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Bioplant is a synthetically derived, spherical material which is intended to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region in the below indications.

1. To maintain and restore the bony alveolar ridge after extraction of tooth-roots, i.e., Ridge preservation/Socket grafting;
2. To restore infra-bony defects caused by destructive periodontal disease, i.e., 2-3 wall defects/Class I, II and III furcations;
3. To augment bony defects, i.e., apicocctomies, cystic formation or tumor removal;
4. Ridge augmentation to restore the height and/or width of severely atrophicd alveolar ridges;
5. Augmentations in the maxillary sinus;
6. Trone voids associated with implant placement.

Bioplant is a synthetic polymer bone void filling material which, due to its porosily characteristics, is capable of supporting ingrowth of bony tissue. This non-resorbable and radio-opaque material is used to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. The material consists of poly methylmethacrylate (PMMA) beads coated with poly hydroxyethyl methacrylate (PHEMA) to increase hydrophlicity of the porous structure, a thin layer of barium sulfate for radio-opacity, and calcium hydroxide for hydrophilicity and to promote bone growth around the PMMA beads. The average particle size of the beads is 750 microns. The product is sterliked using gamma radiation.

The provided document is a 510(k) summary for the device "BIOPLANT," a synthetic bone grafting material. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously marketed devices. This type of document focuses on comparing a new device to existing ones rather than presenting a study outlining specific acceptance criteria and performance metrics in the way a clinical trial or performance study report for an AI/ML medical device would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as it relates to performance validation with specific metrics, sample sizes, expert involvement, or AI/ML-specific details.

Here's why and what information is available (and what is missing):

Information Provided in the Document:

• Device Name: BIOPLANT (Trade Name), Synthetic Bone Grafting Material (Common Name)
• Intended Use/Indications For Use: To fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region for various conditions listed on pages 1 and 4.
• Substantial Equivalence Claim: The document claims substantial equivalence to Heracus Kulzer, Ostim Bone Grafting Material, and Biomet Inc., HTR-MX. This is the primary "proof" offered for its marketability.
• Device Description: Details on its composition (PMMA beads coated with PHEMA, barium sulfate, calcium hydroxide), average particle size (750 microns), and sterilization method (gamma radiation).
• Regulatory Classification: Class II device, Product Code LYC, Regulation Number 21 CFR 872.3930 (Bone grafting material).

Missing Information (which would be present in a study report for an AI/ML device):

1. Table of Acceptance Criteria and Reported Device Performance: This document does not establish specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or performance against a baseline) for the BIOPLANT device, nor does it report specific performance metrics from a study against such criteria. The entire premise is substantial equivalence to existing devices.
2. Sample Size Used for the Test Set and Data Provenance: Not applicable. There is no performance study described with a test set of data.
3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. No ground truth establishment is described for a performance study.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or applicable. This is not an AI/ML device, nor is it a comparative effectiveness study involving human readers.
6. Standalone (Algorithm Only) Performance Study: Not applicable, as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used: Not applicable.
8. Sample Size for the Training Set: Not applicable. There is no AI/ML model or training set.
9. How the Ground Truth for the Training Set Was Established: Not applicable.

Conclusion:

The provided document is a 510(k) summary for a synthetic bone grafting material. It demonstrates the device's substantial equivalence to predicate devices already on the market through comparison of intended use, technological characteristics, and safety information. It does not describe a study with performance acceptance criteria, sample sizes, expert ground truth establishment, or other details typically found in a clinical or performance study report for a novel medical device, especially an AI/ML-driven one.

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