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Flexible Partial Resin is indicated for the fabrication of dental appliances such as dental plates, bite plates, partial denture frame-works and clasps.

The subject device, Flexible Partial Resin, is a light-cured polymerizable resin for the fabrication of partial removable denture bases made in dental laboratories. The resin can be used in DLP printers utilizing a wavelength of 385nm and will be offered in G1 (standard pink), G3 (medium pink), and G4 (dark pink) shades formulated to match gingival tissue. The final medical device is a custom fitted appliance that is compliant to the dental professional's diagnosis and prescription.

The provided document is a 510(k) clearance letter for a dental resin, not a study report for an AI/ML device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and studies for device performance as it pertains to an AI/ML device.

The document discusses the substantial equivalence of a new dental resin (Flexible Partial Resin) to a predicate device (Flexible Block) based on:

• Indications for Use Comparison: Both devices are indicated for fabricating dental appliances such as dental plates, bite plates, partial denture frameworks, and clasps. The predicate has additional indications not claimed by the subject device.
• Technological Comparison: The devices are compared based on material composition and principle of operation. The subject device uses a methacrylate/dimethacrylate-based resin and 3D printing (DLP), while the predicate uses polyamide and milling from blocks.
• Performance Testing: Non-clinical tests were conducted to compare the physical properties of the subject device to the predicate device using ASTM standards (Flexural Strength and Modulus, Tensile Strength, Elongation at Break, Impact Strength, Water Absorption). Printing accuracy was also tested.
• Biocompatibility: The subject device was evaluated per ISO 10993-1:2018, leveraging data from a reference device.

Key takeaway for your request:

The FDA 510(k) clearance letter for "Flexible Partial Resin" does not describe an AI/ML device or a study involving AI/ML performance. Therefore, it does not contain information about:

• Acceptance criteria and performance for an AI/ML device.
• Sample sizes for test sets, data provenance, or ground truth establishment relevant to AI/ML.
• Number of experts, adjudication methods, MRMC studies, or standalone algorithm performance for AI/ML.
• Training set size or ground truth for an AI/ML model.

This document is for a material used in dental device fabrication, not an AI-powered diagnostic or assistive tool.

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The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices.

Sterilization parameters:

Pre-vacuum steam: 132°C (270°F) for 4 minutes with 30 minutes drying time.

Sterilization validations for the worst-case Autoclavable Cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glided Surgical Kit, 476 grams for Glidewell HTTM Implant Surgical Kit. and 192 grams for Glidewell™ Prosthetic Kit.

The Autoclavable Cassettes are designed to store, organize, and protect various surgical and prosthetic instruments that are sterilized by the healthcare provider. The Autoclavable Cassettes are composed of three main components: a lid, a base, and a tray. The components are made of polyphenylsulfone PPSU. The tray has silicone rubber grommets to hold the instruments in place. The lid latches to the base holds the tray, and all three components are designed to secure the kit into a single unit. The cassette protects the interior components during sterilization and subsequent storage. The kits are perforated to allow for penetration of moist heat during steam sterilization and require the use of an FDA-cleared sterilization wrap to maintain sterility. To facilitate the surgical procedure and the correct use and the positioning of the instrument, the tray has instrument descriptions on the surface.

Surgical and prosthetic instruments of the Glidewell Implant System are intended to be placed in the Autoclavable Cassette. These surgical and prosthetic instruments which are the contents of the sterilization cassette are all Class 1 exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories).

The provided text describes the acceptance criteria and the results of the study conducted to demonstrate the safety and effectiveness of the Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific "sample size" in terms of number of individual units tested for each non-clinical test. However, it indicates:

• Worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio, and worst-case instruments to be contained.
• Data Provenance: The study is reported as non-clinical testing conducted by the manufacturer, Prismatik Dentalcraft, Inc. The document doesn't specify the country of origin of the data, but it refers to international standards (e.g., ANSI/AAMI, ISO, ASTM). The nature of these tests suggests they are prospective in that they are performed specifically to validate the device's performance against predefined criteria.

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

This information is not applicable and not provided in the document. The tests performed are non-clinical, objective evaluations against established scientific and engineering standards (e.g., visual inspection for soil, chemical tests for residue, biological indicators for sterility, mechanical testing for durability). They do not involve human interpretation of medical images or expert consensus to establish a "ground truth" in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated above. Adjudication typically applies to studies where human interpretation or consensus is required to determine a reference standard.

