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TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material indicated for:

• Class III and V restorations
• Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
• Base/liner under direct restorations
• Repair of small defects in indirect restorations
• Pit and fissure sealant
• Undercut blockout
• Repair of resin and acrylic temporary materials

TrusFIL-Flow Flowable Composite Restorative is a visible light curing dental restorative material intended to restore carious lesions or structural defects in teeth in combination of a bonding agent and with or without other materials such as luting, etching agents, cavity liners, universal composites and others commonly used in a tooth restoration. The principal organic components are mixtures of dental methacrylate resins (Bis-GMA, TEGDMA, EBPADMA). The inorganic filler loading is about 46% by volume having particle size range of about 0.01 to 3 microns. It is packaged in syringes and single-dose capsules. Single-dose delivery is intended for single patient (single use) only to prevent cross-contamination between patients.
Available shades include opaque dentin shades and regular body shades. All shades are radiopaque.

The provided document is a 510(k) premarket notification for a dental restorative material, TrusFIL-Flow Flowable Composite Restorative. It aims to demonstrate substantial equivalence to a predicate device, not to prove the device meets acceptance criteria for an AI/algorithmic medical device, as implied by the user's request.

Therefore, the document does not contain the information needed to answer the user's questions about acceptance criteria and study details for an AI/algorithmic device. The document primarily focuses on physical and chemical properties, biocompatibility, and intended use for a conventional dental material.

Specifically, the following information is not available in the provided text:

• A table of acceptance criteria and reported device performance for an AI/algorithmic device. The "acceptance criteria" presented are pass/fail criteria for physical properties of a dental material according to ISO standards and FDA guidance, not for an AI.
• Sample size used for a test set or data provenance for an AI.
• Number of experts or their qualifications for establishing ground truth for an AI test set.
• Adjudication method for an AI test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI assistance.
• Standalone performance for an algorithm only.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI.
• Sample size for a training set for an AI.
• How ground truth for a training set was established for an AI.

The document explicitly states under "10. Clinical Performance Data": "Not applicable. Clinical performance testing has not been performed on the subject device." This further confirms that no clinical studies or AI performance evaluations, as requested, were conducted or reported here.

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