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ANTHOGYR's fully autoclavable contra-angles Implantology "MontBlanc" Control are devices intended for a wide range of dental procedures including: Implant surgery such as perforating the bone, tapping and threading procedures This range can be used with special accessories like depth stop.

ANTHOGYR has developed a full range of surgical contra angle intended to be used in implantology. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to N.F. EN ISO 7785-2 "Dental Handpieces -Part 2: Straight and geared angle handpieces: ".

This document describes a Special 510(k) submission for a modification to existing ANTHOGYR dental contra-angles. The information provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with detailed acceptance criteria and performance data for a novel AI/software device.

Therefore, many of the requested sections regarding AI/software performance will be marked as "Not Applicable" or "Information Not Provided," as this submission does not pertain to such a device.

Here's an analysis of the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

Explanation: The acceptance criteria are primarily based on conformity to recognized international and national standards for dental handpieces and medical device quality management. The reported performance is a general statement that the device "conforms" to these standards. There are no numerical performance metrics or specific test results detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not Applicable. This submission describes a modification to a mechanical medical device (dental contra-angle), not a software or AI device that would typically have a "test set" in the context of diagnostic performance. Technical aspects are evaluated against engineering standards.
• Data Provenance: Not Applicable. The data provided refers to conformity with manufacturing and performance standards, not to clinical data or AI model output.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not Applicable. Ground truth as typically understood for AI/software devices (e.g., diagnostic labels) is not relevant here. Compliance with engineering standards is verified through testing and certifications, not expert annotation of a test set.
• Qualifications of Experts: Not Applicable.

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

• Adjudication Method: Not Applicable.

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

• MRMC Study: No. This is a mechanical device, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not Applicable. This is not an algorithm.

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

• Type of Ground Truth: The "ground truth" for this type of device is compliance with established engineering and safety standards (e.g., ISO, NF EN standards) for mechanical performance, material properties, and quality systems. This is verified through testing procedures outlined within those standards, often conducted by manufacturers or certified testing bodies, rather than clinical outcomes or pathology data.

8. The sample size for the training set

• Sample Size for Training Set: Not Applicable. This is not an AI/machine learning device; there is no training set.

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

• Ground Truth for Training Set: Not Applicable.

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ANTHOGYR's fully autoclavable contra-angles "MontBlanc" are devices intended for a wide range of dental procedures including:

• Implant surgery such as perforating the bone, tapping and threading procedures
• General dentistry such as removing carious material, cavity and crow preparation, finishing tooth preparations, restorations and polishing teeth

ANTHOGYR has developed a full range of surgical, reducing, multiplying and 1:1 contra angle intended to be used in implantology and general dentistry procedures. The name of the range is "MontBlanc". ANTHOGYR Contra angles design, size and performance conform to NF EN ISO 7785-2 "Dental Handpieces - Part 2: Straight and geared angle handpieces.

The provided document is a 510(k) summary for a dental device, specifically "ANTHOGYR DENTAL CONTRA-ANGLES AND HANDPIECES." This type of document is for medical device clearance, not for AI/ML software. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable.

The document describes a modification to an existing device (K040674) and focuses on demonstrating substantial equivalence to the predicate device by conformity to recognized consensus standards.

Here's the relevant information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the document. The document refers to "Validation test included within this submission," but doesn't detail the sample sizes for these tests.
• Data Provenance: Not specified. The submitter is ANTHOGYR from SALLANCHES, FRANCE.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this is a traditional medical device, not an AI/ML device relying on expert-annotated ground truth. Performance is demonstrated through conformance to engineering and medical device standards.

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

• Not applicable.

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

• Not applicable.

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

• Not applicable.

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

• For this type of device, "ground truth" is established by demonstrating compliance with recognized engineering and medical device standards (e.g., ISO 7785-2 for dental handpiece performance, ISO 13402 for resistance to autoclaving/corrosion). These standards define the test methods and acceptance criteria for material properties, functional performance, and safety of the device.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

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The FIBIOCORE composite posts are intented for use by dentists to give retention for reconstruction of non-vital teeth. The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

Glass Fiber composite root canal post

The provided text describes a 510(k) premarket notification for the FIBIOCORE Glass Fiber Composite Posts. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than on detailed performance criteria typically associated with software or AI-based devices. Therefore, much of the information requested in your prompt (e.g., acceptance criteria tables, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or available in this document.

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The primary "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to legally marketed predicate devices. This is achieved by showing the new device has similar:
  • Quality of mechanical characteristics
  • Mechanical safety
  • Materials
  • Design
  • Performance
  • Indications for use
• Reported Device Performance:
  • Biocompatibility: Standard ISO 10993-5 "Biological evaluation of medical devices - Tests for Cytotoxicity : in vitro methods" was conducted, showing "no evidence of a cytotoxic response."
  • Mechanical Strength: Mechanical tests were conducted in conformance with ISO 3597-2 (Three-point Bending Standards). The results "showed the material to be suitable for root canal posts." Other unspecified mechanical tests were also conducted to characterize the material.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided in the document as it is not typically required for a 510(k) submission for a Class I dental device. The "test set" in this context refers to samples of the physical device used for mechanical and biological testing, not a dataset for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a physical dental post, not an AI or imaging device requiring expert interpretation for ground truth. Technical experts would have conducted the ISO standard tests.

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

• Not applicable. This refers to adjudication of expert interpretations for AI/imaging studies, which is not relevant here.

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

• No. This is not an AI-assisted device, so MRMC studies are not applicable.

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

• No. This is not an algorithm, so standalone performance is not applicable.

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

• The "ground truth" for this device's performance is established by conformance to international standards (ISO 10993-5 for biocompatibility and ISO 3597-2 for mechanical strength) and by demonstrating similar physical and mechanical properties to predicate devices.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning.

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

• Not applicable. There is no training set for this device.

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