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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.

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ENTaxis™ Nasal Packings are intended for nasal epistaxis and as post operative nasal packings. ENTaxis™ Nasal Packing is intended for - Epistaxis - · Post operative nasal packing

ENTaxis™ Nasal Packings are highly conformable, sterile, hemostatic packings designed for managing bleeding in the nasal cavity and as post operative packings. ENTaxis™ nasal packings are 12" (30cm, 2g) "ropes" that are 100% composed of pure calcium alginate fibers.

The provided text describes the 510(k) summary for the ENTaxis™ Nasal Packing device, which includes information regarding its clinical safety and efficacy study. Based on this information, here’s a summary conforming to your request:

Acceptance Criteria and Device Performance

The clinical study evaluated the ENTaxis™ Nasal Packing against conventional Merocel™ packing for post-operative use in sinus surgery, focusing on specific clinical endpoints. While specific numeric acceptance criteria (e.g., "bleeding must be reduced by X%") are not explicitly stated in a table format, the study's conclusions demonstrate superior performance of ENTaxis™ for the tested endpoints.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: 50 patients (100 nasal cavities).
   • Data Provenance: The study was a multi-center, randomized, and controlled clinical study. The specific country of origin is not explicitly stated, but the submitter is Laboratoires Brothier S.A. from France, suggesting European origin for the clinical trial, or at least a multi-national one. It was a prospective clinical study comparing two different types of packings.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document refers to the study by R. Peynegre, P. Bonfils, L. Castillo, et al. from 1998, conducted in "five ENT surgery departments." This implies multiple clinicians were involved in the assessments. However, the exact number of experts establishing ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed in the provided text. Assessments were made by clinical personnel within the ENT surgery departments.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The text states, "Every patient served as their own control by being treated with both test products." This indicates a paired-comparison or within-subject design where individual patient outcomes for ENTaxis™ were compared against their own outcomes for Merocel™. Different assessments were made by clinicians during surgery, on Day 2 (epistaxis and pain on removal), and on Day 9 (quality-of-healing). There is no explicit mention of an adjudication panel or method like 2+1/3+1 consensus for resolving discrepancies in assessments.

4. 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:

   • No, this was not an MRMC comparative effectiveness study involving AI or human readers. This study evaluated two medical devices (nasal packings) directly through patient outcomes after surgical procedures, not the diagnostic performance of human readers with or without AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This study is a clinical trial evaluating the performance of a physical medical device (nasal packing) in human patients, not an algorithm, and thus standalone performance in an AI context is not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was based on clinical outcomes data directly observed and assessed by medical professionals during and after sinus surgery. This includes objective measures (degree of bleeding) and subjective patient experiences (pain on removal), as well as clinical inspection of healing by ENT specialists.

7. The sample size for the training set:

   • There is no mention of a "training set" in the context of this device study, as this is a physical medical device and not an AI or machine learning algorithm.

8. How the ground truth for the training set was established:

   • Not applicable, as there was no training set for an algorithm.

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