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The Ormco™ Spark™ Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The Ormco™ Spark™ Aligner System positions teeth by way of continuous gentle force.

The Ormco™ Spark™ Aligner System consists of a series of doctor-prescribed, custom manufactured, clear plastic removable orthodontic appliances (aligners) that incrementally move the patient's teeth from an original state to a treated state. Treatment planning, aligner design and aligner manufacture are supported by a proprietary software system. The Ormco™ SparkTM Aligner system consists of multiple interfacing software modules; Web, Design, Approver and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Ormco technicians use a reference Anatomy software and the Ormco™ Spark™ Aligner Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners.

The clinician receives the aligners and provides them, in sequential "stages", to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligner. The trays are held in place by pressure and can be removed by the patient at any time.

Several treatment options may be integrated into the Ormco Spark/Kappa aligner. Attachments or "buttons" may be prescribed by the dental practitioner to facilitate tooth movement and aligner anchorage. The dental practitioner may choose a standard dental composite and adhesive to bond the attachments to the dentition. The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Hooks may be designed into the aligner, then connected by an elastic to a toothbonded button on the opposite arch. to apply additional forces. Bite ramps are step features built into the lingual surfaces of the upper aligner arch that used by the clinician to prevent movement of the teeth during overbite correction treatment. Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to address voids of missing teeth or other gaps during treatment.

The provided text describes the Ormco™ Spark™ Aligner System and its substantial equivalence to a predicate device, the Invisalign System (K143630). However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through specific performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics, performance testing, and a literature review.

Therefore, the requested information elements related to the acceptance criteria and a study proving the device meets them cannot be fully extracted as they are not explicitly present in the provided text.

Here's a breakdown of what can be extracted or inferred based on the supplied document, addressing the prompt's points where possible:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with numerical targets and reported performance values for those targets. Instead, it discusses "performance testing" to demonstrate substantial equivalence to the predicate device.

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

• Sample Size for Test Set: Not specified for any of the performance tests. The document only mentions "all tested samples" for material property tests (translucency, staining, shelf life, shipping) and "specified cycles" for aligner features.
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. The performance testing appears to be bench testing conducted by the manufacturer ("Ormco").

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

• This information is not provided. The document mentions "orthodontic specialists" conducted a "comprehensive scientific literature review and analysis" to support substantial equivalence, but not for establishing ground truth for a test set of the proposed device.

4. Adjudication method for the test set

• This information is not provided. There is no mention of an independent adjudication method for performance 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

• No MRMC comparative effectiveness study was done or mentioned. The device described (Ormco™ Spark™ Aligner System) is a physical orthodontic appliance system, not an AI-assisted diagnostic or treatment planning tool that would typically involve human "readers" or "AI assistance" in the sense of image interpretation. The software components described are for treatment planning, design, and manufacturing workflow, not for AI-driven interpretation or assisted reading by human experts.

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

• This question is not directly applicable. The "algorithm" here refers to the software that assists in designing and manufacturing the aligners. The overall device is a system involving both software and physical aligners, prescribed and managed by a dental professional. The performance tests evaluate the physical properties of the aligners and the accuracy of certain features, not the standalone diagnostic performance of an algorithm.

7. The type of ground truth used

• For the physical and material performance tests (stress relaxation, flexural/tensile strength, translucency, staining, shelf life, shipping, attachment accuracy, etc.), the ground truth would implicitly be measured physical and chemical properties against established industry standards or comparable predicate device properties.
• For biocompatibility, the ground truth was adherence to ISO 10993-1 standards.
• For the overall claim of substantial equivalence, the "ground truth" for efficacy and safety relies heavily on the established performance and safety record of the predicate device (Invisalign System) and general scientific literature on clear aligners, as no clinical performance testing was done on the proposed device.

