(119 days)
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:
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Product compression strength | Not explicitly stated as "acceptance criteria" but "Product compression testing" was conducted. Results are not detailed beyond "found to have similar technological characteristics and to be equivalent" to predicates. |
| Biocompatibility (to ISO 10993) | Meets ISO 10993 requirements (Cytotoxicity, Irritation or Intracutaneous Reactivity, Sensitization, Oral Toxicity). |
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.
§ 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).