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The NOBILCAM IMPAK Disc is a heat cured, moldable, acrylic compound for use in the fabrication of dental appliances and dental prostheses devices including TMJ splint appliances, nightguards, bruxism appliances and other devices as prescribed.

The NOBILCAM IMPAK Disc contains a cured disc, to be used in a CAD/CAM machine to produce an occlusal splint for suffering patients. NOBILCAM IMPAK Disc is mainly composed of acrylic resin and manufactured through compression molding. Depending on the different CAD/CAM machines used for the product, NOBILCAM IMPAK Disc is designed into various specifications and shades to meet different needs.

I am sorry, but the provided text from the FDA 510(k) Clearance Letter does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies for an AI/CADe device.

The document describes the regulatory clearance for a dental material device called "NOBILCAM IMPAK Disc", which is an acrylic compound used for fabricating dental appliances.

It focuses on:

• Physical and Chemical Properties Tests: These are bench tests comparing the material properties (e.g., appearance, dimension, color stability, water sorption, hardness, flexural strength) of the subject device to a predicate device and relevant ISO/ADA standards.
• Biocompatibility Tests: These are biological safety tests performed according to ISO 7405 and ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization).
• Technological Characteristics Comparison: A table comparing ingredients, physical form, indications for use, sterility, storage conditions, and packaging with predicate and reference devices.

There is no mention of:

• An AI or CADe device.
• Any diagnostic or detection performance metrics (e.g., sensitivity, specificity, AUC).
• Human reader studies or multi-reader multi-case (MRMC) comparative effectiveness studies.
• Ground truth established by experts or pathology.
• Sample sizes for training or test sets for an algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on this document, as the document pertains to a physical dental material, not an AI software or diagnostic device that would typically have the performance metrics and study types you've listed.

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Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.

Denture Base Polymers contains powder and liquid, wherein the power is mainly composed of polymethyl methacrylate, and the main composition of the liquid is methyl methacrylate.

This document is a 510(k) premarket notification for a medical device called "Denture Base Polymers." It's a submission to the FDA (U.S. Food & Drug Administration) to demonstrate that the device is "substantially equivalent" to legally marketed predicate devices, meaning it's as safe and effective as a device already on the market.

However, the provided text does not describe a study involving "acceptance criteria" and "device performance" in the context of an AI/algorithm-based diagnostic or prognostic device. It's for a dental material (denture base polymers), which is a physical product, not a software or AI device.

Therefore, I cannot extract the information required for your request, such as a table of acceptance criteria for AI performance, sample sizes for test sets in an AI study, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document primarily focuses on:

• Chemical composition of the denture material.
• Technological characteristics (e.g., heat curing, self-curing).
• Physical and chemical properties that meet ISO standards (ISO 20795-1 for Dental base material).
• Biocompatibility testing (following ISO 10993 standards) to ensure it's safe for use in the human body.
• Comparison to predicate devices to demonstrate substantial equivalence for its intended use (fabrication and repair of partial and full denture base).

It explicitly states: "10. Clinical Performance Data: Not applicable. Clinical performance testing has not been performed on the subject device." This further confirms that no clinical studies in the sense of a performance study for an AI device were conducted or are being reported here.

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Intended for making dental plates, bite plates, frame-works, clasps,personal trays, appliances, occlusal splints and night guards.

Flexible Block is a circular solid (disc) or rectangular solid (block) made from polyamide through high-temperature injection molding, and is used in a CAD/CAM milling machine for production of dental plates, bite plates, frame-works, clasps, personal trays, appliances, occlusal night guards. These blocks are available in a variety of shapes and sizes for different milling systems and in a variety of dental shades.

Here's a breakdown of the acceptance criteria and study information for the Flexible Block device, based on the provided FDA 510(k) summary:

This device is a material (dental polymer blanks) used in a CAD/CAM milling machine to create dental restorations, not a diagnostic AI device. Therefore, many of the typical AI acceptance criteria and study components (like expert ground truth, adjudication, MRMC studies, standalone algorithm performance, and training set details) are not applicable. The "acceptance criteria" here refer to the product's physical, chemical, and biological properties meeting established standards for similar dental materials.

