(264 days)
BMG Pharma's GelX® ORAL GEL 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), irritation due to oral surgery, and traumatic ulcers caused by braces or ill fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.
BMG Pharma's GelX® ORAL GEL is a viscous gel formulation, which is presented in both 300 ml and 450 ml bottles. This combination of substances, when washed around the mouth, forms a protective layer over the oral mucosa.
This 510(k) submission (K081372) for GelX® ORAL GEL is for a medical device that received a substantial equivalence determination. As such, it does not include acceptance criteria or a study proving the device meets acceptance criteria in the same way a diagnostic AI device would.
The substantial equivalence pathway for devices like GelX® ORAL GEL relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves comparing technological characteristics and intended uses.
Therefore, many of the requested points regarding acceptance criteria, performance metrics, sample sizes, expert ground truth, and AI-specific study designs are not applicable to this type of device submission.
Here's an explanation based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is for a medical device (oral gel) where "acceptance criteria" and "device performance" are typically related to chemical composition, efficacy in relieving symptoms, and safety, demonstrated through clinical trials or comparisons to predicate devices, rather than diagnostic accuracy metrics. The document states "BMG Pharma's GelX® ORAL GEL has the same intended/indications for use as the predicate Sinclair Pharmaceuticals, Ltd., Gelclair® Concentrated Oral Gel (K013056)." This implies that its "performance" for its intended use is considered equivalent to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) does not present a "test set" in the context of an AI/diagnostic algorithm. The "data" proving substantial equivalence would typically be from the device's formulation, non-clinical tests (e.g., pH, viscosity, adherence properties), and potentially clinical experience with the predicate device or a small clinical study (though none is detailed here). The document does not specify any clinical study data, sample sizes, or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. "Ground truth" in this context would relate to the clinical effect of the gel (e.g., pain relief, adhesion to mucosa). This typically involves patient reporting in clinical trials, not expert consensus on a diagnostic outcome. The document does not mention any expert review or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no "test set" or adjudication method described for this type of device.
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 an oral gel, not an AI diagnostic system. Therefore, no MRMC study or assessment of human readers improving with AI assistance would 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 or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable for AI/diagnostic algorithms. For a device like an oral gel, "ground truth" would be related to clinical outcomes (e.g., patient-reported pain scores, observations of mucosal healing, adherence to the mouth). The document doesn't provide specific outcome data, relying on the substantial equivalence to a predicate.
8. The sample size for the training set
- Not Applicable. This is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for this device type, this question is not relevant.
In summary, the provided 510(k) summary for GelX® ORAL GEL is for a physical medical device (an oral gel), not a diagnostic AI or imaging device. The regulatory pathway is based on demonstrating substantial equivalence to a predicate device, focusing on intended use and technological characteristics rather than the complex performance evaluation criteria typically associated with AI-powered diagnostics.
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