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

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

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

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

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

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

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

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

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

Both devices are for prescription use only.

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

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

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The Bausch + Lomb Stellaris Elite™ vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/ aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a 532 nm laser module for photocoagulation. The Stellaris Elite™ vision enhancement system was initially cleared under K 162342 which included the introduction of an Adaptive Fluidics feature as well as increase in vitrectomy cut rate. The Vitesse vitrectomy handpiece was introduced and cleared for use on the Stellaris Elite™ vision enhancement system under K170052.

A selection of disposable single-use procedure packs is available for use with this system. These packs contain the necessary tubing to facilitate delivery and removal of air and fluids to/from the patient as well as a selection of components (cannulas, cutters, probes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility. Additional Stellaris Elite™ vision enhancement system procedure packs have been made available and these packs contain components that have been used in previously available procedure packs. Some of these Stellaris Elite™ vision enhancement system procedure packs now include the BiBlade vitrectomy cutter produced by Medical Instruments Development Lab (separately cleared via K153168).

The previously cleared Stellaris Elite™ vision enhancement system introduced new feature sets that are not available on the legacy Stellaris PC systems previously cleared under K133242/K133486 respectively. A summary of these additional feature sets for the Stellaris Elite™ vision enhancement system are listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

The most recent clearance to the Stellaris Elite™ vision enhancement system introduced the Vitesse vitrectomy feature and was cleared via K170052 on April 19, 2017.

This traditional 510(k) incorporates updates to User Interface Computer System on Module (SOM) with an introduction of a new replacement Congatec SOM. In addition. the Stellaris Software platform is updated to Windows 10, since the current Stellaris software platform Windows XP is obsolete/incompatible with the new Congatec SOM.

The features remain the same as the previously approved Stellaris Elite™ vision enhancement system. The configuration matrix is listed in Table 8-1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

The provided document is a 510(k) Summary for the Bausch + Lomb Stellaris Elite™ vision enhancement system. It primarily focuses on demonstrating substantial equivalence to a predicate device after software and hardware updates, rather than presenting a study proving a device meets specific acceptance criteria for performance.

Therefore, many of the requested categories cannot be fully addressed in the traditional sense of a clinical or performance study aimed at defining and meeting specific analytical or clinical performance metrics. The document describes how substantial equivalence was demonstrated, which involves various types of testing, but not a study designed to prove new performance claims against defined acceptance criteria.

Below is the information extracted and interpreted based on the context of this 510(k) submission, highlighting what is available and what is not.

Acceptance Criteria and Device Performance Study for K232084

This 510(k) submission (K232084) is for updates to the Bausch + Lomb Stellaris Elite™ vision enhancement system, not for a new device making novel performance claims. The primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device (K170052 Stellaris Elite™ vision enhancement system) after changes to the User Interface Computer System on Module (SOM) and an update to the operating system from Windows XP to Windows 10. Consequently, the "acceptance criteria" and "device performance" are framed in terms of meeting regulatory standards and maintaining performance equivalent to the predicate device, rather than achieving specific performance thresholds for a novel diagnostic or therapeutic claim.

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

Given the nature of this 510(k) for system updates, the "acceptance criteria" are regulatory compliance and maintained functionality, rather than specific numerical performance metrics for a clinical task.

2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a dataset for AI or clinical study. Instead, it refers to "representative units" for hardware testing (electrical safety, EMC) and software verification/validation.

• Test Set Sample Size: Not applicable in the context of an AI-driven clinical test set. Testing was performed on the device itself and its software.
• Data Provenance: Not applicable as no patient data or image data was used for a test set. This submission is for hardware/software updates to an ophthalmic surgical system. The standards cited (IEC standards for electrical safety, EMC, software lifecycle) are international regulatory standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" for a test set (e.g., diagnostic labels, disease states) was established by experts in this submission, as it's not a diagnostic AI device.

4. Adjudication method for the test set
Not applicable. There was no test set requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic or interpretation device that would involve human readers.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a clinical performance study. For software and hardware validation, the "ground truth" would be the functional requirements and established performance specifications of the predicate device and relevant international standards.

