(149 days)
The BRX PRO™ Bruxism Guard is indicated to protect the teeth and reduce damage caused by bruxing or nighttime grinding and reducing the noise associated with bruxing and grinding.
The BRX PRO is a prescription dual arch bruxism guard which protects the teeth and reduces the damage caused by nighttime bruxism and reduces the noise of bruxing or nighttime grinding. The BRX PRO's two arch trays, when filled with impression material, cover approximately eight teeth on each of the upper and lower arches, thereby creating an air-gap between the posterior teeth that prevents tooth contact upon clenching. The two polycarbonate trays are connected in the front with a dual position stainless steel "T-bar" pin in the upper tray and a pair of stainless steel slots in the lower tray that can be set by the prescriber to maintain the BRX PRO trays in a neutral position by selecting one of four positions, while allowing for lateral mandibular movement.
The provided text describes a 510(k) premarket notification for the BRX PRO™ bruxism guard. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with clinical outcomes. As such, the information typically found in acceptance criteria of a clinical performance study for an AI-powered device is not fully present.
However, based on the provided text, I can infer and extract information related to the device's technical specifications and non-clinical testing.
Here's a breakdown of the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details non-clinical acceptance criteria related to material properties and biological safety. There is no performance data related to clinical effectiveness (e.g., reduction in bruxing events or noise) in this document, as it focuses on substantial equivalence of the device as a physical product.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Physical Characteristics: | |
| Flexural Modulus (≥ 2000 MPa) | Pass |
| Flexural Stress (≥ 65 MPa) | Pass |
| Water Absorption (≤ 32 µg/m³) | Pass |
| Water Solubility (≤ 1.6 µg/m³) | Pass |
| Charpy Notched Impact Strength (≥ 0.9 KJ/m²) | Pass |
| Biological Evaluation (ISO 10993 Series): | |
| Part 1: Risk Management Process | Pass |
| Part 5: In vitro cytotoxicity | Pass |
| Part 10: Irritation and skin sensitization | Pass |
| Other Applicable Standards: | |
| BS EN ISO 15223-1:2012 (Symbols) | Pass |
| BS EN ISO 20795-1:2013 (Dentistry - Base polymers) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing, not clinical trials with patient data. Therefore, there is no "test set" in the context of patient data, nor information on country of origin or whether data was retrospective or prospective. The "samples" would refer to material samples tested in the lab. The sample sizes for these material tests are not specified in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes non-clinical bench testing of material properties and biological safety, not a clinical study requiring expert ground truth in the medical sense.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is involved. The BRX PRO™ is a physical medical device (a bruxism guard), and its clearance is based on substantial equivalence to existing similar devices through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The BRX PRO™ is a physical device, not an algorithm or AI software, so the concept of "standalone performance" for an algorithm doesn't apply.
7. The Type of Ground Truth Used
For the non-clinical tests described, the "ground truth" would be established by international standards and specifications (e.g., ISO for material properties, ISO for biological evaluation). The device's materials were tested against these pre-defined, objective chemical and physical properties.
8. The Sample Size for the Training Set
This information is not applicable. The BRX PRO™ is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
N/A