(86 days)
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
| Acceptance Criteria (General Category) | Reported Device Performance (Specific Tests) |
|---|---|
| Biocompatibility | The silicone rubber material is compliant under ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation. |
| Performance - Protection of Teeth/Mouth Tissues | - Bite Force Testing: Passed within acceptance parameters. |
- 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.
§ 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).