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VisiRad XR is a computer-aided detection (CADe) device intended to identify and mark regions of interest that may be suspicious for lung nodules and masses on chest radiographs. It identifies features associated with pulmonary nodules and masses from 6-60mm in size. Detection of suspicious findings by VisiRad XR is intended as an aid only after the physician has performed an initial interpretation; it is not intended to replace the review by a qualified radiologist and is not intended to be used for trage or to make or confirm a diagnosis. The intended patient population for VisRad XR consists of patients >21 years of age on whom chest radiographs have been acquired in an outpatient or emergency department setting.

VisiRad XR is a computer aided detection (CADe) software as a medical device (SaMD) product intended to detect lung nodules and masses from 6-60mm in chest radiographs. VisiRad XR takes DICOM images as input, utilizes machine learning algorithms to detect suspicious regions and outputs a secondary DICOM with annotated regions of interest (ROIs). VisiRad XR's output secondary DICOM includes text that it was analyzed by VisiRad XR and a link to the user manual. If no ROIs are detected by VisiRad XR, the returned secondary DICOM states "No Nodules/Masses Found". VisiRad XR is intended to be used as a second-read only after the clinician has performed their initial interpretation. The secondary DICOM does not overwrite or replace the primary radiograph, it is returned such that it hangs, using standard DICOM hanging protocol, behind the primary image.

Here's a breakdown of the acceptance criteria and study details for VisiRad XR based on the provided document:

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document explicitly states the primary endpoint for the standalone test was sensitivity and for the clinical study was superiority of aided vs. unaided AUC. Other metrics served as secondary endpoints. The acceptance criteria themselves are implicitly defined by achieving "superiority" and demonstrating "safety and effectiveness" comparable to the predicate.

Study Details

1. Sample size used for the test set and the data provenance:

   • Standalone Test Set: Not explicitly stated as a single number but consisted of data from three sources: National Lung Screening Trials (NLST) and two independent data sites. These independent sites were a Level II trauma center in rural Montana and a Level I trauma center in metropolitan Colorado. Data was acquired from each site's emergency department between 2016 and 2021. The NLST is described as a high-quality, outpatient dataset of current or former heavy smokers with geographic and demographic representation across the country.
   • Clinical Performance Test Set: 600 total patient images (300 per site). The data was retrospective chest radiographs from patients in emergency department and outpatient settings. The patient population was from across the United States (Colorado, Ohio, New Jersey, South Carolina, Iowa, Wisconsin) and represented a range of age, racial, ethnic groups, and geographic diversity. 56% were women, and 47% of those who disclosed racial data identified as a racial group other than white or Caucasian.

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

   • The document mentions that the clinical study ground truth was established by a "reference standard" against which both unaided and aided reader performance was compared. However, it does not explicitly state the number of experts or their qualifications used to establish this reference standard for either the standalone or clinical test sets.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • The document does not explicitly state the adjudication method used to establish the ground truth for the test set.

4. 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:

   • Yes, a fully-crossed MRMC retrospective reader study was performed.
   • Effect Size: The average reader improvement in overall average AUC for both sites was 0.027.
     • Site I demonstrated an average AUC improvement of 0.035 (95% Cl: 0.021, 0.048).
     • Site II demonstrated an average AUC improvement of 0.018 (95% Cl: 0.005, 0.031).
   • Average sensitivity across all readers increased by 0.076.
   • Average specificity across all readers decreased by 0.086.

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

   • Yes, a standalone performance test was executed on VisiRad XR.

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

   • For the standalone test, the document says performance was assessed on a "broad, representative dataset" but does not explicitly state the type of ground truth (e.g., expert consensus, pathology, follow-up).
   • For the clinical performance test, reader performance was compared "as compared to the reference standard." The nature of this "reference standard" (e.g., expert consensus, pathology, follow-up) is not explicitly defined.

7. The sample size for the training set:

   • The document does not provide information regarding the sample size used for the training set.

8. How the ground truth for the training set was established:

   • The document does not provide information on how the ground truth for the training set was established.