8. The sample size for the training set
Not applicable. This device does not use a "training set" in the sense of machine learning for interpretation or diagnosis.

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

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The UniVit™ HE and UniVit™ UHS are single use (disposable) products intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module.

The operation of a vitreous cutter is simple. An air pulse pushes down the diaphragm located inside the vitrectomy probe, leading the port to a closed position (the guillotine movement); at the same time, a spring is compressed and forces the diaphragm back to the open port position. In this submission VisionCare Devices is submitting two new models of vitreous cutter. The first model is the UniVit™ HE, which stands for Universal Vitcutter High Efficiency. The UniVit HE is offered in gauge sizes of 20, 23, 25, and 27). The UniVit™ HE™ operates up to 11,000 CPM depending upon vitrectorny system selection. The second model offered, in this submission, is the UniVit™ UHS™, which stands for Universal Vitcutter Ultra High Speed. The UniVit UHS is offered gauge sizes of 23, 25, and 27. The UniVit operates up to 11,000 CPM depending upon vitrectory system selection. The inner cutter has a port cut into it which allows for cutting forward and backwards; this in effect doubles the cut rate to 22,000 CPM.

The provided text describes the UniVit™ HE and UniVit™ UHS devices, which are vitreous aspiration and cutting instruments. The document is a 510(k) summary, indicating that the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel technology requiring extensive clinical trials.

The acceptance criteria and device performance are primarily detailed through a series of "Non-Clinical Bench Test Summary Reports" and compliance with harmonized standards. No clinical studies involving human patients were conducted for this submission, nor were there any studies mentioned that involved human readers or AI assistance in interpretation. Therefore, much of the requested information regarding human expert involvement, MRMC studies, or AI specific performance will not be applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• UniVit Needle Deformation: All available gauge sizes (20, 23, 25, 27) were tested. The exact number of devices or iterations per gauge is not specified, but it implies a comprehensive test of each type. Data provenance is internal lab testing by VisionCare Devices, LLC.
• UniVit Diaphragm Burst: "Only one gauge of handpiece was required for testing due to the UniVit vitrector family internal operation." This suggests at least one finished device was tested for this specific criterion. Data provenance is internal lab testing by VisionCare Devices, LLC.
• UniVit Fluidics: "(2) rabbit eyes" were used. Data provenance is from studies conducted on rabbit eyes, likely internal lab testing by VisionCare Devices, LLC.
• UniVit Metal Flaking: "The testing was done on a finished device." The number of finished devices tested is not specified beyond this. Data provenance is internal lab testing by VisionCare Devices, LLC.
• UniVit Tip Temperature: "The vitrector was ran in a worse case condition..." The number of devices or runs is not specified. Data provenance is internal lab testing by VisionCare Devices, LLC.
• UniVit Vibrational Testing: "VCD ran the vitrector up to the highest CPM possible..." The number of devices or runs is not specified. Data provenance is internal lab testing by VisionCare Devices, LLC.

All tests appear to be retrospective internal bench tests conducted by VisionCare Devices, LLC. There is no indication of external data sources or geographic origin beyond the company's location in California.

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

There were no human experts used to establish a "ground truth" in the context of interpretation or diagnosis as this device is a surgical instrument, not an interpretative AI/image analysis device. The ground truth for the bench tests was based on measurable physical properties (e.g., fracture, pressure escape, temperature, vibration) and visual inspection (e.g., metal flaking, retinal damage in fluidics test) following defined protocols.

4. Adjudication Method for the Test Set

Not applicable. This device is a surgical tool, and the tests conducted were objective bench tests measuring physical performance, not subjective interpretations requiring adjudication.

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

No. An MRMC study was not done. The device is a surgical instrument, not an AI or image-analysis tool that affects human reader performance. No human readers or AI assistance are involved in the specified testing.

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

Yes, in a way, all the bench tests performed are "standalone" in the sense that they evaluate the device's physical performance independent of human-in-the-loop operation, other than setting up and initiating the tests. However, this is not in the context of an "algorithm only" performance as would be applied to AI/software.

