(126 days)
PacEndo™ Sodium Hypochlorite is intended to irrigate, cleanse, and debride root canal systems. It is also intended to provide irrigation during root canal instrumentation.
PacEndo™ Sodium Hypochlorite is a Sodium Hypochlorite solution in water with surfactant to lower surface tension. The solution is root canal cleanser for use in endodontic procedures.
The provided text describes the 510(k) premarket notification for PacEndo™ Sodium Hypochlorite. Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device in terms of performance characteristics. The document indicates that the subject device (PacEndo™ Sodium Hypochlorite) meets these criteria by demonstrating similar properties and, in one aspect, improved performance.
| Acceptance Criteria | Reported Device Performance (PacEndo™ Sodium Hypochlorite) | Predicate Device Performance (3% and 6% Sodium Hypochlorite with wetting agents marketed as Chlor-XTRA™ (K082470)) |
|---|---|---|
| Appearance | clear to light yellow liquid | clear to light yellow liquid |
| pH | 12.11 | 12.02 |
| % Active Chlorine (w/w) | 4.6% | 5.3% |
| Surface Tension | Lower surface tension compared to the predicate device | Higher surface tension compared to the subject device (implied by the subject device's reported lower tension) |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" and its sample size in the context of clinical or large-scale comparative studies. The performance characteristics (Appearance, pH, % Active Chlorine (w/w), Surface Tension) are likely based on laboratory testing of batches of the product. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective.
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 in the document. The type of device (sodium hypochlorite solution) does not typically involve expert interpretation for its core performance characteristics (pH, active chlorine, etc.).
4. Adjudication method for the test set
This information is not applicable and therefore not provided, as there is no indication of a test set requiring adjudication by multiple experts.
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
There is no mention of an MRMC comparative effectiveness study, nor is AI assistance relevant to this type of device (a chemical solution).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a chemical solution and does not involve algorithms or human-in-the-loop performance. The performance characteristics listed (appearance, pH, % active chlorine) are standalone measurements of the chemical product.
7. The type of ground truth used
The ground truth for the non-clinical tests (Appearance, pH, % Active Chlorine (w/w), Surface Tension) would be defined by standard chemical and physical measurement methods. For instance, pH meters, titration for active chlorine, and contact angle measurement for surface tension. There's no reliance on expert consensus, pathology, or outcomes data for these specific parameters.
8. The sample size for the training set
This information is not provided and is not applicable in the context of "training set" for an AI/algorithm-based device. If "training set" refers to the development and formulation of the chemical product, such details are not disclosed.
9. How the ground truth for the training set was established
As there is no "training set" in the context of AI/algorithm, this question is not applicable. For the development and quality control of the chemical product, the ground truth would be established through documented chemical and physical testing protocols and specifications.
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