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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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