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510(k) Data Aggregation
(138 days)
Provides a soft barrier between wired mouth hardware and oral mucosa to help relieve discomfort for convalescing oral and maxillofacial surgery patients.
The Wired Mouth Protector consists of a non-sterile strip of non-latex foam with a slit in the middle that is inserted into the front of the mouth between the teeth and lip area with the slit in the center to provide a soft barrier to help protect the oral mucosa from contact with wired mouth hardware. It is changed three times daily or more often if needed.
The provided text describes a 510(k) premarket notification for a medical device called the "Wired Mouth Protector." The document indicates that the device has undergone biocompatibility testing. However, it does not include information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of clinical performance (e.g., efficacy in relieving discomfort in patients).
Therefore, based on the provided text, I cannot complete all sections of your request. Here's a breakdown of what can and cannot be extracted:
Acceptance Criteria and Device Performance:
The document focuses on biocompatibility and substantial equivalence to a predicate device, rather than detailed clinical performance metrics with acceptance criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Non-cytotoxic | - Non-cytotoxic in agar diffusion test (L929 mammalian cells) |
| - Non-cytotoxic in MEM elution test (L929 mammalian cells) | |
| - Non-irritating (dermal) | - Primary skin irritation index = 0.0 (rabbits) |
| - Non-irritating (ocular) | - Non-ocular irritant (rabbit eyes) |
| - Non-toxic (acute oral) | - Extracts not considered toxic at 40 mL/kg body weight; LD50 > 40 mL/kg b.w. (mice) |
| Functional Equivalence to Predicate Device: | "The Wired Mouth Protector performs at least as well as the predicate device" in terms of protective function. |
Information that cannot be extracted from the provided text:
- Sample size used for the test set and the data provenance: The biocompatibility tests were conducted on animal models (rabbits, mice) and cell lines. No human clinical "test set" for performance evaluation is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no clinical test set with ground truth established by experts mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
- The type of ground truth used: For biocompatibility, the chemical and biological responses in standardized tests serve as the "ground truth." For clinical efficacy (e.g., discomfort relief), no such study with defined ground truth is presented.
- The sample size for the training set: Not applicable. This device does not have a "training set" in the context of machine learning.
- How the ground truth for the training set was established: Not applicable.
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