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MucoLock has a mechanical action which provides management of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including: Oral Mucositis or Stomatitis (may be caused by chemotherapy or radiotherapy), irritation due to oral surgery, traumatic ulcers caused by braces and ill-fitting dentures, or disease. Also indicated for diffuse aphthous ulcers.

MucoLock® is a low viscosity, pourable, and swish-able gel, which is presented in 16 fl. oz. bottles. This product, when washed around the mouth, forms a protective layer over the oral mucosa.

The provided document is a 510(k) premarket notification for a medical device called MucoLock Oral Gel. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive human studies. Therefore, many of the requested elements for a study proving device performance against acceptance criteria, especially those related to AI/MRMC studies or human clinical outcomes, will not be present in this document.

Here's an analysis of the document based on your request:

Acceptance Criteria and Device Performance:

The primary "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance testing conducted is primarily non-clinical.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) and not a clinical efficacy trial, the "acceptance criteria" are not framed as clinical endpoints or specific performance metrics like sensitivity/specificity for an AI device. Instead, they are related to equivalence.

• Formulation: Different ingredients (e.g., MucoLock uses Water, Isomalt, Pullulan, Glycerin, Beta-glucan, etc.; GelX uses Purified Water, PVP, Taurine, Zinc Gluconate, etc.). The document states that while ingredients differ, they are all listed in GRAS SCOGS, GRAS Notice Inventory, or commonly used in approved oral products at consistent levels, implying no new safety/effectiveness concerns.
• Method of Use: Both are "Use undiluted" and involve rinsing/coating oral tissue.
• Application Frequency: Both are "3 times a day or as needed".
• Claims: Both claim "Management of pain and relief of pain."
• Area of Use: Both are "Oral Mucosa."
• Disease State: Both address "Oral Mucositis/Stomatitis/Oral Lesions."
• Product Type/Presentation: Both are "Ready for use" and "Non-Sterile." |
  | Safety Testing (Biocompatibility): | Meets ISO Standards for Contact Duration:
• Cytotoxicity (ISO 10993-5: 2009): Not Cytotoxic
• Sensitization (ISO 10993-10: 2010 - Buehler Guinea Pig Skin Sensitization Test): Not Sensitizing
• Irritation (ISO 10993-10: 2010 - Primary Direct Oral (Buccal) Irritation Test): Non-Irritant to the buccal tissues |
  | Functional/Performance Testing (Non-Clinical): | Bioadhesiveness: "The adherence and retention time of the fluorescently labelled gel on the human oral buccal tissue constructs were similar for both the subject and device in the predicate family." |
  | No New Questions of Safety/Effectiveness Raised: | Addressed: The submission argues that the differences do not raise new concerns because ingredients are GRAS/commonly used, and non-clinical testing supports similar performance. |

Study Details from the Document:

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

• Test Set: No human clinical test set (i.e., patient data for clinical efficacy/performance) was used for the primary evaluation of this device as part of the 510(k). The document explicitly states: "Clinical performance testing is not included."
• Provenance: N/A for clinical data. The biocompatibility and bioadhesiveness tests were laboratory-based. The bioadhesiveness test used "human oral buccal tissue constructs," which implies ex vivo or in vitro testing, not human subjects.

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

• Not applicable. No human clinical data or expert-adjudicated ground truth for a test set was part of this 510(k) submission.

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

• Not applicable. No human clinical data or adjudication process was involved.

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 is not an AI device, and no MRMC study was performed.

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

• Not applicable. This is not an AI algorithm. Its performance is assessed through non-clinical laboratory tests (biocompatibility, bioadhesiveness) demonstrating its physical and chemical properties and safety.

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

• For the non-clinical tests:
  • Biocompatibility: Ground truth is established by adherence to ISO standards (e.g., cell viability for cytotoxicity, skin reaction for sensitization, tissue reaction for irritation).
  • Bioadhesiveness: Ground truth is established by in vitro or ex vivo measurements of adherence and retention time on tissue constructs, compared to the predicate.

8. The sample size for the training set:

• Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

• Not applicable.

In summary: This 510(k) submission for MucoLock Oral Gel relies on demonstrating substantial equivalence to a predicate device through:

• Identical intended use.
• Similar technological characteristics, with justified differences based on ingredient safety and common usage.
• Non-clinical laboratory testing (biocompatibility and bioadhesiveness) to show the new device is safe and performs functionally similarly to the predicate.

No clinical efficacy studies or AI-related performance evaluations were performed or submitted for this specific 510(k) clearance.

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