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Harvest Dental HD Gum Strip is indicated for adding texture, form and color to the gingival area of a dental prosthesis which includes crowns, bridges and full and partial prostheses. This composite strip is bondable to polymethylmethacrylate (PMMA), metals and ceramics (zirconia).

Harvest Dental HD Gum Strip is a bondable, light-cured composite for adding texture and color to the gingival area of a dental prosthesis which includes crowns, bridges and full and partial prostheses. This composite strip is bondable to polymethylmethacrylate (PMMA), metals and ceramics (zirconia). It is provided in a textured, malleable strip meant to be applied to a dentine/bone-like substructure. The strip is an alternative to the method of using a shaded composite paste to manually build-up and model visible gingival surfaces to look similar to natural gingival tissues. The Harvest Dental HD Gum Strip includes features such as gingival veins formed into its surface as well as being available in various shades of coloration. The strip can be easily cut, applied to the gingival surface of the restoration, then trimmed and finished with appropriate features such as gingival line and interdental papilla. Gum Strip Modifiers (paste versions of the same composite) are available in various shades and used for additional surface features and gingival repairs, and Liquid Modifiers (stains, which are a low-viscosity color-concentrated form of the same composite) are available in several shades and used for enhanced coloration resembling the natural gingiva. The Harvest Dental HD Gum Strip is bonded to the dental prosthesis utilizing a bonding adhesive provided with the strip and modifiers and, after any final detailing and coloring, is to be cured utilizing a typical light-curing device.

The provided document is a 510(k) premarket notification for a dental device, Harvest Dental HD Gum Strip. It details the device's characteristics and its substantial equivalence to a predicate device, Gradia Gum. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The document primarily focuses on biocompatibility and mechanical property testing for a physical dental material. Therefore, most of the requested information regarding AI/ML device evaluation is not present in this document.

Here's the information that can be extracted or inferred based on the provided text, with many fields explicitly stated as "Not Applicable" for an AI/ML device, as this document is not about one.

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)
Not applicable as this is not an AI/ML device studying a dataset. The testing refers to physical material property tests.

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 not an AI/ML device. Ground truth for material properties is established through standardized physical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as this is not an AI/ML device.

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 as this is not an AI/ML device. No human-in-the-loop studies were conducted for this physical dental material.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For physical material properties, the "ground truth" is defined by the standards and methods used in the specified ISO tests (ISO 7405 and ISO 10477).

8. The sample size for the training set
Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable as this is not an AI/ML device.

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Harvest Conceal ZR Block Out is indicated for burn-in zirconia shading. The applied liquid is sintered with the zirconia to adjust the restoration to match the natural color of the patient's teeth. The material is intended for professional dental work only.

Harvest Conceal ZR Block Out is a water-based opacifying solution available in 5 shades. white, A1, B1, C1 and D2, for use with a translucent zirconia core. It is indicated for burn-in zirconia shading. The applied liquid is sintered with the zirconia to adjust the restoration to match the natural color of the patient's teeth. Fabrication using the Harvest Conceal ZR Block Out requires an appropriate drying oven and sintering furnace.

The provided text describes a medical device, "Harvest Conceal ZR Block Out," and its substantial equivalence determination by the FDA. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.

The document states that:

• No human clinical testing was conducted. This implies there would be no data on multi-reader multi-case studies or effect sizes of human readers with AI assistance.
• The device is a "Liquid Stain for Dental Zirconia Restorations," which suggests it is a material used in the fabrication of dental products, not a diagnostic or prognostic AI/ML device.
• Performance testing was "Bench Testing" for physical characteristics, and "Biocompatibility Testing" was conducted in accordance with ISO standards.

Therefore, I cannot extract the requested information such as a table of acceptance criteria and reported device performance, sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, or details about training sets and their ground truth, because this information is not present in the provided text. The document is primarily focused on the device's substantial equivalence to a predicate device based on material properties and intended use, not on the performance of an AI/ML algorithm.

