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510(k) Data Aggregation
(140 days)
ADVANCED AEROMEDICAL, INC.
The Bio-Post is a dental root canal post intended to be cemented into the root canal of a tooth to stabilized and support a restoration.
The Bio-Post is fabricated from a composite of medical grade continuous glass fibers specifically oriented in a vinyl ester matrix around a surgical grade stainless steel wire. The device is radiopaque, and will be available in standard sizes.
The provided text describes a 510(k) premarket notification for the Bio-Post Dental Post System, which focuses on demonstrating substantial equivalence to a predicate device. This type of submission generally does not include detailed clinical study data with acceptance criteria for device performance in the same way a de novo or PMA submission might. Instead, the focus is on comparative technical characteristics.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" for the Bio-Post in the typical sense of a clinical trial or performance study. Instead, it compares the Bio-Post's material properties to existing devices to establish substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied) | Reported Bio-Post Performance (vs. alloy/steel posts) |
|---|---|---|
| Modulus of Elasticity | Lower than predicate devices | Lower modulus |
| Tensile Strength | Higher than predicate devices | Higher tensile properties |
| Biocompatibility | Biocompatible | Materials showed them to be biocompatible |
| Radiopacity | Radiopaque | Device is radiopaque |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of human clinical data. The comparisons made are related to material properties of the device itself.
- Sample Size: Not specified for material testing, or any human-related test set.
- Data Provenance: The data appears to be from material testing conducted internally by the manufacturer or a contracted lab. There's no mention of country of origin for any human data, and no indication of retrospective or prospective studies involving human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The comparisons are based on objective material property measurements, not expert-adjudicated ground truth from clinical images or patient outcomes.
4. Adjudication method for the test set
Not applicable. There's no human adjudication process involved in comparing material properties.
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 a medical device for structural support (root canal post), not an AI-driven diagnostic or image analysis device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
The "ground truth" for the material comparisons was based on objective physical measurements of modulus of elasticity and tensile strength, and biocompatibility testing.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device requiring data for model training.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
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