7. The Type of Ground Truth Used

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

• Pre-defined pass/fail criteria for physical properties (e.g., temperature limits, vibration limits, absence of physical damage or leakage).
• Observational criteria, such as the absence of metal flaking or retinal damage in the fluidics test (using rabbit eyes).
• Compliance with recognized harmonized standards (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization).

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 this type of device.

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The EVA NEXUS™ Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic subretinal microinjection of gases or aqueous fluids.

In addition, the optional laser is indicated for the following:

The EVA NEXUS™ Ophthalmic Surgical System (EVA NEXUS) is a combined anterior and posterior procedure ophthalmic system that is modular in design and is identical in most respects to the recently cleared predicate EVA Ophthalmic Surgical System (K190875). EVA NEXUS (see Figures 1, and 2 for external views) is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy as well as photocoagulation.

This document describes the EVA NEXUS™ Ophthalmic Surgical System, a combined anterior and posterior procedure ophthalmic system. The submission (K213467) seeks to demonstrate substantial equivalence to its predicate device, the EVA Ophthalmic Surgical System (K190875), and other components cleared under different K numbers.

The device includes several modifications and new components compared to its predicate, such as a redesigned infusion pole, a second infusion/irrigation port, "Smart IOP" functionality, microinjection capability, a digitally controlled phaco board, increased cutter speed, and a video overlay device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative thresholds for efficacy or safety endpoints. Instead, it relies on demonstrating substantial equivalence to predicate devices through a combination of bench testing, compliance with international standards, and verification/validation testing. The performance aspects are primarily evaluated by comparison to the predicate device and relevant standards.

However, based on the "Comparison of Technological Characteristics with the Predicate Devices" (Table 5 and subsequent detailed comparisons for individual components like vitrectomy probes, tubing, and laser probes) and "Performance (Bench) Testing" sections, we can infer some performance requirements and reported outcomes:

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The Vista Ophthalmics vitrectomy probe is intended to be used to remove vitreous and dissect tissue in the eye as follows:
· Vitreous aspiration & cutting
· Membrane cutting & aspiration
· Lens removal
· Dissect tissue in the eye
The Vista Ophthalmics probe is designed as a stand-alone handpiece for use with ophthalmic surgical systems having pneumatically driven vitreoretinal functionality.

The Vista vitrectomy probe is a pneumatically actuated device which supports aspiration and guillotine-style cutting functions for the purpose of removing vitreous and/or other tissues from the eye during anterior and posterior ophthalmic procedures. The Vista vitrectomy probe is offered in a two port bi-blade configuration.
The Vista vitrectomy probe utilizes a pressured air pulse to drive the cutting action. The pressure pulse originates from the operational system of choice and distends or expands a silicone rubber diaphragm inside the handpiece. The pressure pulse fills the pressure chamber of the vitrector, actuating the axial extension of the inner-cutting tube to produce a guillotine-type cutting motion. A vacuum originating from the operational system of choice draws biological materials (tissue and fluid) into the outer cutting port area of the cannula that is inserted into the patient's eye. The vacuum-drawn material entering the outer needle port is then resected by the inner-cutter as it travels down the inside diameter of the outer needle. Once the inner-cutter resects (guillotines) the material as it crosses the distal end of the outer needle port cutting edge, the material is aspirated through the inside diameter of the inner-cutting tube. The material continues to be aspirated through the handpiece and into a collection chamber of the vitrectomy system selected for use with the Vista vitrectomy accessory.

This document describes the 510(k) summary for the Vista Ophthalmics Vitrectomy Probe, K220030. It focuses on demonstrating substantial equivalence to a predicate device, the Alcon Hypervit Vitrectomy Probe (K170520), and a reference device, the Vision Care ProCare Plus (K120170).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format with specific thresholds. Instead, it relies on demonstrating that the Vista Vitrectomy Probe's performance is similar to or meets the performance of the predicate and reference devices in various tests. The key performance evaluations can be inferred from the "Performance Data" section.

