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The EyeQ nanoECP System is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view.

Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures.

Not Found

The provided FDA 510(k) clearance letter for the EyeQ nanoECP describes the device's indications for use and regulatory classification but does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria.

This document is a clearance letter, which means the FDA has already reviewed the submitted data and determined substantial equivalence. The detailed performance data and study design (including acceptance criteria, sample sizes, ground truth establishment, etc.) are typically part of the 510(k) submission, which is not fully disclosed in the public clearance letter.

Therefore,Based on the provided text, I cannot extract the information required to populate the table or answer the questions about the study design that proves the device meets the acceptance criteria. The clearance letter only states that the device has been found substantially equivalent for its stated indications for use.

To answer your request, I would need access to the actual 510(k) submission summary or a more detailed performance study report for the EyeQ nanoECP.

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The LenSx Laser system is indicated for use:

• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
• In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.

The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut.

The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system.

The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application.

The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.

Based on the provided FDA 510(k) Clearance Letter for the LenSx Laser System, this document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a new AI or novel diagnostic device.

The clearance is for a modified version of an existing device (LenSx Laser System) with software updates and an expanded indication for Implantable Collamer Lens (ICL) surgery. The general approach taken is to show that these modifications do not raise new questions of safety or efficacy and that the device remains substantially equivalent to its predicate. Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria (especially in the context of an AI/diagnostic device) is not explicitly detailed in this 510(k) summary.

However, I can extract the relevant information presented, acknowledging that it's framed within the context of demonstrating substantial equivalence for a modified device, rather than a de novo clearance for a completely new technology with novel performance claims.

Here's an attempt to answer the questions based on the provided text, highlighting where the information is not applicable or not detailed in this type of submission:

Acceptance Criteria and Device Performance Study (as inferred from the 510(k) Summary)

The 510(k) summary indicates that the modifications to the LenSx Laser System are minor and do not introduce new safety or efficacy concerns. The "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating that the device continues to meet its intended design specifications and functional requirements, performing as intended and being equivalent to the predicate. There are no specific numerical performance metrics provided in the summary that would typically be seen for a new diagnostic or AI device (e.g., sensitivity, specificity, accuracy against a gold standard).

Table of Acceptance Criteria and Reported Device Performance

Since this is a modification to an existing device, the "acceptance criteria" are generally about maintaining the performance and safety profiles of the predicate. The "reported device performance" refers to the successful completion of the tests.

Study Details (as applicable)

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

   • Test Set Sample Size: Not specified in terms of clinical cases or patient data, as no animal or clinical testing was deemed necessary for this submission. The "test set" primarily refers to bench testing, software verification/validation, and regulatory compliance checks.
   • Data Provenance: Not applicable as no clinical or animal data was collected for this submission. The data provenance for compliance testing is internal Alcon laboratories.

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

   • Not applicable as this 510(k) submission does not rely on expert-adjudicated ground truth from a clinical test set. The ground truth for engineering and software tests is based on design specifications, recognized standards, and regulatory guidance. For clinical ground truth, the submission relies on the established safety and efficacy of the predicate device and the assessment that the modifications do not alter this.

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

   • Not applicable. There was no clinical test set requiring expert adjudication.

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 MRMC study was performed or required. The device is a surgical laser, not an AI-assisted diagnostic tool that would typically involve human readers.

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

   • Not applicable in the context of an AI algorithm. However, the device itself, including its software, undergoes standalone functional and safety testing as part of the "Non-Clinical Testing" detailed in Section 7.1, such as "Software verification and validation testing" and "Performance Testing." These tests ensure the device (algorithm and hardware) performs its functions correctly according to specifications, independent of operator interaction after initial surgical planning.

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

   • For the non-clinical and software testing, the "ground truth" is defined by:
     • Engineering Specifications: The pre-defined technical and functional requirements for the laser system.
     • International and National Standards: Compliance with standards like IEC 60601 series, ANSI Z80.36-2021 for safety and performance.
     • FDA Guidance Documents: Compliance with FDA recommendations for software documentation and cybersecurity.
     • Predicate Device Performance: The established safety and effectiveness of the existing LenSx Laser System serves as the clinical benchmark.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that relies on a "training set" of data in the typical sense for a new diagnostic algorithm. The software modifications are deterministic or rule-based enhancements (e.g., embedded calculator, new cut patterns).

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

   • Not applicable for the same reason as above. If there were internal development/optimization processes for the new features (e.g., nomogram calculations), their accuracy and "ground truth" would be established through mathematical validation, simulation, and bench testing against known physical principles or desired outcomes, rather than a data-driven training set.

