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Benda Wedge is an inter-proximal wedge coated with an astringent to be used in combination with other devices to temporarily retain composite or amalgam restorative material as well as to control gingival bleeding during dental restorations.

Benda Wedge is indicated for use as a temporary inter-proximal wedge during dental restorative procedures. Benda Wedge is similar in design to the Wedge Wand predicate device but includes a hemostatic agent to control gingival bleeding. Design features consist of the following: Available in four anatomically-shaped sizes for optimum placement in inter-proximal spaces. Use an injection-molded thermoplastic material which is then coated with a fixed amount of aluminum sulfate hexadecahydrate to help control gingival bleeding.

This document describes a medical device, the "Benda Wedge," which is a dental wedge coated with a hemostatic agent. The submission is a 510(k) premarket notification, indicating that the manufacturer is seeking to demonstrate substantial equivalence to previously cleared devices rather than providing extensive de novo clinical trial data.

Acceptance Criteria and Device Performance:

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific reduction in bleeding, retention strength, etc.). Instead, the entire submission is built around demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs comparably to the predicate devices for its intended use, with the added benefit of a hemostatic agent.

Therefore, the table below reflects the primary claim of similarity rather than specific performance numbers.

1. Sample sizes used for the test set and data provenance:

• Test Set Sample Size: "Clinical testing has not been performed on this product." Therefore, there is no test set in the traditional sense, and thus no sample size for clinical performance evaluation. Non-clinical biocompatibility testing was performed, but sample sizes for this are not specified in the summary.
• Data Provenance: Not applicable, as no clinical testing was performed.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable, as no clinical testing was performed and no ground truth for a test set was established.

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

• Not applicable, as no clinical testing was performed and no ground truth for a test set was established.

4. 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:

• Not applicable. This device is a physical dental wedge, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a physical dental wedge, not an algorithm.

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

• Not applicable, as no clinical testing was performed. For the biocompatibility testing, the ground truth would typically be established by standardized laboratory tests and evaluations against ISO 10993-1 guidelines, with results interpreted by qualified toxicologists or materials scientists.

7. The sample size for the training set:

• Not applicable. This device is a physical dental wedge and does not involve AI or machine learning that would require a training set.

8. How the ground truth for the training set was established:

• Not applicable, as no training set was used.

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DETECTAR is indicated for use in the detection of subgingival dental calculus.
DETECTAR is indicated for the detection of subgingival dental calculus

The DETECTAR probe is similar in intended use, size, and shape to a manual periodontal probe. The DETECTAR probe contains an optical fiber that reads the optical signature of dental calculus and converts it into an electrical signal. From that electrical signal a computer analysis identifies the dental calculus.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in the provided document. However, the study aims to show that DETECTAR performs better than a manual periodontal probe in detecting subgingival dental calculus. The reported device performance is that "The DETECTAR significantly outperformed the manual periodontal probe" in an in vitro evaluation.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The study involved a "piece of pig gingiva... on the root surface of the teeth" and a comparison with a manual periodontal probe. The number of teeth or calculus samples tested is not quantified.
• Data Provenance: In vitro evaluation. The country of origin is not specified but the submitter is from Quebec, Canada. Retrospective or prospective is not applicable for an in vitro study of this nature.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Three experienced clinicians.
• Qualifications: Described as "experienced clinicians." Specific qualifications (e.g., years of experience, specialty) are not provided beyond "experienced." The document implies these clinicians are performing the evaluations and their observations contribute to the findings.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method. The three experienced clinicians appear to have individually conducted the evaluations and their findings were then compared, leading to the conclusion that DETECTAR "significantly outperformed" the manual probe. It does not mention a consensus-building or tie-breaking process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in terms of human readers improving with AI vs. without AI assistance. The study described is a comparison of a device (DETECTAR) against a manual instrument (periodontal probe) in vitro, with clinicians performing the evaluations. It's not a study of human readers' diagnostic accuracy before and after AI assistance.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done. The DETECTAR device, which contains an optical fiber and uses "computer analysis" to identify dental calculus, was evaluated on its own in detecting calculus, with the output then presumably interpreted by the clinicians. The "significant outperformance" refers to the device's capability relative to a manual probe.

7. Type of Ground Truth Used

The ground truth used is implicitly the known presence or absence of subgingival dental calculus on the in vitro model (pig gingiva and tooth root). The "drops of blood" were introduced to simulate conditions, suggesting a controlled environment where the presence of calculus could be pre-established or observed reliably by the "experienced clinicians." It is not explicitly stated if a gold standard like histology or micro-CT was used to definitively label the calculus, but rather the clinicians' assessments appear to contribute to the understanding of ground truth or at least the comparative performance.

8. Sample Size for the Training Set

The document does not provide any information about a training set since this appears to be a direct evaluation of the device's performance rather than a validation of a machine learning model that would require a separate training phase. The "computer analysis" identifies dental calculus from an electrical signal, implying a pre-trained algorithm, but the details of that training are not included.

9. How Ground Truth for the Training Set Was Established

Not applicable, as information regarding a training set is not provided in the document.

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For use in the preparation of root canals prior to the final filling of the root canals in adult or deciduous teeth. The Dentist or Endodontist examines the patient to determine if the method of treatment is to be the removal of the root canal for the appropriate reasons. After opening the tooth with the access bur the first part of the root canal is exposed to the point where the canals tend to branch out about one third of the way. The Dentist then follows his standard procedure of locating the Apex and removal of the nerve and decayed matter from the canal using the Flare--File -- Fill procedures.

Not Found

I am sorry, but the provided text does not contain the information required to elaborate on the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device named "Flare, File, Fill," indicating it is substantially equivalent to a predicate device. However, it does not include details about specific performance criteria, study design, sample sizes, ground truth establishment, or expert qualifications.

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