(446 days)
episil® has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including Oral Mucositis/Stomatitis (may be caused by chemotherapy or radiotherapy).
episil® is a medical device constituting an oromucosal liquid in a multidose container and is without active pharmaceutical ingredient. The oromucosal liquid transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid. episil® has a mechanical action indicated for the management of pain and relief of pain, by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including Oral Mucositis/ Stomatitis (may be caused by chemotherapy or radiotherapy). The oromucosal liquid is made of six ingredients including glycerol dioleate, soy phosphatidyl choline, ethanol, propylene glycol, polysorbate 80, and peppermint oil, which are all GRAS for the intended use.
The provided text describes the 510(k) submission for episil® (K101769) and its substantial equivalence to the predicate device, Gelclair Concentrated Oral Gel (K013056).
However, the provided text does not contain explicit acceptance criteria in a quantitative format (e.g., a specific percentage reduction in pain, or a minimum effect size). Instead, it states that episil® is "as safe and effective as the Gelclair Concentrated Oral Gel" and that "Performance data has been provided which demonstrates the minor differences between episil® and the predicate device raises no new issues of safety or effectiveness."
The study described is a comparative clinical trial.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: No new issues of safety compared to predicate device. | Systemic toxicity testing in Syrian hamsters (including oral irritation) showed no new safety concerns. |
| Effectiveness (Pain Management): Similar reduction in oral pain compared to predicate device. | "The study showed that patients receiving episil® had less pain and required significantly less pain medication and parenteral nutrition than the control group." |
| "The results show a significant reduction of oral pain which is similar to the reduction of pain reported in the literature for the predicate device Gelclair® (Lindsay et al. (2009), Australian Nursing Journal, 16 (9), 30)." | |
| Effectiveness (Reduced Medication/Nutrition Dependence): Implied, as a benefit of reduced pain. | "required significantly less pain medication and parenteral nutrition than the control group." |
Note Regarding Acceptance Criteria: The provided text does not state explicit, quantitative acceptance criteria that the device had to meet (e.g., "reduce pain by X%"). Instead, the acceptance is based on demonstrating "substantial equivalence" to the predicate device, K013056, in terms of safety and effectiveness, and showing "no new issues of safety or effectiveness." The clinical study's outcome of "significant reduction of oral pain which is similar to the reduction of pain reported in the literature for the predicate device" served as the primary evidence for effectiveness.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The text states, "A randomized, repeat dose study of episil® in bone marrow transplant patients suffering from oral mucositis, was performed where episil® was given three times daily during 7 days together with cryotherapy compared against cryotherapy alone." The exact number of patients in the study is not specified in the provided document. It refers to "patients receiving episil®" and a "control group" but doesn't give a numerical count.
- Data Provenance: The country of origin of the data is not specified. The submitter is Camurus AB (Sweden), and the additional correspondent is Premier Research Group, Ltd. (USA), but this doesn't directly indicate where the clinical trial was conducted.
- Retrospective or Prospective: The study is described as "A randomized, repeat dose study," which indicates a prospective clinical trial design.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided in the text. The study involved "bone marrow transplant patients" suffering from oral mucositis, and outcomes like "less pain," "significantly less pain medication," and "parenteral nutrition" were measured. These are likely patient-reported outcomes or clinical assessments, but the role of experts in establishing a "ground truth" (e.g., for pain scores or mucositis grading if that was part of the assessment) is not detailed.
4. Adjudication Method for the Test Set
- This information is not provided in the text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The study described is a clinical trial comparing episil® against cryotherapy alone for pain management in oral mucositis. This is a direct patient-outcome study, not a study involving human readers interpreting cases with and without AI assistance.
- Therefore, the effect size of human readers improving with AI vs. without AI assistance is not applicable and not reported.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. episil® is a medical device (an oromucosal liquid/gel), not an AI algorithm. Its performance is directly measured in patients, not as a standalone algorithm.
7. Type of Ground Truth Used
- The ground truth used was based on clinical outcomes reported by or observed in patients. This includes patient-reported pain levels, and clinical data on the need for pain medication and parenteral nutrition. It is not expert consensus on images, pathology results, or long-term outcomes data in the sense of a diagnostic device.
8. Sample Size for the Training Set
- This information is not applicable/not provided. episil® is a physical medical device (liquid/gel), not a machine learning model or algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
- This information is not applicable/not provided as it's not an AI/ML device requiring a training set.
N/A