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The Navilas® Laser System is an ophthalmic laser integrated with a digital camera. The Navilas® Laser System is indicated for the treatment of ocular pathology in the anterior and posterior segment of the eye, with supporting imaging functions (capture, display, storage and annotation) of the retina of the eye via color and infrared imaging.

The Navilas® Laser System is intended for use in the posterior segment to perform Retinal Photocoagulation, Panretinal photocoagulation, focal photocoagulation or grid photocoagulation for vascular and structural abnormalities of the retina and choroid including:

• Proliferative and non-proliferative diabetic retinopathy
• Macular edema
• Choroidal neovascularization associated with wet age-related macular degeneration
• Age-related macular degeneration
• Central and branch retinal vein occlusion
• Lattice degeneration
• Retinal tears and detachments

Intended for use in the treatment of ocular pathology in the anterior segment including:

• Iridotomy
• Iridoplasty
• Trabeculoplasty

The Navilas Laser System 577SL is a laser photocoagulator with an integrated digital fundus camera. The Navilas Laser System 577SL combines imaging technologies (color and infra-red imaging) with established laser photocoagulation treatment methods by providing the physician a system for imaging and treatment planning prior to the photocoagulation procedure.

The Navilas Laser System 577SL is comprised of:

• A semiconductor laser source that operates at 577nm wavelength. The laser can operate with Continuous Wave (CW) or Micro-Second Pulsing (MSP).
• An integrated delivery system that directs the laser beam through an ophthalmoscope using motorized mirrors.
• A digital camera that provides continuous real-time imaging in color with white light illumination of the fundus, or in monochrome using infrared illumination.
• A software platform that is based on an embedded Windows operating system, that controls the startup, use, calibration, monitoring, and shutdown of the system.

The Navilas Laser System 577SL supports the user during multiple steps of a laser treatment procedure with digital imaging, image storage, planning and laser treatment options including:

Digital imaging - Provided by a color image with white light, supporting mydriatic and nonmydriatic image acquisition (with and without dilated pupils), or a monochrome IR image. Images are presented using a digital display. An illumination mode is selected where images are acquired and either stored, exported or discarded after viewing on the touch sensitive digital display.

Image Storage - Captured images can be digitally stored in the Navilas Laser System 577SL database along with other patient related data to create a complete patient record for future reference. Images from other devices may also be imported and stored.

Planning - Areas identified on acquired or imported images by the user that are selected for future treatment consideration can be marked through the use of treatment planning tools available. The physician has the ability to highlight areas on acquired images (called Points of Interest). These locations are created and manipulated using the touch sensitive digital display.

Laser Treatment - Treatment options are also unchanged from the predicate device with Pre-planned and Ad-hoc Modes available on all Navilas laser models. Pre-positioning of the aiming beam onto locations which are selected by the physician during planning is also facilitated. The position of the aiming beam can be monitored on the real-time image that is displayed on the touch sensitive digital display.

Report generation - Information collected in the database includes images obtained before, during and after treatment. This information can be used for the generation of patient reports for documentation purposes.

The Navilas Laser System 577SL can emit a 577 nm wavelength beam for photocoagulation with power up to 1700 mW and pulse duration up to 4000 ms.

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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.

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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.

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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.

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

The document does not describe specific clinical test sets with patient samples. The studies are primarily non-clinical: biocompatibility testing, laser safety, electrical safety, EMC, software V&V, and bench testing. These types of tests do not typically involve patient samples and thus, information on data provenance like "country of origin of the data" or "retrospective/prospective" is not applicable in the context of this submission. The device is being cleared based on substantial equivalence to existing devices through comparison of design and non-clinical performance.

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

The document does not detail clinical studies involving experts to establish ground truth for a test set. This type of information is typically required for AI/CADe devices or those relying on human interpretation of images/data. The current submission is for a medical laser, and its performance is evaluated based on technical specifications and safety standards, not clinical diagnostic accuracy.

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

Not applicable as there is no described clinical test set requiring expert adjudication.

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

Not applicable. The VISULAS combi is an ophthalmic laser for direct treatment (photocoagulation and photodisruption), not an AI-assisted diagnostic or interpretative device. Therefore, MRMC studies and AI assistance metrics are not relevant to this submission.

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

Not applicable. This device is a treatment laser, not an algorithm.

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

The "ground truth" for this device's acceptance is primarily based on compliance with established technical specifications, international safety standards (e.g., IEC, ANSI, ISO), and performance equivalence to predicate devices, as demonstrated through engineering tests (bench testing). For biocompatibility, the ground truth is established by the results of standardized biological evaluation tests (ISO 10993-1).

8. The sample size for the training set

Not applicable. This device is a hardware-based medical laser, 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, for the same reason as above.

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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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