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

The document does not explicitly state specific sample sizes for each test in the "Performance Data" section. It broadly states that "All validation processes have demonstrated that the functional requirements and finished device specifications are met." without providing numerical details for the number of units tested.

The data provenance is internal testing performed by Vista Ophthalmics LLC. There is no mention of country of origin for data or whether it's retrospective or prospective, as these are typically not applicable to bench and lab testing of a physical medical device for 510(k) clearance based on equivalence.

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

This information is not applicable to this type of device and 510(k) submission. "Ground truth" established by experts is typically relevant for AI/ML-based diagnostic devices where clinical interpretation is involved. For a surgical instrument like a vitrectomy probe, "ground truth" is established by adherence to engineering specifications, validated test methods, and compliance with recognized standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used for clinical studies involving multiple human readers to resolve discrepancies in diagnoses or assessments, particularly in AI device performance evaluations. The performance data presented here are for technical specifications and material properties of a physical device.

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 information is not applicable. The Vista Ophthalmics Vitrectomy Probe is a surgical instrument, not an AI-assisted diagnostic or decision-support device. Therefore, MRMC studies and evaluations of human reader improvement with AI assistance are irrelevant to this submission.

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

This information is not applicable. As stated above, this is a surgical instrument and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

For the performance evaluations, the "ground truth" is established by:

• Recognized standards: ISO 10993-01 (Biocompatibility), ISO 11137 (Sterilization), ANSI/AAMI ST72 (Bacterial Endotoxin), ISTA 6 (Transportation Testing).
• Engineering specifications and validated test methods: For material cutting/aspiration, resistance to deformation, metal flaking, penetration force, and temperature limits. These would be defined internally by the manufacturer, often based on industry best practices and comparison to predicate devices.
• Predicate device performance: The basis for substantial equivalence is that the new device performs similarly to or better than the legally marketed predicate device.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the sense of a clinical diagnostic truth for this type of device's 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical surgical 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 for the same reason as point 8.

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The EVA Ophthalmic surgical system is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery.

In addition, the optional laser is indicated for the following:

The EVA Ophthalmic Surgical System (EVA) is a combined anterior and posterior procedure ophthalmic system that was cleared by FDA in March, 2015 (K142877). The EVA is designed for use in anterior and posterior procedures that require infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery, diathermy as well as photocoagulation.

The purpose of this 510(k) is to obtain clearance for minor improvements to the cleared device. These changes include:

• Footswitch: The footswitch of the EVA has been modified to improve ergonomics and simultaneously integrate the laser pedal functionality. An optional separate laser footswitch will remain available if surgeons prefer.
• Illumination: Due to quality improvements in the LED output, the light output has been increased to improve illumination with small gauge fibers. However, the system controls the absolute output of the module to 40 lumens as previously cleared. As an example, the illumination output for a 27 gauge fiber has been improved from 5 lumens as cleared to 7 lumens in the proposed system. However, the maximum output, and maximum exposure to patient, remains at 40 lumens for any fiber as previously cleared. Thus there are no risks introduced with this change.
• The Posterior Module (Air Functionality): To support use of EVA for fluid/air exchanges (F-AX), independent of the compressed air / gas supply available, the hardware design of the Posterior (VFIE, Air, Proportional Scissors) module has been modified to provide air through two independent circuits, instead of one as previously cleared. As a result, the air for F-AX is provided by a separate circuit that draws air from the environment (with appropriate filtration), whilst the compressed gas drive for other EVA functions is provided from the pneumatic input (supplied by the surgical setting - typically compressed air or Nitrogen) as per the current design. With this improved design, the compressed gas input of the system will only be used for internal system operation while air needed for surgical use will be derived from filtered, ambient air. Thus, the consumption of compressed gas used to operate the EVA is reduced.
• Software: To support these changes the EVA software was upgraded as well as anomaly/bug fixes. A complete detail of these minor improvements can be found in the Software portion of this 510(k) (Section 16 and Annex 5).
• Sterilization of Reusable Accessories: Minor changes to the conditions recommended in the labeling have been made and are supported by validation and performance testing included in this 510(k).
• Shelf life of Disposable Accessories: The shelf-life of peel pouch packed disposable accessories has been extended to 5-years and is supported by validation and performance testing included in this 510(k).
• Accessory Changes: Some packs (combinations of accessories) were discontinued and new configurations added. No new accessories that were not previously cleared were added.

