(30 days)
NasalCEASE™ is intended to be inserted into the anterior nasal cavity to stop minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device.
NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) premarket notification for a medical device (NasalCEASE™), and it primarily focuses on establishing substantial equivalence to a predicate device.
Here's what can be extracted based on the provided text, and where the requested information is missing:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overall "acceptance criteria" here is substantial equivalence to the predicate device, ENTaxis (K985069).
- Reported Device Performance:
- "NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity."
- "Upon contact with blood or other physiological fluids in the nasal cavity it adsorbs those fluids and swells to apply a compressive force."
- "Both physicians and patients were able to use the device correctly and effectively" (referring to the non-clinical testing).
Since the document is a 510(k) summary, detailed performance data against specific acceptance criteria (e.g., success rate, time to stop bleeding) is typically not included in this summary section but would have been part of the full submission.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The non-clinical testing mentions "A panel of physicians used the device and provided it to patients for use at home," but no number is given for either physicians or patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be from a clinical setting, but whether it was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. "A panel of physicians" is mentioned, but their number or specific qualifications (e.g., specialty, years of experience) are not provided.
- Qualifications of Experts: Only "physicians" is stated.
4. Adjudication method for the test set:
- Not specified. The text only says "A panel of physicians used the device and provided it to patients for use at home."
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 medical device (nasal packing), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used:
- Based on "Both physicians and patients were able to use the device correctly and effectively," the ground truth appears to be based on expert (physician) and user (patient) assessment of usability and effectiveness. This is closer to observational data or user feedback rather than a formal medical "ground truth" like pathology or clinical outcomes in a randomized controlled trial for therapeutic efficacy.
8. The sample size for the training set:
- Not applicable/Not specified. There is no mention of a "training set" in the context of this physical device. If "training set" refers to pre-market testing, it's covered by the "panel of physicians" and "patients" mentioned above, for which no sample size is given.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. As above, no "training set" or explicit ground truth establishment method in this context. The "ground truth" for the non-clinical testing would be the real-world observation by physicians and patients regarding the device's functionality and effectiveness in stopping minor nosebleeds at home.
§ 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.