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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

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.

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The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will allow an anesthesia provider to establish a patent airway in an anesthetized patient while simultaneously preventing occlusion of the teeth. It is intended for use during Electroconvulsive Therapy (ECT) procedures or whenever a bite block is required to prevent occlusion of an endotracheal tube.

The Airway with Bite Block and Tongue Depressor is a combined oral airway and bite block that will allow an anesthesia provider to establish a patent airway in an anesthetized patient while simultaneously preventing occlusion of the teeth. It is intended for use during ECT procedures and whenever a bite block is required to prevent occlusion of an endotracheal tube.

The Airway with Bite Block and Tongue Depressor is available in two sizes, Medium - 80 mm and Large - 90 mm.

The provided document is a 510(k) premarket notification for a medical device called "Airway with Bite Block and Tongue Depressor." It focuses on establishing substantial equivalence to existing predicate devices.

This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically expected for AI/ML-based medical devices or comparative effectiveness studies with human readers.

Instead, the document primarily describes the device, its intended use, and a comparison with predicate devices based on technological characteristics and non-clinical performance tests (biocompatibility and compression testing). The "study" mentioned is a set of non-clinical performance tests.

Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies for AI performance is not available in this regulatory submission.

Here's an attempt to answer the questions based only on the provided text, while acknowledging the limitations:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for any of the non-clinical performance tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests are described as non-clinical performance tests, usually performed in a lab setting by the manufacturer or a contract lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a physical device and the "ground truth" for non-clinical performance tests like compression or biocompatibility is determined by standardized test methods, not expert consensus on interpretations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable.

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:

• No, an MRMC comparative effectiveness study was not done. The device is a physical medical device, not an AI/ML diagnostic tool meant to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For biocompatibility, the ground truth or reference standard is conformity to the requirements of ISO 10993 through specific chemical and biological assays.
• For product compression testing, the ground truth would be the physical properties (e.g., force, displacement) measured according to the test method.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable as this is not an AI/ML device.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device