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The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lens identifying the Crystalsert Delivery System in their approved labeling.

The Crystalsert Delivery System is a device used for folding and delivering the Crystalens accommodating intraocular lens (AT-52SE, AT-50SE, HD520, HD500, AT50AO, AT52AO), Trulign™ Toric, and other IOLs indicating use of the Crystalsert Delivery System in their approved labeling into the eye. The Crystalsert Delivery System consists of a syringe shaped body and tip with a plunger and drawer. The Crystalsert Delivery System is a sterile, disposable plastic device, with a small tubular pathway in which the lens can be placed into the eye with one continuous motion, designed for single use only.

The provided document describes the Bausch & Lomb Crystalsert Delivery System, an intraocular lens guide. It outlines the device's description, indications for use, and a comparison to a predicate device. However, the document does not contain a study that proves the device meets specific acceptance criteria in the format typically expected for clinical or performance studies with quantitative results.

Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (K123736, Crystalsert Delivery System) based on similar indications for use, contraindications, materials, single-use nature, sterility, sterilization method, sterility assurance level, and shelf life.

The "Brief Summary of Nonclinical Test and Results" section states: "The Crystalsert Delivery System has successfully undergone functional and biocompatibility testing and was found in conformance with the requirements set forth in respective standards." However, it does not provide specific acceptance criteria or the reported device performance from these tests. The details of these tests (e.g., sample sizes, methodology, and quantitative results) are not included in this summary document.

Therefore, most of the requested information regarding acceptance criteria and a study demonstrating the device meets these criteria cannot be extracted from the provided text.

Here's an attempt to answer the questions based only on the information available in the provided text, with explicit notes where information is missing:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit, quantified acceptance criteria with corresponding performance data from a specific study. Instead, it relies on demonstrating equivalence to a predicate device by matching various characteristics.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary. The summary only states that "functional and biocompatibility testing" was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The document describes a medical device (an IOL delivery system), and the testing mentioned (functional, biocompatibility) typically involves engineering and laboratory assessments against standards, rather than expert-derived ground truth as might be seen in diagnostic AI.

4. Adjudication method for the test set

Not applicable and not provided, as the tests mentioned are functional and biocompatibility, not expert-based assessment requiring 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 device is a delivery system, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This device is a physical delivery system, not an algorithm.

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

For the functional and biocompatibility testing, the "ground truth" would be adherence to established industry standards or internal specifications for mechanical performance and biological safety. The specific standards or specifications are not detailed in this summary.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

Not applicable. This device is a physical product, not an AI algorithm.

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The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert delivery system in their approved labeling.

The Crystalsert Delivery System 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 document describes the Bausch & Lomb Crystalsert Delivery System, a device for inserting intraocular lenses. However, it does not contain a study to prove the device meets acceptance criteria in the context of an AI/ML algorithm or a typical clinical trial with acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Instead, this 510(k) submission focuses on demonstrating substantial equivalence to a predicate device through comparative analysis and functional testing against an international standard.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will address the parts that are relevant to this type of device submission.

Here's the breakdown of what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria or reported performance in the typical format of a study for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, safety and effectiveness are established through demonstrating equivalence to a predicate device and conformance to an international standard.

2. Sample size used for the test set and the data provenance

Not applicable for this type of device submission. This is a medical device for IOL insertion, not an AI/ML algorithm evaluated on a data set. The "test set" would be the functional testing of the device itself (e.g., number of units tested during engineering verification), which is not explicitly stated but implied by the "successful functional testing" claim. Data provenance like country of origin or retrospective/prospective is not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for an AI/ML algorithm is not relevant. The "ground truth" for this device would be its ability to correctly fold and insert an IOL, which is assessed via engineering and performance testing against a standard. Experts would be engineers and quality control personnel.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1) are for human interpretation of data for AI/ML algorithm training/testing. This device relies on objective functional testing against a standard.

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 prognostic device for human readers.

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

Not applicable. This device is a manual tool, not an algorithm.

7. The type of ground truth used

For this device, the "ground truth" is established by conformance to an international standard (ISO 11979-3, section 5) and successful functional performance specifications for its intended use (folding and inserting an IOL without damage). This is validated through engineering and performance testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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