(43 days)
Metapex calcium hydroxide with lodoform is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexificaation, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
Metapex is intended for use by qualified healthcare personnel trained in its use.
Metapex calcium hydroxide with Lodoform is a device consisting of a temporary root canal sealer paste contained within a plastic syringe, packaged with disposable applicator tips and a plastic ring rotator for direction control of the tip. It is a device intended for use by qualified healthcare personnel trained in its use.
The Metapex device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.
The provided text is a 510(k) Summary for a dental device called "Metapex". This document is for a medical device seeking clearance based on substantial equivalence to a predicate device, not for a new device requiring rigorous clinical trials to prove efficacy against acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, in the typical sense of a novel device, is not explicitly present.
For 510(k) submissions, the "acceptance criteria" are generally demonstrating substantial equivalence to a legally marketed predicate device by showing similar indications for use, technological characteristics (materials, design, operational principles), and performance (often through adherence to recognized standards for physical, chemical, and biological properties). The "study" isn't a prospective clinical efficacy study but rather testing to show the new device meets the same standards as the predicate.
However, I can extract the relevant information presented in the document that aligns with the spirit of your request.
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are typically aligned with relevant international standards and direct comparisons to a predicate device. The performance is reported as meeting these standards or being similar to the predicate.
| Acceptance Criteria (based on ISO 6876 & ISO/TR 7405) | Reported Device Performance (Metapex) |
|---|---|
| Physical Properties (per ISO 6876): | |
| - Fluidity | Meets ISO 6876 |
| - Working Time | Meets ISO 6876 |
| - Film Thickness | Meets ISO 6876 |
| - Radiopacity | Meets ISO 6876 |
| - Solubility & Disintegration | Meets ISO 6876 |
| Biocompatibility: | |
| - Freedom from toxicity (Agar diffusion test) | Meets ISO/TR 7405 (Freedom from toxicity) |
| - Biocompatible (Acute intravenous application) | Meets ISO 10993-11 (Biocompatible) |
| Design, Construction, Components: | Premixed paste, packaged in plastic syringe ready to be dispensed |
| Labeling/Intended Use Equivalence | Temporary or permanent root canal sealer; similar to predicate |
| Human Factors | Dispensed ready to use (similar to predicate) |
"Study" Proving Acceptance Criteria:
The "study" in this context is a series of tests and analyses conducted to demonstrate that the Metapex device meets the specified ISO standards for dental root canal sealing materials (ISO 6876) and biocompatibility (ISO/TR 7405 and ISO 10993-11), and that it is substantially equivalent to the predicate device (Vitapex Pre-Loaded Dental Syringe (K973667)). This is not a clinical efficacy trial, but rather a set of bench tests and a comparison of device characteristics.
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 does not provide specific details on the sample sizes used for each individual test (e.g., how many samples were tested for fluidity, working time, etc.). The data provenance is implied to be from laboratory testing conducted by or for the manufacturer (Meta Dental Co. / Meta Biomed Co., Ltd). The specific country of origin for the lab data is not explicitly stated, but the manufacturer is based in Elmhurst, NY, and the correspondent in South Korea (Meta Biomed Co., Ltd). This would be considered prospective laboratory testing rather than retrospective data analysis.
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 is not applicable. For a 510(k) submission focusing on substantial equivalence through physical and biological property testing, "ground truth" is established by adherence to recognized international standards (ISO 6876, ISO/TR 7405, ISO 10993-11) and direct comparison to a legally marketed predicate device. There is no expert consensus on the "truth" of an image or clinical outcome in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in expert opinions. This 510(k) summary focuses on laboratory testing against established standards.
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
Not applicable. This device is a dental material, a root canal sealer, not an AI software or imaging system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" for demonstrating device performance and safety is based on internationally recognized technical standards (ISO 6876 for physical properties of dental root canal sealers, and ISO/TR 7405 / ISO 10993-11 for biocompatibility). The "truth" is that the device's measured properties adhere to these standards and are similar to those of the predicate device.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this type of device (a dental material). This term is relevant for machine learning or AI models.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.