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TN-Brush 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.

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets acceptance criteria for the "TN-Brush." The document is an FDA 510(k) clearance letter for the device, which primarily addresses its substantial equivalence to a predicate device and general regulatory compliance.

The document does not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance for any studies.
• The number or qualifications of experts used for ground truth.
• Adjudication methods for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes related to human reader improvement with AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for a training set.
• How ground truth for a training set was established.

The provided text focuses on the regulatory clearance process for a dental device (TN-Brush) and its indicated use for debridement of titanium dental implants. It does not delve into the specifics of performance studies or acceptance criteria that would fall under the scope of AI/ML device validation.

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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

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.

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Straumann® TiBrush 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 Straumann® TiBrush is made of Grade 5 Titanium and stainless steel for single patient use and is attached to a dental handpiece. It is used during open flap surgery to remove biofilms (plaque and calculus) from the surfaces of dental implants where the surface of the implant is exposed due to peri-implantitis. The TiBrush mechanically removes the biofilms from the surface of the implants without damaging the integrity of the roughened implant surface.

The provided document describes the acceptance criteria and performance testing for the Straumann® TiBrush. Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The performance testing section mentions "implant cleaning" and "implant surface" but does not detail the number of implants or the source of this test data.

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 testing appears to be primarily bench testing (physical and mechanical properties, cleaning efficacy) rather than a study involving human expert assessment for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document, as the testing described does not appear to involve an adjudication process as typically understood in studies involving human reads.

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 indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor is there any mention of AI assistance. The device is a mechanical cleaning instrument, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the Straumann® TiBrush is a mechanical dental instrument, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance testing appears to be based on:

• Mechanical measurements/observations: Bristle length, scratch assessment, corrosion absence, plaque removal quantification (implicitly, through comparison to curette).
• Adherence to standards: ISO 10993 for biocompatibility and ISO 11137 for sterilization.

8. The sample size for the training set

This question is not applicable. The device is a mechanical instrument, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable. The device is a mechanical instrument, not a machine learning algorithm.

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