(258 days)
Intended Use: Symptomatic treatment of xerostomia.
Indications for Use: Relieve symptoms of dry mouth, refresh, moisturize, clean and soothe oral irritation, and lubricate oral dryness.
Oral77M products are specially formulated saliva substitutes which contain moisturizers, humectants, proteins and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Oral7™ Moisturizing Gel, Mouthwash, and Mouth Spray:
Important Note: This document is a 510(k) summary, which is a premarket notification for devices that are "substantially equivalent" to legally marketed predicate devices. It primarily focuses on demonstrating equivalence rather than proving the device's efficacy through extensive clinical trials. Therefore, many of the typical acceptance criteria and study details for novel or high-risk devices will not be present.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative "acceptance criteria" in the format typically seen for algorithm performance (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" is demonstrated through non-clinical and bench testing, focusing on safety and technological similarity.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic/non-harmful when in contact with the body. | Cytotoxicity: Mild reactivity observed, attributed to known sensitive test nature and presence of lysozyme, lactoperoxidase, mentha piperita, and potassium thiocyanate. This was deemed acceptable as it does "not impact safe use." |
| Sensitization: Non-sensitizing. | |
| Oral Mucosal Irritation: Non-irritating. | |
| Stability/Shelf-life: Maintain product characteristics over time. | No significant changes in product characteristics over a three-year period for Oral7™ Moisturizing Gel and Mouthwash. The Mouthwash data supports the shelf-life for the Mouth Spray due to identical formulation and bottle type. |
| Conclusion: Data supports a three (3) year shelf-life. | |
| Compositional Equivalence: Similar materials, humectants, proteins, and enzymes to predicate devices. | Oral7™ products utilize the same materials (moisturizers, humectants, proteins, salivary enzymes) as primary predicate devices. All ingredients are commonly used for their intended functions at equivalent or higher levels than in the proposed formulation. |
| Intended Use Equivalence: Same indications for use as predicate devices. | The intended use and indications for use ("symptomatic treatment of xerostomia," "relieve symptoms of dry mouth, refresh, moisturize, clean and soothe oral irritation, and lubricate oral dryness") are identical to the predicate devices. |
| Technological Characteristics Equivalence: Similar physical properties, method of use, application frequency, disease state, and area of use. | Oral7™ products share the same technological properties (ready-to-use gel/liquid/spray, as needed application, for xerostomia, oral cavity use, non-sterile presentation) as the primary and reference predicate devices (Oral Balance Gel (K061331) and Biotène® Dry Mouth Oral Rinse (K101477)/Biotène® Moisturizing Mouth Spray (K103745)). Physical properties and available delivery forms are similar to predicate devices. |
| Safety and Effectiveness Equivalence: Demonstrated to be as safe and effective as predicate devices. | Based on similarities in chemical composition, available delivery forms, physical properties, nonclinical testing (biocompatibility), and shared intended use, the Oral7™ products are considered "as safe and as effective" as the primary and reference predicate devices. No adverse effects were reported from the nonclinical tests that would preclude safe use. Materials and manufacturing are same as predicates, with no impact on safety and effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set: The "test set" in this context refers to the samples of the Oral7™ products used for nonclinical (biocompatibility) and bench (stability) testing.
- Biocompatibility Testing: The number of samples/replicates used for ISO 10993-1, -5, and -10 testing is not specified in the summary document. It's typically done on representative finished devices.
- Stability Testing: Three (3) batches each of Oral7™ Moisturizing Gel and Oral7™ Moisturizing Mouthwash were tested.
- Data Provenance: Not explicitly stated, meaning a specific country of origin for test specimens or an explicit retrospective/prospective design is not detailed in this summary. Biocompatibility and stability testing are generally prospective tests conducted specifically for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The ground truth for biocompatibility is established by standardized laboratory tests (e.g., cell cultures for cytotoxicity, animal models for sensitization) and recognized international standards (ISO 10993). The ground truth for stability is established by analytical chemistry and physical property measurements over time. No human experts establish a "ground truth" in the way they would for diagnostic imaging.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used when multiple human readers independently evaluate data (e.g., medical images) and their interpretations need to be reconciled to form a definitive "ground truth." This submission involves laboratory and bench testing, not subjective human evaluation of product performance in a clinical context.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the impact of a diagnostic aid (often AI) on human reader performance. This device is a therapeutic product (saliva substitute) and not a diagnostic tool where human interpretation of cases is involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This device is a physical product (gel, mouthwash, spray), not a software algorithm.
7. The Type of Ground Truth Used
- Biocompatibility: The ground truth is based on established international standards (ISO 10993) and their defined criteria for cytotoxicity, sensitization, and irritation.
- Stability: The ground truth is based on analytical chemistry and physical property measurements defined in product specifications and monitored over time. This determines if the product remains within acceptable limits.
- Equivalence: The overarching "ground truth" for the submission is the predicate device's known safety and effectiveness as previously cleared by the FDA. The Oral7™ products' ground truth is its demonstrated similarity in intended use, technological characteristics, and safety profile to these established predicates.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm 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 an AI/ML algorithm, no ground truth needed to be established for it.
N/A