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The PATI device is a single-use (disposable) oral protector for use during spontaneous seizures and any circumstances requiring the protection of the teeth, lips, tongue, and buccal mucosa. The PATI is indicated for use with any individual aged 12 or older who suffers from seizures and can be used in a clinical or non-clinical environment.

The Protector Against Tongue Injury (PATI) device is a symptom-management, oral device technology that helps to protect against oral injury during seizures, while also allowing fluids to naturally drain or be suctioned. The device will be administered by the patient, an assistant, or medical personnel, (such as hospital staff, EEG technicians, or first responders, including EMTs and paramedics), prior to full onset of a seizure. The device is single use and disposable.

This document is a 510(k) summary for the NeuroVice PATI (Protector Against Tongue Injury) device. It describes the device, its intended use, and how it is substantially equivalent to a predicate device.

Here's the breakdown of the acceptance criteria and study information provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way one might expect for a quantitative AI/ML study. Instead, it demonstrates substantial equivalence through a direct comparison of attributes with a predicate device and by reporting on various non-clinical and human factors tests.

However, based on the provided text, we can infer some "acceptance criteria" through the lens of establishing substantial equivalence and the reported performance as a confirmation of meeting these criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Human Factors Testing: 30 users across adolescent and adult user groups.
• Data Provenance: Not explicitly stated, but Human Factors testing is typically prospective, involving participants performing tasks with the device.

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 device is not an AI/ML algorithm that relies on expert interpretation of data to establish ground truth. Therefore, this question is not directly applicable. The "ground truth" for the performance and human factors testing would be derived from direct observation and measurement of device function and user interaction.

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

Not applicable, as this is not an AI/ML study involving diagnostic imaging or similar data requiring expert adjudication. The "ground truth" for human factors testing would be objective data collected on device usability and safety, not expert consensus on interpretations.

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

Not applicable. This device is a physical medical device (bite block), not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical device and does not involve an algorithm.

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

For the tests described:

• Biocompatibility: Laboratory test results (e.g., cytotoxicity, sensitization, irritation) against established ISO standards.
• Performance Testing (Simulated Use Bite Force and Displacement): Objective physical measurements of the device's mechanical properties.
• Human Factors Testing: Objective observations and data collected from user interactions with the device, and potentially subjective feedback, to assess usability, safety, and effectiveness. The "ground truth" here is whether users can safely and effectively use the device as intended.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML system.

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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 SurgeoBite® device is single-use (disposable) oral protector for use during seizures induced by electroconvulsive therapy, spontaneous seizures, neuromonitoring stimulation, and any circumstances requiring protection of the teeth, lips, tongue, and buccal mucosa.

The SurgeoBite is designed to be an easy to use and safe device for use in the patient's mouth. The shape of the device allows for easy positioning into the mouth and provides a biting surface between the teeth making sure that the tongue and cheeks are not between the biting surfaces. During seizures induced by electroconvulsive therapy, neuromonitoring stimulation, spontaneous seizures, and circumstances requiring protection, the jaw muscles can contract and cause potential damage to the teeth and mouth tissues. By placing the oral protector in the patient's mouth, it will provide protection of the teeth, lips, tongue, and buccal mucosa. The SurgeoBite is sold nonsterile, single use, and is discarded after use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SurgeoBite device:

The provided document is a 510(k) summary for the SurgeoBite, a bite block. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove efficacy through extensive clinical trials as would be required for a PMA (Premarket Approval). Therefore, the "study" referred to in your prompt is primarily focused on demonstrating safety and performance characteristics in comparison to existing devices.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

