(252 days)
DIAPEX PLUS is a calcium hydroxide paste with iodoform, used as a temporary root canal filling material. Application : Root canal filling material / Apexification and hard tissue formation/ Apexogensis
The subject device is packaged with the following:
- 0 Syringe
- Disposable Tip .
- Silicon Cap .
The provided text is a 510(k) summary for a dental device called "DIAPEX PLUS," a root canal filling material. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence for regulatory clearance. Since this document is a regulatory submission for a medical device that needs to demonstrate substantial equivalence to a predicate device, it contains extensive information about the characteristics of the new device and the predicate device, and how they are similar. This is not a study that presents a test set, acceptance criteria and results against it.
However, based on the information provided, here's an attempt to structure a response using the requested categories, noting where information is not present in the document.
Acceptance Criteria and Study for DIAPEX PLUS
The document provided does not present a typical "acceptance criteria" table with reported performance against specific quantitative thresholds for the device itself. Instead, it demonstrates conformance to recognized international standards and compares the device's technological characteristics to legally marketed predicate devices. The "study" implicitly refers to the non-clinical performance data and the comparison presented to support substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of explicit acceptance criteria with numerical thresholds, the document states conformance to various ISO standards. The "reported device performance" is essentially that the device conforms to these standards and is substantially equivalent to the predicate devices.
| Acceptance Criteria (based on Conformance to Standards and Equivalence) | Reported Device Performance |
|---|---|
| ISO 6876:2012 (Dentistry — Root canal sealing materials) | Conforms |
| - Flowability | Conforms |
| - Film Thickness | Conforms |
| - Radio-opacity | Conforms |
| ISO 7405:2008 (Dentistry — Evaluation of biocompatibility of medical devices used in dentistry) | Conforms |
| ISO 10993-1:2009 (Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process) | Conforms |
| ISO 10993-3:2014 (Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity) | Conforms |
| - Genotoxicity Bacterial Reverse Mutation | Conforms |
| - Genotoxicity Mouse Lymphoma Assay | Conforms |
| ISO 10993-5:2009 (Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity) | Conforms |
| - Cytotoxicity | Conforms |
| ISO 10993-6: 2016 (Biological evaluation of medical devices — Part 6: Tests for local effects after implantation) | Conforms |
| - 4 Week Systemic Toxicity | Conforms |
| ISO 10993-10:2010 (Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization) | Conforms |
| - Sensitization | Conforms |
| ISO 10993-11:2017 (Biological evaluation of medical devices — Part 11: Tests for systemic toxicity) | Conforms |
| - Acute Systemic Toxicity | Conforms |
| - Pyrogenicity | Conforms |
| - 4 Week Systemic Toxicity | Conforms |
| Technological Characteristics (vs. Predicate Devices) | |
| - Intended Use/Indications for Use | Equivalent |
| - Directions for Use | Equivalent |
| - Package Contents (differences noted, but overall equivalence claimed) | Equivalent |
| - Period of Use | Equivalent |
| - Composition | Similar (biocompatibility and performance tests confirm substantial equivalence) |
| - Biocompatibility | Equivalent |
| - Delivery forms | Equivalent |
| - Standards | Equivalent |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated in the document. The non-clinical performance data likely involved various samples tested according to the referenced ISO standards.
- Data provenance: Not explicitly stated. These would typically be laboratory tests conducted by the manufacturer or a contract research organization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided because this is a regulatory submission demonstrating substantial equivalence through conformance to standards and comparison of technical characteristics, not a clinical study with expert-established ground truth. The "ground truth" here is adherence to specified standard test methods and established benchmarks within those standards.
4. Adjudication method for the test set:
- Not applicable as this is not a study requiring adjudication of expert interpretations (e.g., medical imaging classification). The results would be objectively measured parameters defined by the ISO 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 root canal filling material, not an AI-assisted diagnostic tool. No MRMC study was conducted or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic or AI device. The device's performance is standalone in the sense that its physical and chemical properties and biocompatibility are tested independently.
7. The type of ground truth used:
- The "ground truth" for this submission is established through conformance to international standards (e.g., ISO 6876, ISO 10993 series) and through demonstration of substantial equivalence of technological characteristics to legally marketed predicate devices. The tests are bench tests measuring physical, chemical, and biological properties according to standardized methods.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI device, there is no training set or associated ground truth.
§ 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.