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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 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.

Ask a specific question about this device

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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