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The Leos system is indicated for intraoperative photocoagulation of the ciliary processes in the treatment of glaucoma, proliferative retinopathies, retinal detachment, and for evaluation of the internal ocular structures in patients with dense opacifications of the anterior segment which do not allow a posterior view.

Glaucoma - This instrument is indicated for the treatment of glaucoma in patients who have failed with conventional topical and systemic medications, or previous laser photocoagulation, or trabeculectomy and other filtering procedures, or cyclocryotherapy or other cyclodestructive procedures.

Vitreoretinal Surgery - The endoscopically controlled endophotocoagulation that is possible with the ophthalmic laser endoscope is also useful for endophotocoagulation:

• During vitreous surgery to produce chorioretinal scar around retinal breaks or retinotomy sites.
• To perform intraoperative panretinal photocoagulation (PRP) in proliferative retinopathies.
• To perform intraoperative retinal photocoagulation on a scleral buckle.
• To perform intraoperative photocoagulation around focal neovascularization

The Leos Laser and Endoscopic System is a next generation ophthalmic laser and endoscopy system used for the treatment of glaucoma, vitreoretinal diseases, and intraocular visualization. The system contains an 810 nm powered diode laser delivered by the stainless-steel endoscopic laser probe (trade name: VueProbe), which is placed into eye tissue to illuminate and visualize the target tissue and deliver laser energy under direct visualization. The console is a fully integrated portable device, containing a laser module assembly, viewing and control monitors, and a wireless footswitch for activating the laser. The larger passive monitor is for viewing the endoscopic video image and key treatment information, while the smaller touchscreen is used for parameters selection, rotation and viewing. The camera chip uses CMOS technology and is located at the tip of the probe. The LED light source is located within the plastic handpiece of the probe and illumination fibers carry the light to the tip. Additionally, the probe contains a laser fiber within its full length.

Based on the provided FDA 510(k) Clearance Letter for the Leos Laser and Endoscopy System, here's an analysis of the acceptance criteria and study that proves the device meets them:

It's important to note that the provided document is a 510(k) clearance letter, which focuses on substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria from a clinical trial. Therefore, explicit acceptance criteria are not detailed in this document in the way they would be for a clinical study report. Instead, the "acceptance" is based on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "study" in this context is primarily a non-clinical bench testing regimen designed to ensure the device performs within acceptable parameters and is comparable to predicate devices. Clinical studies were explicitly stated as not applicable and not required for this clearance.

Here's the breakdown of the information requested, as extractable from the provided document:

Acceptance Criteria and Device Performance Study (Based on 510(k) Substantial Equivalence)

The "acceptance criteria" for a 510(k) clearance are primarily met by demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and performance. The performance data presented are primarily from non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since specific quantitative clinical "acceptance criteria" are not given in a 510(k) clearance letter (which relies on equivalence, not novel performance claims), this table will reflect the performance characteristics demonstrating equivalence as described in the document. The "criteria" are implicitly that the performance is comparable or superior to the predicate and meets relevant safety standards.

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

• Sample Size for Test Set: Not explicitly stated as a number of patients or cases. The "test set" in this context primarily refers to bench testing of the device and its components. The document indicates:
  • Design Verification and Validation Testing: Confirms product meets requirements.
  • Software Verification and Validation: Completed successfully.
  • Biocompatibility, Sterilization, Shelf life testing.
• Data Provenance: Not applicable in terms of patient data. The provenance is from internal lab bench testing and verification activities. The study is non-clinical.

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

• Number of Experts: Not applicable. For non-clinical bench testing, "ground truth" is established by engineering specifications, regulatory standards (e.g., IEC, ISO, ASTM), and validated test methods. Human expert review of data is inherent but not quantified in this summary.
• Qualifications of Experts: Not specified. This would typically be internal R&D, Quality, and Regulatory personnel with expertise in device design, testing, and regulatory compliance.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This refers to the process of resolving discrepancies among human readers or raters in clinical studies. For non-clinical bench testing, "adjudication" is achieved through adherence to specifications, standards, and robust quality control processes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. The device is an Ophthalmic Laser and Endoscopy System, not an AI-powered diagnostic imaging device requiring a comparative effectiveness study with human readers.
• Effect Size of Human Reader Improvement: Not applicable.