8. The sample size for the training set

• This information is not provided. The document describes a "proprietary software system" with "multiple interfacing software modules" for treatment planning, aligner design, and manufacture. If these modules involve machine learning, no details about training set size are given. Given the nature of the device (orthodontic aligners), "training set" may refer to data used for software development and design rather than a clinical AI model training.

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

• This information is not provided. As with point 8, if there's an AI/ML component implying a "training set," the document does not elaborate on how ground truth for such a set would be established. For traditional software development, "ground truth" might align with engineering specifications and clinical requirements documented by the developers and dental professionals.

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The Steri-Cassettes and Steri-Cages are intended to contain dental instruments for cleaning, sterilization, organization, storage and handling. The Steri-Cassettes and Steri-Cages are suitable for pre-vacuum and gravity displacement steam sterilization methods. The cassettes and cages are not intended to maintain sterility; they are intended to be used in conjunction with validated, FDA-cleared sterilization wrap in order to maintain sterility of the enclosed devices.

The validated steam sterilization cycle parameters are as follows:

| Steam Sterilization
Cycle | Minimum Exposure
Temperature | Minimum
Exposure Time | Minimum Dry Time |
|-------------------------------------------------------------|---------------------------------|--------------------------|------------------|
| Gravity
Displacement
(wrapped) | 250°F (121°C) | 30 Minutes | 15 Minutes |
| Gravity
Displacement
(wrapped) | 270°F (132°C) | 15 Minutes | 15 Minutes |
| Gravity
Displacement
(wrapped) | 275°F (135°C) | 10 Minutes | 30 Minutes |
| Gravity
Displacement
(unwrapped for
immediate use) | 132°C (270°F) | 3 Minutes | None |
| Pre-Vacuum
(wrapped) | 270°F (132°C) | 4 Minutes | 30 Minutes |
| Pre-Vacuum
(wrapped) | 275°F (135°C) | 3 Minutes | 16 Minutes |
| Pre-Vacuum
(unwrapped for
immediate use) | 273°F (134°C) | 3 Minutes | None |

Steri-Cassettes and Steri-Cages are used to hold instruments in a secure way for cleaning, sterilization and presentation at point of use. They keep instrumentation organized in an efficient way. They are available in a variety of sizes to accommodate instruments of various sizes and are offered in an assortment of colors to aid in office organization.

Steri-Cassettes and Steri-Cages have perforations consisting of open-slots on the lid and the base which allows exposure of the device to the sterilant during sterilization. All the five variations of the stackable Steri-Cassettes and Steri-Cages have the same design of open-slot perforations on their lid and base (1) Steri-Cassette AA - Shallow - High Heat, (2) Steri-Cassette AA - Shallow - Standard Heat, (3) Steri-Cassette AB - Medium -High Heat, (4) Steri-Cassette BB - Deep - High Heat and (5) Steri-Cage - Standard Heat. Steri-Cassettes include instrument holder inserts, which are removable and individually hold instruments.

Cassettes and cages are manufactured by Injection Molding process from either high-heat resin or polypropylene with color - materials widely used in the medical field. The colors are already pre-mixed and vary by color in the supplier's proprietary resin mixtures: Steri-Cassettes High-Heat: RoHs-compliant, high-heat resin - Ultem Resin 1000 and Steri-Cassettes Standard Heat and Steri-Cages: polypropylene with color.

The cassettes and cage have a latching lid to contain the products. The proposed devices are designed to fit any standard autoclave and ultrasonic machine, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization cycles. Since the proposed cassettes and cages have open slots, a legally-marketed and FDA-cleared sterilization wrap must be used for sterilization purposes to maintain the sterility of the contents.

The proposed Steri-Cassettes and Steri-Cages are packaged in non-sterile, plastic shrinkwrap, which is then appropriately labeled and includes a validated Cleaning and Sterilization/ Dry Time Instructions for use.

