(116 days)
The Bausch & Lomb Stellaris 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 phacoemulsification, irrigation/aspiration, bipolar, coaxial, and bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb disposable packs and handpieces designated for use with the system.
The Bausch & Lomb Stellaris® Vision Enhancement System is an integrated ophthalmic microsurgical system designed for use in anterior segment surgery including phacofragmentation and vitreous aspirating and cutting- anterior vitrectomy. The system is based on the technology and the performance of the existing Stellaris® system, and this special 510(k) incorporates software revisions and minor hardware changes.
Here's an analysis of the provided text regarding the Bausch & Lomb Stellaris® Vision Enhancement System, structured to address your specific points:
Since this is a 510(k) submission for a medical device that has been updated with software revisions and minor hardware changes, and it's being compared to a predicate device, the "acceptance criteria" and "device performance" in this context refer to demonstrating substantial equivalence rather than a clinical study with primary performance endpoints. The "study" proving it meets acceptance criteria is the nonclinical testing showing compliance with applicable standards and verification/validation activities for software changes.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for a modified device, the acceptance criteria are primarily about meeting safety standards and demonstrating equivalence to the predicate. Performance is generally shown by passing technical tests.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Safety Standards | Compliance with IEC 60601-1: Edition 3: 2007 (General Requirements for Safety) | The Stellaris® Vision Enhancement System "passed all of the above tests with no exceptions." |
| Compliance with IEC 60601-1-2: Edition 3:2007-03 (Electromagnetic Compatibility - Requirements and Tests) | The Stellaris® Vision Enhancement System "passed all of the above tests with no exceptions." | |
| Software Validation | Verification and validation of software changes in accordance with Bausch & Lomb software quality procedures (EN62304) | "Software changes were verified and validated in accordance with the Bausch & Lomb software quality procedures which comply with EN62304." Functional requirements met. |
| Functional Equivalence | Functional requirements of the modified device are equivalent to the predicate device. | "This testing demonstrates that the functional requirements have been met and that the modified device is equivalent to the predicate device." |
| Intended Use | Identical to predicate device (K082473). | "Exactly the same as K082473." Confirmed in "Indications for Use Statement." |
| Technological Equivalence | Substantially equivalent technological characteristics to predicate device. | "The technological characteristics of the Stellaris Microsurgical system are substantially equivalent to those of the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve patient data or a "test set" in the traditional sense of a clinical study evaluating diagnostic or treatment outcomes using patient samples. The "test set" here refers to the actual device and its components undergoing engineering and software verification/validation testing.
- Sample Size: Not applicable in terms of patient data. The "sample" is the medical device itself and its software. Testing would have been conducted on prototypes or production units of the Stellaris® Vision Enhancement System.
- Data Provenance: Not applicable in terms of country of origin or retrospective/prospective patient data. The tests were performed internally by Bausch & Lomb and its designated testing facilities to meet international safety standards (IEC) and software development standards (EN62304).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission does not involve "experts" establishing a "ground truth" for a test set in the context of diagnostic accuracy or clinical outcomes. The "ground truth" for the engineering and software testing is defined by the technical specifications, international standards (IEC), and the functional requirements of the device and its predicate.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for subjective assessments, to resolve disagreements among multiple readers or experts. This is not relevant to the engineering and software testing described in this 510(k) summary.
- Adjudication Method: None.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a clinical study design used to assess the performance of diagnostic devices by comparing multiple readers' interpretations of multiple cases. This submission focuses on engineering and software substantial equivalence, not clinical diagnostic performance.
- Effect Size of Human Readers with/without AI: Not applicable, as this is not an AI-assisted diagnostic device or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is an ophthalmic surgical system, not an algorithm. Its operation inherently involves a human surgeon (human-in-the-loop).
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Technical Specifications and Design Requirements: The device's performance is compared against its own design specifications and the established performance of the predicate device.
- International Safety Standards: Adherence to standards like IEC 60601-1 and IEC 60601-1-2 constitutes a "ground truth" for electrical and electromagnetic safety.
- Software Quality Standards: Compliance with EN62304 for software development provides the "ground truth" for software functionality and safety.
8. The Sample Size for the Training Set
This submission does not involve a "training set" in the context of machine learning or AI algorithms. The device is a physical surgical system with software, not a system that learns from data.
- Sample Size for Training Set: Not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device submission.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.