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Stabilization of mobile teeth Temporary replacement of missing teeth Maintain of inter-dental spaces Maintain of microachar of temporary or permanent bridges

Box containing: - 8 ribbons (Braided polyethylene terephtalate fibers) individually wrapped in aluminium bags (width: approximately 2.5 mm - length: approximately 50 mm - thickness: ~ 0,15 mm). - Accessories: BIOSPLINT™ Thermal cutter, BIOSPLINT™ Accessories: brushes and probes -

Acceptance Criteria and Device Performance Study for BIOSPLINT Splinting Ribbons

This document details the acceptance criteria and the studies performed to demonstrate the safety and efficacy of the BIOSPLINT Splinting Ribbons, based on the provided 510(k) summary (K053328).

1. Table of Acceptance Criteria and Reported Device Performance

The BIOSPLINT Splinting Ribbons are a dental device. For such devices, acceptance criteria primarily focus on biocompatibility and mechanical properties (efficacy in its intended use). The efficacy is often established through literature and clinical experience in similar devices, while safety is evaluated through extensive biocompatibility testing.

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

For the safety studies (biocompatibility tests), specific sample sizes are rarely explicitly stated in 510(k) summaries but are implied by adherence to standard regulatory guidelines (e.g., OECD, USP, ASTM, ISO). These guidelines prescribe the number of animals or cells required for each test.

• AMES test: The test uses bacterial strains (TA-98, TA-1535, TA-1537, and TA-1538). The "sample size" here refers to the number of bacterial colonies tested, which would be numerous and performed in replicates according to the guideline O.C.D.E.n°471. Data provenance is implied to be laboratory testing internal or contracted by the manufacturer.
• Pyrogenes test: Typically performed on rabbits. The French Pharmacopoeia would specify the number of rabbits (usually 3 or more).
• Sensitization test on guinea pigs: Conducted on guinea pigs, with ASTM F 619-79 likely dictating the number of animals (e.g., 10-20 for the test group). Data provenance is implied to be laboratory testing.
• Intramuscular implantation on the rabbit: Conducted on rabbits, with USP XXII specifying the number of animals for the implantation (e.g., 2-4 rabbits).
• Toxicity by systemic injection on the mouse: Conducted on mice, with USP XXII specifying the number of animals (e.g., 5-10 mice per extract type).
• Intradermal injection on the rabbit: Conducted on rabbits, with USP XXII specifying the number of animals (e.g., 2-4 rabbits).
• Biocompatibility evaluation (Implantation test on the rabbit): Performed on rabbits. The adaptation of ASTM F 763-87, F 981-87, and ISO 10993-6 would specify the number of animals for implantation (e.g., 2-4 rabbits) and the duration of observation (1, 4, 12, 26 and 52 weeks).
• In-vitro Cytotoxicity: Performed on cell cultures. USP XXIII would specify the number of cell culture plates/wells used.

Data Provenance: All safety studies are "retrospective" in the sense that they were conducted for the purpose of regulatory submission, likely at contract research organizations. The country of origin for the studies is not explicitly stated, but the submission is from France, and references to French Pharmacopoeia suggest some studies were conducted in France or according to French standards.

For the efficacy claims, the data provenance is primarily from established professional literature and clinical experience in Europe (since 1997), specifically citing French professional literature. This is retrospective observational data. No specific "test set" in terms of a controlled clinical trial with a defined sample size for the BIOSPLINT device is provided for efficacy; rather, the efficacy is established by "substantial equivalence" to predicate devices and general acceptance of the technology.

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

For the safety studies, the "ground truth" is established by adherence to recognized international standards and pharmacopoeias (e.g., OECD, USP, ASTM, ISO). The interpretation of results (e.g., histopathological observations, cytotoxicity readings) would be performed by qualified laboratory scientists specialized in toxicology and pathology, following the procedures outlined in these standards. The number of such experts is not specified but is inherent to the execution of such standardized tests.

For efficacy, the ground truth is established through the consensus in professional literature and successful clinical use over time. The "experts" in this context are the authors of the cited articles and the general dental professional community who have adopted and published on this type of technology. Their specific qualifications (e.g., years of experience) are not detailed but are implied by their publication in peer-reviewed journals and academic affiliations (e.g., "G.KOUBI Chairman of university Marseilles France").

4. Adjudication Method

For the safety studies, an explicit "adjudication method" in the sense of multiple independent expert reviews of a single case is not typically described for these types of standardized laboratory tests. The results are based on objective measurements and interpretations by trained laboratory personnel following established protocols. Any discrepancies would be resolved through re-testing or internal quality control procedures.

For efficacy, there is no explicit adjudication method detailed as the evidence is based on published literature and general clinical acceptance rather than a specific test set requiring adjudication.

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

No MRMC comparative effectiveness study was mentioned or performed. This type of study is more common for diagnostic imaging AI devices, where the "reader" is a clinician interpreting images. The BIOSPLINT device is a material used in dentistry, not a diagnostic tool where human interpretation is a primary variable to be assessed for improvement with AI assistance.

6. Standalone Performance Study

No standalone (algorithm only without human-in-the-loop performance) study was done, as this is not an AI-powered diagnostic or therapeutic algorithm. The "device" is a physical material (splinting ribbon).

7. Type of Ground Truth Used

For safety, the ground truth is based on standardized test results and expert pathological/toxicological interpretation against established biological criteria (e.g., no mutagenicity, no sensitization, no local adverse effects).

For efficacy, the ground truth is based on expert consensus from professional literature and positive clinical outcomes data from real-world use over time in Europe. It relies on the documented success of similar dental splinting techniques using fiber reinforcement.

8. Sample Size for the Training Set

Not applicable. The BIOSPLINT Splinting Ribbons are a physical material, not a machine learning model that requires a training set. The efficacy and safety are established through material testing and clinical literature, not AI model training.

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

Not applicable, as there is no training set for this device.

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