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

This information is not applicable and not provided in the document. The device in question is an "Autoclavable Cassette" (sterilization wrap accessory), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device type.

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

This information is not applicable and not provided in the document. The device is a physical medical device (sterilization cassette), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is based on objective, measurable standards and criteria established by recognized regulatory and industry standards (e.g., SAL ≤10^-6 for sterility, specific chemical residue limits for cleaning, visual inspection for damage, cellular vitality percentages for biocompatibility). These are not based on expert consensus, pathology, or outcomes data in the usual sense of diagnostic or therapeutic devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical product and does not involve AI/machine learning, thus there is no "training set."

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

This information is not applicable and not provided in the document, as there is no training set for this type of device.

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BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

BruxZir® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.

The provided text describes the regulatory submission for a dental material (BruxZir® Esthetic NOW) and its comparison to a predicate device. It includes performance data, but NOT information typically associated with AI/ML device studies, such as sample sizes for test sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, the response will focus on the available information regarding acceptance criteria and the study that proves the device meets those criteria, highlighting the lack of AI/ML-specific details where applicable.

Here's a summary of the acceptance criteria and study findings based on the provided document:

1. Acceptance Criteria and Reported Device Performance

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Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

Glidewell™ 3DP Denture Base Resin, is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates. Glidewell™ 3DP Denture Base Resin, is a light-cured methacrylic material with photo initiators that form a polymer during 3D printing. Glidewell™ 3DP Denture Base Resin is printed using digital light processing (DLP). The DLP printer and resin are optimized to each other in order to achieve complete and precise printed parts. The light source provided by the DLP printer (405nm wavelength), and the post-curing light box polymerize the resin which forms a hardened denture base. Once cured, Glidewell™ 3DP Denture Base Resin has the mechanical property that meets the performance criteria for Type 4: Light-activated materials as defined in the FDA-recognized consensus standard ISO 20795-1:2013 Dentistry - Base polymers - Part 1: Denture base polymers, including flexural strength, flexural modulus, water sorption and water solubility.

The subject device, Glidewell™ 3DP Denture Base Resin, has the same formulation and manufacturing process as the predicate device, Glidewell™ 3DP Denture Base Resin (K213765), which contains silver sodium hydrogen zirconium phosphate. In vitro studies on the subject device, Glidewell™ 3DP Denture Base Resin, demonstrated a reduction in the following microorganisms: Streptococcus mutans, Streptococcus mitis, Staphylococcus aureus, Escherichia coli, Klebsiella pneumonia, Candida albicans, Candida glabrata, Candida tropicalis, MRSA (Methicillin Resistant Staphylococcus aureus), VRE (Vancomycin Resistant Enterococcus).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them, presented in the requested format.

It's important to note that this document is a 510(k) Summary, which is a regulatory submission for medical devices. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results. Therefore, some information typically found in a full clinical study report (like detailed sample sizes for training sets or expert qualifications for ground truth) may not be explicitly stated for components not directly studied in this submission. The "study" described herein refers primarily to the in vitro antimicrobial testing.

Acceptance Criteria and Device Performance

Glidewell™ 3DP Denture Base Resin is a Class II device (Product Code EBI, Regulation Number 21 CFR 872.3760). The primary focus of the additional testing in this 510(k) submission (K241493) seems to be the antimicrobial properties of the resin, as its physical properties are stated to be identical to the predicate device (K213765).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Antimicrobial Tests (Test Set): The specific number of samples (replicates) used for each microorganism in the in vitro tests (ASTM E2180-07 and ASTM E2647-13) is not explicitly stated in this summary. These are typically material tests on prepared resin samples, not patient-derived data.
• Physical Properties: Not explicitly stated as the data for the subject device is leveraged from the predicate device (K213765), implying prior testing was performed for the predicate.
• Data Provenance: The studies are in vitro laboratory tests conducted by the manufacturer or their contracted labs. The provenance is internal to the manufacturer (Prismatik Dentalcraft, Inc.) and is retrospective as it supports a 510(k) submission. No country of origin for data generation is specified beyond the company's location in Irvine, California, USA.

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

• Not Applicable. For these in vitro material and microbiology tests, "ground truth" is established by the standardized methods themselves (e.g., cell counts, optical density measurements, mechanical property testing according to ISO standards). This is not equivalent to establishing ground truth for AI algorithms based on expert interpretation of medical images. The tests measure objective physical and biological properties.