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IMICRYL COMPOSITE (Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe)

• · Direct anterior & posterior restorations
• · Core Build Ups
• · Splinting

IMICRYL COMPOSITE FLOW (Nova Compo HF, Othocompo, Luxera, Maritza)

• · Class III, V & smaller Class IV restorations
• · Base/liner in Class I & Class II restorations
• · Repair resin, porcelain & acrylic temporary materials
• · Pit & fissure sealant
• · Undercut blockout
• Restoration of minimally invasive cavity preparations

IMICRYL Composite Materials include the brands Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo and Swarpe. IMICRYL Composite Materials; It is a light-cured, radiopaque, universal hybrid composite suitable for use in the anterior and posterior regions. It is packaged in a black syringe to protect it from light.

IMICRYL Flow Composite materials include the Nova Compo HF, Othocompo, Luxera and Maritza brands. IMICRYL Flow Composite materials; It is a light-cured hybrid radiopaque composite with a fluid consistency. Composite materials are a mixture of organic resin and inorganic filler. The resin matrix contains Bis-GMA and TEGDMA is added to decrease the viscosity.

There are differences in viscosity between composites and flowable composites.

The provided document is a 510(k) Premarket Notification for dental composite materials. It is not about an AI/ML-enabled medical device, diagnostic tool, or a study that assesses human performance with or without AI assistance. Therefore, it does not include information on acceptance criteria, expert adjudication, MRMC studies, standalone AI performance, or ground truth establishment in the context of AI/ML.

The document focuses on demonstrating the substantial equivalence of the IMICRYL Composite, Composite Flow Materials to a legally marketed predicate device (ProFil Composites). The acceptance criteria are implicit in the comparison tables, showing that the new device's performance characteristics are comparable to or meet the standards set by the predicate device and relevant ISO standards.

Here's an attempt to answer the questions based on the provided document, acknowledging its limitations regarding AI/ML:

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

The document compares the new device (IMICRYL Composite, Composite Flow Materials) against a predicate device (ProFil Composites) using various technological and non-clinical bench testing parameters. The "acceptance criteria" can be inferred as achieving values comparable to the predicate device, as the submission aims to prove substantial equivalence.

IMICRYL Composite Performance vs. Predicate Device (ProFil Composite)

IMICRYL Composite Flow Performance vs. Predicate Device (ProFil Composite Flow)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document refers to "bench tests" and does not specify sample sizes (e.g., number of specimens for each test like compressive strength). It implies in-house testing was performed for the IMICRYL products to generate the reported data. The country of origin for the data generation (testing) would likely be Turkey, where the manufacturer (IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.) is located. These are laboratory-based, non-clinical tests, not human subject data.

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)

This question is not applicable to this type of device submission. There were no human experts establishing "ground truth" as it relates to image interpretation or clinical outcomes. The "ground truth" for material properties is established by adherence to recognized international standards (e.g., ISO 4049, ISO 17304) and laboratory testing methodologies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is a non-clinical bench testing submission, not an clinical study requiring expert adjudication of data.

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 document is for a dental restorative material, not an AI-enabled diagnostic device. No MRMC study was performed.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for this submission are the physical, mechanical, and biological properties of the material, measured through standardized non-clinical bench tests (e.g., compressive strength, flexural strength, biocompatibility tests). These measurements are quantifiable and objective, not dependent on expert consensus, pathology, or outcomes data in the way medical imaging AI devices are. The "truth" is established by laboratory measurements according to ISO standards.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set and thus no ground truth established for one.

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Nova Resin dual cure, self adhesive resin cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, bridges, posts and veneers. *

Additional indications include core-buildup material, pit and fissure sealant, and cementation of crowns restorations to implants.

• Adhesive application on the prep is required for veneer cementation using Nova Resin dual cure, self adhesive resin cement.

Resin Cement dual cure, self adhesive resin cement for the cementation of indirect restorations made of high strength all ceramic, composite, metal-ceramic and metal.

When Resin Cement dual cure, self adhesive resin cement is used, additional bonding agents are not required. The automix double syringe enables saving time direct application of the luting cement into restoration.

