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The Bausch + Lomb IOL Injector is indicated for folding and injection of Bausch + Lomb IOLs approved for use with this injector.

The Bausch + Lomb IOL Injector is a sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.

The provided text describes a 510(k) premarket notification for the Bausch + Lomb IOL Injector, INJ100. The submission aims to demonstrate substantial equivalence to predicate devices, primarily through functional and safety testing. However, the provided document does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria with quantifiable metrics, sample sizes for test and training sets, details about ground truth establishment, or any information about multi-reader multi-case studies or standalone algorithm performance.

Based on the available information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The Bausch + Lomb IOL Injectors have successfully undergone functional testing and are found to deliver the Bausch + Lomb IOLs in conformance with the requirements set forth in ISO 11979-3, section 5."

Without access to ISO 11979-3, section 5, the specific acceptance criteria and their associated performance metrics cannot be reported in detail. However, the general performance reported is "successful delivery of Bausch + Lomb IOLs in conformance with requirements."

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified, but implied to be from functional/safety testing conducted by Bausch & Lomb, Inc.

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

This information is not provided in the document. The testing appears to be functional and mechanical, not related to expert interpretation of medical images or data requiring ground truth established by medical professionals.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Given the nature of functional/safety testing for a medical device (IOL injector), adjudication methods as typically understood in the context of diagnostic AI tools (e.g., 2+1, 3+1) are unlikely to be relevant or applicable. The testing would likely involve objective measurements and observations of the injector's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No MRMC comparative effectiveness study was mentioned or implied. This type of study is typically relevant for diagnostic AI tools that assist human readers in interpreting medical images or data. The Bausch + Lomb IOL Injector is a physical device for delivering intraocular lenses, not a diagnostic imaging or data interpretation tool.

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

The device is a physical injector; therefore, the concept of a "standalone algorithm" is not applicable. The "functional testing" mentioned can be considered a form of standalone performance evaluation for the device's mechanical and operational capabilities.

7. The Type of Ground Truth Used:

The ground truth for this device would be based on objective measurements and observations of the injector's performance against predefined engineering and performance specifications outlined in standards like ISO 11979-3, section 5. This would involve criteria such as:

• Successful folding and insertion of the IOL.
• Absence of IOL damage.
• Smoothness of injection.
• Consistency of delivery.
• Absence of device malfunction.

It is not expert consensus, pathology, or outcomes data in the traditional sense, but rather engineering and functional performance criteria.

8. The Sample Size for the Training Set:

This information is not provided in the document. The concept of a "training set" is usually applicable to machine learning algorithms. For a physical device like an IOL injector, the "training set" might loosely correspond to the R&D and design verification activities, but specific sample sizes for such a "training set" are not mentioned.

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

This information is not provided. Similar to point 8, the concept of "ground truth for a training set" is typically for AI/ML. For this device, the design and performance parameters would have been established through engineering design, material science considerations, and iterative testing, guided by relevant industry standards and clinical needs.

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