The provided text is a 510(k) summary for the D.O.R.C. EVA Ophthalmic Surgical System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through modifications to ergonomic features, illumination, air functionality, software updates, and accessory sterilization/shelf-life.

Based on the available information, the document does not describe a study involving an AI/machine learning component that generates performance metrics (e.g., sensitivity, specificity, AUC) against acceptance criteria. Instead, it details various performance tests to ensure compliance with standards and functionality.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them in the context of an AI/ML-based performance evaluation. The document does not contain information about:

1. A table of acceptance criteria and reported device performance (in terms of AI metrics).
2. Sample sizes used for a test set (for AI evaluation).
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication methods for a test set.
5. MRMC studies or effect sizes for human readers with/without AI assistance.
6. Standalone (algorithm-only) performance evaluations.
7. Type of ground truth used for AI evaluation.
8. Sample size for a training set (for AI).
9. How ground truth for a training set was established (for AI).

The performance data section in the 510(k) summary focuses on biocompatibility, electrical safety/EMC, software verification/validation (for general software functionality, not AI performance), and bench performance testing related to physical and functional aspects of the surgical system (e.g., illumination, pneumatic system, compliance with IEC/ISO standards).

In summary, the provided document does not contain the information requested about AI performance testing or a related study with acceptance criteria for such a system.

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The Cetus Laser System is indicated for use in phacofragmentation of the cataractous crystalline lens.

The Cetus system is a 1064nm. pulsed, Nd: YAG Q-switched laser system used together with a sterile, single use laser probe and a Phaco machine. The system console has a digital touch screen and it is used in conjunction with the Cetus probe and a Phacoemulsification machine in the operating room. The probe converts the laser light energy into acoustic energy which is used to perform the fragmentation of the the crystalline lens and has integrated aspiration and irrigation functions.

The provided text is a 510(k) summary for the Cetus System, a laser system for phacofragmentation of cataractous crystalline lenses. It focuses on demonstrating substantial equivalence to a predicate device through comparison of technical specifications and non-clinical performance data.

However, the document does not contain information related to acceptance criteria, clinical studies, or performance metrics in the way your prompt describes for AI/medical device performance evaluation. Such information would typically include:

• Acceptance Criteria for Device Performance: Specific numerical thresholds for metrics like accuracy, sensitivity, specificity, etc.
• Reported Device Performance: Actual results from tests against these criteria.
• Sample Sizes, Data Provenance, Ground Truth: For clinical or simulated clinical studies demonstrating performance.
• Expert Review/Adjudication: Details on how ground truth was established, especially in diagnostic/imaging devices.
• MRMC or Standalone Studies: Type of clinical efficacy study.

Therefore, based solely on the provided text, I cannot complete the table or answer the questions related to clinical performance, acceptance criteria, or studies proving the device meets them because this information is not present.

The document explicitly states: "Clinical Performance Data: None".

The "performance data" referred to in the document is non-clinical and focuses on compliance with various safety, sterilization, packaging, and risk management standards, rather than the device's clinical efficacy or output performance as measured by typical diagnostic/treatment metrics.

Here's what I can extract from the provided text relevant to the device and its testing, but it does not address your specific request for acceptance criteria and clinical performance study details:

1. Table of Acceptance Criteria and Reported Device Performance:

• None provided for clinical performance. The document only lists non-clinical compliance standards.

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

• Not applicable / Not provided. No clinical test set.

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

• Not applicable / Not provided. No clinical test set.

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

• Not applicable / Not provided. No clinical test set.

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. The document explicitly states "Clinical Performance Data: None." This device is a surgical tool, not an AI diagnostic tool, so an MRMC study is not relevant in the context of this submission.

