(278 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Provide oral protection during seizures and other circumstances requiring protection of oral tissues. | Met: Both PATI and the predicate (Surgovations SurgeoBite) are described as "oral protectors for use during spontaneous seizures and any circumstances requiring the protection of the teeth, lips, tongue, and buccal mucosa." |
| Design and Principles of Operation Equivalence: General design features (mouth guard walls, bite pads, salivary drainage opening). | Met: Both devices have "mouth guard walls that reside in the space between the buccal tissues and the teeth, bite pads to cushion teeth during biting or clenching, and an opening in the front of the device for salivary drainage." |
| Biocompatibility: Safe for patient contact based on type and duration of contact. | Met: PATI underwent biocompatibility testing (Cytotoxicity, Sensitization, and Irritation) according to ISO 10993-1 and FDA Guidance, similar to the predicate device. |
| Performance (Mechanical/Functional): Ability to function as a bite protection device. | Met: "Simulated Use Bite Force and Displacement Testing" was conducted to support the premarket notification. While specific metrics are not provided, the inclusion implies successful performance. |
| Human Factors: Safe and effective use by various user groups. | Met: "Summative Human Factors testing was performed using 30 users across adolescent and adult user groups to demonstrate that the subject device promotes safe and effective use across all user groups." |
| Indications for Use (Specific Patient Population/Environment): Protection for individuals aged 12 or older, in clinical or non-clinical environments. | Met: This was addressed through "design, risk analysis, product labeling, and the Summative Human Factors Testing" to ensure safety and effectiveness for the adolescent and non-clinical user populations. |
| Sterilization: Non-sterile. | Met: Both PATI and the predicate are "Non-sterile." |
| Reuse: Single use. | Met: Both PATI and the predicate are "Single use." |
| Prescription Status: RxOnly. | Met: Both PATI and the predicate are "RxOnly." |
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.
§ 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).