(85 days)
The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir. to the surgical handpiece irrigation line, during ophthalmic surgical procedures.
The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir. to the surgical handpiece irrigation line, during ophthalmic surgical procedures.
The provided text is a 510(k) premarket notification for a medical device (Storz DP5200 Irrigation Administration Set Pack). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth is NOT available in this type of submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not available. The document is a 510(k) submission, not a study report. It focuses on demonstrating substantial equivalence to existing predicate devices, meaning it aims to show the new device is as safe and effective as a legally marketed device, rather than proving performance against predefined quantitative acceptance criteria. The comparison chart provided only lists device characteristics, not performance metrics or acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available. No test set or associated data is described, as this is a substantial equivalence submission.
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 available. No ground truth establishment or expert involvement for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not available. No adjudication method is mentioned as there is no test set or study described in this context.
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. This device is an irrigation administration set, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study with AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a passive medical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not available. Ground truth is not discussed as no study requiring it is presented. The "proof" in a 510(k) relies on demonstrating the new device is identical or nearly identical in function and materials to existing approved devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device relying on a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth.
In summary: The provided document is a 510(k) summary, which aims to establish substantial equivalence to predicate devices. It does not contain information about studies designed to meet specific performance acceptance criteria for a novel device, nor does it involve AI or human readers. The 'proof' of safety and efficacy comes from demonstrating that the new device shares fundamental characteristics (intended use, materials, sterilization, etc.) with devices already deemed safe and effective by the FDA.
§ 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.