(83 days)
The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.
The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460 and K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.
This document is a 510(k) summary for a medical device (Storz DP5100 Anterior Collection Cassette Pack) and does not contain information about studies related to device performance against specific acceptance criteria in the way you've described (e.g., accuracy, sensitivity, specificity for an AI/diagnostic device).
The context of this document is a regulatory submission demonstrating substantial equivalence to existing predicate devices, rather than a clinical performance study with predefined acceptance criteria for a diagnostic or AI-driven medical device.
Therefore, I cannot provide the requested information for acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader studies because these details are not present in the provided text.
The document primarily focuses on:
- Device Description and Intended Use: What the device is and what it's for.
- Predicate Device Comparison: Showing how the new device is "substantially equivalent" to already-cleared devices, primarily through comparing physical characteristics, materials, sterilization, and intended use.
This comparison chart (provided in your input) is the "study" that proves the device meets the "acceptance criteria" of being substantially equivalent to predicate devices. The "acceptance criteria" here are met by demonstrating that the modified device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicates.
In summary, none of the specific points you asked for regarding acceptance criteria for device performance, sample sizes, ground truth, or MRMC studies are applicable to this type of 510(k) submission document.
§ 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.