Here's an analysis of the acceptance criteria and study information for the Steri-Cassette and Steri-Cage Sterilization Packaging System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving absolute safety and effectiveness through extensive standalone studies typical for novel devices. Therefore, the information regarding "acceptance criteria" and "studies" will primarily relate to demonstrating that the new device performs as well as or in a similar manner to the legally marketed predicate device, especially in terms of sterilization parameters and material compatibility. The document often references standards rather than detailed study protocols and results.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format with direct performance metrics in the way one might expect for a novel performance claim (e.g., "X% accuracy"). Instead, the substantial equivalence is demonstrated by aligning the device's capabilities and validated parameters with recognized standards and the predicate device's performance. The key "performance" for this device relates to its ability to withstand and facilitate sterilization effectively.

The closest we get to acceptance criteria are the validated steam sterilization cycle parameters and the general compatibility with cleaning and sterilization processes.

• 250°F (121°C) for 30 Min Exposure, 15 Min Dry Time
• 270°F (132°C) for 15 Min Exposure, 15 Min Dry Time
• 275°F (135°C) for 10 Min Exposure, 30 Min Dry Time
  Pre-Vacuum:
• 270°F (132°C) for 4 Min Exposure, 30 Min Dry Time
• 275°F (135°C) for 3 Min Exposure, 16 Min Dry Time |
  | Steam Sterilization Cycle Parameters (Unwrapped, immediate use) | Gravity Displacement:
• 132°C (270°F) for 3 Min Exposure, None Dry Time
  Pre-Vacuum:
• 273°F (134°C) for 3 Min Exposure, None Dry Time |
  | Reusable Life Cycle | "Yes, validated to be reused at least five (5) times." (Implies the device maintains its structural integrity and functionality for at least 5 sterilization cycles). |
  | Material Compatibility with Sterilization Method | "Yes - Materials are compatible with sterilization method" and "Materials of construction are compatible with steam sterilization." (Implies no degradation or adverse effects from sterilization). |
  | Sterilant Penetration | "Yes - Sterilant (steam) penetration through perforations in base and lid - Steam Sterilization Validation testing." (Implies effective sterilant access to contents). |
  | Microbial Barrier (Packaging Integrity) | "To be used with a validated, FDA-cleared sterilization wrap." (The device itself is not a microbial barrier; acceptance is based on its intended use with appropriate external packaging). |
  | Biocompatibility | "Yes - Materials are known to be biocompatible and do not come into direct contact with patient." (Implies non-toxic to patients and users under normal conditions, given the no-patient-contact nature). |
  | Heat Resistance | Standard Heat Steri-Cassettes and Steri-Cages: Withstand 275°F.
  High Heat Steri-Cassettes: Withstand 320°F. (As per performance and sterilization testing and resin specifications). |

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

The document is a 510(k) summary, which typically does not provide granular details about sample sizes for each validation test performed. The studies are described in a general manner by referencing standards.

• Sample Size for Test Set: Not explicitly stated for any specific test. The phrase "Cleaning Validations conducted," "Sterilization Validation testing," and "validation testing" implies that a sufficient number of units were tested to satisfy the requirements of the referenced standards (e.g., ISO 17665-1, AAMI ST77, etc.).
• Data Provenance: The studies were conducted by Sybron Dental Specialties (Kerr Corporation) for their product. It is implied the data is prospective as it's part of the premarket notification process for a new device. The location of the testing is not specified, but the manufacturing involves Mexico (SDS de Mexico S. de R.L. de C.V.) and the applicant is in the USA (Orange, CA).

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

This type of information is generally not applicable to the evaluation of a sterilization packaging system. "Ground truth" in this context would be established by validated scientific methods and measurements (e.g., temperature probes, biological indicators for sterility, chemical analysis for cleaning residuals, mechanical testing for durability), rather than expert consensus interpretations of medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "truth" is established by direct measurement and validated scientific methods, not by expert review or consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a sterilization packaging system and does not involve such an interface.