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

• Standalone Performance: Not applicable. This refers to AI algorithm performance. The Leos system is a direct medical intervention device (laser and endoscopy), not an AI diagnostic algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical tests, the "ground truth" is based on:
  • Engineering specifications: The device is designed to meet certain performance parameters (e.g., laser power, resolution).
  • Regulatory standards: Compliance with international and national standards (e.g., IEC 60601 series, ISO 10993 series, ANSI Z80.36, ASTM D4169-22, ISO 11135, ISO 11607-1, AAMI TIR 28).
  • Predicate device characteristics: The Leos system's performance is compared against the established characteristics of the predicate devices for substantial equivalence.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

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

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of the "Study" Proving Acceptance:

The "study" proving the device meets the (implicit) acceptance criteria for 510(k) clearance is a comprehensive non-clinical testing program that includes:

• Bench Testing: Verifying electrical safety, electromagnetic compatibility (EMC), laser and optical safety, and general design performance against engineering specifications and relevant industry standards.
• Software Verification and Validation: Ensuring the software operates correctly and safely, given its "Major" level of concern.
• Biocompatibility Testing: Confirming the materials used in the probe are safe for contact with patients.
• Sterilization and Shelf Life Testing: Validating the sterilization process and ensuring the product maintains sterility and functionality over its intended shelf life.

The conclusion drawn from this testing is that the Leos Laser and Endoscopy System is substantially equivalent to its predicate devices, performing similarly (or better in some aspects like image resolution) while not raising any new safety or effectiveness concerns. This substantial equivalence is the basis for its FDA clearance.

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The Norlase LYNX Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

Not Found

I apologize, but the provided text from the FDA 510(k) clearance letter for the LYNX Photocoagulator does not contain information on the acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device. It briefly touches on device classification, regulations, and mentions the intended use of the device.

To describe the acceptance criteria and the study that proves the device meets them, I would need access to the actual 510(k) submission summary or a more detailed technical report which would typically include sections on performance testing, design specifications, and clinical or non-clinical data. The provided document only details the regulatory clearance, not the underlying performance data.

Therefore, I cannot fulfill your request with the given input.

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VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including:
• Photocoagulation of the retina

• Trabeculoplasty
• · Iridotomy
• · Posterior capsulotomy
  · Posterior membranectomy

This device is Prescription Use (Rx) only.

VISULAS combi is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength and standard photodisruption treatments of ocular tissues at a wavelength of 1064 mm. VISULAS combi is operated in the following treatment modes:

• single-spot mode (software license VERTE) -
• multi-spot mode (software license VITE)
• YAG disruption mode (software license YAG). -

VISULAS combi consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.

The provided text is a 510(k) premarket notification for the VISULAS combi ophthalmic laser. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new device type through clinical studies. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test sets, expert involvement for ground truth, MRMC studies, and detailed training set information, is not explicitly provided in this document.

However, based on the document, I can extract information related to the acceptance criteria in the context of demonstrating substantial equivalence and the types of studies performed.

Here's an analysis of the provided text:

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

The document primarily focuses on demonstrating substantial equivalence to predicate devices, VISULAS green (K232051) for photocoagulation and VISULAS yag (K230350) for photodisruption. The "acceptance criteria" are implied by the similarity to these predicate devices in terms of indications for use, technological characteristics, and principle of operation.

• Trabeculoplasty
• Iridotomy
• Posterior capsulotomy
• Posterior membranectomy (combines indications of both predicates) |
  | Laser Type | Solid state laser, frequency-doubled (for photocoagulation) Q-switched Nd:YAG laser (for photodisruption) | - Photocoagulation: solid state laser, frequency-doubled
• Photodisruption: Q-switched Nd:YAG laser |
  | Wavelength | 532 nm (for photocoagulation) 1064 nm (for photodisruption) | - Photocoagulation: 532 nm
• Photodisruption: 1064 nm |
  | Power/Energy | 50 to 1500 mW (photocoagulation) 9.0 mJ to 45.0 mJ (photodisruption) | - Photocoagulation: 50 to 1500 mW
• Photodisruption: Pulse Mode 1 (Single Pulse): 9.0 mJ to 13.0 mJ
  Pulse Mode 2 (Double Pulse): 18.0 mJ to 28.0 mJ
  Pulse Mode 3 (Triple Pulse): 29.0 mJ to 45.0 mJ |
  | Pulse Duration/Length | 10 - 2500 ms and cw (photocoagulation)

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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 MR Q and the MR SUPINE are intended to perform:

• Posterior capsulotomy -
• Iridotomy -

The MR Q SLT in YAG mode is intended to perform:

• Posterior capsulotomy -
• -Iridotomy

The MR Q SLT in SLT mode is intended to perform:

• Selective laser trabeculoplasty

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria, study details, and specific performance metrics of the device.

