(108 days)
Under the supervision of a healthcare professional, TGO Spray® is intended to provide relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjögren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. TGO Spray® relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste.
TGO Spray® is an oral artificial saliva that contains oxygenated triglycerides from corn oil that have lubricating and moisturizing properties. The product is preserved, and supplied in a glass spray bottle containing 40 mL (1.35 fl.oz.). The spray pump delivers a metered dose of 0.100 mL per spray or approximately 400 sprays.
The provided text describes a premarket notification for the TGO Spray® device, an artificial saliva intended for the symptomatic treatment of xerostomia (dry mouth). However, it does not contain a study that proves the device meets specific acceptance criteria.
The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices. It mentions that TGO Spray® has undergone certain safety studies, but these are not presented as having specific acceptance criteria or performance metrics in the context of a clinical study.
Therefore, many of the requested sections regarding acceptance criteria, study details, and performance are not present in the provided text.
Here's an breakdown of the information that can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not mentioned for performance effectiveness. The document states "The TGO Spray® formulation has been shown in studies, including tests for acute oral toxicity, skin and mucous membrane irritation, skin sensitization, acute eye irritation, oral toxicity, skin and mucous membrane irritation, skin sensitization its in oral toxicity, skin and inucous membrand infriduent sim sective for its intended use." This indicates safety testing, but no specific performance acceptance criteria (e.g., a certain percentage reduction in dry mouth symptoms or duration of relief) are provided.
- Reported Device Performance: Not explicitly stated in terms of quantitative performance metrics. The document claims the device is "effective for its intended use" based on the safety studies listed, and that it "relieves symptoms of dry mouth," but no data points are given to support this.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not provided.
- Data Provenance: The studies mentioned are described generally (e.g., "studies, including tests for acute oral toxicity"). There is no information on the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable / Not provided. The document does not describe a study involving expert assessment to establish ground truth for performance. The studies mentioned are toxicology and irritation tests, which typically don't involve "experts establishing ground truth" in the way clinical performance studies do.
4. Adjudication Method for the Test Set:
- Not Applicable / Not provided. No such method is described as there's no clinical performance test set with ground truth adjudication mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No such study was done or reported. The document does not describe any comparative effectiveness study with human readers (or users in this context) to evaluate the device's performance with or without AI assistance. The device itself is a spray, not an AI-powered diagnostic tool.
6. Standalone Performance Study (Algorithm Only):
- Not Applicable. The device is a physical product (artificial saliva spray), not an algorithm.
7. Type of Ground Truth Used:
- Not Applicable / Not provided for performance. For the safety tests mentioned (toxicity, irritation, sensitization), the "ground truth" would be established by standard laboratory procedures and observations for adverse reactions. There's no clinical performance "ground truth" (like pathology or outcomes data) described in the provided text as part of a performance study.
8. Sample Size for the Training Set:
- Not Applicable / Not provided. There is no "training set" mentioned, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not provided.
Summary of available information related to the device:
The document serves as a 510(k) premarket notification, primarily focusing on demonstrating substantial equivalence to predicate devices for its intended use. It confirms that the device is a non-sterile, lipid solution spray for symptomatic treatment of xerostomia, to be used in the oral cavity as needed. Safety tests for acute oral toxicity, skin and mucous membrane irritation, and skin sensitization were performed, and the formulation was found to be effective for its intended use based on these studies. However, detailed performance acceptance criteria or a clinical study proving performance against such criteria are not included in this document.
N/A