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

Yes, in essence. The performance evaluations (cleaning, sterilization efficacy, material compatibility, durability) are for the device itself as it functions in the sterilization process defined by its intended use, without human-in-the-loop performance measurement. The device's "performance" is its intrinsic capability to withstand and facilitate sterilization according to established parameters.

7. The Type of Ground Truth Used

The ground truth for the performance of this device is established through:

• Validated Sterilization Parameters: Achieving sterility (e.g., a Sterility Assurance Level, SAL of 10^-6) under the specified time, temperature, and pressure conditions using biological indicators (BIs) and physical monitors.
• Material Compatibility Testing: Demonstrating that the materials do not degrade, off-gas harmful substances, or otherwise interfere with the sterilization process or the instruments being sterilized. This is often based on adherence to ISO 10993 and ISO 7405 standards.
• Cleaning Efficacy Testing: Demonstrating that the device can be effectively cleaned to reduce organic and inorganic residues to predetermined acceptable levels.
• Physical Durability/Life Cycle Testing: Showing that the device maintains its structural integrity and functional requirements over a specified number of reprocessing cycles.
• Adherence to Recognized Industry Standards: The listed standards (e.g., AAMI ST77, ANSI/AAMI/ISO 17665-1) define the "ground truth" for how such devices should be tested and validated.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm, so there is no "training set."

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

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

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Image Alginate Dental Impression materials are irreversible hydrocolloids for dental impressions used by the dentist to take the anatomical data of the patient's mouth and subsequently realize a plaster mold useful to diagnose problems, define the required interventions and/or chectiveness. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Alginate impression materials are elastic, irreversible hydrocolloid impression materials made from seaweed. They are used to take primary or preliminary impressions of a patient's teeth and gums. This colloidal material forms a gel when the powder is mixed with water. It solidifies into an elastic mass capable of producing a negative reproduction of the oral cavity (an impression). Alginate impressions are taken to obtain diagnostic study models, which are the positive reproductions of the teeth and surrounding structures. They are also used to fabricate bleaching trays and mouth guards. Alginate is the most universally utilized impression material in dentistry. Image Alginate is a green-colored, mint flavored alginate and comes in two options Regular Set, Fast Set. The packaging configurations include a 1 lb. (454 g) bag and a singles pack of 18 g.

The document is a 510(k) Premarket Notification for "Image Alginate Dental Impression Materials" (K160097). It details the substantial equivalence of the proposed device to predicate devices (Identic Alginate and KromaFaze Alginate, K160441).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is compared against the ISO 1563:1990 standard for Dental Elastic Impression Materials Part 2 Alginate dental impression material. The acceptance criteria are essentially the "Pass" values defined by this standard.

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

The document does not explicitly state the sample sizes used for each specific non-clinical performance test. It broadly mentions "Non-clinical performance data included testing for Work time, Dimensional Changes, Set Time, Mixing Time... etc." The data provenance is not specified regarding country of origin or whether it's retrospective or prospective, beyond stating that "Biocompatibility testing was performed at a third party laboratory."

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

This information is not applicable as the described studies are non-clinical, laboratory-based performance tests and biocompatibility assessments, not studies involving human interpretation or clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical performance testing has not been performed for Image Alginate Dental Impression Materials."

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

This is not applicable as the device is a dental impression material, not an AI algorithm. The performance evaluation is for the material's physical and chemical properties.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" (or reference standard) is established by the ISO 1563:1990 standard for Dental Elastic Impression Materials Part 2 Alginate dental impression material. For biocompatibility, the ground truth is against ISO 10993-1:2009 and ISO 10993-5:2009 Biological Evaluation of Medical Devices. There is no mention of pathology or outcomes data as it is a non-clinical evaluation of a material.

8. The Sample Size for the Training Set

This is not applicable as the device is a material, not a machine learning model, and therefore does not have a "training set" in the context of AI.

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

This is not applicable for the same reasons as point 8.

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The Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is used for permanent obturation of the root canal space with the aid of obturating points.