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

• No. The document explicitly states "Clinical Performance Data: None."

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

• Not applicable / Not provided. No clinical test set.

8. The sample size for the training set:

• Not applicable / Not provided. No training set for an AI algorithm is mentioned as this is a physical medical device.

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

• Not applicable / Not provided. No training set for an AI algorithm is mentioned.

Summary of Non-Clinical Performance Data from the document:

The device's safety and effectiveness were demonstrated through compliance with various non-clinical standards:

• Electrical Safety: AAMI ANSI ES60601-1:2005(R) 2012 and A1:2012
• Laser Safety: IEC 60825-1:2007
• Electromagnetic Compatibility: IEC 60601-1-2:2007
• Sterilization: DIN EN ISO 11135-1:2014
• Packaging Integrity: ASTM F1886/ F1886M-09:2013
• Accelerated Ageing of Sterile Barrier: ASTM F1980-07:2011
• Sterile Packaging: DIN EN 868-5:2009
• Microbial Ranking of Porous Packaging Materials: ASTM F1608-00:2009
• Biological Evaluation of EO Residuals: DIN ISO 10993-7:2009
• Risk Management: ISO 14971: 2007 + Am 2010

The document concludes based on these non-clinical tests that the Cetus system is "as safe and effective as the predicate device."

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The Bausch + Lomb Stellaris Elite vision enhancement system is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal, and air/fluid exchange operations. The Stellaris Elite Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

The Bausch + Lomb Stellaris Elite Vision Enhancement System is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite Vision Enhancement System may be configured with a 532 nm laser module for photocoagulation.

The Stellaris Elite Vision Enhancement System is a rebranding of the currently cleared Stellaris (K133242) Vision Enhancement System and Stellaris PC (K133486) Vision Enhancement System. The system is based on the technology and the performance of the existing Stellaris and Stellaris PC Vision Enhancement Systems, and this traditional 510(k) incorporates software and hardware revisions to support the introduction of the new Vitesse vitrectomy feature (including 2 new Vitesse handpieces and supporting accessories). The new Vitesse vitrectomy feature is available on the Stellaris Elite Vision Enhancement System based on the configuration matrix listed in Table 1. The various available system configurations allow for system feature flexibility and are made available for physician convenience.

This document describes the Bausch + Lomb Stellaris Elite Vision Enhancement System, a device intended for surgical procedures related to cataracts and vitrectomy, and its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Stellaris Elite Vision Enhancement System are based on compliance with various international electrical and medical device standards, and successful functional, simulated use, environmental, and transport testing. The reported device performance is that it met all these criteria.

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

The document does not specify a "test set" in terms of patient data or
clinical cases. The testing conducted was primarily hardware and software performance verification. The non-clinical tests involved "representative units" of the device. There is no information regarding country of origin of data or whether it was retrospective or prospective, as the testing described is not clinical in nature.

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 listed tests are engineering and compliance standards, not clinical studies requiring expert ground truth establishment for patient data. Expert involvement would be in the form of engineers, quality assurance personnel, and regulatory specialists ensuring compliance with the standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in clinical studies when there's uncertainty about ground truth or disagreement among readers (e.g., radiologists). The testing described here is based on objective measurements against engineering and safety standards.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through technical characteristics and compliance with standards, not on comparing human reader performance with and without AI assistance. This device is not an AI-powered diagnostic tool, but a surgical system.

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

This concept is not directly applicable to the Stellaris Elite Vision Enhancement System. As a surgical system, it is inherently designed for human-in-the-loop operation. The "standalone" performance being assessed relates to the system's compliance with engineering and safety standards as an independent medical device, not as an algorithm performing a task without human intervention. The software verification and validation would be considered "standalone" in the sense of the software itself being tested, but in the context of contributing to the overall device's safety and functionality.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by its adherence and successful execution to various international engineering and medical device safety standards (e.g., IEC 60601 series, EN ISO IEC 62304). These standards define the acceptable performance, safety, and operational parameters for such medical equipment.

