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DRFP propoint obturation points are designed for permanent sealing of root canals when used with DRFP smartpaste Dental Sealer or Brasseler USA EndoSequence® BC Sealer following established endodontic procedures by qualified healthcare professionals.

The propoints are identical to the points cleared for marketing with K100248. They are made of a radiopaque core and an opaque hydrophilic coating of cross-linked hydrophilic polymers that have been used in the contact lens industry for more than 20 years.

propoints are offered in the traditional 4% and 6% sizes and for use with variable taper files (such as ProTaper™ and Sendoline S5™). They are biocompatible and fully opaque. The hydrophilic coating expands radially to push the sealer into irregularities and voids present in the root canal system for a tight mechanical seal with the dentine. The coating only expands into available space and does not exert pressure on tooth structures. Dimensional length stability is maintained.

The points are packaged in clean room conditions and come individually wrapped to prevent cross-contamination. They can be cut to exact tip size and length.

No heating or compression equipment is required. Post insertion can commence immediately after root canal has been filled. The hydrophilic properties of the device allow extraction without softeners in revision procedures.

propoints are

• coated with DRFP smartpaste prior to insertion into the root canal . (K100248) or
• inserted after the root canal has been filled with EndoSequence® BC. .

This report describes the acceptance criteria and study that proves the device meets the acceptance criteria for DRFP Ltd.'s Propoints with iRoot SP Sealer.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Approximately 2000 treatments were reviewed for clinical performance.
• Data Provenance: The clinical data is retrospective, derived from the "DRFP User Panel of practicing dentists". The country of origin for the data is not explicitly stated, but the submission is from DRFP Ltd. in the United Kingdom and their "User Panel" is mentioned, implying data collected from dental practices.

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

• Number of Experts: A "DRFP User Panel of practicing dentists" was used. The exact number of dentists on this panel is not specified.
• Qualifications of Experts: They are described as "practicing dentists." Their specific qualifications (e.g., years of experience, specialization) are not detailed in the provided text.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The failure rate and clinical observations appear to be reported directly by the "DRFP User Panel of practicing dentists."

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 involved in this device. This submission is for a conventional medical device (root canal obturation points and sealer).

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 physical medical device (root canal obturation system), not an algorithm or AI.

7. The Type of Ground Truth Used

• For Clinical Performance: The ground truth for clinical performance (failure rate, healing, bonding effectiveness) was established through observations and reporting by a "DRFP User Panel of practicing dentists" and confirmed through "clinical x-rays."
• For Bench Tests: The ground truth for bench tests (dye penetration, sodium hypochlorite/EDTA interaction, radiopacity) was based on laboratory measurements and visual assessment (e.g., microscopic assessment for dye ingress).
• For Biocompatibility: Ground truth was established by testing according to ISO 10993 and ISO 7405 standards.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of an algorithm or AI. This submission is for a physical medical device, not an AI/ML product.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no "training set" for an algorithm.

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The DRFP ProSmart Root Canal Obturation System is designed for permanent sealing of root canals following established endodontic procedures by qualified healthcare professionals. The ProSmart Root Canal Obturation System is intended for Prescription Use.

The ProSmart Root Canal Obturation System is using hydrophilic polymer technology. This causes the material to expand into irregularities and tubules of the root canal to assure a tight mechanical seal with the dentine. The hydrophilic properties of the system allow extraction without softeners in revision procedures. The system consists of ProPoint Obturation Points and ProRes Paste.

Here's a summary of the acceptance criteria and the study details for the DRFP ProSmart Root Canal Obturation System, based on the provided document:

DRFP ProSmart Root Canal Obturation System Performance Summary

1. Acceptance Criteria and Reported Device Performance

The non-clinical performance tests for the ProRes Sealer adhere to ISO 6876:2001 & ANSI/ADA Specification #57. For the ProSmart System and ProPoint Obturation Points, adherence to ISO 6877:2006 and ADA/ANSI Specification #78, along with device-specific tests, formed the basis of acceptability.

