(385 days)
The ECT Cotton Bite Block is a single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy (ECT), to protect the patient's lips, teeth and tongue. It is placed between the back molars, with the tongue medial, and one side of the bite block sticking out of the patient's mouth to keep the mouth open.
During the passage of the electrical stimulus during ECT, despite the fact that the patient has been given a systemic muscle relaxant, the masseter muscles contract forcefully, necessitating the use of a bite block or mouth guard. The ECT Cotton Bite Block is intended for single-use only, and is placed between a patient's back molars in order to protect the teeth and tongue during an electroconvulsive therapy (ECT) treatment. Patients who are mentally ill commonly have poor oral hygiene. The placement of the bite block, only on one side of the mouth, allows for any damaged or compromised molars on the opposite side of the mouth to be free from compression. In addition, incisors avoid the risk of being damaged during compression, and the ¾' thick soft cotton provides necessary cushioning for the remaining teeth that are biting down on the cotton roll. One end of the bite block remains outside of the mouth, propping the mouth open for oxygen to be administered, and to ensure that the bite block is staying in place.
Material: The ECT Cotton Bite Block is made of 100% purified medical grade cotton, and is a cylindrical shaped dense cotton roll wrapped in cotton silky yarns.
Sizes: There are two sizes, and size used is determined by the patient's mouth size. The large size is 3/4 inch diameter and 4 inches long, and the medium is ¾ inch diameter and 2 ¾ inches long.
Environment: Electroconvulsive Therapy is administered in a hospital operating room or ECT Suite.
The provided text describes the MECTA Corporation's ECT Cotton Bite Block, a single-use oral protector for use during electroconvulsive therapy (ECT). This document is a 510(k) summary, which establishes substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of efficacy or clinical performance in the same way one would for a diagnostic or therapeutic AI device.
However, based on the information provided, we can infer the "acceptance criteria" relate to the physical performance and biocompatibility of the bite block, and the "study" refers to the engineering and biocompatibility testing performed.
Here's a breakdown of the requested information based only on the provided text, recognizing that this is an FDA 510(k) submission, not a clinical trial report for an AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Cushioning teeth under maximum human bite force (600 N) while maintaining sufficient thickness. | Passed. The ECT Cotton Bite Block was found to compress enough to cushion the teeth, but did not compress under the lower limit of 7 mm compression. |
| Material Biocompatibility: | |
| Non-sensitizing | Passed. Score of all zeros in sensitization testing. |
| Material Biocompatibility: | |
| Non-intracutaneous irritant | Passed. Score of all zeros in intracutaneous irritation testing. |
| Material Biocompatibility: | |
| Non-cytotoxic | Passed. Score of all zeros in cytotoxicity testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the mechanical compression testing or the biocompatibility testing. It only states that the tests were conducted. Data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable in the context of this device and testing. The "ground truth" here is based on objective physical measurements (compression, chemical reactions), not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the testing involves objective measurements, not subjective expert reviews requiring adjudication.
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
This question is not applicable. The device is a physical medical device (bite block), not an AI algorithm or a diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical performance (compression): The ground truth is based on the physical properties of the material and its ability to withstand/cushion force, measured against a specified deformation limit (7 mm).
For biocompatibility: The ground truth is established by standard laboratory tests for sensitization, intracutaneous irritation, and cytotoxicity, yielding objective scores.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of the physical testing described for this device.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set.
§ 882.5070 Bite block.
(a)
Identification. A bite block is a device inserted into a patient's mouth to protect the tongue and teeth while the patient is having convulsions.(b)
Classification. Class II (performance standards).