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The Bausch & Lomb StellarisPC Vision Enhancement System is intended for the emulsification and removal of catarior and posterior segment virectory. The system is designed for use in both anterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimigation, bipolar coagulation, virectory, viscous fluid injection/removal and sir/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laster trabeculaplasty.

The Bausch + Lomb Stellaris PC Vision Enhancement System is 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, this model includes an optional 532nm laser module for photocoagulation.

The system is based on the technology and the performance of the existing Stellaris PC Vision Enhancement System, and this traditional 510(k) incorporates software revisions, a hardware revision to the power supply, and the additional of an optional laser photocoagulation module.

The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency.

This submission describes the Bausch + Lomb Stellaris® PC Vision Enhancement System, an integrated ophthalmic microsurgical system. The submission focuses on demonstrating the substantial equivalence of the updated device to previously cleared predicate devices, rather than establishing de novo acceptance criteria for a novel device. Therefore, the information provided does not align with a typical AI/ML device submission that would include acceptance criteria and a study proving those criteria were met through performance metrics like sensitivity, specificity, etc.

However, based on the provided documents, I can extract the relevant information pertaining to the "acceptance criteria" (understood here as compliance with standards and functional requirements for safety and performance) and the "study" (referring to the nonclinical tests conducted) that "proves" (demonstrates compliance) the device meets these.

Here’s an interpretation of the requested information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Bausch + Lomb Stellaris® PC Vision Enhancement System are primarily met through compliance with established electrical, safety, usability, and software standards, as well as successful functional, simulated use, environmental, and transport testing. The "reported device performance" is essentially that the device passed all these tests and demonstrated substantial equivalence to predicate devices, thus fulfilling its intended use.

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

This submission is for a traditional surgical system, not an AI/ML device in the modern sense. Therefore, the concept of a "test set" for performance evaluation in terms of AI model predictions (e.g., images for classification or detection) is not applicable. The "tests" performed were nonclinical engineering and functional tests on representative units of the device.

• Sample Size for Test Set: "Representative units" of the Stellaris PC Vision Enhancement System were used for functional, simulated use, environmental, and transport testing. Specific numbers are not provided in this summary but would be detailed in the full test reports.
• Data Provenance: Not applicable in the context of an AI/ML device where "data provenance" typically refers to the origin of training or test data (e.g., patient demographics, clinical sites, geographical distribution). The testing here relates to the engineering performance and safety of the physical device and its software.

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

This request is not directly applicable to the type of device and submission.

• Number of Experts: Not applicable. Ground truth, in the context of this device, refers to the established standards and specifications that the device must meet, verified through engineering and functional tests.
• Qualifications of Experts: The "experts" involved would be the Bausch + Lomb engineers and testers responsible for performing and evaluating the nonclinical tests, ensuring compliance with the cited regulatory standards. Their qualifications would be in engineering, quality assurance, and regulatory compliance for medical devices.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. There was no "test set" requiring expert adjudication in the context of AI/ML evaluation. The evaluation was based on passing predefined engineering and performance metrics against established standards.

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

• Was an MRMC study done? No. This type of study is typically used for diagnostic or screening AI/ML devices where reader performance is a key metric. The Stellaris PC Vision Enhancement System is a surgical system, and its evaluation focuses on safety, functional performance, and substantial equivalence, not human reader improvement with AI assistance.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Was a standalone study done? No. This device is a surgical system; it does not feature a standalone algorithm that performs a diagnostic or prognostic task without human-in-the-loop performance in the way an AI/ML-based diagnostic device would. Its "performance" is integrated into its function during surgery.

7. Type of Ground Truth Used

The "ground truth" for this submission is implicitly defined by:

• International Standards: Compliance with electrical safety (IEC 60601 series), usability (IEC 60601-1-6, IEC 62366), software quality (EN ISO IEC 62304), and laser safety (IEC 60825-1) standards.
• Functional Specifications: The device's ability to perform its intended functions (e.g., phacoemulsification, vitrectomy, laser photocoagulation) as designed and specified, verified through functional and simulated use testing.
• Predicate Device Performance: The established safety and effectiveness of the predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use an AI/ML model that would require a "training set" of data in the typical sense. Any software development would follow standard software engineering practices, with internal testing and validation, but not "training" on a dataset for algorithmic prediction.

