Search Results

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.

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.

Ask a specific question about this device

The BigEasy™ Non-Rebreathing Valve is intended to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support or cardiopulmonary resuscitation (CPR) rescue techniques.

The BigEasy™ Non-Rebreathing Valve is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the patient end that will adapt to standard masks (22mm ID) or endotracheal tubes (15mm OD) used for resuscitation. It provides a path for a rescuer to blow expired air into a mask or endotracheal tube through a silicone valve in the device and has a rigid one-way valve that directs exhaled air from the patient away from the rescuer. It also incorporates an oxygen inlet port on the rescuer's side of the valve for the adding of supplemental oxygen without requiring a separate adapter.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the BigEasy™ Non-Rebreathing Valve.

Here's the breakdown of the information requested:

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

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

The document does not explicitly state the sample sizes for each specific test or the data provenance (country of origin, retrospective/prospective). The studies are described as "Non-clinical test results" and "Bench Tests," which typically implies laboratory testing rather than human subject data.

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 information is not provided. Given that the tests are primarily "Bench Tests" and "Biocompatibility Testing," they typically involve objective measurements against established standards, rather than expert interpretation for ground truth.

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

This information is not provided. The tests appear to be objective measurements against predefined standards, thus not requiring an adjudication method by human experts.

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 MRMC comparative effectiveness study was done. This device is a non-rebreathing valve, which is a physical medical device, not an AI-powered diagnostic tool. The "performance testing" focuses on physical and material properties, not diagnostic accuracy with or without AI.

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

A standalone performance evaluation was done, but it was for the physical device itself, not an algorithm. The device was tested independently against various physical, material, and operational standards.

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

The "ground truth" for the performance tests was based on established industry standards and regulations, such as:

• AS 4259-1995 (Ancillary devices for expired air resuscitation)
• ISO 13544-2:2002 (Respiratory Therapy Equipment – Part 2: Tubing and Connectors)
• ISO 5356-1:2004 (Anaesthetic and Respiratory Equipment – Conical Connectors - Part 1: Cones and Sockets)
• BS EN ISO 10651-4:2009 (Lung Ventilators – Part 4: Particular requirements for operator-powered non-rebreathing valves)
• ISTA-2A:2011 (Packaged-Products weighing 150 lbs (68 kg) or Less)
• ISO 10993-1:2009 COR 1 2010 (Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process)
• FDA Guidance Document (Draft) (Reviewer Guidance on Face Masks and Shield for CPR)
• BS EN ISO 15223-1:2012 (Medical Devices – Symbols to be used with Medical Devices Labels, Labelling and Information to be supplied– Part 1: General Requirements)
• EPA-453/R-98-008B (Method TO-15, Determination Of Volatile Organic Compounds (VOCs) In Air)

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm requiring a 'training set.'

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

Not applicable. There is no training set for this type of device.

Ask a specific question about this device