This document, an FDA 510(k) summary for the "NOVA RESIN dual cure, self adhesive resin cement," describes the device and its equivalence to a predicate device, but it does not describe an AI/ML device or its associated acceptance criteria and study data.

The document focuses on the physical and chemical properties of a dental cement. The "acceptance criteria" and "reported device performance" provided in the table are for these physical properties (e.g., film thickness, flexural strength), not metrics related to AI/ML performance like sensitivity, specificity, or AUC.

Therefore, I cannot extract the information requested regarding a study proving an AI/ML device meets acceptance criteria, as this document does not pertain to an AI/ML device.

Here's why the requested information cannot be found in the provided text:

• No mention of AI/ML device or algorithm: The entire document describes a dental cement and its physical properties. There is no mention of algorithms, machine learning, artificial intelligence, or any form of software that processes data for diagnostic or predictive purposes.
• Acceptance criteria are for physical properties: The table provided lists metrics such as Film Thickness, Working Time, Flexural Strength, etc. These are standard engineering and material science metrics for dental cements, not performance metrics for an AI system.
• No "test set," "training set," "ground truth," or "experts" in the AI context: These terms are specific to the validation of AI/ML models. The document refers to "non-clinical performance testing" which are bench tests, not clinical studies involving human experts or patient data for AI validation.
• No MRMC study: A Multi-Reader Multi-Case study is a type of clinical trial specifically designed to evaluate the impact of AI on human reader performance in medical imaging. The provided document does not mention any clinical studies of this nature.
• No "standalone performance": "Standalone" performance refers to the algorithm's performance without human intervention. This is irrelevant for a dental cement.

In summary, this document is a regulatory submission for a dental material, not an AI/ML medical device.

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PUTTY SOFT is to be used as preliminary materials for:
-Two-step Putty-wash impression technique
-One-step Putty-wash impression technique
HEAVY BODY materials for:
-One-step impression technique (simultaneous technique) using single or dual viscosities
-Two-step impression technique using dual viscosities
-Functional impression
MEDIUM/MONOPHASE/REGULAR BODY tray or syringeable impression material for:
-Taking impressions over fixed/removable restorations and implants (i.e., transferring impression posts and bridge components)
-Functional impressions
-Fabricating crown and bridgework or inlays
-Fabricating full or partial dentures
-Reline impressions
-Use in the simultaneous mixing technique as well as the putty-wash and triple tray techniques
-Transferring root posts when fabricating posts and cores indirectly
LIGHT BODY is to be used as syringeable impression materials for:
-Two-step putty-wash impression technique
-One-step putty-wash impression technique
-Two-step impression technique using dual viscosities
-Reline impressions
-Fabricating full or partial dentures
EXTRA LIGHT BODY is to be used as syringeable impression materials for:
-Two-step putty-wash impression technique
-One-step putty-wash impression technique
-Two-step impression technique using dual viscosities
-Reline impressions
-Fabricating full or partial dentures
BITE REGISTRATION is used for impression as below.
-Taking occlusal surfaces
-Confirming occlusal surfaces
-Recording after putting the articulator

The IMICRYL family of silicone impression materials: includes the brand names SPIRIAS, NICETY, REFLECT and PE Sil. It is used by dentists to obtain anatomical data of the patient's mouth and then to obtain a useful plaster cast to diagnose problems, identify necessary interventions and/or check their effectiveness. They are elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy and resistance to permanent deformation, cured by addition reaction.
The IMICRYL family of silicone impression materials consists of six different viscosities (putty soft, heavy body, medium/monophase/regular body, light body, extra light body, bite registration) for various application systems. Putty Soft consists of 1:1 250 and 1:1 300 mL jars, other consistencies 1:1 50 mL syringes. Although the consistency and composition of medium, monophase and regular body products, which have type 2 consistency, are exactly the same, they are offered for sale under three different names.

The provided text describes the acceptance criteria and performance of the IMICRYL Impression Materials device, specifically focusing on its physical properties and comparison to a predicate device. However, it does not describe an AI/ML-based medical device. Therefore, I cannot extract information related to ground truth establishment, expert adjudication, MRMC studies, or training/test set sizes for AI/ML models.