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

• How Ground Truth for Training Set was Established: Not applicable. As there is no AI/ML training set in this context, the concept of establishing ground truth for it does not apply.

Summary of Device and Acceptance:

The Bausch + Lomb Stellaris® PC Vision Enhancement System obtained 510(k) clearance by demonstrating substantial equivalence to existing predicate devices (K101325, K022760, K071687). The "acceptance criteria" are the regulatory and engineering standards that the device must meet to ensure safety and effectiveness, and the "study" comprises a series of nonclinical tests (electrical, functional, simulated use, environmental, transport, and software verification/validation) that demonstrated the device's compliance with these standards and its ability to perform its intended functions. The FDA's letter (K133486) confirms this substantial equivalence based on the provided data.

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The Bausch & Lomb™ Stellaris® PC™ Vision Enhancement System device 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 phacofragmentation (coaxial or bimanual), irrigation/aspiration, bipolar diathermy, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Uses only Bausch & Lomb™ disposable packs and handpieces designated for use with the system.

The Bausch & Lomb™ Stellaris® PC™ Vision Enhancement System is an integrated ophthalmic microsurgical system designed for use in anterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. The Stellaris® PC™ Vision Enhancement system is the next generation Stellaris® NGX Microsurgical System. The new system is based on the technology and the performance platform of the existing Stellaris® NGX Microsurgical System and is designed to improve surgical efficiency, surgeon ergonomics, control of fluidics and aesthetics. The system incorporates vacuum based fluidics to meet the needs of anterior and posterior procedures. The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency. The ultrasound lens removal system extends and improves upon existing technologies with new and improved designs in the phaco hand-piece.

The provided 510(k) K101325 describes the Bausch & Lomb™ Stellaris PC Vision Enhancement System, an ophthalmic microsurgical system. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the device's surgical functions. Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to predicate devices.

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

The document describes the submission as containing "all testing data and validation summaries supporting system function" derived from non-clinical testing (standards-based). It does not refer to a test set in the context of clinical images or patient data.
The testing is described as "System verification and validations," which likely involve engineering bench testing, simulated use, and compliance testing against the listed standards.

• No specific sample size for a "test set" of clinical data is mentioned because no clinical study was performed.
• Data provenance is not from patient data; rather, it appears to be from internal engineering and lab testing conducted by Bausch & Lomb, Inc. in the context of verifying compliance with international and domestic standards.

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

Not applicable. Since no clinical study using patient data was conducted and no specific "ground truth" for diagnostic or intervention performance was established via expert review, this information is not provided. The "ground truth" for the non-clinical testing would be the specifications and requirements of the various listed standards.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set involving human judgment or interpretation was used. The compliance with technical standards is not typically adjudicated in this manner.

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

Not applicable. This device is an ophthalmic microsurgical system, not an AI-powered diagnostic or assistive tool for image interpretation by human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

Not applicable. The device is a surgical system requiring human operation, not a standalone algorithm. Its "performance" refers to its mechanical, electrical, and fluidic functions, not algorithmic output.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the requirements and specifications defined by the numerous international and domestic standards (IEC, UL, EN, FCC, ISO, ISTA, ASTM D4169) for medical electrical equipment, biocompatibility, light hazard protection, and transportation. The device's performance was measured against these predefined technical benchmarks and safety parameters.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a "training set" of data. The "system verification and validations" would have involved testing of the manufactured system components and the integrated system based on engineering specifications.

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

Not applicable, as no training set (in the context of AI/ML) was used. The "ground truth" for the device's design and engineering specifications was established through the design control process, incorporating regulatory requirements and engineering principles. The "ground truth" for validation was adherence to the various listed standards.

Summary Takeaway:

The K101325 submission for the Bausch & Lomb™ Stellaris PC Vision Enhancement System relies on demonstrating substantial equivalence to previously cleared predicate devices and compliance with a comprehensive set of international and domestic performance, safety, and quality standards. It is not a submission based on clinical efficacy data derived from a study comparing patient outcomes or diagnostic performance against a clinical ground truth. The device is an integrated surgical system, and its "performance" is evaluated through rigorous engineering, safety, and functional verification and validation processes against established technical standards, rather than through clinical studies with acceptance criteria for patient outcomes or diagnostic accuracy. The FDA's clearance letter confirms the substantial equivalence determination based on the provided data.

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