The Tubli-Seal product line (Tubli-Seal Xpress/ Tubli-Seal EWT/ Tubli-Seal EWT Xpress) is a Zinc Oxide Eugenol root canal sealer to be used for permanent obturation of the root canal space in conjunction with obturating points. It is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. Then the mixture is carried to the root canal with endodontic obturation points, or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe. The product is available in two (2) working times. Regular and Extended Work Time (EWT) for both delivery options of tubes or dual-barrel syringes.

The proposed is available packaged in tubes (Tubli-Seal and Tubli-Seal EWT) and dualbarrel syringes (Tubli-Seal Xpress and Tubli-Seal EWT Xpress) used with single-use automix tips. The tubes are dispensed onto a mixing pad, hand mixed and then applied to the canal with an endodontic point. Tubli-Seal Xpress has the same formulation and indications for use as Tubli-Seal, and Tubli-Seal EWT Xpress has the same formulation and indications for use as Tubli-Seal EWT. The proposed syringe-delivery products are branded as "Tubli-Seal Xpress" and "Tubli-Seal EWT Xpress" and offer the convenience of single-use automix tips that remove the need for hand mixing. The dual-barrel and single-use automix tips allow the dental professional to deliver the desired volume of Tubli-Seal Xpress or Tubli-Seal EWT Xpress directly into the prepped root canal.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress)

This submission is for a modified version of an existing root canal sealer (Tubli-Seal/Tubli-Seal EWT). The core of the study is to demonstrate that the modified product line is substantially equivalent to the predicate device, essentially performing as well despite minor formula changes and a manufacturing location change.

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

The acceptance criteria are based on the international standard ISO 6876:2012 for Dental - Root Canal Sealing Materials. The reported performance of the proposed device is compared to the predicate device, with the standard as the overarching acceptance benchmark.

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Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.

Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. They are Zinc Oxide/Eugenol root canal sealants. The products are made up of two separate components, a powder base and a liquid catalyst. to form the final device. The liquid catalyst is the same formulation for both products. Pulp Canal Sealer is a fast setting material, while Pulp Canal Sealer EWT features an extended work time of greater than 6 hours on the pad.

The provided text describes a 510(k) premarket notification for a dental device, "Pulp Canal Sealer and Pulp Canal Sealer EWT." The submission aims to demonstrate substantial equivalence to a predicate device (K945244). The information focuses on non-clinical performance data and does not include details about Artificial Intelligence (AI) or machine learning algorithms. Therefore, many of the requested points related to AI studies (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance of an algorithm) are not applicable to this document.

However, I can extract information related to the acceptance criteria and non-clinical study for the device's physical and mechanical properties.

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

The acceptance criteria for the physical and mechanical properties are implicitly derived from the predicate device's performance and the ISO 6876 standard for "Dental Root Canal Sealing materials." The reported device performance is compared against the predicate and against the ISO standard's maximum limits where specified.

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Sealapex/Sealapex Xpress is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

Sealapex/Sealapex Xpress is a non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is indicated for use as a root canal sealing and filling material, and is used during an endodontic procedure to seal off the prepared root canal apical foramen and tubules from blood, exudates, and infection. The proposed is a two-part, base/catalyst - paste/paste system that is mixed in equal portions. Then, the mixture is carried to the root canal with endodontic obturation points or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe.

The proposed is available packaged in tubes (Sealapex) and dual-barrel syringes (Sealapex Xpress) used with single-use automix tips. The tubes are dispensed onto a mixing pad, hand mixed and then applied to the canal with an endodontic point. Sealapex Xpress has the same formulation and indications for use as Sealapex, but is branded as "Sealapex Xpress" since it offers the convenience of single-use automix tips that remove the need for hand mixing. The dual-barrel and single-use automix tips allow the dental professional to deliver the desired volume of Sealapex Xpress directly into the prepped root canal.