4. Adjudication Method for the Test Set

• Not Applicable. As these are in vitro laboratory tests measuring objective properties, an adjudication method among experts (like 2+1 or 3+1 for image reviews) is not relevant.

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. This device is a denture base resin, not an AI software intended to assist human readers (e.g., radiologists). Therefore, an MRMC comparative effectiveness study is not relevant to this submission. The summary explicitly states: "Clinical studies have not been conducted to demonstrate that the presence of silver sodium hydrogen zirconium phosphate in Glidewell™ 3DP Denture Base Resin results in improved clinical outcomes."

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

• Not Applicable. This is a material (resin) device, not an algorithm.

7. The Type of Ground Truth Used

• For Antimicrobial Tests: Ground truth is established by quantitative microbial culture methods (viable plate counts) as per ASTM E2180-07 and ASTM E2647-13. The "control samples of regular denture without antimicrobial agent" serve as the baseline for comparison.
• For Physical Properties: Ground truth is established by standardized mechanical testing procedures as per ISO 20795-1:2013.
• For Biocompatibility: Ground truth is established by standardized biological evaluation tests per ISO 10993-1:2018 and ISO 7405:2018.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this device because it is a physical material, not an AI/ML algorithm that requires training data.

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

• Not Applicable. As there is no training set for an AI/ML algorithm.

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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Keystone® Dental PrimaConnex® Implant System, Neodent® GM Implant System, Straumann® BLX Implant System, Implant Direct® Legacy® Implant System, Implant Direct® InterActive® Implant System, Implant Direct® RePlant® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM F136-13(2021), Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. The zirconium coping intended for use with the Inclusive® Titanium Abutments are made from zirconium oxide ceramic, conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136-13(2021) and used in conjunction with the OEM Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® multi-unit abutments. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multiunit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

The provided document is a 510(k) Summary for a dental device (Inclusive® Titanium Abutments). It details the device's technical characteristics and claims substantial equivalence to a predicate device based on non-clinical testing. However, it does not include specific quantitative acceptance criteria or detailed results of a study designed to compare the device performance against such criteria.

The document discusses "performance data" in general terms, referring to several non-clinical tests (Biocompatibility, Mechanical Properties, Sterilization Validation, Shelf Life and Packaging Validation, and Use in MR Environment). It states that these tests were performed to "demonstrate substantial equivalence" and to "address questions related to substantial equivalence based on the differences in technical specifications," but it doesn't present the data in a way that allows for filling out the requested table of acceptance criteria and reported performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, or training set details, as this information is not present in the provided text.

The document explicitly states:

• "Non-clinical testing data are submitted to demonstrate substantial equivalence. No clinical data was included in this submission."

This indicates that clinical trials with human subjects, which would typically involve expert ground truth establishment and detailed performance metrics comparing against specific acceptance criteria, were not part of this submission for substantial equivalence.

The "Mechanical Properties" section mentions:

• "Static load and fatigue testing of the implant/abutment assembly was considered according to the FDA Guidance Document, Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801:2016 standard with the worst-case scenario. The fatigue limit data demonstrated that the subject device has sufficient strength for its intended use."

This implies that there were performance targets based on ISO 14801:2016 for fatigue strength, but the specific acceptance critiera (e.g., minimum fatigue strength in Newtons) and the actual reported performance values are not provided in this summary. It only states that the device "has sufficient strength."

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BruxZir® NOW SRC is a pre-manufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. BruxZir® NOW SRC consists of two major parts. Specifically, the precemented titanium abutment and zirconia superstructure components make up a two-piece abutment. All digitally designed CAD/CAM customizations for BruxZZir® NOW SRC are only intended to be designed and manufactured according to digital dentistry workflow, which incorporates of the digital dentistry workflow including scan files from Intra-Oral Scanners, CAD software, milling machine and associated tooling and accessories.

BruxZir® NOW SRC is a pre-manufactured two-piece hybrid abutment crown composed of a fully sintered zirconia superstructure and a pre-installed Ti-base (titanium base) that is used with the glidewell.io™ In-Office Solution. The zirconia and Ti-base components make up a two-piece abutment, which is used in conjunction with endosseous dental implants to restore chewing function. The CAD/CAM software is intended to design the final abutment shape including anatomic features and facilitate in-office milling.