• Displacement Testing: Passed within acceptance parameters.
• Testing with Endotracheal Tubes: Passed within acceptance parameters. |
  | Safety and Reliability | All testing results passed within the acceptance parameters and demonstrated a safe and reliable device for providing protection of the teeth, lips, tongue, and buccal mucosa. (Specific numerical acceptance values are not provided in this summary.) |
  | Same Principles of Operation & Indications for Use (vs. Predicate) | The SurgeoBite has the same basic technology characteristics (one-piece, single-use bite block) and indications for use as the predicate device (Ventil-A). |
  | Technological Characteristics Equivalency (vs. Predicate) | The device has similar technological characteristics, despite using a different profile and medical-grade silicone rubber (closed-cell foam for predicate). The differences are not considered to raise new questions of safety or effectiveness. |

Note: The document states that "All of the testing results for SurgeoBite passed within the acceptance parameters," but it does not explicitly state the quantitative acceptance criteria for each test (e.g., maximum bite force resistance, acceptable displacement range). Such details would typically be found in the full 510(k) submission, not necessarily in the summary provided.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not provide details on the sample size used for the performance tests (Bite Force, Displacement, Endotracheal Tubes). It also does not mention the data provenance (e.g., country of origin, retrospective/prospective), which is typical for performance bench testing rather than clinical study data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided. The "ground truth" concept is more relevant for studies involving human interpretation (e.g., image analysis, diagnosis). For bench performance testing of a physical device like a bite block, the "ground truth" is established by adherence to engineering specifications and standardized test methods.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple human readers or evaluators assess cases and disagreements need to be resolved. This is not relevant for the bench performance testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where the performance of human readers with and without AI assistance is compared. The SurgeoBite is a physical medical device (bite block), and its evaluation focuses on physical performance and biocompatibility.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this is not applicable. The SurgeoBite is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance and biocompatibility testing described, the "ground truth" is based on:

• Established engineering specifications and accepted medical standards: For tests like Bite Force, Displacement, and Testing with Endotracheal Tubes, the "ground truth" or acceptance criteria would be derived from expected functional requirements for a bite block and comparison to the predicate device's known performance.
• International Standards (ISO 10993-1): For biocompatibility, the ground truth is compliance with the requirements outlined in ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation. These standards define the acceptable responses.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" refers to data used to train an algorithm or AI model. The SurgeoBite is a physical device, not an AI system.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reason as point 8.

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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.

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The EpiGuard is intended for the prevention of oral soft tissue damage during epileptic tonic-clonic seizures proceeded by an aura.

The EpiGuard is a single use oral protective device manufactured from biocompatible silicone. It is provided clean (non-sterile). Besides providing a physical barrier to prevent tongue and cheek damage of the user, the device will maintain an open airway in the mouth cavity and allow the free flow of air and vomit. In addition, the device is griped under the palatals and teeth of the user while also being held in front by the interior surface of the lips. This allows the EpiGuard to be fixed to the necessary position to prevent it from being swallowed.

This document describes the acceptance criteria and the study that proves the device meets those criteria for the EpiGuard bite block.

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: 10 subjects.
   • Data Provenance: The study was an observational study conducted by the manufacturer, EpiSafe Medical Devices, Ltd., in Israel. The nature (retrospective/prospective) is not explicitly stated, but "observational study" typically implies prospective data collection for the specific evaluation.

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

   • Not applicable. The study involved subjects grading the device's performance, not experts establishing ground truth for a diagnostic output.

3. Adjudication method for the test set:

   • Not applicable. The study involved subject self-grading (scale of 1-5) on device performance, not expert adjudication of a classification.

4. 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 MRMC comparative effectiveness study was done. This device is a physical bite block, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. This device is a physical bite block, not an algorithm.

6. The type of ground truth used:

   • Subjective assessment of device performance by the users (subjects) themselves, graded on a scale of 1-5 for 13 specific aspects.

7. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI/ML algorithm requiring a training set in the conventional sense. The "dimensions were based upon the measurements from dental impressions of men and women above the age of 10," which might be considered analogous to "training data" for design, but it's not a computational training set.

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

   • Not applicable as it's not an AI/ML algorithm. The design of the device was based on "measurements from dental impressions of men and women above the age of 10." The "ground truth" for the design would be anatomical averages and variations within the target user population.

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