8. The Sample Size for the Training Set

This information is not applicable. This document describes a medical device, not an AI model that relies on training sets of data. The software within the device undergoes verification and validation, but this is distinct from machine learning model training.

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

This information is not applicable as there is no mention of a "training set" for an AI model in the context of this device's submission.

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The Bausch + Lomb Stellaris Elite Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Bausch + Lomb Stellaris Elite Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.

The Bausch + Lomb Stellaris Elite Vision Enhancement System is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, the Stellaris Elite Vision Enhancement System may be configured with a 532 nm laser module for photocoagulation. The system is based on the technology and the performance of the existing Stellaris and Stellaris PC Vision Enhancement Systems. This traditional 510(k) incorporates software and hardware revisions to support the introduction of new features including Adaptive Fluidics, high speed vitrectomy, and supporting accessories. The Stellaris Elite Vision Enhancement System is available in various configurations.

This document is a 510(k) premarket notification for the "Stellaris Elite Vision Enhancement System" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study proving performance against specific acceptance criteria in the manner one might expect for an AI/ML-based device.

Therefore, many of the requested sections (including specific acceptance criteria, sample sizes for test sets, expert consensus details, MRMC studies, standalone performance, and details on training sets) are not provided in this document. The document describes a traditional medical device (a surgical system that enhances vision), not an AI/ML product.

Here's a breakdown based on the information provided in the document:

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

The document does not present a table of specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity thresholds) for the device's clinical performance. Instead, it demonstrates compliance with recognized electrical and medical device safety standards and verifies functional performance to support substantial equivalence.

• IEC 60601-1:2005 + C1(2006) + C2(2007) + AM1(2012) or IEC 60601-1:2012 (General requirements for basic safety and essential performance)
• IEC 60601-1-2 ed3.0 (2007) (Electromagnetic compatibility)
• IEC 60601-1-6:2010 (Usability)
• IEC 60601-2-2:2009 (High frequency surgical equipment) |
  | Laser Safety Standards | Complies with:
• IEC 60601-2-22:2007 (Diagnostic and therapeutic laser equipment) |
  | Device-Specific Standards | Complies with:
• IEC 80601-2-58:2008 (Lens removal and vitrectomy devices) |
  | Functional Performance | Successful test results for functional, simulated use, biocompatibility, shelf life, and transport testing. |
  | Software Quality | Software changes verified and validated in accordance with Bausch + Lomb software quality procedures, complying with EN ISO IEC 62304:2006 (Medical device software life cycle processes). |
  | Clinical Equivalence | Demonstrated substantial equivalence in indications for use, design features, and functional features to predicate devices (K133486 Stellaris PC Vision Enhancement System, K133242 Stellaris Vision Enhancement System). |

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 does not provide details on specific sample sizes for test sets in a clinical performance study involving patient data. The "test sets" mentioned would refer to units of the device or its components for engineering and performance validation rather than patient data for AI model evaluation.

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. There is no mention of expert-established ground truth for a test set of medical cases. The assessment is based on compliance with standards and functional testing by engineers/testers.

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

Not applicable. No clinical test set requiring adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted diagnostic or therapeutic device that would typically undergo an MRMC study.

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

Not applicable. The device is a surgical system operated by a human surgeon. It is not an algorithm performing a task autonomously.

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

For this type of device (a surgical system), the "ground truth" for its performance is typically defined by:

• Compliance with validated international and national standards (e.g., IEC standards for electrical safety, electromagnetic compatibility, usability, and device-specific requirements).
• Successful completion of functional and simulated use testing to ensure the device operates as intended (e.g., proper phacoemulsification, vitrectomy, fluidics).
• Biocompatibility testing of materials.
• Shelf-life and transport testing to ensure product integrity.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML model that undergoes "training" on a dataset. The software development follows traditional software life cycle processes (EN ISO IEC 62304:2006).

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

Not applicable, as there is no "training set" in the context of an AI/ML model. Software validation involves verification against requirements and pre-defined test cases, not ground truth labeling for machine learning.

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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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