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BracePaste Fluoride Sealant is a light-cure primer / sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bondable devices by preparing the bonding surface during orthodontic treatment to the etched enamel.

BracePaste Fluoride Sealant is indicated for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

American Orthodontics' BracePaste Fluoride Sealant is a light-curing primer that is intended for use in orthodontic treatment as diagnosed by a trained dental professional or orthodontist. The primer prepares the enamel during orthodontic treatment to increase adhesion to the bonding surface by wetting the bonding surface of the object to be bonded.

The provided document describes the FDA 510(k) clearance for the BracePaste Fluoride Sealant. It is a submission for a dental device, specifically a light-cure primer/sealant for orthodontic bonding. As such, it does not involve AI/ML technology or image processing. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.

The acceptance criteria and study information provided in the document are primarily for demonstrating substantial equivalence to a predicate device (Opal Seal) through non-clinical performance and biocompatibility testing.

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

The document does not explicitly present a table of acceptance criteria with numerical targets for each performance test. Instead, it states that "Results of all conducted testing was found acceptable and does not raise any new issues of safety or effectiveness." and "Results of bench testing indicate that BracePaste Fluoride Sealant performs as well as the predicate Opal Seal." This implies that the acceptance criteria are met if the new device's performance is comparable to or performs as well as the predicate device or meets established standards (e.g., ISO 29022:2013 for Shear Bond Strength).

However, based on the non-clinical performance tests listed, here's a conceptual table:

2. Sample sizes 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 the exact sample sizes for each non-clinical test conducted (e.g., how many samples were tested for Shear Bond Strength). It only lists the types of tests.

Given the nature of the device and studies (non-clinical bench testing), data provenance typically refers to the testing being performed in an accredited lab, often in the country of the manufacturer. However, this specific detail (country of origin for the data) is not provided in the document. All testing described is prospective, as it was conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This is a non-clinical bench testing submission for a dental material, not an AI/ML device requiring expert ground truth for interpretation.

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

Not applicable. This is a non-clinical bench testing submission for a dental material.

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 non-clinical bench testing submission for a dental material, not an AI-assisted diagnostic or treatment planning device.

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

Not applicable. This is a non-clinical bench testing submission for a dental material, not an algorithm.

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

The "ground truth" for non-clinical performance testing typically refers to:

• Established physical and chemical standards: For tests like depth of cure, water sorption, water solubility, and fluoride measurements, the ground truth is often defined by industry standards or specifications for dental materials.
• Predicate device performance: For comparative tests like shear bond strength, the "ground truth" or benchmark is the performance of the legally marketed predicate device (Opal Seal).
• Biocompatibility standards: For biocompatibility, the ground truth is defined by international standards like ISO 10993 series and ISO 7405, which specify acceptable limits for various biological responses.

8. The sample size for the training set

Not applicable. This is a non-clinical bench testing submission for a dental material; there is no "training set" as it does not involve AI/ML.

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

Not applicable. There is no training set for this type of device submission.

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The Cleo bracket line is intended to operate together with other orthodontic devices to apply forces to teeth. Under the supervision of a trained dental professional or orthodontist, this may result in changes to the position of teeth.

The Cleo bracket line is indicated for orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.

The Cleo bracket line of products are single-use ceramic orthodontic brackets intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth.

The Cleo bracket line of products are made of 99.9% alumina through the process of ceramic injection molding.

Visual placement aids (VPAs) are placed in the Cleo bracket line to help provide visual contrast at the arch wire slot and intertwin areas of the bracket. The VPA is removed from the bracket before orthodontic treatment begins; VPAs do not serve a function during the orthodontic treatment. The presence of the VPA within the bracket prior to treatment will not impact the safety and performance of the bracket during the device's intended use.

The VPAs are made of polyurethane raw material through the process of injection molding.

The provided text is a 510(k) summary for the "Cleo" orthodontic bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI/software device.

Therefore, the information required to answer the requested questions about acceptance criteria, study design (sample size, data provenance, ground truth, expert adjudication, MRMC, standalone performance, training set details) is not present in the provided document.

This document describes a physical medical device (orthodontic brackets) and its comparison to existing similar devices based on material, design parameters, and intended use, rather than a software or AI-based device that would typically undergo the type of performance evaluation outlined in your questions.

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A light cure orthodontic band cement intended to bond orthodontic bands to teeth.

American Orthodontics' BracePaste Band and Build LC is a light-cure band cement that is intended to bond orthodontic bands to teeth.

When an orthodontic band is required for orthodontic treatment, band cement is applied to the inside of the orthodontic band and then the band is seated onto the tooth. Once the band is seated properly, excess adhesive is cleaned up from the proximity of the band and tooth and the adhesive is cured via curing light. The polymerization of the adhesive forms a bond between the orthodontic band and / or the tooth enamel. Upon completion of orthodontic treatment, the orthodontic band is removed and any adhesive remaining on tooth enamel is cleaned up and removed from the tooth.

The provided document describes the 510(k) submission for "BracePaste Band and Build LC," an orthodontic band cement. The document states that no clinical performance testing has been conducted. The submission relies on non-clinical performance testing and a comparison to a predicate device to establish substantial equivalence.