Based on the information provided, here's an attempt to answer your questions with the available data, clarifying where information is missing due to the nature of the device:

Device Type: Dental Impression Material (not an AI/ML device)
Study Purpose: To demonstrate substantial equivalence to a legally marketed predicate device (HySil Impression Materials, K170736) for FDA 510(k) clearance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the ISO 4823:2021 standard requirements and the comparison to the predicate device's performance. The "Remark" column in the provided table indicates where the new device's performance is considered "Same" or comparable, even if the exact numerical acceptance criteria aren't explicitly stated as pass/fail thresholds. The reported device performance is directly given in the "New Device" columns.

Note: "Pass" as a predicate device performance often implies that it met the ISO standard for that parameter. Some specific numerical benchmarks for "acceptance criteria" are derived from the predicate's performance or implied by the ISO standard.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document refers to "in-vitro bench tests." The specific sample sizes for each physical test (e.g., how many samples were tested for consistency, dimensional change, etc.) are not specified in this summary document.
• Data Provenance: The tests were conducted by the manufacturer, IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S., which is based in Turkey. These are laboratory bench tests, not patient data. The nature is prospective in the sense that the tests were performed specifically for this 510(k) submission on manufactured material samples.

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

This is not an AI/ML device, so there is no "ground truth" derived from expert consensus on medical images or clinical outcomes. The "ground truth" for the physical properties is established through standardized laboratory bench testing methods defined in ISO 4823:2021. The results are objective measurements (e.g., mm, %, sec, μm), not subjective interpretations requiring expert review.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/ML device involving human interpretation review. Bench tests are objective measurements based on specified protocols.

5. Is 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 is a material testing for a dental impression material, not an AI/ML device designed to assist human readers. No MRMC study was performed.

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

Not applicable. This is a physical material, not an algorithm.

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

The "ground truth" for this device's performance is based on objective physical measurements conducted in a laboratory setting according to the ISO 4823:2021 standard (Dentistry-Elastomeric impression and bite registration materials). The measurements include consistency, working/mixing time, detail reproduction, dimensional change, elastic recovery, strain-in-compression, and hardness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device. There is no concept of a "training set" for physical material properties.

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

Not applicable. As this is not an AI/ML device, no "ground truth for a training set" was established. The "ground truth" (physical properties) is determined by direct laboratory measurement.

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Nova Glass L:
-Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & bridges
-Cementation of orthodontic bands
-Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns
-Base/liner
Nova Glass F:
-Class III, V and limited class I cavities
-Restoration of primary teeth
-Core Build Up
Nova Glass LC:
-Class III and V restorations
-Restoration of Cervical erosions and root surface caries
-Core build up
-Base/liner
Nova Glass BF:
-Class I & II cavities
-Decidious teeth: final restorative for Class I, II and V
-Long term restorative in non-load bearing areas of Class I, II and V
-Intermediate restorative & sandwich material for heavy stress bearing
-Core build up material
Nova Glass L Plus:
-Metal-based restorations
-Ceramic inlays
-Reinforced ceramic crowns and bridges
-All kinds of acrylic/resin crowns, inlays, onlays and bridges

• Nova Glass Cements are devices intended to serve as a temporary tooth filling or as a base ● cement to affix a temporary tooth filling.
• . Nova Glass Cements are based on the reaction of silicate glass powder and polyalkeonic acid. (acid-base reaction)
• . Nova Glass Cements are formulated to provide a powder and a liquid portion. In use the two are combined and a chemical reaction takes place to provide set cement.

The provided text is a 510(k) Premarket Notification for dental cements (Nova Glass Cements). This document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through comparison of indications for use, functional characteristics, composition, and physical properties, along with biocompatibility testing results.

Crucially, this document does not describe a study involving an AI/software device that requires human expert review for ground truth or MRMC studies. The device in question is a material-based dental cement. Therefore, many of the requested elements related to AI algorithm performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the physical and biological properties testing conducted on the dental cements themselves, to show they perform comparably to their predicate devices and meet established standards for safety and effectiveness.

