(146 days)
PacEndo™ Chlorhexidine is intended to irrigate and cleanse root canal systems after endodontic instrumentation.
PacEndo™ Chlorhexidine is a 2% Chlorhexidine Gluconate solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.
This document is a 510(k) premarket notification for a medical device, specifically PacEndo™ Chlorhexidine, an endodontic cleanser. The document focuses on establishing substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be directly extracted from this document as it pertains to a different type of evaluation.
Here's a breakdown of what can be inferred or is missing based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not define explicit "acceptance criteria" in the sense of predefined thresholds for clinical efficacy or safety that might be found in a clinical trial protocol. Instead, it relies on comparison to a predicate device.
| Acceptance Criterion (Inferred from comparison) | Reported Device Performance (PacEndo™ Chlorhexidine) | Predicate Device Performance (CHX and CHX-Plus™) | Summary/Conclusion |
|---|---|---|---|
| Intended Use Equivalence | Intended to irrigate and cleanse root canal systems after endodontic instrumentation. | Used as a final endodontic rinse after instrumentation to irrigate and cleanse the root canal system for long lasting cleansing. | Both devices are used for endodontic procedures to irrigate and cleanse the root canal. |
| Compositional Comparability | Chlorhexidine Gluconate, Surfactant | Chlorhexidine Gluconate, Surfactant, Colorant | The functions of the ingredients in subject and predicate devices are the same. (The presence of colorant in the predicate is noted as a difference but not affecting substantial equivalence of function). |
| Performance - Appearance | Clear to light yellow liquid | Clear to light blue liquid | The difference in appearance doesn't affect substantial equivalence. |
| Performance - pH Testing | Similar pH values (specific values not provided but implied to be comparable to predicate) | Similar pH values (specific values not provided but implied to be comparable to subject device) | Both devices share similar pH values. |
| Performance - Surface Contact Angle Testing | Performs as well as the noted predicate device (specific values not provided) | Performs as well as the noted subject device (specific values not provided) | The subject device performs as well as the noted predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No human or clinical "test set" for performance evaluation is described. The "test set" essentially refers to laboratory samples used for non-clinical comparative testing. The document does not specify the number of samples (e.g., number of pH measurements, number of contact angle measurements) used for these non-clinical tests.
- Data Provenance: Not applicable for a non-clinical comparison study. No information on country of origin for non-clinical lab data.
- Retrospective or Prospective: Not applicable as this is not a clinical study involving patients. The non-clinical tests would have been performed prospectively as part of the device development and submission process.
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)
Not applicable. "Ground truth" in the context of clinical expert consensus is not relevant to this type of non-clinical, comparative device evaluation. The "ground truth" for the non-clinical tests (pH, contact angle) would be the physical measurements themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study involving human readers or interpretation of medical images/data that would require an adjudication method.
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
No. This is not mentioned as this device is a chemical solution (root canal cleanser), not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This question applies to AI-driven devices, which this is not. The "performance" here is intrinsic to the chemical properties of the solution.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests (pH and surface contact angle) would be the results of the physical and chemical measurements obtained in a laboratory setting. There is no expert consensus, pathology, or outcomes data used for this type of submission.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned or implied.
N/A