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TPH Spectra® ST Flowable Composite Restorative is indicated for:

• Direct restoration of cavities and lesions
• · Filling of defects and undercuts in crowns, inlays, and onlays
• Blockouts
• · Repair of defects
• · Pit and fissure sealants
• · Cementation of light transmissible indirect restorations

TPH Spectra® ST Flowable Composite Restorative is a visible light cured, radiopaque composite resin restorative material with flow characteristics that make it ideal for use in anterior and posterior teeth. The new device contains methacrylate-based resin, photo initiator, silanated inorganic filler and pigments. Available shades include opaque dentin shades, regular body shades and translucent enamel shades. TPH Spectra® ST Flowable Composite Restorative is applied to the tooth following use of a methacrylate-based dental adhesive and/or a cement, which bonds the restoration to the tooth structure. TPH Spectra® ST Flowable Composite Restorative is packaged in multi-use dispensing packages and pre-dosed Compula® Tips for intraoral dispensing.

The provided text is a 510(k) summary for the TPH Spectra® ST Flowable Composite Restorative. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, this document does not describe a study that uses a device to meet acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) or an AI algorithm's performance.

Instead, it pertains to a dental restorative material and its acceptance criteria are related to physical properties and biocompatibility as per established international standards for dental materials.

Therefore, I cannot provide the information requested in your prompt based on the given document, as it outlines the regulatory clearance process for a material rather than the performance evaluation of a diagnostic or AI-driven medical device.

Key points from the document indicating why it doesn't fit your request:

• Device Type: The device is a "Tooth Shade Resin Material" (flowable composite restorative), not a diagnostic device or an AI algorithm.
• Acceptance Criteria Focus: The criteria are related to material science (biocompatibility, compressive strength, flexural strength, radiopacity, water sorption, etc.) and adherence to ISO standards (ISO 4049:2009, ISO 10993-1, ISO 7405).
• No Clinical Performance Data: The document explicitly states, "No data from human clinical studies has been included to support the substantial equivalence of the proposed device TPH Spectra® ST Flowable Composite Restorative." This confirms there's no performance study in humans for diagnostic accuracy.
• No AI Component: There is no mention of an AI component or algorithm.

Therefore, I cannot populate the table or answer the specific questions about test set sample size, ground truth, expert qualifications, MRMC studies, or standalone performance, as these are not relevant to the evaluation described in the provided 510(k) summary.

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