Here's a breakdown of the relevant information provided in the document:

Acceptance Criteria and Device Performance (for a Dental Cement)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" against which a study directly proves the device meets them in the way one might for an AI algorithm's performance metrics (e.g., sensitivity, specificity). Instead, it demonstrates substantial equivalence by comparing the physical properties of the new device to its predicate devices and showing biocompatibility testing results against general safety standards.

Here's how the information can be presented for the dental cements, drawing from Section "PHYSICAL PROPERTIES" on page 7 and "NON-CLINICAL PERFORMANCE TESTING" on page 8.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is primarily non-clinical performance testing, consisting of:

• Physical Testing: In-vitro bench tests performed on all Nova Glass Cements according to the requirements of ISO 9917-1:2007 (Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements).
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1 (Biological Assessment Medical Devices - Part 1: Evaluation and Testing) standard, specifically for Nova Glass F as a representative. For other products (Nova Glass LC, Nova Glass BF, Nova Glass L Plus), equivalence is asserted based on existing components in legally marketed devices.

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

• Sample Size: The document does not specify exact sample sizes for the physical or biocompatibility tests. For physical properties, it states "In-vitro bench tests were performed." For biocompatibility, it lists test names and "Report Numbers" but not the sample sizes used in those reports.
• Data Provenance: The tests were conducted to support a submission from a Turkish company (IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S.). The testing itself would likely have been done in a laboratory environment, but the origin of the "data" itself isn't described as retrospective or prospective patient data, as this is a material-based device.

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

• Not Applicable: This criterion is for AI/software devices requiring human expert review to establish ground truth. For dental cements, ground truth is established by standardized laboratory testing procedures and the results are objective measurements (e.g., setting time, strength, toxicity).

4. Adjudication Method for the Test Set

• Not Applicable: This is an AI/software specific criterion for resolving discrepancies among human annotators.

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 is an AI/software specific criterion. No human readers or AI assistance are involved in the function or testing of these dental cements.

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

• Not Applicable: This is an AI/software specific criterion. There is no algorithm.

7. The Type of Ground Truth Used

• Objective Laboratory Measurements/Standards:
  • Physical Properties: The ground truth for physical properties (e.g., film thickness, setting time, compressive strength) is based on the methods and limits defined in the international standard ISO 9917-1:2007 for water-based cements. The device demonstrates compliance with these established empirical standards and similarity to the predicate devices.
  • Biocompatibility: The ground truth for biocompatibility is based on the negative/positive control findings and criteria for safe biological response defined by ISO 10993-1 and specific test methodologies (e.g., OECD guidelines for genotoxicity).

8. The Sample Size for the Training Set

• Not Applicable: This is an AI/machine learning specific criterion. Dental cements do not have a "training set."

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

• Not Applicable: As above, no training set exists for this device.

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• 1. Direct restorations using light-cured composite resin
• 2. Cavity sealing as a pretreatment for indirect restorations
• 3. Treatment of exposed root surfaces
• 4. Treatment of hypersensitive teeth
• 5. Intraoral repairs of fractured restorations
• 6. Post cementation and core build-ups
• 7. Cementation of inlays, onlays, crowns, bridges and veneers

R&D Series Nova Compo- B Plus is a Light-cure ethanol/water-based, self-etching, one-step, all in one universal adhesive. It can be used reliably in total-etch or selective-etch mode for both direct and indirect restorations. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching procedures. The product is intended to be used for both direct and indirect restorations. The 4-MET RDX multi-functional carboxylate methacrylate polymer creates a 3-dimensional, high-strength bond with calcium. MDP (Methacryloyloxydecyl Dihydrogen Phosphate) monomer binds to Ca+2 ions on all surfaces of the tooth. The R&D Series Nova Compo- B Plus forms a micro-mechanical bond between the dentine channels to form the resin tags. Depending on the indication, the adhesive is used as self-etching or with phosphoric acid for selective enamel etching or total-etching procedures.