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Harvest Printable Resin is indicated for the fabrication of dental bases for full removable dentures, artificial teeth, dental bite splints and guards and try-in devices, i.e., denture base and teeth. The material is an alternative to traditional heat-curable and auto-polymerizing resins and is intended for professional dental work only. This material is intended to be used by dental lab technicians and approved by licensed practitioners before being provided to the patient.

Harvest Printable Resin is a light-cured resin developed for additive manufacturing (3D printing) of individual full denture bases, artificial teeth, bite splints and guards and try-in devices, i.e., denture base and teeth. After being utilized in a 3D stereolithographic printer to generate a dental device based on a solid model, the device is placed in a UV light curing unit for final polymerization. Fabrication using Harvest Printable Resin requires an appropriate computer-aided Design and Manufacturing (CAD/CAM) system, a digital light processing (DLP) printer, and post-processing light curing equipment. It has been optimized for use with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Pro95 S and Pro55 S) printers and, therefore, may only be used in conjunction with these printers and their associated software systems. It is also only to be used in conjunction with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Procure and Procure 2) curing units for post-processing. The 3D printer is not included with the device.

The provided document describes a medical device, "Harvest Printable Resin," and its substantial equivalence to predicate devices based on technological characteristics and performance data, primarily through biocompatibility testing and ISO 20795-1 & -2 testing.

Here's an analysis of the acceptance criteria and the study proving the device meets them, 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

The document does not explicitly state the sample sizes used for the ISO 20795-1 & -2 tests or the biocompatibility tests. It also does not specify the provenance (e.g., country of origin, retrospective or prospective) of the data. These tests are typically conducted in a laboratory setting on standardized test specimens.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. The "ground truth" for material property testing (like ISO 20795-1 & -2) and biocompatibility is established by adherence to recognized international standards and laboratory measurements, not by expert consensus on clinical cases. No human-in-the-loop performance is being evaluated here.

4. Adjudication method for the test set

Not applicable. As noted above, this is material property and biocompatibility testing, not a clinical assessment requiring adjudication of human expert opinions.

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 MRMC comparative effectiveness study was done. The document explicitly states: "No human clinical testing was conducted to support substantial equivalence." This device is a material, not an AI-assisted diagnostic tool.

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

Yes, "standalone" performance was effectively done in the form of laboratory testing of the material properties described in section 1 and biocompatibility. The performance evaluation focuses solely on the inherent characteristics of the Harvest Printable Resin itself, without any human intervention in its measurement or any AI algorithms.

7. The type of ground truth used

The ground truth for the performance evaluation relies on:

• Established International Standards: ISO 20795-1:2013 and ISO 20795-2:2013 for physical/mechanical properties. These standards define the methodology and acceptance criteria.
• Recognized Biocompatibility Standards: ISO 7405:2018 and ISO 10993-1 as recognized by the FDA for biocompatibility. These standards outline tests to ensure the material is safe for biological contact.

8. The sample size for the training set

Not applicable. This device is a material, not an AI model, so there is no "training set."

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

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

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For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.
-Provisional anterior and posterior crowns & bridges

• Implant and abutment supported prosthetics.
• Partial, complete and hybrid denture prosthetics (base and teeth) - Removable appliances (splint)

Harvest Dental Polymer Blocks are industrially polymerized, pre-colored or clear dental milling discs and blocks designed for milled fabrication of temporary anterior and posterior crowns and bridges (tooth-colored variants) or bite splints and dental CAD/CAM systems.

The Harvest Dental Polymer Blocks device is a dental milling disc and block designed for the CAD/CAM fabrication of temporary anterior and posterior crowns and bridges, as well as provisional removable denture and appliance prosthetics. The submission demonstrates substantial equivalence to its predicate device, Idodentine (K150432), based on similar technological characteristics, indications for use, and performance testing.

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

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The Harvest Dental Polymer Blocks (ZCAD) are PMMA blanks for manufacturing temporary crowns and bridges by a CAD/CAM system.

Harvest Dental Polymer Blocks (ZCAD) are PMMA blanks.

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product. It does not contain information about acceptance criteria for a device's performance through a study. Instead, it is a regulatory document confirming substantial equivalence based on prior predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document does not discuss performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

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