(90 days)
The STORZ DP4310 surgical accessory pack contains an auxiliary drape (K934445), a Mayo arm drape, an irrigation administration tube assembly, a collection cassette (K953078), and an irrigation/aspiration (I/A) tube assembly. Other components included are a pair of IIA test chambers, a pair of infusion sleeves, a tube stopper, a male Luer cap, and a needle wrench. These components are to be used in conjunction with the STORZ Protegé (K921758 and K950114), PREMIERE® (K894278, K921460, and K946227) or DAISY® (K854508) Microsurgical Systems in the performance of phacoemulsification.
Phacoemulsification involves the ultrasonic disintegration of the opacified crystalline lens (cataract) from the eye. This process is accomplished by means of an electronically driven ultrasonic handpiece which 1) emulsifies the lens; 2) facilitates the irrigation of the anterior chamber; and 3) facilitates the aspiration of the emulsified lens material and irrigant from the eye. The Storz DP4310 Pack provides the accessories necessary to enable use of the Storz Phacoemulsification Handpieces (K935926) with the above Storz microsurgical systems.
The STORZ DP4310 surgical accessory pack contains an auxiliary drape (K934445), a Mayo arm drape, an irrigation administration tube assembly, a collection cassette (K953078), and an irrigation/aspiration (I/A) tube assembly. Other components included are a pair of IIA test chambers, a pair of infusion sleeves, a tube stopper, a male Luer cap, and a needle wrench. These components are to be used in conjunction with the STORZ Protegé (K921758 and K950114), PREMIERE® (K894278, K921460, and K946227) or DAISY® (K854508) Microsurgical Systems in the performance of phacoemulsification.
This document describes a 510(k) premarket notification for a medical device accessory pack and does not include information about acceptance criteria, device performance, or a study demonstrating the device meets such criteria in the way a clinical trial or algorithm validation would.
Therefore, I cannot fulfill your request for the specific information points you've outlined. The document primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for low-risk devices.
Here's a breakdown of why I cannot extract the requested information based on the provided text:
- Acceptance Criteria and Reported Device Performance: This document does not describe specific performance metrics (e.g., accuracy, sensitivity, specificity) for the device itself or any acceptance criteria related to these. It's an accessory pack for a surgical system, and its "performance" is implicitly tied to its ability to facilitate the function of the main phacoemulsification systems. The comparison chart focuses on design and labeling rather than performance data.
- Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document does not describe a study in the context of evaluating the performance or diagnostic capabilities of the device in a clinical or analytical setting. It's a regulatory submission for substantial equivalence based on comparing design and intended use with a previously cleared device. There's no mention of a test set, training set, ground truth, experts, or any of the other study-related metrics you requested.
The provided text is a 510(k) summary, which is a regulatory document to demonstrate that a new medical device is at least as safe and effective as a legally marketed predicate device. This is achieved by comparing the new device to the predicate device, focusing on similarities in intended use, technology, and performance, rather than conducting a full-scale clinical performance study in the way AI or diagnostic devices might be evaluated.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.