(57 days)
Permanent root canal filling in combination with gutta-percha points in case of inflamed or necrotic pulp. Permanent root canal filling in combination with gutta-percha points following a retreatment procedure.
BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is hydrophilic mineral root canal sealer presented as a ready-to-use paste in a syringe. BioRoot™ Flow 0.5g, BioRoot™ Flow 2g is based on a tricalcium silicate reaction with in situ water to seal the root canal. The sealer ensures a good adaptation to the root canal, tight interface with gutta-percha point and an adequate radiopacity. It is an implantable medical device intended to be used in dentistry. It is part of endodontic cements used as permanent root canal sealer. BioRoot™ Flow 0.5g. BioRoot™ Flow 2g is used in combination with gutta-percha points to fill the root canal.
This document, K212283, is a 510(k) summary for a medical device called "BioRoot™ Flow 0.5g, BioRoot™ Flow 2g" manufactured by Septodont. It describes a root canal filling resin. The document establishes substantial equivalence to predicate devices based on non-clinical and clinical testing, primarily focusing on physical-chemical properties and functional characteristics.
Here's an analysis based on the provided text, addressing your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that were tested for the new device. Instead, it presents a side-by-side comparison of the subject device (BioRoot™ Flow) with its predicate devices (BioRoot™ RCS and iRoot SP) and claims "substantial equivalence" based on various characteristics. The performance reported is essentially the successful demonstration of this equivalence through bench testing and by leveraging clinical data from the predicate.
Here's a table based on the provided "Side-by-Side Comparison" section, highlighting where performance is discussed implicitly:
| Characteristic | BioRoot™ Flow 0.5g, BioRoot™ Flow 2g (Subject Device) | BioRoot™ RCS (Primary Predicate) | iRoot SP (Secondary Predicate) | Similarities and Differences / Performance (Implied Acceptance) |
|---|---|---|---|---|
| Classification device code | KIF | KIF | KIF | Same; Substantially Equivalent |
| Classification Name | Resin, Root canal filling | Resin, Root canal filling | Resin, Root canal filling | Same; Substantially Equivalent |
| Class | Class II | Class II | Class II | Same; Substantially Equivalent |
| Intended Use | Permanent root canal sealer | Permanent root canal sealer | Permanent root canal sealer | Same; Substantially Equivalent |
| Indications | Permanent root canal filling in combination with gutta-percha points in case of inflamed or necrotic pulp. Permanent root canal filling in combination with gutta-percha points following a retreatment procedure. | Permanent root canal filling in combination with gutta-percha points in case of inflamed or necrotic pulp. Permanent root canal filling in combination with gutta-percha points following a retreatment procedure. BioRoot™ RCS is suitable for use in single cone technique or cold lateral condensation. | Permanent obturation of the root canal following vital pulp-extirpation. Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings. | iRoot SP - Similar, indications statement does not mention gutta-percha points. BioRoot™ RCS – Similar, does not include the statement regarding being suitable for use in single cone technique or cold lateral condensation (due to the change in design, obturation is no longer limited to specific techniques). Implied Acceptance: The differences are considered minor and do not raise new questions of safety or effectiveness. |
| Intended Users | Dental healthcare professional. | Dental healthcare professional. | Dental healthcare professional. | Same, Substantially Equivalent |
| Intended Patient Population | Permanent and mature teeth | Permanent and mature teeth | Permanent and mature teeth | Same, Substantially Equivalent |
| Prescription/over-the-counter use | Prescription | Prescription | Prescription | Same, Substantially Equivalent |
| Single-use/multiple use | Multi-Use Device (only the tips are considered single use) | Single Use Device (The bottle of powder is multi-use, whereas the single dose containers are single use) | Multi-Use | iRoot SP - Same; Substantially Equivalent. BioRoot™ RCS - Different; container closure system is different due to different delivery system. Implied Acceptance: This difference in use model is not deemed to impact substantial equivalence. |
| Galenic Forms (Delivery System) | Paste (paste syringe) | Powder/Liquid (powder liquid mixing) | Paste (paste syringe) | iRoot SP - Same; Substantially Equivalent. BioRoot™ RCS - Different; container closure system is different due to different delivery system. Implied Acceptance: Differences in delivery system are acceptable given other equivalences. |
| Ingredients and quantities | Paste (per 100g): Tricalcium silicate (36.07g), Zirconium oxide (30.00g), Calcium carbonate (3.50g), Propylene glycol (27.93g), Polyvidone K90 (1.00g), Sepineo P600 (1.00g), Aerosil R1812S (0.50g) | Powder (per 100g): Micronized C3S (30.00g), Tricalcium silicate (30.00g), Zirconium oxide (35.00g), Polyvidone K90 (5.00g). Liquid (per 100g): Dihydrated Calcium Chloride (29.40g), Neomere Tech (2.00g), Purified water (68.60g) | Paste: Tricalcium silicate, Dicalcium silicate, Calcium Phosphate, Zirconium oxide, Calcium hydroxide, Solvent, Gelifying Agent, Stabilizer. Quantities are unknown as this is proprietary information. | Performance: "The ingredients contained in BioRoot™ Flow... and iRoot SP are similar and determined to be substantially equivalent." "BioRoot™ Flow... has similar ingredients to BioRoot™ RCS with a few additional ingredients to allow for the paste. The quantities also differ... however once reconstituted the cements have the same amount of Tricalcium silicate and Zirconium oxide (approx. 66%) indicating an equivalent composition. Performance reports have demonstrated substantial equivalence." |
