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510(k) Data Aggregation
(250 days)
Removal of necrotic or inflamed tissue from the apical foramen and periapical region during root canal treatment.
The Apexum device consists of two parts, designed to be used sequentially: the Apexum NiTi Ablator and the Apexum PGA Ablator. It is designed to remove inflamed tissue during root canal treatment with a powered handpiece device.
This report is for a Class I dental handpiece, meaning the regulatory requirements are less stringent than for higher-class devices. The submission indicates that safety and effectiveness evaluations were based on animal and clinical studies, but specific acceptance criteria and detailed study results beyond a general statement of "substantial equivalence" are not provided in the supplied text.
Here's an attempt to structure the information based on the provided text, while noting the significant gaps due to the nature of the submission for a Class I device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device must be as safe as predicate devices. | "Safety and effectiveness evaluations based on animal and clinical studies indicate the device is substantially equivalent to the predicates cited." |
| Effectiveness: Device must be as effective as predicate devices for the intended use. | "Safety and effectiveness evaluations based on animal and clinical studies indicate the device is substantially equivalent to the predicates cited." |
| Technological Characteristics: Must have similar technological characteristics to predicate devices. | "The Apexum Ablator and the cited predicate devices have the same technological characteristics and indication for use." |
| Minor Differences: Any technical parameters that differ must not affect safety or effectiveness. | "Some technical parameters differ between the Apexum Ablator and the predicate devices, but these differences are minor and do not affect safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the "animal and clinical studies."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The provided text does not mention the number of experts used to establish ground truth or their qualifications. Given the device class and the information provided, it's unlikely that such specific details would be included in a 510(k) summary for this type of device.
4. Adjudication Method for the Test Set
The provided text does not mention any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of an MRMC comparative effectiveness study is made. This type of study is generally conducted for diagnostic imaging devices where human interpretation plays a significant role. For a Class I dental handpiece, it's highly improbable such a study would be performed or required.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study is mentioned. This device is a physical handpiece, not an algorithm, so a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated. However, given it's a dental device, "clinical studies" would likely involve observations of clinical outcomes (e.g., successful tissue removal, absence of complications) in animal models and potentially human subjects as part of the "substantial equivalence" justification.
8. Sample Size for the Training Set
No training set sample size is mentioned. This concept is typically relevant for machine learning algorithms, which is not applicable to this device.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an algorithm. The "ground truth" for the overall device's safety and effectiveness would have been established through a combination of animal studies and clinical observations, likely comparing outcomes to those achieved with predicate devices.
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