(73 days)
The splinting system is designed for use in oral splintings or to support laboratory-processes composite bridge/denture work
- QUARTZ SPLINT™ UD (Unidirectional): Composite laboratory bridge strengthening/ reinforcement
- QUARTZ SPLINT™ WOVEN: Direct Splinting/Bridge and Implant positioning reinforcement. Splinting of mobile teeth/temporary stabilization in Clinical use. Retention of teeth subsequent to orthodontic therapy.
- OUARTZ SPLINT™ ROPE: Laboratory splint fabrication for bridge reinforcement or denture repair .- Periodontal splinting of mobile teeth in Clinical use.
- QUARTZ SPLINT™ MESH: Denture reinforcement and denture repair.
- QUARTZ SPLINT™ RESIN: for additional wetting during the application of the finished splints
- QS FLOWTM: a nano filled, light cured flowable composite designed to be used with the QUARTZ SPLINT system for reinforcement and stabilizing of mobile teeth.
Quartz Splint is made of quartz fibers impregnated a light-cured resin matrix. Quartz Splint is a complete system that contains different structures and it is available in different structures and sizes:
Quartz Splint UD
Quartz Splint WOVEN
Ouartz Splint ROPE
Quartz Splint MESH
Ouartz Splint Resin/Flow
The provided text contains information about the "Quartz Splint" dental device and its substantial equivalence to predicate devices, but it does not include details about specific acceptance criteria, a standalone study proving meeting those criteria, or a multi-reader multi-case (MRMC) comparative effectiveness study.
Instead, the submission focuses on demonstrating substantial equivalence based on:
- Similar technological characteristics to predicate devices.
- Compliance with an international standard (ISO 4049:2009 for physical and mechanical properties and ISO 10993-5 for biological evaluation).
- No new clinical studies were utilized for the purpose of obtaining safety or effectiveness data with the Quartz Splint.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical and Mechanical Properties (ISO 4049:2009) | The testing results indicate that the subject and predicate devices comply with the requirements of ISO 4049:2009. Internal and external tests demonstrate that QUARTZ SPLINT system compared to the predicate devices performs as well as, or better, in mechanical features which are the main function for a splint. |
| Biological Evaluation (ISO 10993-5 - Cytotoxicity) | Conducted, and results comply with the requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided regarding a distinct "test set" with a specified sample size for this specific device. The evaluation relies on compliance with ISO standards and comparison to predicate devices, implying standard testing for material properties rather than a clinical "test set" in the context of diagnostic device assessment. No data provenance (country of origin, retrospective/prospective) is specified for performance testing, other than "Internal and external tests."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable as the device's performance is assessed against ISO standards for material properties and biological safety, not against a "ground truth" established by experts for a diagnostic task.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data."
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The "performance" section refers to physical, mechanical, and biological evaluations according to ISO standards. This can be considered a standalone evaluation of the material properties and biological response, without human-in-the-loop performance, as it concerns the device itself rather than a diagnostic interpretation task. However, it's not a standalone study demonstrating performance in a diagnostic or clinical scenario in the way a medical AI algorithm would be evaluated.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance appears to be established by:
- International Standards: ISO 4049:2009 for physical and mechanical properties and ISO 10993-5 for biological evaluation.
- Comparative Performance to Predicate Devices: The device is stated to perform "as well as or better" than predicate devices in mechanical features.
8. The Sample Size for the Training Set:
Not applicable. This device is a material/medical device, not an AI algorithm that requires a "training set" in the conventional machine learning sense. The "training" here would be related to the manufacturing processes to ensure the material meets specifications.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as point 8.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.