(158 days)
Tigran™ PeriBrush™ is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium Implant surfaces in bone defects caused by peri-implantitis.
The Tigran™ PeriBrush™ is made of pure titanium (brush part) and nitinol (stem part). It is intended to use for mechanical debridement of surgically exposed dental titanium implant surfaces to remove plaque and calculus due to peri-implantitis. The product has a connector that fits into the head (chuck) of a dental handpiece accepting instruments complying with ISO 1797-1. The instrument is delivered sterile. The Tigran™ PeriBrush™ is for single use only.
Here's an analysis of the acceptance criteria and supporting study for the Tigran™ PeriBrush™ based on the provided document:
This device (Tigran™ PeriBrush™) is a Class II medical device that appears to have gone through the 510(k) premarket notification pathway, which means it demonstrated substantial equivalence to a previously legally marketed device (the predicate device). In this regulatory pathway, the primary "acceptance criteria" is typically showing that the new device is as safe and effective as the predicate device, often through comparisons of technological characteristics and performance testing. A formal prospective clinical trial with specific performance metrics and acceptance thresholds (e.g., sensitivity, specificity for diagnostic devices) is usually not required for 510(k) substantial equivalence.
Based on the provided text, the "study" demonstrating the device meets acceptance criteria is primarily a comparative study against a predicate device and pre-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for 510(k)) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same intended use as predicate device. | Tigran™ PeriBrush™ has the same intended use as the predicate device (Straumann® TiBrush, K111724): "mechanical debridement of dental titanium implant surfaces to remove plaque and calculus due to peri-implantitis." |
| Technological Characteristics Equivalence: Similar materials, design principles, and operating mechanisms to predicate. | Materials: Made of pure titanium (brush part) and nitinol (stem part). (Implicitly considered equivalent to predicate). |
| Mechanism: Removes contaminants from the surface of implants using a rotating brush with stiff titanium bristles and a flexible stem. (Implicitly considered equivalent to predicate). | |
| Safety: Biocompatibility validation, sterilization validation. | Biocompatibility: Conducted in accordance with ISO 10993-5; all materials met relevant standards. |
| Sterilization: Validation conducted in accordance with ISO 11137. | |
| Performance/Effectiveness: Ability to perform mechanical surface debridement as intended. | Mechanical Tests & Simulated Clinical Performance Tests: Allows for mechanical surface debridement. The preclinical tests support that the device, when used as intended, is substantially equivalent. "Clinical evaluation showed that the brush is substantially equivalent." |
| Conclusion: Functions as intended and is substantially equivalent to the predicate. | "The results from the testing conducted demonstrated that the Tigran™ PeriBrush™ functions as intended and is substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for "mechanical tests and simulated clinical performance tests" or the "clinical evaluation." It generally refers to "preclinical tests" and "clinical evaluation" without quantifying participants or samples.
- Data Provenance: Not explicitly stated, but given Tigran Technologies AB is located in Sweden, it is likely some, if not all, of the data originated from (or was supervised by) European entities. The terms "retrospective" or "prospective" are not used in the document for any studies. The "clinical evaluation" may imply prospective data collection, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. For a 510(k) substantial equivalence submission, particularly for a mechanical debridement tool, the concept of "ground truth" derived from expert consensus (as one might see for AI diagnostic tools) is generally not applicable in the same way. The "ground truth" for this device is its physical ability to debride surfaces, which is assessed through mechanical and simulated tests and, possibly, observational clinical evaluation.
4. Adjudication Method for the Test Set
- This information is not provided and is generally not relevant for this type of device and regulatory pathway. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical trials or studies where multiple readers assess outputs (like images) and resolve discrepancies, which does not appear to be the nature of the evaluation performed here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. This type of study focuses on the performance of human readers/interpreters, often with and without AI assistance, and is not applicable to a mechanical debridement tool like the Tigran™ PeriBrush™.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm-only) study was not done. This concept is relevant for software algorithms or AI tools, not for a physical mechanical device like the Tigran™ PeriBrush™. The device itself is the instrument, and its performance is evaluated in its intended use, typically by a human operator.
7. The Type of Ground Truth Used
- For the performance testing:
- Mechanical performance: Likely based on objective measurements (e.g., surface cleanliness, material removal efficiency) established by engineering standards or internal validation protocols.
- Biocompatibility: Based on established ISO 10993-5 standards for material safety.
- Sterilization: Based on established ISO 11137 standards for sterility assurance.
- Clinical evaluation: The "ground truth" here would be the observed effectiveness of the debridement procedure, potentially compared to the predicate device, as assessed by clinicians or through patient outcomes (though specific metrics are not detailed). It emphasizes the device's ability to clean implant surfaces "to remove plaque and calculus due to peri-implantitis."
8. The Sample Size for the Training Set
- No training set is mentioned or applicable. This device is a physical, mechanical instrument, not an AI/ML algorithm that requires a "training set" to learn.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of device.
§ 872.4840 Rotary scaler.
(a)
Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.(b)
Classification. Class II.