The Ti-base of BruxZir® NOW SRC is pre-cemented to a post-sintered zirconia superstructure, which is to be designed and fabricated to support screw-retained prosthetic restorations. After machining in the fastmill.io"M In-Office Mill, this two-piece abutment is mounted onto the implant and fixed with a screw. BruxZir® NOW SRC can be milled in-office by a dental professional and dental laboratories.

The digital workflow requires the use of the following equipment:

• Scanner: Intra-oral scanner
• Design Software: CloudPoint FastDesign Chairside (K231529)
• Restorative Material: Fully sintered zirconia; BruxZir® NOW(K220816)
• Milling Unit: fastmill.io™ In-Office Mill

The BruxZir® NOW SRC is designed and fabricated to be compatible with the Hahn™ Tapered Implant System (K143353) and the Inclusive® Tapered Implant System (K121406, K153099). BruxZir® NOW SRC is provided non-sterile and intended for single use and prescription use.

The provided text describes the BruxZir® NOW SRC, a dental implant abutment, and its substantial equivalence to a predicate device. It primarily focuses on mechanical, sterilization, biocompatibility, shelf-life, and packaging data to support its claims. There is no information provided in the document about acceptance criteria, device performance, AI/algorithm studies, ground truth establishment, or expert involvement. The document primarily reports on non-clinical testing.

Here's a breakdown of what CANNOT be answered based on the provided text:

• Acceptance criteria and reported device performance (in the context of clinical or AI performance): The document doesn't define specific acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, as it's not evaluating an AI/diagnostic device. It broadly states the device has "sufficient strength" and provides a "maximum angulation correction of 20 degrees" based on mechanical testing.
• Sample size for test set and data provenance (for AI): Not applicable as there is no AI or clinical test set described.
• Number of experts used to establish ground truth and qualifications: Not applicable.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable.
• Type of ground truth used (for AI/clinical performance): Not applicable.
• Sample size for the training set (for AI): Not applicable.
• How the ground truth for the training set was established (for AI): Not applicable.

However, I can extract information about the non-clinical studies performed and their general conclusions:

Non-Clinical Studies and Findings:

Sample Sizes and Data Provenance for Non-Clinical Tests:

• Mechanical Testing: The document refers to "worst-case scenario" testing but does not specify the number of samples or the origin of the data. It's implicitly laboratory-based data for device components.
• Sterilization Validation: Refers to "testing sample used in the previous steam sterilization validation testing for the reference device (K160979)" which "represented the worst-case scenario." No specific number is given for the subject device itself.
• Biocompatibility Evaluation: This is a biological evaluation following ISO 10993-1. Sample size not specified.
• Shelf Life: Based on material science principles; no direct sample size for testing is implied.
• Packaging Validation: "Previous packaging validation" for a reference device was used. No specific sample size for the subject device's packaging.
• MR Environment: Based on scientific rationale and published literature; not a direct experimental study with a sample size for this submission.

Further Notes:

• The document states "No clinical data was included in this submission." This explicitly confirms that the information requested about clinical performance, expert ground truth, and reader studies is not present in this document.
• The device is a "pre-manufactured prosthetic component" for dental implants, not an AI or diagnostic software. Therefore, the questions related to AI-specific performance metrics, training/test sets, and ground truth are not applicable to the scope of this FDA submission.

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The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

BruxZir® Esthetic blanks are zirconia milling blanks used for the production of highly esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Esthetic restorations make them viable for use in all regions of the mouth. The manufactured dental restorations are made utilizing a CAD/CAM system for design and manufacture. The designed and manufactured dental restorations are then sintered at a high temperature. BruxZir® Esthetic blanks are available in white, bleach, and pre-shaded varieties that can be easily adjusted to match the final shade.

The provided text describes the submission for a dental device, BruxZir® Esthetic (K240882), and compares it to a predicate device (K213425). The focus of the submission is to demonstrate substantial equivalence through non-clinical testing. This is not a submission for an AI/ML powered device, and therefore, many of the requested elements related to AI/ML specific studies (e.g., MRMC studies, standalone AI performance, training set details, ground truth establishment for AI models) are not applicable.

However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets those criteria, specifically concerning the physical and chemical properties of the dental material.

Here's a breakdown of the requested information based on the provided text, while noting the inapplicability of AI/ML specific questions:

Device: BruxZir® Esthetic (K240882)
Device Type: Zirconia milling blanks for dental restorations. This is a material, not an AI/ML powered device.

