(78 days)
Endolymphatic Sac fluid increases during Meniere's disease attacks. This simple 'T' type endolymphatic sac shunt is designed to act as a continuous drain, allowing endolymphatic sac fluid to be shunted into the Mastoid. The shunt is placed in the sac along with decompression of the sac and the adjacent dura.
This device is a small, T-shaped piece of silicone rubber sheet, approximately 8.5mm x 1mm x 0.125mm. The T-bar is 5mm wide.
The provided documents describe a 510(k) pre-market notification for a medical device called the "Endolymphatic Sac to Mastoid T-Shunt." This type of submission relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials with acceptance criteria for device performance.
Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets them is not present in these documents. The 510(k) process does not typically involve detailed performance metrics and studies as would be seen for new or high-risk devices.
Here's how the provided information relates to your request:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The 510(k) submission for the Endolymphatic Sac to Mastoid T-Shunt does not include a table of acceptance criteria or performance metrics derived from a study. The focus is on demonstrating similar function and safety to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No test set or associated data provenance is mentioned in the context of device performance. The submission relies on a comparison to predicate devices, which would have had their own historical data or clinical use.
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 Applicable. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method 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:
- Not Applicable. This device is a physical shunt, not an AI-assisted diagnostic tool. An MRMC study is irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical shunt. Standalone algorithmic performance studies are irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. No specific ground truth for performance evaluation is described. The "truth" in a 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set:
- Not Applicable. There is no mention of a training set as this is a physical medical device, not an algorithm that requires training.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or associated ground truth establishment is described.
Summary based on the provided documents:
The Endolymphatic Sac to Mastoid T-Shunt (K974224) was cleared by the FDA through the 510(k) process because it was deemed substantially equivalent to existing predicate devices: the Richards Endolymphatic Shunt Tube (Austin Modification) and the Richards Silicone Elastomer Endolymphatic Shunt Tube (House type).
The submission states that the new device's function is the same as the predicates, and it differs primarily in its form ("T-bar stays in the sac and the long portion comes out through a separate incision...preventing extrusion. The flat form is easier to insert and stays in place...more anatomical"). The fit is described as "very similar" but does not require insertion into the subarachnoid space, which implies a potential safety or ease-of-use improvement.
The FDA's letter explicitly states that the finding of substantial equivalence permits the device to proceed to market, highlighting that this process relies on comparison to predicate devices rather than independent performance studies with acceptance criteria during the 510(k) review.
§ 874.3820 Endolymphatic shunt.
(a)
Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to relieve the symptons of vertigo. The device permits the unrestricted flow of excess endolymph from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. This device is made of polytetrafluoroethylene or silicone elastomer.(b)
Classification. Class II.