(127 days)
MYSHELL is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter
MYSHELL is an ergonomically designed y-connector/hemostatic valve that accepts materials up to 9F in size (
The provided text states that "The safety and efficacy of MYSHELL and its accessories... have been demonstrated," but it does not provide any specific acceptance criteria or details of a study verifying those criteria.
Therefore, I cannot populate the table or answer the specific questions about the study from the provided document. The submission is a 510(k) summary for a medical device (Y-Connector/Hemostatic Valve), which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results with acceptance criteria.
Information not found in the provided document:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set.
- Data provenance for the test set.
- Number of experts used to establish ground truth for the test set.
- Qualifications of experts.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Effect size (if MRMC was done).
- Whether a standalone performance study was done.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.