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The Bausch & Lomb™ D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb STELLARIS® and Bausch & Lomb MILLENNIUM®, Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic procedures.

The Bausch & Lomb D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb Stellaris (K063331) Microsugrical System. The device is for use as an air exchange system during posterior segment ophthalmic surgical procedures. The D4600A Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.

The provided text is a 510(k) summary for the Bausch & Lomb D4600A Air Exchange Line Pack. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trials or performance evaluations for AI/software devices.

This document is a regulatory submission for a physical medical device (an accessory for ophthalmic surgery), not an AI/software device. Therefore, the specific types of information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or typically included in this kind of 510(k) submission for a physical accessory.

Instead, the "proof" for this device lies in its substantial equivalence to a legally marketed predicate device as demonstrated in the "DEVICE COMPARISON CHART."

Here's a breakdown of why each requested point cannot be answered from the provided text, along with what is provided:

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

• Not Applicable/Not Provided: The document does not define specific "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy) for a new algorithm, nor does it report performance data against such criteria.
• What is provided: The comparison chart (Table in {1}) lists characteristics of the subject device (D4600A) and the predicate device (D4600), demonstrating their equivalence in design, intended use, recommended systems, and sterility. This comparison serves as the basis for regulatory acceptance through substantial equivalence.

The acceptance criterion implicitly met is substantial equivalence to the predicate device in terms of safety and effectiveness, based on these similar characteristics.

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

• Not Applicable/Not Provided: This device is a physical accessory evaluated for substantial equivalence, not a software/AI device that would use a "test set" of data in the sense you're describing. There's no data provenance information.

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

• Not Applicable/Not Provided: There is no "ground truth" established by experts for a test set in this context. The substantial equivalence relies on comparing the device's physical and functional attributes to a predicate.

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

• Not Applicable/Not Provided: No adjudication method for a test set is relevant or mentioned.

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/Not Provided: This is a physical accessory, not an AI system. MRMC studies are not relevant.

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

• Not Applicable/Not Provided: This is a physical accessory, not an algorithm.

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

• Not Applicable/Not Provided: The basis for approval is substantial equivalence to a predicate device, not comparison to a "ground truth" derived from expert consensus, pathology, or outcomes data for performance evaluation in the context of an AI/software device.

8. The sample size for the training set

• Not Applicable/Not Provided: This device does not involve a "training set" in the context of machine learning.

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

• Not Applicable/Not Provided: No training set or ground truth for it is relevant.

In summary: The K082132 document is a 510(k) premarket notification for a disposable ophthalmic surgical accessory. Its "acceptance criteria" are implicitly met by demonstrating substantial equivalence to an existing, legally marketed predicate device (Bausch & Lomb D4600 Air Exchange Line Pack, K962131). The provided "study" is primarily the comparison table detailing the physical and functional characteristics of the new device against the predicate. This approach is standard for many medical devices that are not complex software or AI systems.

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