Search Results

The TD Clip is intended to be used with MATRx or MATRx plus Titration Trays to form a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The device is intended to be fitted with assistance from a healthcare professional and used during sleep for a total of less than 30 nights.

The TD Clip is a temporary oral appliance. The patient uses the temporary oral appliance to alleviate mild to moderate obstructive sleep apnea and/or snoring while waiting for a custom oral appliance to be manufactured. The dentist fabricates temporary titration trays consisting of upper and lower dental trays. The trays are custom fit to the patient using polyvinyl siloxane impression material. The healthcare provider may use the clip assembly to fasten the titration trays at the target therapeutic position to form the TD Clip temporary oral appliance. Patients may use the temporary oral appliance as treatment while waiting for their custom oral appliance. Adjustment of the position requires the setting of a new TD Clip by the healthcare professional.

The acceptance criteria and study proving the device meets them are described below for the TD Clip.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified for any of the performance tests. The document only mentions "mechanical and environmental use conditions" and "repeated use and exposed to normal sleep forces over 30 nights of use".
• Data Provenance: The tests described are "Bench testing" and "simulated mechanical and environmental use conditions," indicating these were laboratory/engineering tests rather than human clinical trials. Thus, there is no country of origin or retrospective/prospective distinction for data provenance in the traditional sense; the data is from an engineering test setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not applicable. The ground truth for these performance tests would be based on engineering specifications and direct measurements against those specifications, rather than expert interpretation of medical data. The evaluation was for mechanical and material performance.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies with human evaluators to establish ground truth for ambiguous cases. These were bench tests against predetermined engineering criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• No MRMC comparative effectiveness study was done. Clinical testing was explicitly stated as "not performed as the device has no technological differences from the predicate."

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

• Not applicable. The TD Clip is a physical medical device (an intraoral appliance) and not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply here. The performance tests focused on the physical integrity and function of the device itself.

7. The Type of Ground Truth Used:

• The ground truth for the performance testing was based on engineering specifications and predefined performance limits (e.g., no breakage, maintenance of protrusive positioning, quick and injury-free removal, adherence to biocompatibility standards). This is a form of objective, empirical measurement and adherence to established material and mechanical standards.

8. The Sample Size for the Training Set:

• Not applicable. As a physical medical device undergoing bench testing, there is no "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set.

Ask a specific question about this device

The Urbanek Device is for the amelioration of clenching and bruxing associated with TMD and is to aid in the relief of symptoms of TMD/TMJ.

The Urbanek Device is an intraoral, maxillary posterior dis-occluding device designed to aid in the treatment of clenching and bruxing associated with TMD/TMJ. The purpose of the device is to keep posterior maxillary and mandibular teeth (molars and premolars) from occluding in the centric or eccentric positions. Constructed of heat cured dental resin and two metal ball clasps for retention, the device is customized for each patient (per prescription by a dentist). The device is designed to be worn for 24 hours per day (except at meals), 7 days per week for a set interval of time (e.g., 9 weeks). At scheduled follow-up visits, patients are assessed for symptom relief and the device inspected for comfort, proper design, excessive wear and vertical dimension for the inter-incisal distance with the device in place. The device may be adjusted for comfort and inter-incisal distance to ensure no posterior tooth or portion of a tooth occludes with the opposing tooth.

The provided text does not contain information about acceptance criteria and a study to prove the device meets those criteria. Instead, it describes a substantial equivalence determination for the "Urbanek Device" (K170985) against predicate devices (NTI-TSS NTI Tension Suppression System and MigraTherapy LLC Brux-TMD QuickSplint).

The document explicitly states:

Performance Testing: "Performance testing has not been performed as there are no recognized standards to which prescription mouthguards are tested; however, the material composition of the Urbanek Device base has been found in legally marketed devices and found previously safe for dental use since 2001 and meets the requirements of ISO 20795-1:2008 Dentistry -- Base polymers -- Part I: Denture base polymers (previously ISO 1567:1999)."

Therefore, I cannot provide the requested information. The device's clearance was based on its substantial equivalence to previously cleared devices, particularly regarding its materials and mechanism of action (disocclusion), rather than specific performance testing demonstrating fulfillment of a set of acceptance criteria.

Ask a specific question about this device