Here's an analysis of the provided text regarding the acceptance criteria and study for Sealapex/Sealapex Xpress:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be adherence to the ISO 6876:2012 standard for "Dentistry - Root Canal Sealing Materials" and substantial equivalence to the predicate device, Sealapex 4 (K010940).

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

The document does not explicitly state the sample sizes for the performance tests. It mentions "Performance testing on stability, work time, set time and slump were performed on the modified formula." and "The sealer was tested to meet ISO 6876:2012 standard." and "The predicate and proposed devices produced Flow results..." This implies that samples were tested, but the number of samples tested for each characteristic is not provided.

The data provenance is from non-clinical bench testing. It doesn't specify the country of origin for the data generation, but the manufacturing location for the proposed device is noted as Scafati Salerno, Italy. The predicate device's tests would have been performed by Kerr Corporation in Romulus, MI, USA. The current testing was performed on the "modified formula" which has been on the EU market for several years.

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

This document describes a material science/bench testing study, not a clinical study involving experts establishing ground truth for a diagnostic device. Therefore, this information is not applicable to this submission. The "ground truth" for this study is defined by the objective, measurable standards set by ISO 6876:2012.

4. Adjudication Method for the Test Set

As this is a bench testing study evaluating physical and mechanical properties against an international standard (ISO 6876:2012) and comparison to a predicate device, an adjudication method for a "test set" in the human-reader sense is not applicable. The results are quantitative measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a root canal filling material, and the evaluation focuses on its physical and mechanical properties, not on diagnostic accuracy involving human readers.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a material, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this study is based on:

• International Standard Specifications: Specifically, ISO 6876:2012 for "Dentistry - Root Canal Sealing Materials."
• Predicate Device Performance: The performance characteristics of the legally marketed Sealapex 4 (K010940) served as a benchmark for comparison to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This type of study for a material science device does not involve a "training set" as would be used for an AI/ML algorithm. Therefore, this question is not applicable.

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

As there is no "training set" in the context of this material science submission, this question is not applicable.

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Zone/Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements used for the cementation of temporary restorations.

Zone, Zone A1 and ZoneFree are Zinc Oxide Non-Eugenol temporary cements. They are self-cure materials that set by a reaction between Zinc Oxide present in the catalyst paste and Dimer Acid present in the base paste. The proposed temporary cements are to be placed in the mouth for up to 30 days. Zone comes in three options - the standard Zone cement, Zone A1 shade cement, and ZoneFree a translucent variant. The design of ZoneFree is based on Zone, but uses only small particle size Zinc Oxide to achieve both translucency and color-blending properties. Zone and Zone A1 are designed to set one minute slower than ZoneFree. The delivery systems include an automix syringe, 15 ml syringe, and a unit dose. Zone and Zone A1 are also available in a tube delivery.

The provided text describes a 510(k) premarket notification for dental cements (Zone, Zone A1, and ZoneFree) and focuses on demonstrating substantial equivalence to a predicate device (Temp-Bond NE 2). It does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/human reader performance study.

Instead, the document outlines the comparison of the new devices to the predicate based on non-clinical performance data and technological characteristics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria using the information provided, as the nature of the information (dental cement characteristics) does not align with the type of study implied by the questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance).

The document explicitly states:

• "Clinical performance testing has not been performed for Zone/Zone A1 or ZoneFree." This directly indicates an absence of the type of human reader or AI performance study that your questions pertain to.

If the request were about the non-clinical acceptance criteria described in the document, here's how some of that information would be presented:

Non-Clinical Performance Acceptance Criteria and Reported Device Performance

However, this does not answer the specific questions about AI/human reader performance studies. The document demonstrates substantial equivalence through material properties and performance in laboratory settings, not through clinical or reader-based evaluations.

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Nexus Universal/Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants.

• Adhesive application on the preparation is required for veneer cementation using Nexus Universal Chroma.