The document is a 510(k) clearance letter from the FDA, which confirms that the device (Meridian AG's MR Q, MR Q SUPINE, MR Q SLT) is substantially equivalent to legally marketed predicate devices for its stated indications for use. It outlines regulatory requirements and general information but does not include the results of clinical studies, acceptance criteria, or detailed performance data for the device.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for test sets.
• Information on Multi-Reader Multi-Case (MRMC) studies or the effect size of AI assistance.
• Results from standalone algorithm performance studies.
• Details on the type of ground truth used.
• Sample sizes for training sets or how ground truth for training data was established.

The "Indications for Use" section (page 3) describes what the device is intended to do (e.g., Posterior capsulotomy, Iridotomy, Selective laser trabeculoplasty), but not the performance metrics or studies used to demonstrate those capabilities.

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The Eagle device is a prescription device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam. The Eagle device has the same intended use as the predicate device. The Eagle device has the following Indications for Use (IFU) statement:

The Eagle device is indicated for use in selective laser trabeculoplasty (SLT).

The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser that is intended for use in performing selective laser trabeculoplasty. The laser spots produced by the Eagle device have a 400 um spot size, a 3 ns pulse duration, and a 50-Hz pulse repetition rate. The sequence of laser spots consists of 120 spots in a predefined circumferential elliptical pattern delivered at a pre-defined pulse energy level. The spots are delivered through the limbus to the trabecular meshwork in a non-contact fashion, without the need for the use of a contact gonioscopy lens. The device automatically locates the treatment location. The treatment location may be adjusted slightly by the operator. Once confirmed by the operator, the device then automatically applies the laser treatment sequence to the limbal region of the eye, while the eye tracker compensates for any eye movement. The default energy setting is 1.8 mJ/pulse.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list "acceptance criteria" for the device's performance in the typical sense of numerical thresholds for a specific metric that must be met. Instead, it describes a non-inferiority study where the Eagle device (subject device) is compared to a conventional SLT device (predicate). The implicit acceptance criteria appear to be the demonstration of non-inferiority in effectiveness (IOP reduction) and a comparable safety profile to the predicate device.

Implicit Acceptance Criteria and Reported Device Performance

• Eagle: 5.48 ± 0.52 mmHg reduction
• Conventional SLT: 6.29 ± 0.53 mmHg reduction
  Difference (SLT - Eagle): -0.80 mmHg (95% Cl -2.28, 0.68). The study concluded that the Eagle device demonstrated acceptable effectiveness comparable to conventional SLT. |
  | Safety (Adverse Events) | Primary Safety Outcome: Rate of ocular adverse events (AEs) in the Eagle treatment group at or prior to 12 months should be comparable to the conventional SLT group. | Overall Safety Profile:
• Serious Ocular SAEs (0-6 months): 1 in Eagle (0%) vs 1 in conventional SLT (1.1%) (subluxation of pre-existing IOL deemed related to conventional SLT).
• Serious Ocular SAEs (6-12 months): 1 in Eagle (1.0%) (acute optic neuropathy, non-glaucomatous) vs 0 in conventional SLT.
• Most Common Non-Serious AE (0-6 months): Punctate subconjunctival hemorrhage (20.8% in Eagle vs 1.1% in conventional SLT) - resolved without sequelae.
• Cataract progression (0-6 months): 3.1% in Eagle vs 1.1% in conventional SLT.
• Overall, comparable safety profile to the conventional SLT device, with some differences in types and frequencies of non-serious AEs. |
  | SLIT Lamp Examination (AC Cells & Flare) | Changes in anterior chamber cells and flare from screening should be minimal and comparable between groups. | AC Cells (Increase +0.5 or more):
• Post Procedure: Eagle 31.3% vs SLT 20.9%
• 1 Day: Eagle 18.9% vs SLT 12.1%
• Rapid reduction over time, with negligible increases beyond 1 month for both groups.
  AC Flare (Increase +0.5 or more):
• Post Procedure: Eagle 20.8% vs SLT 16.5%
• 1 Day: Eagle 11.6% vs SLT 7.7%
• Rapid reduction over time, with negligible increases beyond 1 month for both groups. |

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

• Sample Size for Test Set:
  • Randomized Participants (ITT Population): 196 participants (99 to Eagle, 97 to conventional SLT)
  • Participants Underwent Assigned Procedure: 187 participants (96 Eagle, 91 conventional SLT)
  • Modified Per Protocol (mPP) Population: 152 participants (77 Eagle, 75 conventional SLT)
• Data Provenance: Prospective, multi-center, randomized, controlled trial. The specific countries of origin for the data are not explicitly stated, but it's a multi-center study.

