(154 days)
DIA-ROOT BIO Sealer is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.
DIA-ROOT BIO Sealer is a hydraulic material, and a premixed form that does not require mixing. It blocks the root canal by hardening by reacting with water in the oral cavity. It is contained in a waterblocked syringe and corresponds to ISO 6876:2012, Dentistry-Root canal sealing materials. DIA-ROOT BIO Sealer has two models and they are packaged with components; Disposable tip, Silicone cap.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DIA-ROOT BIO Sealer, structured according to your request:
Acceptance Criteria and Device Performance Study for DIA-ROOT BIO Sealer (K200175)
This document describes a 510(k) premarket notification for the DIA-ROOT BIO Sealer, a root canal filling resin. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Well-Root ST). The performance assessment for this device is based on non-clinical performance data and biocompatibility tests, as no clinical data was submitted.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the DIA-ROOT BIO Sealer are derived from the international standard ISO 6876:2012, "Dentistry - Root canal sealing materials." The device's reported performance is compared to these criteria and also to the predicate device (Well-Root ST).
| Performance Characteristic | Acceptance Criteria (ISO 6876:2012) | Reported Device Performance (DIA-ROOT BIO Sealer) | Predicate Device Performance (Well-Root ST) | Equivalence Assessment |
|---|---|---|---|---|
| Flow | Not less than 17 mm | Not less than 17 mm | Not less than 17 mm | Equivalent |
| Film Thickness | Not more than 50 µm | Not more than 50 µm | Not more than 50 µm | Equivalent |
| Solubility | Not more than 3 % | Not more than 3 % | Not more than 3 % | Equivalent |
| Radio-opacity | Not less than 3 mm | Not less than 3 mm | Not less than 3 mm | Equivalent |
| Biocompatibility | Conformance to ISO 7405, ISO 10993 series | Biocompatible | Biocompatible | Equivalent |
| Performance Standard | Conformed to ISO 6876 | Conformed to ISO 6876 | Conformed to ISO 6876 | Equivalent |
Note: The submission states, "The test results corresponded the requirements of standards. Therefore, the subject device is substantially equivalent to the primary predicate device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of units or samples used for each non-clinical test (Flow, Film Thickness, Solubility, Radio-opacity, Biocompatibility). It only refers to "tests conducted on the subject device."
- Data Provenance: The tests are non-clinical in nature and were conducted to verify conformance to international standards. The country of origin of the data is not explicitly stated, but the applicant, DiaDent Group International, is based in the Republic of Korea. The data is retrospective (i.e., collected before the submission date for this premarket notification).
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This section is not applicable as the provided documentation describes a non-clinical evaluation comparing a new device to a predicate device based on performance standards and biocompatibility, not on human interpretation of clinical data or images. Ground truth in this context would refer to the established values defined by the ISO standards, which are objective measurements, not expert consensus.
4. Adjudication Method for the Test Set
This section is not applicable as the evaluation involved objective physical and chemical testing against defined standard criteria, not subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data was collected or provided to support substantial equivalence between the subject and primary predicate device." The evaluation was based solely on non-clinical performance and biocompatibility.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This section is not applicable. The device is a physical medical device (root canal sealer), not an algorithm or AI-based software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on established objective criteria defined by international standards, specifically ISO 6876:2012 for physical and mechanical properties (Flow, Film Thickness, Solubility, Radio-opacity) and the ISO 10993 series for biocompatibility. This is a form of objective measurement/standard conformance rather than expert consensus, pathology, or outcomes data, as no clinical studies were performed.
8. Sample Size for the Training Set
This section is not applicable as the device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as the device is not an AI/ML algorithm requiring 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.