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510(k) Data Aggregation
(63 days)
Stela Capsule System
Stela Primer: - Dentin and enamel bonding
Stela Capsule - Direct Class I, II, III and V cavities. Ideally Class I and II - Base or liner - Core build-ups.
The Stela Capsule System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:
- Stela Capsule - a capsule consisting of powder and liquid components which are mixed and activated when the capsule is pushed down. After mixing with a triturator (amalgamator) an applicator is used to dispense the paste.
- Stela Primer an adhesive liquid packaged in a bottle. A bendable disposable brush applicator is used to apply Stela Primer.
The combination of Stela Primer and Stela Capsule will bond to both enamel and dentin without scrubbing or light curing.
This is a 510(k) premarket notification for a dental device, specifically the Stela Capsule System. The provided text describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not contain the detailed acceptance criteria for a study and the specific performance reported against those criteria in the format you requested for AI/algorithm performance.
The document discusses bench testing for physical and chemical properties of the dental material, and biocompatibility testing. These are not studies that define acceptance criteria or performance for an "AI/algorithm" device in the manner you've described.
Therefore, I cannot populate the table or answer questions 2 through 9 as they pertain to AI/algorithm performance in medical image analysis or similar AI-driven diagnostic/therapeutic applications.
The document indicates:
- The device is not an AI/algorithm-based device. It's a dental restorative material (capsule system and primer).
- No standalone or human-in-the-loop performance studies directly related to AI/algorithm performance were conducted or reported.
- No ground truth derived from experts or pathology for AI training/testing is mentioned.
- No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned.
However, I can extract information regarding the bench testing performance for the Stela Capsule System and how it met ISO standards, which serves as a form of "acceptance criteria" for this type of medical device.
Based on the provided text, here's what can be extracted regarding the material performance and acceptance criteria for the Stela Capsule System:
The Stela Capsule System underwent biocompatibility testing and non-clinical performance data (bench testing) to demonstrate its safety and effectiveness relative to predicate devices and relevant ISO standards.
1. Table of Acceptance Criteria and Reported Device Performance (for Bench Testing):
| Acceptance Criteria (ISO Standard Requirement, where applicable) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO 7405:2018, ISO 10993-5:2009) | Low potential for unacceptable adverse biological response |
| Delayed-type hypersensitivity (ISO 10993-10:2010) | Low potential for unacceptable adverse biological response |
| Irritation/intracutaneous reactivity (ISO 10993-10:2010) | Low potential for unacceptable adverse biological response |
| Systemic toxicity (ISO 10993-11:2017) | Low potential for unacceptable adverse biological response |
| Genotoxicity (ISO 10993-3:2014) | Low potential for unacceptable adverse biological response |
| Non-clinical Performance (Bench Testing): | |
| Working time (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Setting time (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Flexural strength (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Shade (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Colour stability (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Radio-opacity (ISO 4049) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Shear bond strength to dentin (ISO 29022:2013) | Met relevant ISO standard requirement; performed comparably to predicate devices |
| Shear bond strength to enamel (ISO 29022:2013) | Met relevant ISO standard requirement; performed comparably to predicate devices |
Regarding the other questions (AI/Algorithm specific):
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/algorithm study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/algorithm study. Ground truth in this context refers to chemical/physical measurements and biological reactions, not expert interpretations of data.
- Adjudication method for the test set: Not applicable.
- 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 study was not done as this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI device.
- The type of ground truth used: For biocompatibility, the "ground truth" is the universally accepted biological response measures defined by ISO 10993 series. For bench testing, the "ground truth" is the physical and chemical properties measured against ISO 4049 and ISO 29022 standards.
- The sample size for the training set: Not applicable. This device does not involve a training set for an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
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