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

• Non genotoxicity (ISO 10993-3)
• Non cytotoxicity (ISO 10993-5)
• Non sensitization or irritation (ISO 10993-10)
• Non systemic toxicity (ISO 10993-11) | Met (Biocompatibility tests performed and "satisfy the ISO 10993 standards," including systemic toxicity, skin irritation, skin sensitization, in vitro cytotoxicity, in vitro mammalian cell TK gene mutation test, in vitro mammalian chromosome aberration test, and bacterial reverse mutation study) | NA (Predicate "Flexible Block" stated as "NA" for specific 10993 tests in the comparison table, but overall assumed biocompatible as a marketed device.) |
  | Regulatory Classifications | Class II | Class II |
  | Indications for Use | Similar (Intended for making dental plates, bite plates, frame-works, clasps, personal trays, appliances, occlusal splints and night guards.) | Similar (for making dental plates, bite plates, frame-works, clasps, personal trays, appliances, occlusal splints and night guards) |
  | Contraindications | Same | Same |
  | Labeling | Similar | Similar |
  | Target Population | Dental patients | Dental patients |
  | Anatomical Site | On teeth | On teeth |
  | Where Used | Hospital, dental clinic, and relevant places | Hospital, dental clinic, and relevant places |
  | Human Factors | Dental professional | Dental professional |
  | Design | Circular solid (disc) or rectangular solid (block) of polyamide. | Circular solid (disc) or rectangular solid (block) of super polyamide and thermoplastic compound. |
  | Cautions | Similar | Similar |
  | Standards Met | Same (implicitly, by meeting specific ASTM and ISO standards) | Same (implicitly, by meeting specific ASTM and ISO standards) |
  | Sterility | Non-sterile | Non-sterile |
  | Chemical Safety | Similar | Similar |

Study to prove acceptance criteria:

The study performed was a series of bench tests to evaluate the physical, chemical, and biological properties of the Flexible Block device.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated in terms of number of blocks tested for each physical property. However, it mentions "We selected our Flexible Block (Model: monolayer; Specification: 98×20mm; Shade: Clear) as the representative in biocompatibility tests," implying a single representative model was used for biocompatibility.
• Data Provenance: The tests were conducted by the manufacturer, Shandong Huge Dental Material Corporation, based in China ("No. 68 Shanhai Road, Donggang District Rizhao City, Shandong 276800 China"). This is a retrospective evaluation of a newly manufactured material against established standards.

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

• Not Applicable. For a material device, "ground truth" is established by adherence to physical, chemical, and biological standards (e.g., ASTM, ISO). There are no human "experts" establishing ground truth in the context of diagnostic performance here. The "experts" would be the personnel in the testing laboratories who perform the tests according to the specified standards.

4. Adjudication method for the test set

• Not Applicable. There is no adjudication method in the context of evaluating a material against objective physical and chemical standards.

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 a material device, not an AI-enabled diagnostic tool. 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 material device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device is based on established material science standards (e.g., ASTM D638, ASTM D570, ASTM D256, ASTM D790) for physical properties, and international biocompatibility standards (ISO 10993 series) for biological safety.

8. The sample size for the training set

• Not Applicable. This is a material device, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing process of the material could be seen as analogous to a "training set" in a very abstract sense (optimizing the material's properties), but it does not use a data-driven training set like AI models.

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

• Not Applicable. As there is no training set for an AI model, there is no ground truth established for it. The development of the material's properties would be based on material science principles and iterative testing against target performance specifications.

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A-Silicone for Bite Registration is indicated for making occlusal registrations.

