Search Results
Found 1 results
510(k) Data Aggregation
(151 days)
BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P
The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, composed of materials such as polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novo:lign P are used for temporary or partial or full dentures.
Permanent veneering:
- telescopic and conical crowns
- CoCr clasp restorations
- crowns and bridges
- implant-supported restorations
- coverdenture techniques
Veneer-up:
- selection of esthetic shade, shape and tooth position
Temporary restorations:
- laboratory-made temporaries based on impression and wax-up
- veneer on temporary abutments after placement of the implant
The devices are offered in non-sterile condition.
Bredent novo.lign A / novo.lign P artificial are multi-layer veneers for anterior and posterior teeth. Theses teeth devices are chemically based on polymethacrylate-polymers and their chemical properties. These reformed plastic dentures are used when fabricating any kind of dental restauration (see application range beneath).
The provided text describes a 510(k) premarket notification for "bredent novo.lign A / novo.lign P" artificial teeth, which are preformed plastic denture teeth. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria or specific performance metrics as typically seen for AI device evaluations (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating equivalence to a predicate device through compliance with recognized standards and a summary statement of similar performance.
| Acceptance Criteria Category | Specific Criteria (Implicit from text) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 7405 "Dentistry - Evaluation of biocompatibility of medical devices used in dentistry". | Bredent certifies compliance with ISO 7405. |
| Physical/Material Properties | Compliance with ADA / ANSI ADA Specification No.15 "Synthetic Polymer Teeth" and ISO 22112 "Dentistry - Artificial teeth for dental (Specification No.15 - Synthele Polyment)". | Bredent certifies compliance with ADA / ANSI ADA Specification No.15 and ISO 22112. |
| General Safety & Effectiveness | Technical characteristics, design, Indications for Use, target population, usage, performance, and biocompatibility similar to the predicate device (K962456). | "The bredent product is similiar to the predicate device in terms of technical characteristics, design, Indications for Use, target population, where it is used, performance, biocompatibility characteristics as well as sizes and configurations." and "products perform as well as or better than the comparison to the predicate device for their intended use and do not raise any questions predice device, but affectiveness." |
| Clinical History | No device failures over an extended period of use in Europe. | "All models that are covered by this 510(k) premarket nouncation have been one med and do not raise any kind of question regarding safety and effectiveness of the finished product." (Implies successful use, "one med" is likely a typo for 'on market' or similar.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a traditional "test set" or a study involving patient data in the context of AI/diagnostic device evaluation. The evaluation appears to be based on adherence to standards for material properties and biocompatibility.
- Sample Size: Not applicable in the context of an AI-like test set. The material testing would involve specific quantities of the artificial teeth but these are not disclosed as "sample sizes" for a clinical study.
- Data Provenance: Not applicable for a traditional test set. The compliance tests would have been performed in a laboratory setting. No country of origin for specific "data" or whether it's retrospective/prospective is mentioned for a clinical evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. The device is a physical product (artificial teeth) and the evaluation is based on engineering and material standards, not diagnostic interpretation by experts. There is no concept of "ground truth" established by experts in the way an AI diagnostic algorithm would require.
4. Adjudication Method for the Test Set:
Not applicable. There is no "test set" requiring expert adjudication for this type of device.
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:
Not applicable. This is not an AI diagnostic device. No human-in-the-loop study, MRMC study, or AI assistance is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used:
Not applicable in the context of AI evaluation. The "ground truth" for this product would be the established scientific and engineering specifications and performance requirements defined in the referenced ISO and ADA/ANSI standards for implantable/dental materials.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set for this device.
Ask a specific question about this device
Page 1 of 1