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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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For photocoagulation and illumination during ophthalmic surgery. This device delivers illumination as well as laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.

The 23ga Curved Illuminating Laser Probe is an ophthalmic light and laser delivery device. It consists of glass fiber with PVC jacket, an SMA connector, an acetal handpiece and a needle set consisting of 304 stainless steel and nitinol. There is also an acrylic fiber with PVC jacket and an acetal connector. Both connectors plug into existing laser and light sources.

The device is designed to be an accessory for an Iridex medical laser (cleared under K071687) in the Vis-NIR transmission range of 532 nm to 810 nm with a maximum power output of 2.5 Watts and that is appropriate for photocoagulation. The device can be used with other lasers but they must be FDA approved and also meet the above specifications. The light portion of the device was designed for use with the Bausch & Lomb Stellaris PC light source which is a component of the Bausch & Lomb Stellaris PC Vision Enhancement System (cleared under K101325). The Stellaris PC uses a 75 Watt Xenon arc lamp that emits light with an output of 30 lumens within the wavelength range of 441nm to 665nm (photocoagulation is not applicable to the illumination aspect of the probe).

Here's an analysis of the provided text regarding the acceptance criteria and study for the 23ga Curved Illuminating Laser Probe (K122997).

It's important to note that this 510(k) summary is for a substantially equivalent device, meaning much of the performance evaluation relies on demonstrating equivalence to an already cleared predicate device (Peregrine's Illuminated Laser Probe, K031023) rather than proving de novo safety and effectiveness through extensive clinical trials. Therefore, the information provided isn't as detailed as what might be found for a novel device.

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for substantial equivalence, the "acceptance criteria" are primarily defined by the performance characteristics of the predicate device. The goal is to show that the new device either meets or performs similarly to the predicate in key areas, or that any differences do not raise new questions of safety or effectiveness.

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional clinical study sense. The testing involved comparing parameters of one new device (23ga Curved Illuminating Laser Probe) against one predicate device (PD600.10).
   • Data Provenance: The testing was conducted by the manufacturer, Peregrine Surgical. No information on the country of origin or whether it was retrospective/prospective is provided, but it would have been prospective testing specifically for this 510(k) submission.

2. 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 in the context of this device. This is a comparison of physical and functional characteristics of medical instruments, not an evaluation requiring expert consensus on images or diagnoses. The "ground truth" for performance is established by direct measurement and comparison to the predicate's known performance or accepted engineering standards.
   • The document mentions that "Surgeons understand that light outputs are compromised due to the use of smaller needle/tube gauges," implying a general expert consensus or understanding within the ophthalmic surgical community, but no specific experts were involved in a formal ground truth establishment process for the test set.

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

   • Not applicable. This is not a study requiring adjudication of findings. Performance measurements were objective.

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

   • Not applicable. This is a physical ophthalmic instrument, not an AI-powered diagnostic device, so no MRMC study was performed.

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

   • Not applicable. This is a physical medical device, not an algorithm. Performance tests were done on the device itself.

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

   • The "ground truth" for demonstrating substantial equivalence was the measured performance of the legally marketed predicate device (PD600.10) and established engineering/biocompatibility standards. For biocompatibility, testing results demonstrating 100% biocompatibility according to recognized standards served as the ground truth. For sterility, the specified SAL and validation method (AAMI Overkill, ISO 11135-1) serve as the ground truth.

7. The sample size for the training set

   • Not applicable. This is a physical device, not an AI-based system requiring a training set.

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

   • Not applicable given that no training set was used.

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