(109 days)
HASS Zirtooth is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crown, bridges, inlays, and onlays.
HASS Zirtooth is a zirconia porcelain product to be used to make the core of the all porcelain crown. It consists of ceramic blocks and corresponds to ISO 6872 Type 2 Class 1. This ceramic product provides the supporting structure for mounting the ceramic restoration. The shelf life of the ceramic block is semi-permanent.
The provided text describes a 510(k) submission for a dental device, "HASS Zirtooth," and focuses on its substantial equivalence to a predicate device based on physical characteristics. However, it does not contain information about a clinical study involving human subjects or AI performance. The summary details engineering and materials testing, not a clinical trial with specific performance metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot, based on your request:
Acceptance Criteria and Study Details for HASS Zirtooth (HASS Corp.)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards) | Reported Device Performance (HASS Zirtooth) |
|---|---|
| ISO 6872 | Met the test criteria |
| ISO 9693 | Met the test criteria |
Note: The document states: "The following properties were tested for the device according to ISO 6872 and 9693 and all the results met the test criteria." It lists some of the properties under each standard (e.g., Uniformity, Extraneous Materials, Chemical Solubility, Flexural Strength, Radioactivity of dental ceramic, Flexural strength after the low-temperature deterioration for ISO 6872; Coefficient of thermal expansion and Bonding strength with veneer ceramic for ISO 9693). Specific numerical thresholds for acceptance criteria and the exact numerical performance values are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for test set: Not specified. The study was a materials engineering test, not a clinical study on a patient population.
- Data Provenance: Not applicable in the context of clinical data. It's an in-vitro materials test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the study was based on material property testing according to established ISO standards, not expert clinical assessment for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This relates to clinical interpretation and adjudication, which was not part of this materials standard testing.
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, an MRMC comparative effectiveness study was not done. This submission is for a dental material, not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a ceramic material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance was adherence to material property specifications defined by ISO 6872 and ISO 9693 standards.
8. The sample size for the training set
- Not applicable. There was no "training set" as this is a physical material, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. There was no "training set" or corresponding ground truth establishment in the context of machine learning.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.