(113 days)
EDS Combo-Rinse is intended to cleanse root canal systems by irrigating root canals.
EDS Combo-Rinse is an aqueous solution for use during the irrigation phase of endodontic root canal preparation procedures. The device has a dual purpose of flushing out any loosened debris and removing the smear layer produced from root canal instrumentation.
The provided text describes a 510(k) summary for the EDS Combo-Rinse device, which is an aqueous solution for use during root canal preparation. The submission focuses on demonstrating substantial equivalence to a predicate device (QMix™ 2in1 Endodontic Irrigating Solution). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of equivalence to the predicate device, rather than independent performance metrics defined specifically for EDS Combo-Rinse.
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on predicate device equivalence) | Reported Device Performance (for EDS Combo-Rinse) |
|---|---|
| Biocompatibility equivalent to predicate device (QMix™ 2in1 Endodontic Irrigating Solution) | Demonstrated equivalence to the predicate device in five biocompatibility tests according to ISO 10993. |
| Smear layer removal performance equivalent to predicate device (QMix™ 2in1 Endodontic Irrigating Solution) | Demonstrated equivalence to the predicate device in smear layer removal performance. |
| Safety equivalent to legally marketed devices containing the same components | Prior use of components in legally marketed devices (including predicate devices with common components) supports safety. |
| Effectiveness equivalent to legally marketed devices containing the same components | Prior use of components in legally marketed devices (including predicate devices with common components) supports effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for the biocompatibility or smear layer removal testing.
Regarding data provenance:
- The tests were conducted to determine equivalence to the predicate device.
- The document implies these were non-clinical tests.
- Country of origin is not specified but is assumed to be part of the manufacturer's testing process.
- The studies were retrospective in the sense that they compared the new device to existing predicate devices, but the testing itself would have been prospective for the EDS Combo-Rinse samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" here is the established safety and performance profile of the predicate device and the accepted standards (ISO 10993). There is no mention of human experts establishing ground truth for a test set in the context of device performance. The assessment is based on laboratory test results against established benchmarks.
4. Adjudication Method for the Test Set
Not applicable. There was no explicit adjudication method for a test set described, as the evaluation was based on objective, standardized tests (biocompatibility according to ISO 10993, and smear layer removal testing).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not relevant for a root canal irrigating solution and was not performed. The device is a physical/chemical irrigant, not an imaging or diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The biocompatibility and smear layer removal tests are standalone evaluations of the device's physical and chemical properties and performance, without human intervention in the device's function during testing. This is a "device only" performance assessment.
7. The Type of Ground Truth Used
The ground truth used for comparison was:
- Established performance of the predicate device: QMix™ 2in1 Endodontic Irrigating Solution, particularly its biocompatibility and smear layer removal capabilities.
- International standards: ISO 10993 for biocompatibility testing.
- Regulatory precedence: The fact that components have been "used in legally marketed devices and were found safe for dental use."
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is not relevant to this type of device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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