The provided text describes a 510(k) premarket notification for a dental bonding agent, R&D Series Nova Compo-B Plus. It assesses the device's substantial equivalence to predicate and reference devices based on indications for use, composition, and physical properties. However, this document does not contain information about an AI/ML-based medical device study that would involve the typical acceptance criteria and study design elements requested in the prompt (e.g., test set sample size, expert ground truth, MRMC studies, standalone performance).

The information provided is for a traditional medical device (a dental adhesive), comparing its physical properties like bond strength, appearance, and curing time to existing, legally marketed dental adhesives. It's a standard regulatory submission for a Class II medical device, focusing on bench testing and biocompatibility.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving an AI/ML device meets those criteria, as the provided text relates to a non-AI/ML dental bonding agent.

Specifically, the document states:

• Trade/Device Name: R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
• Regulation Name: Resin Tooth Bonding Agent
• Device Description: "R&D Series Nova Compo- B Plus is a Light-cure ethanol/water-based, self-etching, one-step, all in one universal adhesive."

This clearly indicates a chemical and physical product, not an AI/ML software device.

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R&D Series Nova Compo N is a light-curing, radiopaque, nano-hybrid universal composite for anterior restorations. It is intended for professional use by below mentioned Indications for Use;

• · Restorations of deciduous teeth
• · Splinting of mobile teeth
• · Restoration in the posterior region (Classes I and II)
• · Anterior restorations (Classes III, IV)
• · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• · Extended fissure sealing in molars and premolars
• · Veneering of discoloured anterior teeth
• · Repair of composite and ceramic veneers

R&D Series Nova Compo N is a light-curing, radiopaque, nano hybrid composite for anterior and posterior restorations.

According to the applicable FDA recognized consensus standard: ISO 4049:2009 "Dentistry-Polymer Based Restorative Materials", this device is classified into the following:

• -Type 1: polymer-based filling and restorative materials;
  -Class 2: Materials whose setting is effected by light;

-Group 1: Materials whose use requires the energy to be applied intra-orally.

R&D Series Nova Compo N light cure nano hybrid composite is designed with the high reduced shrinkage resin. The higher molecular weight of the resin results in less shrinkage, reduced aging and a slightly softer resin matrix. Additionally these resins impart a greater hydrophobicity and are less water absorption. Prepolymerized fillers provide low stress, non-sticky, easy handling and shaping formulation. High loading Prepolymerized fillers provide better wear resistance than traditional less loaded Prepolymerized fillers in other marketing composites. The nanofillers provide high polish, high wear, surface hardness and making the material smooth.

R&D Series Nova Compo N light cure nano hybrid composite was tested for biocompability and found to be biocompatible as a result of testing.

The user is asking for specific details about the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA 510(k) summary.

Here's an analysis of the provided text and the answers to your questions:

The provided document is an FDA 510(k) premarket notification for a dental composite material, R&D Series Nova Compo N. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through comparison to established standards (like ISO) and predicate device performance, along with bench testing.

Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, it presents the performance of the new device (R&D Series Nova Compo N) in comparison to the performance of its predicate devices, implying that performance similar to or better than the predicates, and adherence to relevant ISO standards, constitutes the "acceptance criteria."

The closest representation of this is Table 1 in the "Substantial Equivalence" section of the document, which compares the physical properties of the new device with its predicates. The "acceptance criteria" can be inferred as being at least equivalent to the predicate devices and meeting the requirements of the ISO 4049:2009 standard.

Inferred Acceptance Criteria and Reported Device Performance (from Table 1 and text):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the physical property bench tests. It states, "In-vitro bench tests were performed on the R&D Series Nova Compo N light cure nano hybrid composite according to the requirements in ISO 4049: 2009 (Dentistry - Polymer-based restorative)." ISO standards typically specify minimum sample sizes for various tests, but these specific numbers are not detailed in the summary.

• Sample Size for Test Set: Not explicitly stated for individual tests.
• Data Provenance: The studies are in-vitro bench tests and biocompatibility tests. No mention of human patient data (retrospective or prospective) for performance evaluation. The submitting company is IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. from Turkey, so it can be inferred the testing was conducted under their purview, likely in Turkey or by an accredited lab.

