, not an algorithm.

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

• Not specified for clinical efficacy. The document implies that the "effectiveness" is demonstrated by substantial equivalence to predicate devices that treat acne with similar light therapy, and by meeting various safety and performance standards. No specific clinical ground truth (e.g., lesion counts, photographs assessed by dermatologists) is described in this 510(k) summary for this device's performance study.

8. The sample size for the training set

• Not applicable / Not specified. The device is not an AI algorithm requiring a training set in the specified context. If there was a clinical trial, its participant numbers would be the "sample size," but none are detailed here.

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

• Not applicable / Not specified.

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The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes who may have 10.00D or less of astigmatism.

The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may have 0.75D or less of astigmatism.

The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.

These lenses are also indicated for the attenuation of bright light as they contain a photochromic additive which dynamically absorbs visible light.

These lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2-weeks (14 days).

The subject device is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal-toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date a 2-year shelf-life has been established.

The subject device is made of a silicone hydrogel material containing an internal wetting agent and UV absorbing monomers. A combination of a benzotriazole UV absorbing monomer and a naphthopyran monomer (photochromic additive) is used to block UV radiation and dynamically absorbs visible light. The transmittance characteristics for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 316 nm to 380 nm for the entire power range.

Additionally, the photochromic additive absorbs visible light in the range from 380 nm to 780 nm to a minimum 84% transmittance in the inactivated (closed) state. The activated (open) state dynamically absorbs visible light dependent on the lens thickness and the level of UV and high energy visible (HEV) radiation to a minimum of 23% transmittance.

Here's a breakdown of the acceptance criteria and study information for the ACUVUE® (senofilcon A) Soft Contact Lens with Photochromic Additive, based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" for clinical performance in a pass/fail format with numerical thresholds. Instead, it describes general safety and effectiveness. However, it does provide specific physicochemical properties with target values and the outcome of the clinical study regarding visual acuity and driving performance.

For physicochemical properties, the "Subject Device" column implicitly represents the reported device performance against the defined properties. For clinical performance, the statement "no evidence of driving performance or visual acuity concerns" indicates the device met the safety and performance expectations.

Table of Acceptance Criteria (or Expected Properties) and Reported Device Performance

Note: The "Acceptance Criteria" for clinical performance are inferred as "no concerns" based on the study's conclusion.

Study Information

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: 24 subjects
   • Data Provenance: Australia (field-based driving studies on a closed-road driving circuit at night and during the day). The study was prospective/real-world.

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

   • The document does not specify the number or qualifications of experts for establishing ground truth related to visual acuity or driving performance. The results are based on quantitative measurements of vision and driving performance, suggesting objective data collection rather than expert adjudication for ground truth.

3. Adjudication method for the test set:

   • The document does not mention an adjudication method for the test set, as the primary and secondary endpoints involved quantitative measurements (e.g., overall driving performance score, visual acuity, contrast threshold, road sign recognition percentage, hazard avoidance percentage, pedestrian recognition distance).

4. 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. This study is focused on the performance of a contact lens in human subjects, not an AI system assisting human readers.

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

   • No, a standalone algorithm performance study was not done. This device is a contact lens, not a computational algorithm.

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

   • The ground truth for the clinical study was based on quantitative measurements of human physiological and behavioral responses. This includes:
     • Low luminance high contrast distance visual acuity
     • Distance visual acuity
     • Low luminance contrast threshold
     • Road sign recognition (percentage)
     • Percentage of hazards avoidance
     • Pedestrian recognition distance
     • Overall driving performance score.

7. The sample size for the training set:

   • There is no training set mentioned in the context of this device's evaluation. The studies described are for the validation of the contact lens itself, not for an AI algorithm.

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

   • Not applicable, as there was no training set for an AI algorithm mentioned.

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The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may have 10.00D or less of astigmatism.

The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens MULTIFOCAL is indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia in phakic or aphakic persons with nondiseased eyes who may need up to 4.00D of ADD power and may have 0.75D of astigmatism or less.

The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D of astigmatism or less.

These lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see REPLACEMENT SCHEDULE). When prescribed for daily disposable wear, lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional.

The ACUVUE® (senofilcon C) Soft Contact Lens is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal-toric design. The composition of the lens is 59% senofilcon C and 41% water by weight when hydrated and stored in buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date, a 4-year shelf-life has been established.

The ACUVUE® (senofilcon C) Soft Contact Lens is made of a silicone hydrogel material containing an internal wetting agent. The lens is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. A benzotriazole UV absorbing monomer is used to block UV radiation. 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 316 nm to 380 nm for the entire power range.

This document is a 510(k) premarket notification for ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lenses. It details the safety and efficacy of the device by comparing it to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate device in various safety and performance aspects. The reported device performance is outlined against these implicit criteria through direct comparison with the predicate device.

Note: Differences in specific values (e.g., water content, Dk, specific astigmatism limits) are presented and argued not to adversely affect safety and efficacy.

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

• Test Set (Clinical Study):
  • Sample Size: 221 subjects total (109 for the test lens, 112 for the control lens).
  • Data Provenance: Conducted in the U.S. (United States), described as a prospective, randomized, parallel group design.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical test set beyond implying the involvement of "Eye Care Professionals" who would make clinical determinations (e.g., for visual acuity, slit lamp findings, etc.). It mentions "clinical evaluation" and "clinically relevant areas of vision and health," which implies expert assessment, but no explicit details on the number or their specific qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes a "prospective, randomized, parallel group design" clinical study, where data points like slit lamp findings and visual acuity were collected. This suggests standard clinical assessment by the study's optometrists/ophthalmologists, but no specific multi-reader adjudication process is detailed for reaching a "ground truth."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study's design was a direct clinical comparison of the new contact lens to a predicate contact lens, focusing on physiological and performance equivalence, not on the improvement of human readers with AI assistance. The device is a contact lens, not an AI diagnostic tool.

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

This question is not applicable. The device is a contact lens, not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for this product.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was established through standard clinical assessments and measurements performed by Eye Care Professionals during the study. This includes:

• Slit lamp findings
• Visual acuity measurements
• Keratometry changes
• Evaluations of problems, symptoms, and complaints
• Adverse reactions
• Reasons for discontinuation

This can be broadly categorized as expert clinical assessment and outcomes data as observed and recorded during the prospective clinical trial.

8. The Sample Size for the Training Set

This question is not applicable. The device is a contact lens and does not involve AI or machine learning that would require a "training set" of data.

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

This question is not applicable, as there is no training set for this device.

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