A-Silicone for Bite Registration is a vinylpolysiloxane (addition silicone), also known as A-Silicones, polyvinyl siloxanes (PVS), or vinyl polysiloxanes (VPS), especially made for bite registration work in the surgery and laboratory. It mainly contains polydimethylsiloxane, silica and platinum catalyst.

This document does not describe a study involving a medical device with AI components or an AI/ML algorithm that requires specific performance metrics like sensitivity, specificity, or measures of human reader improvement.

The device in question, "A-Silicone for Bite Registration," is a dental impression material. The information provided relates to its substantial equivalence application to the FDA, focusing on its physical and chemical properties and biocompatibility.

Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI) are not applicable to this kind of medical device submission.

However, I can extract the acceptance criteria and performance data for the physical properties testing that was conducted:

1. Acceptance Criteria and Device Performance (Physical Properties)

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical, laboratory-based physical properties tests.

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

• The document does not specify the sample size for each physical properties test.
• Data provenance: The tests were conducted internally by "Shandong Huge Dental Material Corporation" as per "our company's" pre-test planning approaches and test methods. The country of origin for the data can be inferred as China, where the manufacturer is located. The tests are retrospective to the submission date.

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

• Not applicable. The ground truth for physical properties (e.g., consistency, dimensional change, detail reproduction) is established by standardized laboratory measurement techniques defined by ISO 4823, not by expert consensus in a clinical sense.

4. Adjudication method for the test set:

• Not applicable. The physical properties tests follow standardized protocols. There is no mention of adjudication, which is common in clinical imaging studies.

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 material, not an AI diagnostic tool.

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

• Not applicable. This device is a material, not an AI algorithm.

7. The type of ground truth used:

• For physical properties: The ground truth is defined by the objective, measurable standards set forth in ISO 4823 Fourth edition 2015-08-01 Dentistry - Elastometric impression materials.
• For biocompatibility: The ground truth is established by the results of tests performed fully following the ISO 10993 standards (Cytotoxicity, Sensitization, and Irritation).

8. The sample size for the training set:

• Not applicable. This device is a material, not an AI algorithm that requires a 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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The Orthodontic Appliance is indicated for the correction of tooth malocclusion in patients with permanent dentition. The Orthodontic Appliance moves the teeth by continuous gentle force.

The Orthodontic Appliance is a series of clear, lightweight, plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. The product is made of a polymer thermoplastic material (polyvinyl ester mixture) by pressing.

The doctor-prescribed Orthodontic Appliance are provided non-sterile and are customized for each patient according to the 3D printed data designed by Clear Aligner Design Software. Shandong Huge Dental Material Corporation manufactures the Orthodontic Appliance by thermoforming commercially available thermoplastic material and send them to the clinician. The clinician confirms the fit of the aligners upon delivery to the patient and monitors the patient's progress throughout treatment. Depending on the patient need and the treatment plan, a series of aligners may be used. The duration of use for each pair of appliance is 2-3 weeks, wear the appliances for at least 20 hours every day and it is to be worn except during eating or cleaning of the oral cavity.

The type of Orthodontic Appliance is LX-A with various thickness so that the clinician can select suitable thickness based on patients' teeth micromaxillary deformity conditions. Different thickness are identical in chemical compositions, indications for use, functions, performance characteristics, operation principle and other aspects.

The provided document is a 510(k) summary for an Orthodontic Appliance. It details the device's indications for use, its description, comparison to a predicate device, and non-clinical performance testing. However, it explicitly states that no clinical testing was required or performed to support the device's clearance.

Therefore, many of the requested details regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document, as such a study was not conducted for human performance. The focus of the provided document is on demonstrating substantial equivalence to a predicate device through non-clinical means (material properties, biocompatibility, and software V&V for ordering/processing).

Here's what can be extracted based on the information provided:

Acceptance Criteria and Device Performance (Non-Clinical)

Since no clinical study was performed, the "device performance" relies on non-clinical tests and comparison to a predicate. The acceptance criteria essentially stem from demonstrating that the subject device is comparable to the predicate device in terms of performance characteristics.

