(81 days)
The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 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 Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.
This document, K962131, is a 510(k) Premarket Notification for an ophthalmic surgical accessory pack. It aims to demonstrate substantial equivalence to existing predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving those criteria cannot be found or inferred from the provided text.
Here's an breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, not on presenting specific performance acceptance criteria and test results against those criteria. The provided table in the "DEVICE COMPARISON CHART" (
{1}) shows comparisons of device characteristics (intended use, recommended system, instructions, sterility, etc.), not performance metrics against 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)
- Cannot be provided. No test set or clinical study is described. The comparison is feature-based against predicate devices.
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)
- Cannot be provided. No ground truth establishment by experts is mentioned, as there is no described test set or clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. Not applicable as no test set or clinical study is described.
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
- Cannot be provided. No MRMC study or AI component is mentioned. This device is an ophthalmic surgical accessory pack.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. Not applicable as no ground truth is established for a performance study. The "ground truth" here is the characteristics of the predicate devices to which the new device is compared for substantial equivalence.
8. The sample size for the training set
- Cannot be provided. No training set is mentioned. This is a physical medical device, not an AI model.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable as no training set is mentioned.
Summary regarding the provided document:
The K962131 document is a 510(k) submission for a medical device accessory. Its purpose is to demonstrate that the new device, the Storz D4600 Air Exchange Line Pack, is "substantially equivalent" to legally marketed predicate devices (existing Storz D4600 and Intek International TR-9006-11 Air Delivery Tubing System). This is achieved by comparing characteristics like intended use, recommended system compatibility, sterility, and packaging, as shown in the "DEVICE COMPARISON CHART" ({1}). This type of submission generally does not include extensive clinical studies with defined acceptance criteria for novel performance claims but rather focuses on demonstrating safety and effectiveness based on similarity to already cleared devices.
§ 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.