(8 days)
Repair of Root Perforations
Repair of Root Resorption
Root End Filling
Apexification
Pulp capping
BioAggregate is a white hydraulic cement-like powder composed of biocompatible ceramic particles. The BioAggregate Powder promotes cementogenesis upon mixing with BioA Liquid and forms a hermetic seal inside the root canal.
This document describes the 510(k) summary for BioAggregate, a root canal repair filling material. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a table format with numerical targets. Instead, it describes a comparison to a predicate device (WHITE MTA MATERIAL) and other predicate devices for specific chemical compounds. The performance is assessed based on substantial equivalence in various properties.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical state | Equivalent to WHITE MTA MATERIAL (powder-liquid mix) | BioAggregate is a "white hydraulic cement-like powder composed of biocompatible ceramic particles." It forms a hermetic seal upon mixing with BioA Liquid. |
| Working Time | Equivalent to WHITE MTA MATERIAL | Bench tests included Working Time; concluded as "substantially equivalent." |
| Setting Time | Equivalent to WHITE MTA MATERIAL | Bench tests included Setting Time; concluded as "substantially equivalent." |
| Solubility | Equivalent to WHITE MTA MATERIAL | Bench tests included Solubility; concluded as "substantially equivalent." |
| Radiopacity | Equivalent to WHITE MTA MATERIAL | Bench tests included Radiopacity; concluded as "substantially equivalent." |
| Chemical Compounds | Similar major chemical compounds to WHITE MTA MATERIAL and other predicate devices' specific compounds shown to be safe and effective. | BioAggregate has "similar major chemical compounds" to WHITE MTA MATERIAL, but is aluminum-free and includes calcium phosphate. Other chemical compounds in BioAggregate were found in predicate devices like Tantalum Beads, chronOS™, and PerioGlas, indicating their safety and effectiveness. |
| Non-mutagenic | Non-mutagenic (like WHITE MTA MATERIAL) | Biocompatibility tests determined BioAggregate is "non-mutagenic." |
| Non-cytotoxic | Non-cytotoxic (like WHITE MTA MATERIAL) | Biocompatibility tests determined BioAggregate is "non-cytotoxic." |
| Allergenic Potential | Does not cause allergenic potential | Biocompatibility tests determined BioAggregate "does not cause allergenic potential to tissues after multiple uses." |
| Subcutaneous Tolerance | Good tolerance by subcutaneous tissues | Biocompatibility tests determined BioAggregate "has good tolerance by subcutaneous tissues." |
| Indications for Use | Same as WHITE MTA MATERIAL | BioAggregate has the "same indications for use" (Repair of Root Perforations, Repair of Root Resorption, Root End Filling, Apexification, Pulp capping). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "extensive bench and biocompatibility testing" but does not specify the sample sizes (e.g., number of units tested for working time, number of animals/cells for biocompatibility). The data provenance (country of origin, retrospective/prospective) is not provided. It's implied these are laboratory (bench) tests and biocompatibility studies.
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)
This section is not applicable as the study is not based on expert-established ground truth on clinical images or patient outcomes. The evaluation is against established properties of a predicate device and chemical safety/effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3.
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
This section is not applicable. This submission is for a dental filling material, not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. This is a material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is essentially the established and accepted properties of the predicate device (WHITE MTA MATERIAL) and scientific consensus on the safety and effectiveness of specific chemical compounds found in the additional predicate devices. For biocompatibility, it's based on standard biological evaluation tests (e.g., ISO 10993 series).
8. The sample size for the training set
This section is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This section is not applicable. There is no "training set" or corresponding ground truth establishment in this context.
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.