Nexus Universal / Nexus Universal Chroma is indicated for cementation of all indirect restorations including ceramic, resin, and metal-based inlays/onlays, crowns, bridges, posts, and veneers*. Additional indications include core build-ups and cementation of crowns to implants.

• Adhesive application on the preparation is required for veneer cementation using Nexus Universal and Nexus Universal Chroma.

Nexus Universal and Nexus Universal Chroma are offered in paste/paste formulations for use as self-etch, self-adhesive resin cements or as bonded resin cements. These cements are considered permanent and not temporary.

The dual-cure material is packaged in dual barrel syringes with single-use automix tips and optional curved dispensing tips to allow the user to deliver the desired volume of cement directly into the restoration and/or tooth preparation.

Nexus Universal and Nexus Universal Chroma are offered in multiple shades. The difference between Nexus Universal and Nexus Universal Chroma is that Nexus Universal Chroma offers a gel-state color indicator, which visually displays the optimal time to remove the excess cement.

The provided document describes the acceptance criteria and a study to demonstrate substantial equivalence for the dental cement "Nexus Universal" and "Nexus Universal Chroma."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document uses the predicate device (Maxcem 2, K073209) as a benchmark for acceptance criteria. The Nexus Universal/Chroma is considered substantially equivalent if its performance is comparable or improved.

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

The document does not explicitly state the sample sizes for each specific test mentioned (e.g., bond strength, film thickness). It globally refers to the data as "Non-Clinical Performance Data" and "internal performance testing."

• Sample Size: Not explicitly stated for individual tests.
• Data Provenance: The data is described as "internal performance testing." This implies the tests were conducted by the manufacturer, Sybron Dental Specialties. The country of origin is not specified but given the submitter information, it is likely the US. The data is retrospective as it refers to completed tests.

3. 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 tests are non-clinical (laboratory-based) and don't involve human expert assessment for ground truth in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" for these tests would be the measured physical and chemical properties of the material.

4. Adjudication method for the test set

This information is not applicable as the study is based on non-clinical laboratory tests, not subjective expert assessment requiring 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

There was no MRMC comparative effectiveness study done. This device is a dental cement, and the evaluation is based on material properties and non-clinical performance, not on AI-assisted human reading of medical cases.

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

This information is not applicable. The device is a dental cement, not an algorithm or AI system.

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

The ground truth for the non-clinical performance tests would be the measured physical, chemical, and mechanical properties of the dental cement, determined through standardized laboratory testing methods (e.g., ISO standards, FDA guidance). For example, a bond strength measurement has a direct numerical ground truth.

8. The sample size for the training set

This information is not applicable. The device is a physical material (dental cement), not an AI model requiring a training set.

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

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

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Life Fast Set/ Life Regular Set is a hard-setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.

Life Regular Set/Life Fast Set are hard setting Calcium Hydroxide cavity liners and pulp capping agents to be used in conjunction with all permanent restorative techniques. Life is a two-part, base/catalyst- paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Fast Set and Regular Set.

The provided document is a 510(k) premarket notification for a medical device called "Life Regular Set and Life Fast Set," which are calcium hydroxide cavity liners and pulp capping agents. It seeks to demonstrate substantial equivalence to a predicate device, "Life 2 (K012717)."

The document does not include the detailed information requested regarding specific acceptance criteria for device performance (e.g., accuracy metrics, thresholds), a study comparing the device against these criteria, or information on human reader studies, ground truth establishment with experts, or training set details for an AI/CAD system.

Instead, the document focuses on demonstrating substantial equivalence based on:

• Similarity in intended use and technological characteristics: The new device has the same intended use and a very similar formulation to the predicate. The primary difference in formulation is a change in the type of fumed silica, which is stated to be insignificant as it does not participate in the reaction.
• Manufacturing and packaging changes: The manufacturing location has changed, and the packaging material has been updated. These changes were validated internally.
• Non-clinical performance data: Verification and validation activities were performed according to design control requirements (21 CFR 820.30 and ISO 13485:2012) and risk analysis (ISO 14971:2012). The conclusion states these activities demonstrated substantial equivalence and that no new hazards were identified based on post-market data from the internationally sold product.