Additional ProSmart System Acceptance Criteria & Performance:

• Expansion on Hydration (ProPoints coated with ProRes): Expand up to 20%. Reported: ProPoints coated with ProRes expand up to 20%.
• Resistance to Tooth Cracking (Worst Scenario Bench Test): Insertion of ProRes-coated ProPoints in heat-sterilized extracted teeth (more brittle and desiccated than patients' teeth) should show no sign of cracking or damage due to product expansion. Reported: Showed no sign of cracking or damage due to product expansion.
• Exposure to Sodium Hypochlorite: No effect on safety and effectiveness if the manufacturer's recommendation to rinse the canal three times prior to insertion is followed, resulting in a remaining value of 0.01% sodium hypochlorite. Reported: The remaining value of 0.01% sodium hypochlorite will have no effect on the safety and effectiveness of the device.
• Exposure to EDTA: No effect from undiluted 17% EDTA. Reported: Undiluted 17% EDTA has shown to have no effect on the system.
• Radiopacity (ProSmart System): Adequate radiopacity for the intended purpose (verify point location, working length, no apex penetration, and assessment of healing). Reported: Extensive testing and continuous interaction with practicing dentists after three years of use in Europe demonstrate adequate radiopacity.

ProPoint Obturation Points Acceptance Criteria & Performance:

• ISO 6877:2006 Compliance: Full compliance with all applicable performance testing of this standard. Reported: All applicable performance testing showed the points to be in full compliance with this standard.
• ADA/ANSI Specification #78 Compliance: Compliance with all relevant requirements. Reported: DRFP ProPoints comply with all relevant requirements.
• Device-Specific Material Differences: ProPoints differ from Gutta Percha in color (white core and translucent coating) and radiopacity (radiopaque core and radiolucent coating), yet are visible when x-rayed for effectiveness verification. Reported: ProPoints are visible in the filled root canal when x-rayed so that the endodontist can verify the effectiveness of the obturation.

Clinical Evaluation Acceptance Criteria & Performance (assessed after one year of a three-year investigation):

• Healed Periapical Tissue: Positive clinical outcome. Reported: 33% healed.
• Improved Periapical Tissue: Positive clinical outcome. Reported: 35% improved.
• Same Periapical Tissue: Acceptable outcome (not worsened). Reported: 25% same periapical tissue.
• Widening of Periodontal Ligament: Identified as not an effect of the ProSmart system but an assessment of tissue state. Reported: 6% widening of the periodontal ligament.
• Symptom-free and in function: All treated teeth should meet this criterion. Reported: All teeth treated with ProSmart Root Canal Obturation System were symptom-free and in function.
• No teeth extracted: Should meet this criterion. Reported: No teeth had to be extracted.
• None retreated or required clinical intervention: Should meet this criterion. Reported: None had to be retreated or required a clinical intervention.

2. Sample Size and Data Provenance (Clinical Evaluation)

• Sample Size for Test Set: Not explicitly stated as a number of patients or teeth. The description refers to "Radiographic images of an on-going, controlled three-year investigation."
• Data Provenance: The clinical evidence is based on "three (3) years of use in Europe," suggesting retrospective data collection from European clinical practice for confirming findings. The "on-going, controlled three-year investigation" itself is a prospective study design.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: The clinical evaluation was done to "evaluate the ease of use by operating dentists, the handling characteristics and the specific root filling techniques." This implies evaluation by practicing dentists, but their specific qualifications (e.g., years of experience, specialization) are not detailed.

4. Adjudication Method

• Adjudication Method: Not specified. The reported outcomes ("healed," "improved," "same," "widening") suggest a consensus or independent assessment by the "operating dentists" or researchers involved in the "controlled three-year investigation," but the method is not explicitly stated.

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

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study comparing human readers with AI vs. without AI assistance was not mentioned or performed. This is a medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: No, a standalone algorithm-only performance study was not performed. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used (Clinical Evaluation)

• Ground Truth: The clinical evaluation used radiographic images and clinical outcomes (symptom-free, in function, no extractions, no retreatments) to assess "healed," "improved," "same periapical tissue," and "widening of the periodontal ligament." This suggests a combination of radiological and clinical assessments serving as the ground truth.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of its development and testing as described.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of medical device.

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