(25 days)
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping
iRoot BP Plus Root Repair Material (iRoot BP Plus) is a convenient ready-to-use white hydraulic premixed bioceramic paste developed for permanent root canal repair and surgical applications. iRoot BP Plus is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot BP does not shrink during setting and demonstrates excellent physical properties. iRoot BP Plus is packaged in a preloaded container.
The provided text describes a 510(k) summary for the iRoot BP Plus Root Repair Material. This submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical (bench and shelf life) testing, rather than a clinical study with acceptance criteria and device performance metrics in the typical sense of diagnostic performance (e.g., sensitivity, specificity).
Therefore, the requested information elements related to clinical study design, ground truth, expert consensus, and reader performance are not applicable in this context. The acceptance criteria here would be demonstrating equivalent chemical, physical properties, and performance specifications through bench and shelf-life testing.
Here's an adaptation of the requested table and information based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Specifics from document) | Reported Device Performance (Specifics from document) |
|---|---|---|
| Chemical Composition | Comparable to iRoot BP | Stated as "comparable chemical composition" to iRoot BP. |
| Physical Properties | Comparable to iRoot BP | Stated as "comparable physical properties" to iRoot BP. |
| Performance Specifications | Equivalent to iRoot BP | Stated as "equivalent...performance specifications" to iRoot BP. |
| Safety and Effectiveness of Packaging Materials | Equivalent to materials in BioAggregate, Cavit-W, and VitalCare I.V. Administration Set deemed safe and effective. | Additional material components in iRoot BP Plus's packaging were found to be safe and effective based on predicate devices BioAggregate, Cavit-W, and VitalCare I.V. Administration Set. |
| Delivery System | Comparable to Cavit-W | Stated as having "a comparable delivery system to Cavit-W." |
| Indications for Use | Equivalent to iRoot BP | Stated as having "equivalent indications for use" to iRoot BP. |
Study Details (as applicable to a 510(k) for substantial equivalence based on non-clinical data):
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Sample size used for the test set and the data provenance:
- Test Set: Not applicable in the context of a clinical test set with human or patient data. The "test set" here refers to the iRoot BP Plus product itself undergoing bench and shelf-life testing. The sample size for these non-clinical tests is not specified, but it would have involved multiple samples of the material.
- Data Provenance: The data is from non-clinical (bench and shelf-life) testing conducted by the manufacturer, Innovative BioCeramix Inc. The location of the testing is not specified, but the company is based in Vancouver, BC, Canada. This is not retrospective or prospective clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to the measured chemical, physical, and performance properties of the materials themselves, established through laboratory testing, not expert interpretation of clinical data.
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Adjudication method for the test set:
- Not applicable. There was no clinical test set requiring adjudication.
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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 was a 510(k) for a root repair material, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This was a 510(k) for a root repair material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or reference standard) for this submission consisted of the known chemical compositions, physical properties, and performance specifications of the predicate device (iRoot BP) and other materials (BioAggregate, Cavit-W, VitalCare I.V. Administration Set), established through validated laboratory methods and existing regulatory approvals.
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The sample size for the training set:
- Not applicable. There was no "training set" in the machine learning sense for this medical device submission. The device itself (iRoot BP Plus) was developed based on existing knowledge and materials (the predicate devices).
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How the ground truth for the training set was established:
- Not applicable, as there was no training set in the machine learning sense. The "ground truth" for the development of iRoot BP Plus would be the established scientific and engineering principles for dental materials and the properties of its predecessor and other predicate devices.
§ 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.