1. Table of Acceptance Criteria and Reported Device Performance

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The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

Contraindication: This device is contraindicated for dental restorations greater than 3-units in length.

BruxZir® Radiant are zirconia milling blanks used to produce highly esthetic zirconia dental restorations. The high esthetics and high strength of BruxZir® Radiant restorations make them viable for use in all regions of the mouth. The manufactured dental restorations are made utilizing a CAD/CAM system for design and manufacture. The designed and manufactured dental restorations are then sintered at a high temperature. BruxZir® Radiant Blanks are available in 6 shades, Brite, White, 100, 200, 300, 400, that can be easily adjusted to match the final shade.

The provided document is a 510(k) summary for the medical device BruxZir® Radiant. It outlines the acceptance criteria and the studies conducted to demonstrate that the device meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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CloudPoint FastDesign Chairside is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. CloudPoint FastDesign Chairside is intended for use by a dental practitioner or dental laboratory staff for designing the patient-matched component of a two-piece hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant to create the final device.

CloudPoint FastDesign Chairside (also known as FastDesign), is a software suite intended to be used by trained dental practitioners or dental laboratory staff to design the patient-matched component of a two-piece hybrid dental implant abutment. A titanium base-type abutment and hybrid abutment-crown component are combined to make the two-piece hybrid dental implant abutment. The software allows a dental practitioner or dental laboratory staff to design the matching dental abutment based on imported scan data containing topographical characteristics of the patient's dentition. The resulting abutment design will be exported to a remote milling machine to make the final device.

CloudPoint FastDesign Chairside, is restricted to be used with 510(k) cleared abutment systems. The software includes design parameters from the 510(k) cleared abutment systems such as maximum and minimum dimensions (e.g., abutment post height, gingival height, angulation, gingival margin diameter, etc.). CloudPoint FastDesign Chairside designs the endosseous dental implant abutment under the directions of a clinical professional and maintaining accordance to the requirements of the compatible 510(k) cleared abutment systems with cleared design parameter size ranges.

The provided text describes the "CloudPoint FastDesign Chairside," a dental abutment design software. However, it does not contain the detailed acceptance criteria for device performance, nor the specifics of a study proving the device meets those criteria, as typically requested in your prompt.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Abutment Design K200100) based on intended use, indications for use, and technological characteristics. It mentions "Software verification and validation" and "Cybersecurity Analysis" as non-clinical data submitted, but does not provide a table of acceptance criteria with reported device performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The document states that software verification and validation were conducted to "verify that the software development output met the input requirements, and to validate that the software specifications confirm to user needs and its intended uses," but it does not list these specific requirements or their direct performance outcomes.
2. Sample sizes used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
4. Adjudication method: Not specified.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or conducted. The document states "No clinical data is included in this submission."
6. Standalone (algorithm only) performance study: Not explicitly detailed with performance metrics. The software verification and validation focused on confirming design limitations and specifications.
7. Type of ground truth used: Not specified.
8. Sample size for the training set: Not applicable as this is a design software, not an AI/ML diagnostic algorithm that typically relies on a training set in the same way. The document highlights "software design verification and validation."
9. How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance data is:

• Non-clinical data submitted:
  • Software verification and validation, according to the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005.
  • Cybersecurity Analysis, according to the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued on October 02, 2014.
• No clinical data is included in this submission.
• Software Verification and Validation details:
  • Conducted by Prismatik Dentalcraft, Inc. to verify that software development output met input requirements and validate that software specifications conform to user needs and intended uses.
  • Used to address questions related to substantial equivalence based on technical feature differences.
  • Provided for the compatible abutment design library to demonstrate use with the software suite.
  • Conducted to demonstrate that "restrictions prevent design of the patient-matched component of the two-piece hybrid dental abutment outside of the allowable design limitations, including screenshots under user verification testing."
  • Established that "the design limitations and specifications are locked and cannot be modified within the abutment design library."
• Cybersecurity Analysis details:
  • Risk assessment (hazard analysis, mitigation, design considerations for intentional and unintentional cybersecurity risks) was performed.
  • Concluded that benefits outweigh residual risk after mitigation, and all risks were mitigated as far as possible.

In summary, the provided text confirms the device underwent software verification and validation and cybersecurity analysis as non-clinical testing to support its substantial equivalence, but it does not offer the specific device performance acceptance criteria or detailed study results you've requested.

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