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The Storz Millennium™ High Speed Vitrectomy System is a new device intended for removal of vitreous matter from the posterior vitreous cavity during ophthalmic vitrectomy surgery. The Storz high speed vitrectomy system consists of the Storz CX5800 module to be used with the Storz Millennium™ Microsurgical System, Storz CX5810 handpiece, and the Storz CX4804 sterile single use accessory pack.

The Storz Millennium™ High Speed Vitrectomy System is intended for the aspiration of vitreous matter from the eye during ophthalmic vitrectomy surgery. The system consists of the Storz CX5800 Millennium™ System High Speed Vitrectomy module used with the Storz Millennium™ Microsurgical System, Storz CX5810 High Speed Vitrectomy handpiece, and the Storz CX4804 High Speed Vitrectomy single use disposable pack.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the Storz Millennium™ High Speed Vitrectomy System:

Summary of Acceptance Criteria and Study Information:

This 510(k) submission, K980488 for the "Storz Millennium™ High Speed Vitrectomy System," is a premarket notification for a new device claiming substantial equivalence to existing predicate devices. It does not contain information about specific performance acceptance criteria for the new device as a standalone product, nor does it detail a study that directly proves specific numerical performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence in design, materials, and intended use to already legally marketed predicate devices. The "performance" assessment is implied through the comparison of characteristics and specifications against these predicates. This is a common approach for 510(k) submissions, where the new device is not required to meet novel performance criteria but rather to demonstrate it is as safe and effective as a legally marketed device.

Therefore, the table below will reflect the comparison of characteristics rather than specific "acceptance criteria" and "reported device performance" in the traditional sense of a clinical or analytical study with defined endpoints.

1. Table of Acceptance Criteria and Reported Device "Performance" (as presented in the 510(k) for substantial equivalence):

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

• This 510(k) submission does not refer to a "test set" or a formal clinical study with human subjects designed to evaluate the performance of the new device.
• The data provenance is based on published information and specifications of legally marketed predicate devices, as maintained by the manufacturers and available to the FDA through previous 510(k) clearances (e.g., K961310, K961078, K961738). There is no mention of country of origin for specific "data," as it's a comparison of specifications.
• The approach is a retrospective comparison against existing predicate device characteristics, not a prospective study.

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

• Given that no "test set" or clinical study for the new device is described, no experts were used to establish ground truth in this context.
• The "ground truth" here is effectively the accepted specifications and intended uses of the predicate devices as cleared by the FDA.

4. Adjudication Method for the Test Set:

• Not applicable. No test set was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices to assess the impact of AI on human reader performance, which is not applicable to a vitrectomy system.

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

• Not applicable. The device is a surgical instrument and system; it is not an algorithm, and the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used:

• The "ground truth" for demonstrating substantial equivalence relies on the established specifications, intended uses, and safety/effectiveness profiles of the identified legally marketed predicate devices, as detailed in their respective 510(k) clearances. There is no external clinical ground truth (like pathology or outcomes data) directly generated for this new device's submission.

8. The Sample Size for the Training Set:

• Not applicable. This device is a vitrectomy system, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set mentioned, no ground truth needed to be established for one.

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