(92 days)
The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.
Not Found
Based on the provided documents, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested level of detail.
The documents are a 510(k) clearance letter and an "Indications For Use" statement for the "Ultracell Packing with Sleeve (Nasal Pack)". This type of submission (510(k)) is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through detailed performance studies with ground truth establishment, expert adjudication, or MRMC studies.
The provided information indicates:
- Device: Ultracell Packing with Sleeve (Nasal Pack)
- Regulatory Class: I (21 CFR 874.4100/Procode: EMX) - Devices in this class generally have lower risk and often do not require extensive clinical or performance studies for 510(k) clearance if their technological characteristics and indications for use are similar to predicate devices.
- Indications For Use: "The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions."
- Nature of Clearance: Substantial Equivalence to a predicate device marketed prior to May 28, 1976. This means the FDA determined the device is as safe and effective as a legally marketed device, not that it met specific quantitative performance metrics from a formal study as would be required for higher-risk devices or novel technologies.
Therefore, I cannot provide the requested information in the format of a table with acceptance criteria, study details, sample sizes, expert qualifications, or adjudication methods because these are typically not part of a Class I 510(k) submission for a device like a nasal pack. Such details would be expected for AI/ML-driven devices, diagnostic devices, or higher-risk therapeutic devices.
The documents only address the regulatory clearance through the 510(k) pathway based on substantial equivalence, not the detailed performance evaluation against specific, measurable acceptance criteria that would be relevant for an AI/ML device as implied by your questions.
§ 874.4100 Epistaxis balloon.
(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.