(267 days)
The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.
The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.
The provided text is a 510(k) Notification for a dental product (porcelain) and does not describe a software-based medical device or AI system. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance) is not applicable to this document.
The document discusses the substantial equivalence of the "Matchmaker/Propaque porcelain" to a predicate device named "Creation". The equivalence is based on chemical similarities, application similarities, and performance similarities.
Here's a breakdown of what can be extracted from the provided text, aligning with the spirit of your request where possible, but acknowledging it's not an AI/software device:
1. Table of Acceptance Criteria and Reported Device Performance
This product is demonstrated to meet acceptance criteria by conforming to an established international standard for dental materials.
| Acceptance Criterion (Specified in ISO 9693:1991) | Reported Device Performance (Matchmaker/Propaque porcelain) |
|---|---|
| Flexural Strength | Conforms to ISO 9693:1991 |
| Chemical Solubility | Conforms to ISO 9693:1991 |
| Fired Porosity | Conforms to ISO 9693:1991 |
| Coefficient of Expansion | Conforms to ISO 9693:1991 |
| Glass Transition Temperature | Conforms to ISO 9693:1991 |
| Metallo-ceramic Bond Characterization | Conforms to ISO 9693:1991 |
The document states, "Both products are manufactured to conform to ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material." This implies that the Matchmaker/Propaque porcelain, to achieve substantial equivalence, meets the performance criteria specified in this standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a material science claim, not a data-driven AI device. The "test set" would be physical samples of the porcelain material tested according to ISO 9693 methods. The sample sizes for these material tests are not specified in the provided text.
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)
Not applicable. Ground truth for material properties is established by standardized physical and chemical testing methods, not by expert consensus on interpretations as in medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations or diagnostic decisions, not for objective material property measurements.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is objective measurements of physical and chemical properties as defined and standardized by ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material. This standard specifies how to measure properties like flexural strength, chemical solubility, etc.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a word that appears to be handwritten in white against a black background. The word is "Schottlander". The letters are connected, giving it a cursive appearance.
NOV 19 1996
510(K) Notification for Matchmaker/Propaque Porcelain
- 510(K) Summary of the safety and effectiveness information upon which the substantial equivalence determination for Matchmaker/Propaque porcelains are based
| Name of contact person: | Mr B D Schottlander |
|---|---|
| Date that Summary was prepared | 16 February 1996 |
| Trade name | Matchmaker/Propaque porcelains |
Common name Classification name
maker/Propaque por Bonding porcelain or metallo ceramic 872.6660-porcelain powder for clinical use
The legally marketed device to which we are claiming equivalence is called Creation.
The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.
Comparison to predicate device.
Chemical Similarities
Both products are feldspathic porcelains conforming to ISO 9693:1991 and are used in dentistry for fusing to a metal frame work to form an enamel porcelain layer. Both products are supplied with different layers ie; opaque, dentine, enamel etc. in order to replicate different colour layers in a natural tooth. Both products fall within the same class and part numbers. Both products are claimed on the labelling and directions for use to have essentially the same properties and usage.
Application Similarities
Both products are supplied as a powder for mixing together with a liquid to form a paste or as a pre-mixed paste. Both products are supplied with different layers ie; opaque, dentine, enamel etc. in order to replicate different colour layers in a natural tooth and these layers are built up and fired in a furnace in the same order and at similar temperatures (see also below).
Performance similarities.
Both products have essentially the same firing characteristics including low temperature for insertion into the furnace, drying time, final temperature and requirement for vacuum. Both products are manufactured to conform to ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material. This standard specifies performance criteria such as flexural strength, chemical solubility, fired porosity, coefficient of expansion, glass transition temperature and metallo-ceramic bond characterisation.
From the above information it is concluded that Matchmaker/Propaque porcelain possess substantial equivalence to the predicate device.
§ 872.3920 Porcelain tooth.
(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.