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)

This is not applicable as the studies are primarily in-vitro bench tests and biocompatibility tests. "Ground truth" in the clinical sense (e.g., expert consensus on medical images or pathology reports) is not required or established for this type of device and testing. The ground truth for these tests comes from the established physical and chemical properties as measured by standardized laboratory methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the in-vitro bench tests and biocompatibility studies described. Adjudication methods are typically employed in clinical studies or studies involving human interpretation of data (e.g., medical imaging) to resolve discrepancies.

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 is not applicable. The device is a dental composite material, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant nor were they conducted.

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

This is not applicable. The device is a dental composite material, not a software algorithm.

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

For the physical properties, the "ground truth" is established by standardized laboratory measurements according to ISO 4049:2009. For biocompatibility, the "ground truth" is established by laboratory tests according to ISO 10993-1 and ISO 7405, which determine the biological response (e.g., cytotoxicity, sensitization). There is no "expert consensus" or "pathology" in the medical diagnostic sense for these tests.

8. The sample size for the training set

This is not applicable. Since this device is a physical material (dental composite) and not an AI algorithm, there is no "training set."

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

This is not applicable as there is no "training set" for a physical dental composite device.

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IMIX PanoRad and PanoRad SL X-Ray Systems are indicated for use in generating radiographic images of human anatomy. They have Solid State X-ray Imaging systems intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)

The modified device can produce digital x-ray images in various configurations.

The provided text is a 510(k) summary for the IMIX ADR Finland OY PanoRad and PanoRad SL Systems. This document aims to demonstrate substantial equivalence to previously cleared devices, rather than establishing acceptance criteria for a new, distinct device's performance.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, and ground truth establishment because it is focused on demonstrating that the revised device is substantially equivalent to existing, legally marketed devices.

Here's why each of your requested points is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document doesn't define new performance criteria or report performance against them. Instead, it compares the characteristics of the modified device to a predicate device to show they are essentially the same.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test sets or clinical studies for performance evaluation are described. The filing relies on the established safety and effectiveness of the existing predicate devices and the individual components.
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): Since no new performance studies are detailed, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there's no new test set described.
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 is not an AI/CAD device. It's an X-ray imaging system, so MRMC studies, especially with AI assistance, are not relevant to this filing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a hardware device (X-ray system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no new performance study requiring ground truth.
8. The sample size for the training set: Not applicable, as this is not an AI/Machine Learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as point 8.

In summary, the provided document focuses on demonstrating substantial equivalence of a modified X-ray system to a predicate device by comparing technical specifications and intended use, rather than presenting a de novo performance study with specific acceptance criteria and ground truth validation.

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IMIX PanoRad and SomaRad X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)

The PanoRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 65 kW high frequency generator. A 4 way floating table. An Image Acquisition workstation with DICOM 3 compliance.

The SomaRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 50 kW high frequency generator. A table. An Image Acquisition workstation with DICOM 3 compliance.

The provided text describes a 510(k) summary for the IMIX PanoRad and SomaRad X-Ray Systems (K101435). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study.

Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how training set ground truth was established, and specific quantifiable acceptance criteria) are not applicable in this context. The document's purpose is to show that the new device is as safe and effective as previously cleared devices by comparing technical specifications and intended use.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is primarily based on substantial equivalence to predicate devices. The device "meets acceptance criteria" if it is determined to be as safe and effective as the predicate devices, with no new indications for use or significant technological differences that would raise new questions of safety or effectiveness.

Study Information (Based on the provided text)

1. Sample size used for the test set and the data provenance:

   • The document mentions "user (clinical image pairs)" as part of the testing data. However, it does not specify the sample size (number of images or patients) used for this "user" testing.
   • The data provenance (country of origin, retrospective/prospective) is not explicitly stated.

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

   • This information is not provided in the document. The "user (clinical image pairs)" testing implies some form of review, but the details of who performed this review, their number, or qualifications are absent. Given it's a 510(k) for an X-ray system rather than an AI diagnostic device, formal ground truth establishment by multiple experts is less common.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not provided.

