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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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The Storz Millennium™ Viscous Fluid System is intended for the injection of viscous fluids and Balance Salt Solution (BSS) into to eye as well as aspiration of viscous fluids from the eye during ophthalmic posterior vitreoretinal and retinal translocation surgery.

The Storz Millennium Viscous Fluid Injector system (VFI) is a Class II device in accordance with 21 CFR Section 880.5725. Further, the VFI and its accessories was previously cleared, via the Premarket Notification process and was assigned 510(k) file number K972664 and Classification Code 86 MRH. The VFI system module (CX5700) is a self-contained pump system used in conjunction with the Storz Millennium™ Microsurgical System (K961310). The Storz viscous fluid system consists of the Storz CX5700 module to be used with the Storz Millennium™ Microsurgical System and the Storz CX5710 sterile single-use accessory pack consisting of an infusion tube set, a syringe, a Cannula and instructions for use.

This document is a 510(k) premarket notification for a medical device and does not contain information from a clinical study with acceptance criteria and reported device performance. It is a regulatory submission to demonstrate substantial equivalence to a previously cleared device. Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and device performance based on this document.

Here's why and what information can be extracted:

• No Clinical Study Details: This document explicitly states that the device (Storz Millennium Viscous Fluid Injector system, VFI) remains "unchanged in that there will be no changes to the design, functional characteristics, sterilization method(s), product specifications, or intended use" compared to its predicate device (K972664), except for the addition of administering Balanced Salt Solution for retinal translocation procedures. This suggests that extensive new performance testing or clinical studies were likely not performed for this 510(k) submission, as the goal is to demonstrate substantial equivalence, not novel performance.
• Focus on Substantial Equivalence: The entire document revolves around demonstrating that the new VFI system is "substantially equivalent in design and intended use" to previously cleared devices. This is a regulatory pathway that often relies on existing data, design similarities, and sometimes limited bench testing, rather than new, large-scale clinical trials with specific acceptance criteria as you'd find for novel devices.

Information that can be extracted from the provided text, but not in the context of a performance study:

1. Acceptance Criteria and Reported Device Performance: Not applicable as no new performance study is described. The acceptance criterion for this submission was "substantial equivalence" to a predicate device.
2. Sample sized used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: Not applicable for a performance study. For the 510(k) submission, the "ground truth" was the existing regulatory clearance and established performance of the predicate device.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The submission itself serves as the "study" for regulatory clearance, where the primary objective is to demonstrate substantial equivalence to an already legally marketed device. The "acceptance criteria" were met by showing that the differences between the proposed device and the predicate device (K972664, and others like K963434, K902835) did not raise new questions of safety or effectiveness. The key "performance" reported is its intended use, which is identical to the predicate except for the additional capability of administering Balanced Salt Solution for retinal translocation procedures. No specific quantitative performance metrics from a new study are presented in this 510(k).

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The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.

The Storz DP4210 Venturi Economy Anterior Pack and DP5000 ASC Daypack are intended to be used as accessory devices with the Storz DAISY® (K854508), PREMIERE® (K894278, K921460 and K946227), Protege® (K921758 and K950114), and Millennium™ (K961310) Ophthalmic Microsurgical Systems. Both accessory packs facilitate use of Storz phaco handpieces (K935926) and Storz I/A handpieces (K951463) with the above referenced microsurgical systems in various anterior segment ophthalmic surgical procedures, e.g., phacoemulsification and residual cortical material removal following a planned Extracapsular Cataract Extraction.

The Storz DP4210 Venturi Economy Anterior Pack is provided non-sterile and contains reusable components consisting of an anterior collection cassette, I/A tubing set, and I/A test chambers. The Storz DP5000 ASC Daypack is provided sterile and contains both reusable and single use components. The DP5000 reusable items include an anterior collection cassette, I/A test chambers, needle wrench, and infusion sleeve. The DP5000 single use items include an I/A tube assembly and a BSS administration tube assembly.

This document is a 510(k) premarket notification for two ophthalmic accessory packs, the Storz DP4210 Venturi Economy Anterior Pack and the Storz DP5000 ASC Daypack. It focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a study with performance metrics.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text because this type of 510(k) submission generally relies on demonstrating similarity to legally marketed devices, not on new clinical performance studies with defined acceptance criteria and statistical analysis as would be required for a novel device or a Premarket Approval (PMA) application.

Here's what can be extracted and what is missing based on the provided text:

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

• Not explicitly stated in the document. The document's purpose is to demonstrate substantial equivalence to predicate devices, not to present performance metrics against predefined acceptance criteria. The "performance" is implicitly deemed equivalent to the predicate devices if substantial equivalence is established.

2. Sample sized 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 is a 510(k) premarket notification for accessory packs, which typically does not involve a "test set" and performance data in the way a clinical study for a drug or novel device would. The assessment is based on comparing device characteristics and intended use to predicate devices. There is no mention of a clinical study or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. No "ground truth" establishment by experts for a test set is mentioned, as this is not a performance study.

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

• Not applicable/Not provided. No adjudication method is 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. MRMC studies are not relevant to this type of device and submission. There is no AI component mentioned.

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

• Not applicable/Not provided. This device does not involve algorithms or AI.

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

• Not applicable/Not provided. No ground truth determination is described.

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 or algorithms.

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

• Not applicable/Not provided. No training set or ground truth establishment relevant to this context is described.

Summary of what the document does provide in relation to regulatory acceptance:

The document outlines a process of demonstrating substantial equivalence to existing legally marketed predicate devices, which is the "acceptance criteria" for a 510(k) submission.

• Predicate Devices:
  • Storz DP4210 Venturi Economy Anterior Pack: Substantially equivalent to Storz DP4210 Universal I/A and Phaco Pack (K882240).
  • Storz DP5000 ASC Daypack: Substantially equivalent to Storz DP4210 Universal I/A and Phaco Pack (K882240) and Storz DP4310 Deluxe Phaco Pack (K955901).
• Method of "Proof": Device comparison charts (Pages 2-3) are used to highlight similarities in:
  • 510(k) reference (i.e., previous clearance)
  • Pack Name
  • Intended Use
  • Individual Pack Components
  • Anterior Collection Cassette design (for DP4210 comparison)
  • Reusable Components
  • Limited Reuse (number of times)
  • Pack Provided Sterile (Yes/No)
  • Pack Sterilization method (for DP5000 comparison)
• Result of "Study" (FDA Outcome): The FDA reviewed the 510(k) notification and determined the device (both packs) to be substantially equivalent for its stated indications for use (Page 4). This determination allows the device to be marketed.

This document serves as an example of a 510(k) submission where "acceptance criteria" and "study" are framed by the regulatory concept of substantial equivalence, rather than a clinical trial with specific performance endpoints.

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