| Operations (Mixing and Dispensing) | No mixing required, product is a ready-to-use paste | Mixing: liquid added to powder and mixed by hand by the dentist. | No mixing required, product is a ready-to-use paste | iRoot SP - Same; Substantially Equivalent. BioRoot™ RCS - Different; mixing is required. Implied Acceptance: Simpler operation is a difference but does not prevent equivalence. |
| Consistency | Paste | Not Performed (not a paste) | Paste | iRoot SP - Same; Substantially Equivalent |
| Setting Time | 1h to 6h | 55min to 300min | 4h | Performance: "Performance testing have demonstrated that BioRoot™ Flow... is substantially equivalent to BioRoot™ RCS and iRoot SP sealer regarding setting time." |
| Additional Performance Claim | "BioRoot™ Flow... has undergone extensive bench testing to provide evidence that its physical-chemical properties are substantially equivalent to the predicate devices, BioRoot™ RCS and iRoot SP. All three (3) devices are provided non-sterile, have comparable setting time, sealing and adhesion." | Not specified in detail. | Not specified in detail. | Implied Acceptance: Comparable sealing and adhesion demonstrated. |
| Biocompatibility | "Biocompatibility test results determined that considering all existing data resulting from the chemical characterization and associated toxicological risk assessment, and from biological data, the biocompatibility profile of BioRoot™ Flow 0.5g, BioRoot™ Flow 2g can be considered acceptable when used as intended." | Not specified in detail, but implied as a predicate. | Not specified in detail, but implied as a predicate. | Implied Acceptance: Biocompatibility is acceptable. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily relies on non-clinical bench testing for the new device and equivalence to a predicate that likely had clinical data.
- Test Set Sample Size: The document does not specify the sample sizes for the bench tests conducted on BioRoot™ Flow. It states "extensive bench testing" and that results demonstrated "substantial equivalence" for physical-chemical properties, setting time, sealing, and adhesion.
- Data Provenance: The document does not specify the country of origin of the data nor whether the studies were retrospective or prospective. Given it's a 510(k), regulatory submissions typically rely on a mix of existing data and new testing. The reference to "existing data" for biocompatibility suggests some retrospective component, but the bench testing would be prospective for the new device.
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)
The document does not mention using experts to establish ground truth for a test set. This device is a dental material, and its equivalence is based on physical, chemical, and biological properties, not interpretative tasks (like image reading) that would require expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. Since there is no mention of expert review or interpretation of data in a way that would require adjudication (e.g., in an image-based diagnostic study), no adjudication method is specified.
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 MRMC study was done. This is a root canal filling material, not an AI-assisted diagnostic device. The "clinical testing" mentioned (Section 8) refers to demonstrating clinical equivalence to the primary predicate based on the predicate's existing clinical data, rather than performing new clinical trials for the subject device. It states, "Clinical evaluation data obtained using the equivalent device, BioRoot™ RCS, was used to support clinical evidence of BioRoot™ Flow 0.5g, BioRoot™ Flow 2g and can be extended to BioRoot™ Flow 0.5g, BioRoot™ Flow 2g in terms of clinical performance and clinical safety."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a physical medical device (root canal sealer), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing of the subject device (BioRoot™ Flow), the "ground truth" would be established by standardized laboratory testing procedures and predefined specifications for material properties (e.g., setting time measurement according to ISO standards, or specific measurements for sealing and adhesion). For biocompatibility, it's based on chemical characterization and toxicological risk assessment, and biological data (likely in vitro and/or in vivo animal studies as per ISO 10993).
For the claim of clinical equivalence, the "ground truth" for the predicate device's clinical performance would have been established through its own clinical studies and outcomes data, which are then leveraged for the new device by demonstrating substantial equivalence in technology and intended use.
8. The sample size for the training set
Not Applicable. This document describes a traditional medical device (dental material), not an AI/ML product that would have a "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment process for that purpose.
§ 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.