Therefore, I cannot provide the requested table or detailed information because the provided text does not describe a study that establishes acceptance criteria in terms of quantitative reported device performance for an AI/CAD system, nor does it detail a study proving the device meets distinct performance thresholds. The document's purpose is to demonstrate substantial equivalence to an existing device based on material, manufacturing, and packaging changes, supported by non-clinical validation and risk analysis, rather than a clinical performance study with specific metrics.

If this were an AI/CAD device, the requested information would be crucial. However, for this type of dental material, the FDA's review focuses more on the safety and efficacy of the formulation and manufacturing process, and its equivalence to a device already on the market.

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SonicFill 2 is indicated for direct placement in all cavity classes in anterior teeth. Additional indications include: base/liner material, repair of enamel defects, repair of povisionals, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, luting of composite/ceramic veneers, core build-ups and incisal abrasions.

SonicFill 2 is a light-cured, low-shrink, resin-based, dental restorative designed for direct placement. SonicFill 2 is used in combination with the SonicFill 2010 Handpiece (K091091), which activates the restorative sonically for delivery. Upon delivery the restorative drops in viscosity, allowing the composite to closely adapt to the cavity walls. When the cavity is filled and the SonicFill 2010 Handpiece (K091091) is deactivated, the restorative resin returns to its original viscosity. The composite in the cavity is then shaped and sculpted to the contours of the tooth. SonicFill 2 is designed to have a high depth of cure and low shrinkage stress allowing a cavity up to 5mm in depth to be filled and cured in a single bulk increment.

The provided text describes the regulatory submission for the dental restorative material, SonicFill 2. It does not contain information about a study based on acceptance criteria for an AI/ML powered device, or a standard clinical trial with outcomes, or an MRMC study.

However, it does detail non-clinical performance testing for SonicFill 2, comparing it to a predicate device (Metamorphosis K091023). Based on this information, I can construct a table for the non-clinical performance and extract relevant details.

Here's the information extracted from the document, tailored to your request as much as possible given the content:

Device: SonicFill 2 (Dental Restorative Material)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it compares SonicFill 2's performance to established standards (e.g., ISO 4049, ISO 10993 series) and to its predicate device, Metamorphosis (K091023), often indicating "Pass" or "Equivalent to Predicate."

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

The document specifies "non-clinical performance data included testing for mechanical strength, polishability, water sorption and solubility, flexural strength, depth of cure, light sensitivity, radiopacity, volumetric shrinkage, shrinkage stress, and color stability. Working Time testing, stability testing and biocompatibility testing were also performed." This indicates laboratory testing of the material itself.

• Sample Size for Test Set: Not explicitly stated in terms of number of samples for each test. The tests are laboratory-based material characterization tests.
• Data Provenance: The document does not specify a country of origin for the data or whether it's retrospective or prospective, as these terms are more typically applied to clinical studies. It describes internal laboratory testing data.

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 material properties in this context is established by standardized testing methods (e.g., ISO standards), not by human expert consensus or interpretation.

4. Adjudication method for the test set

Not applicable. This is not a study involving human interpretation of data requiring 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

No, an MRMC comparative effectiveness study was not done. This document pertains to a dental restorative material, not an AI-powered diagnostic or assistive device that would involve human readers. The document explicitly states: "Clinical performance testing has not been performed for SonicFill 2."

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

No, this is not an AI/ML algorithm. It is a dental material.

7. The type of ground truth used

The ground truth is based on standardized laboratory testing and measurements of material properties as defined by international standards (e.g., ISO 4049, ISO 10993 series). The comparison is also made against the performance of a legally marketed predicate device (Metamorphosis K091023).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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