Specific tested items included:Appearance and surface characteristicsDimensionspH valueElasticity variableVolume weightWater sorptionSolubilityThe comparative testing between the proposed and predicate device for these properties was conducted to demonstrate substantial equivalence. The implication is that the subject device's performance aligns with or is sufficiently similar to the predicate device and established material properties. |
| Biocompatibility (ISO 10993 Standards): | The document states: "Biocompatibility tests were performed to satisfied the ISO 10993 standards. The test results of the tests met the requirements of the study protocols..."

Specific tests conducted:Cytotoxicity (ISO 10993-5)Skin Sensitization (ISO 10993-10)Intracutaneous Reactivity (ISO 10993-10)Subchronic systemic toxicity (ISO 10993-11)Genotoxicity (ISO 10993-3)The results indicated the device met the requirements, supported by the long history of safe use of the thermoplastic material and the predicate device's information. |
| Software Verification & Validation: | The document states: "Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Orthodontic Appliance to support that the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a 'moderate' level of concern." This indicates that the software was tested and verified to perform its intended functions related to device ordering and processing, meeting the requirements for its risk classification. |

Study Details (Based on the document's claims of no clinical testing required)

Many of these categories are not applicable (N/A) because the submission explicitly states:
"The performance of Orthodontic Appliance in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there was no clinical testing required to support Orthodontic Appliance, as the indications for use is equivalent to the predicate device."

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

   • Clinical Test Set: N/A (No clinical test set was used for human performance evaluation).
   • Non-Clinical Test Set: Not specified in terms of sample numbers, but tests were performed on material samples and the device itself (e.g., for dimensions, appearance, physical/chemical properties). Data provenance is from Shandong Huge Dental Material Corporation's internal testing and material suppliers' data.
     • Biocompatibility Tests: Sample sizes for ISO 10993 tests are not explicitly mentioned in this summary, but these are standard lab tests performed on material extracts or samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No clinical ground truth was established as no clinical study was performed for this 510(k)).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set requiring adjudication).

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: N/A (No MRMC study was performed as no clinical study was conducted, and the device is a physical appliance, not an AI-based diagnostic tool for human readers).

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (The device is a physical appliance, not an algorithm, and no standalone clinical performance was evaluated). Non-clinical standalone tests were performed as detailed in the table above (physical/mechanical properties, biocompatibility).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (No clinical ground truth as no clinical study for human performance was conducted. For non-clinical tests, "ground truth" would be the established ISO standards and material specifications).

7. The sample size for the training set: N/A (The device is a physical orthodontic appliance, not a machine learning model. Therefore, there's no "training set" in the context of an AI/ML device). The design of the appliance is based on 3D printed data generated by "Clear Aligner Design Software", but this itself is part of the manufacturing process, not a training set for an AI algorithm.

8. How the ground truth for the training set was established: N/A (No training set for an AI/ML model).

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Self-curing glass ionomer based radiopaque filling cement, for dental use only. Recommended Indications:
(1) Restoration of primary teeth.
(2) Restorations of Class III, V and limited Class I cavities.
(3) Base linings under composite and amalgam.
(4) Core build-up.

Glass Ionomer Cement (Filling) has two types: Filling II. It is a device composed of various materials including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as a permanent or temporary tooth filling or as base linings. It's a powder liquid system. The basic operation principle of Glass Ionomer Cement (Filling) is acid-base reaction.

The provided document describes the acceptance criteria and the study (physical and chemical properties tests) for the "Glass Ionomer Cement (Filling)" device (K160345).

Here's the breakdown of the requested information:

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 specify the sample size used for each physical and chemical properties test. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that it refers to ISO standards and a submission by a Chinese company, it's highly probable the testing was conducted in a laboratory in China following international standards.

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

This section is not applicable as the study described is a series of laboratory-based physical and chemical properties tests against predefined ISO standards, not a clinical study involving human assessment or interpretation requiring expert ground truth establishment.