4. 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 study was done or mentioned. This document is for an X-ray imaging system, not an AI-assisted diagnostic tool. Its purpose is to demonstrate the safety and effectiveness of the hardware and software for image acquisition, primarily through comparison with predicate devices' technical specifications.

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

   • Not applicable. This is an X-ray system, not a standalone algorithm for diagnosis. The "standalone" performance here refers to the system's ability to produce diagnostic quality images, which is addressed by a combination of bench testing, user testing, and adherence to standards.

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

   • The term "ground truth" in the context of an X-ray system's performance is typically less about definitive diagnostic labels (like pathology) and more about the diagnostic quality of the images produced and their ability to aid in general diagnostic procedures. The "user (clinical image pairs)" testing likely involved qualitative assessment of image quality for diagnostic purposes, relative to the predicate devices. However, the specific type of ground truth (e.g., clinical interpretation, comparison to established standards for image quality) is not detailed.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm trained on a dataset in the way a diagnostic AI would be. The device's software is "identical to K070618" (a DICOM Pacs device), indicating it's a pre-existing software component rather than one developed through machine learning.

8. How the ground truth for the training set was established:

   • Not applicable for the same reasons as above.

Summary of the Study and Conclusion:

The "study" or evaluation performed for the IMIX PanoRad and SomaRad X-Ray Systems was a substantial equivalence comparison. This involved:

• Bench testing: Evaluating the technical specifications and performance of the components.
• User testing (clinical image pairs): Likely qualitative assessment of image quality in a clinical setting by users. The details of this testing (sample size, expert involvement, ground truth, adjudication) are not provided.
• Standards testing: Ensuring compliance with relevant industry and safety standards (e.g., UL listed).

The conclusion was that the device is "as safe and effective as the predicate devices, have few technological differences, and have no new indications for use," thereby establishing substantial equivalence. This is a regulatory pathway, not a clinical trial designed to quantify performance against a specific clinical acceptance criterion.

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IMIX Insight X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. IMIX Insight X-Ray Systems are not indicated for diagnostic X-ray mammography.

System Features

• URS Radiographic Stand .
• Fully motorized movements with intelligent anti-collision system .
• Automatic settings for 40 and 72 inch SID, auto-position for table exposures .
• Patient Table capacity of 440 lbs .
• Collimator with light field and laser positioning .
• X-Ray Subsystem 65 kW High Frequency Compact Generator .
• Full Anatomical Programming .
• Automatic Exposure Control .
• High Capacity (300kHU) X-ray tube with 0.6/1.2mm focus (27/75kW) .
• Microprocessor System Monitor .
• IMIX Insight Detector: High Resolution 9 megapixel or 16 megapixel CCD detector .
• 40cm x 40cm Image Format (16 x 16 inch) .
• Spatial Resolution: >3.1 1p/mm (4Mp) or >4.3 1p/mm (16Mp) .
• Image Acquisition: 16 bit .
• 3 Field Ionization Chamber .

The provided text (K073114) describes an X-ray system called the IMIX Insight X-Ray System. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance studies.
7. The type of ground truth used.
8. The sample size for the training set.
9. How ground truth for the training set was established.

The document primarily states:

• Device Name: IMIX Insight X-Ray Systems
• Intended Use: Generating radiographic images of human anatomy, replacing radiographic film/screen systems in general-purpose diagnostic procedures. Not indicated for diagnostic X-ray mammography.
• Substantial Equivalence: The device is a modified combination of a cleared device (IMIX Digital Thorax K974863) with exempt devices, and is functionally identical to the SEDECAL URS LP X-Ray Units with Digital Detector (K042876) and similar to Vidar Vision 3000 and 4000 (K071193).
• Device Description: Provides details about system features like the URS Radiographic Stand, X-Ray Subsystem, and IMIX Insight Detector specifications (e.g., 9 or 16 megapixel CCD detector, 40cm x 40cm image format, spatial resolution >3.1 lp/mm or >4.3 lp/mm, 16-bit image acquisition).

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