(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.
§ 872.6890 Intraoral dental wax.
(a)
Identification. Intraoral dental wax is a device made of wax intended to construct patterns from which custom made metal dental prostheses, such as crowns and bridges, are cast. In orthodontic dentistry, the device is intended to make a pattern of a patient's bite to make study models of the teeth.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.