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

This was a clinical trial involving patients, not an AI review of images needing expert consensus for ground truth. The "ground truth" for effectiveness was objective physiological measurements (Intraocular Pressure reduction) and for safety, it was the occurrence of adverse events monitored by clinical investigators. Therefore, standard expert-based ground truth establishment (e.g., from radiologists) is not applicable here. Clinicians at the 14 sites would have assessed patients, but "experts" for ground truth in the AI sense are not mentioned.

4. Adjudication Method for the Test Set

This was a clinical trial with objective measures and adverse event reporting. Therefore, an adjudication method like "2+1" for discrepancies in expert readings (common in AI imaging studies) is not directly applicable. Clinical trial protocols typically have methods for reporting, verifying, and adjudicating adverse events and protocol deviations, but this isn't detailed in the provided summary.

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

No, an MRMC comparative effectiveness study was not done. The study directly compared two laser devices (Eagle vs. conventional SLT) in a randomized controlled trial on human patients, measuring clinical outcomes (IOP reduction and adverse events), not human reader performance with or without AI assistance.

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

No, a standalone algorithm-only performance study was not conducted in the traditional sense of evaluating an AI's diagnostic accuracy. The Eagle device is a laser system that automatically locates treatment areas and applies laser sequences, with the operator able to make slight adjustments and confirm. The study evaluates the device's clinical performance when used by an operator, not a purely autonomous AI algorithm against a manual process.

7. The Type of Ground Truth Used

The ground truth used in this clinical study was based on:

• Effectiveness: Objective physiological measurement of unmedicated Intraocular Pressure (IOP).
• Safety: Clinical observation and reporting of ocular adverse events (AEs).

8. The Sample Size for the Training Set

The provided document describes a clinical validation study for the Eagle device, which is a medical device (laser system), not an AI algorithm that requires a separate training set. Therefore, there is no "training set" in the context of machine learning. The clinical trial directly evaluated the device's performance in patients.

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

As there is no "training set" for an AI algorithm, this question is not applicable. The device itself is the subject of the clinical investigation, with its internal automation being part of its design.

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VISULAS green is intended for use in photocoagulating ocular tissues of the treatment of diseases of the eve, including

• · Photocoagulation of the retina
• Trabeculoplasty
• · Iridotomy

VISULAS green is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength. VISULAS green is operated in single-spot mode or in multi-spot mode.
VISULAS green consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.

The provided FDA 510(k) summary for the VISULAS green device (K232051) focuses on establishing substantial equivalence to a predicate device (VISULAS green, K181682) rather than presenting a study demonstrating the device meets a specific set of clinical performance acceptance criteria. Therefore, much of the requested information regarding a comparative effectiveness study, standalone performance, ground truth, and expert involvement is not present in this document.

However, I can extract information about the types of testing performed and the general conclusion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria for clinical performance that the device was tested against. Instead, it states that the device underwent various forms of testing to demonstrate equivalence and compliance with standards.

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

Not applicable. The document describes engineering and software verification and validation, as well as biocompatibility testing, but does not detail a clinical test set for evaluating device performance against diseases of the eye. The focus is on demonstrating equivalence to a predicate device through technical specifications and non-clinical testing.

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

Not applicable. As no clinical test set is described, there's no mention of experts establishing a ground truth for such a set.

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

Not applicable. No clinical test set is described.

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

Not applicable. The device (VISULAS green) is an ophthalmic laser for photocoagulation, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's submission.

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

Not applicable. The VISULAS green is a medical device (laser system), not a standalone algorithm. Its performance is inherent to its physical operation and interaction with ocular tissues, guided by a human operator.

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

For the technical testing detailed (biocompatibility, safety, software, bench testing), the "ground truth" would be the established engineering specifications, recognized industry standards, and the performance characteristics of the predicate device. No clinical "ground truth" (e.g., pathology, outcomes) is described as being directly used to measure the subject device's efficacy in treating specific diseases in a clinical study.

8. The sample size for the training set

Not applicable. This device is a laser system, not an AI/ML algorithm that requires a training set of data.

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

Not applicable. This device is a laser system, not an AI/ML algorithm.

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