Search Results

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.

Ask a specific question about this device