(136 days)
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- Furcation or root perforation treatment via canal
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- Furcation or root perforation treatment via surgical
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- Internal reabsorption treatment via canal or surgical
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- External reabsorption treatment
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- Retrofilling in parendodontic surgery
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- Direct and indirect pulp capping
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- Apexification
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- Apexogenesis and Pulpotomy
One-Fil putty is a permanent root canal filling repair material with tricalcium aluminate compound that are premixed and designed to be convenient for use. It is hardened by moisture, has characteristics of adhesion and workability. The product is packaged in a paper box with one or two syringes in a tray, and the contents in the glass syringe are white paste type.
The provided document is a 510(k) summary for the medical device "One-Fil Putty." This device is a dental root canal sealer. The document describes the device's characteristics and compares it to a predicate device to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present "acceptance criteria" in a separate table format with pass/fail thresholds. Instead, it lists "Performance Tests in accordance with ISO 6876" as the standards against which the device was evaluated. The results for the "One-Fil Putty" are presented within the "Comparison Chart" (Section 8.1) alongside the predicate device's information for some parameters.
Here's a consolidated table of the performance data extracted from the document, with the understanding that the accepted performance is inferred from compliance with the mentioned ISO standards:
| Test Item | Acceptance Criteria (Inferred from ISO 6876) | Reported Device Performance (One-Fil Putty) | Predicate Device Performance (BIO-C REPAIR) |
|---|---|---|---|
| Foreign substance | No foreign matter (ISO 6876:2012(E) 5.1) | No foreign matter | - |
| Volume | (No specific criterion mentioned, likely for control) | 1.77% | - |
| Packaging | No damage or cracks, no mixing of foreign substances, no other harmful defects in use (ISO 6876:2012(E) 6.3) | No damage or cracks, no foreign substances, no harmful defects | - |
| Setting time | (Standard specified in ISO 6876:2012(E) 5.4, but specific range not stated as acceptance criteria) | 53 min | 90-120 minutes |
| Solubility | (Standard specified in ISO 6876:2012(E) 5.6, but specific limit not stated as acceptance criteria) | 1.3% | - |
| Radio-opacity | Radiopacity of >3mm aluminum (ISO 6876:2012(E) 5.7, ISO 13116:2014) | >3mm aluminum | ~7 mm Al |
| pH | (No specific criterion mentioned as acceptance criteria) | 12.79 | 12.5 |
| Biocompatibility | Biocompatible (in accordance with ISO 10993 series) | Biocompatible | Biocompatible |
| Shelf-Life | (No specific criterion mentioned as acceptance criteria, but duration of predicate is 2 years) | 2 years | 2 years |
Note: The document only provides the performance results for the subject device and in some cases for the predicate. It does not explicitly state the numerical acceptance criteria for many of these tests. Compliance with the cited ISO standards (e.g., ISO 6876) implies that accepted criteria were met. For "Foreign substance" and "Packaging," the description given serves as the implied acceptance criterion. For "Setting time" and "Solubility," specific numerical limits for ISO 6876 are not provided in this document, only the measured values for the subject device.
2. Sample sized used for the test set and the data provenance:
The document does not provide details on the sample sizes used for the non-clinical performance tests (e.g., how many units were tested for setting time, solubility, etc.).
The data provenance (country of origin of the data, retrospective or prospective) is also not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document describes performance testing of a physical material (dental root canal sealer) against international standards (ISO 6876, ISO 13116, ISO 10993, etc.), not a diagnostic or AI-based device requiring expert ground truth for interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the document describes performance testing of a physical material, not a diagnostic study requiring adjudication of interpretations.
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 information is not applicable as the device is a physical dental material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a physical dental material, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the performance tests (foreign substance, setting time, solubility, radiopacity, pH, biocompatibility, shelf-life) is established by objective measurements and laboratory tests conducted according to recognized international standards (ISO 6876, ISO 13116, ISO 10993).
8. The sample size for the training set:
This information is not applicable as the device is a physical material and does not involve an algorithm or a training set in the context of AI/machine learning.
9. How the ground truth for the training set was established:
This information is not applicable as the device is a physical material and does not involve an algorithm or a training set.
§ 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.