4. Adjudication method for the test set

This section is not applicable as the study described is a series of laboratory-based physical and chemical properties tests against predefined ISO standards. There is no mention of adjudication for these types of tests.

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 section is not applicable. The document describes a traditional device clearance for a dental material (Glass Ionomer Cement), not an AI-powered diagnostic or assistive device.

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

This section is not applicable as the device is a physical dental material, not an algorithm or AI.

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

The "ground truth" for the performance criteria in this context is established by the ISO 9917-1:2007 standard for Dentistry — Water-based cements - Part 1: Powder/liquid acid-base cements. The reported performance is a direct measurement against these internationally recognized physical and chemical property specifications.

8. The sample size for the training set

This section is not applicable as the device is a physical dental material and not an AI/ML algorithm that requires a training set.

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

This section is not applicable for the same reason as point 8.

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Self-curing glass ionomer based radiopaque luting cement, for dental use only. Recommended indications:

(1) Cementation of metal-based inlays, onlays, crowns and bridges;

• (2) Cementation of high strength (zirconia based) all ceramic crowns and bridges;
• (3) Cementation of posts and screws made of metal or high-strength ceramic;
• (4) Cementation of orthodontic bands;
• (5) Restoration of caries in unstressed area (Luting II only).

Glass Ionomer Cement (Luting) has two models: Luting II. It is a device composed of various materials mainly including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as luting to affix dental devices such as metal-based inlays, onlays, crowns, bridges, and orthodontic bands. It's a powder liquid system, with each part is packaged separately when not in use. The basic operation principle of Glass Ionomer Cement (Luting) is acid-base reaction.

The provided document is a 510(k) summary for a "Glass Ionomer Cement (Luting)" device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on algorithm-driven performance. Therefore, most of the requested information about AI/algorithm-related studies (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable to this document.

However, the document does contain a table of acceptance criteria and reported performance for physical and chemical properties based on the ISO 9917-1:2007 standard.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

• Powder: Free from extraneous material.
• Unset cement: Homogeneous and of a smooth consistency. | Within spec set by standard |
  | 8.1 Net setting time | - For luting: 1.5~8 min
• For restoration: 1.5~6 min | Within spec set by standard |
  | 8.2 Film thickness | - For luting: ≤25 µm
• For restoration: N/A | Within spec set by standard |
  | 8.3 Compressive strength | - For luting: ≥50 MPa
• For restoration: ≥100 MPa | Within spec set by standard |
  | 8.4 Acid erosion | - For luting: ≤0.17 mm
• For restoration: ≤0.17 mm | Within spec set by standard |
  | 8.6.2 Acid-soluble Lead content | - For luting: ≤100 mg/kg
• For restoration: ≤100 mg/kg | Within spec set by standard |
  | 8.7 Radio-opacity | The radio-opacity shall be at least equivalent to that for the same thickness of aluminium. | Within spec set by standard |

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each physical/chemical property test. It mentions that "Biocompatibility tests were performed to satisfied the ISO 10993 standards," but does not detail the specific sample counts for those tests. The data provenance is internal testing conducted by SHANDONG HUGE DENTAL MATERIAL CORPORATION, presumably prospective testing for this specific device.

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

Not applicable. The tests are for physical and chemical properties, measured objectively according to ISO standards, not interpreted by human experts.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements, not subject to adjudication.

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 a dental cement, not an AI-powered diagnostic device.

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

Not applicable. This is a dental cement, not an algorithm.

7. The type of ground truth used

The "ground truth" for the physical and chemical property tests is defined by the specific measurement methodologies and acceptable ranges stipulated in the ISO 9917-1:2007 standard. For biocompatibility, the ground truth would be the thresholds and methodologies defined by ISO 10993 standards.

8. The sample size for the training set

Not applicable. There is no AI algorithm being trained.

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

Not applicable. There is no AI algorithm being trained.

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