Therefore, the following information regarding acceptance criteria, study details, and ground truth cannot be extracted as they are not present in the provided text.

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

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

• Sample Size (Test Set): Not applicable (no clinical testing).
• Data Provenance: Not applicable (no clinical testing).

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

• Not applicable (no clinical testing).

4. Adjudication method for the test set:

• Not applicable (no clinical testing).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was done. This device is an orthodontic band cement, not an AI device for diagnostic reading.

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

• Not applicable, as this is not an AI algorithm.

7. The type of ground truth used:

• Not applicable (no clinical testing). For non-clinical testing, relevant benchmarks were likely derived from material science standards.

8. The sample size for the training set:

• Not applicable (no machine learning model to train).

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

• Not applicable (no machine learning model to train).

Non-Clinical Performance Testing Details (as provided):

The document states that the following non-clinical performance tests were conducted:

• Shear Bond Strength Test (ISO 29022:2013)
• Accelerated Aging Stability Test
• Interaction with Accessories

The conclusion states that the "combination of in-house testing and side-by-side comparison performed by the original manufacturer has demonstrated the efficacy or suitability to the intended purpose of the BracePaste Band and Build LC." It also states, "Results of bench testing indicate that BracePaste Band and Build LC performs as well as the predicate Light-Cured Orthodontic Band Cement." However, specific numerical acceptance criteria or reported performance values for these tests are not provided in the document.

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Orthodontic Primers are intended to be used in the bonding procedure (direct or indirect) of brackets and tubes by preparing the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The Primer wets the bonding surface of the object to be bonded (i.e. enamel, composite materials, etc.) to promote adhesion.

American Orthodontics' BracePaste MTP Light Cure Primer is a light-curing primer that is intended to be used in direct or indirect bonding procedures of brackets and tubes. The primer prepares the enamel during orthodontic treatment to increase adhesion to wet or dry, normal and atypical enamel surfaces. The primer "wets" the bonding surface of the object to be bonded [i.e. enamel, composite materials, etc.) to promote adhesion. The primer will be available in liquid form in a dropper bottle.

The primer contains Bisphenol a Diglycidyl Ether Dimethacrylate and 2-Hydroxyethyl Methacrylate resin compounds. These resin compounds are mixed with ethyl alcohol and water to form an aqueous solution. This solution has the hydrophilic characteristics necessary for the primer to adhere under wet conditions. Using a curing light, the irradiation causes the methylacrylate resins to undergo polymerization. This polymerization forms a bond between the etched enamel surface and the bracket adhesive.

The document describes the BracePaste MTP Light Cure Primer (K181910), an orthodontic primer, and its substantial equivalence to a predicate device, the Transbond MIP Primer (K962785). The primary acceptance criteria for such a device are related to its bond strength and other physical/chemical properties to ensure it performs as intended.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" values for bond strength. Instead, it presents a comparison of the subject device's performance against the predicate device, implying that performance similar to the predicate is the basis for acceptance.

The conclusion states that the BracePaste MTP Light Cure Primer "performs as well as the predicate Transbond MIP Primer," indicating that matching or exceeding the predicate's performance is the criterion for determining efficacy and suitability.

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

The document does not explicitly state the sample size in terms of the number of individual tests or specimens used for the non-clinical performance tests.

Data Provenance: The studies are described as "in-house testing" and "side-by-side comparison performed by the original manufacturer." This indicates the data is retrospective and likely originated from internal laboratory testing. The country of origin is not specified but is implicitly the location of the manufacturer (American Orthodontics, Sheboygan, Wisconsin, USA).

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

Not applicable. This device is an orthodontic primer, and the studies performed are non-clinical (in vitro and bench testing). The "ground truth" for these types of tests (like bond strength or refractive index) is established by direct physical measurement, not by expert interpretation or consensus.

4. Adjudication Method for the Test Set

Not applicable. As the "ground truth" is based on direct physical measurements from bench tests, there is no need for expert 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 physical device (orthodontic primer), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI-related effectiveness are not relevant.

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

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

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the non-clinical performance tests (e.g., average bond strength, refractive index) is derived from direct physical and chemical measurements obtained through standardized laboratory testing (e.g., DIN 13990-2, ISO 29022:2013).

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."

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

Not applicable. This is a physical device, not a machine learning algorithm.

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Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative material. The Acid Etchant will be available in gel and liquid form. The gel form will be contained in syringes and the liquid form will be contained in dropper bottles. Applicator tips will be provided with the gel form. The Acid Etchant contains water, 37% phosphoric acid (CAS# 7664-38-2), silica and green dye. The silica is used as a thickener. The amount of silica will determine the flow behavior and viscosity of the Acid Etchant. The green dye is to provide contrast to the tooth's color. The combination of the flow behavior, delivery system and green dye provides and facilitates accurate and controlled application of the Acid Etchant during orthodontic treatment.

The provided document describes a premarket notification (510(k)) for a dental device called "Acid Etchant." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving clinical performance through extensive comparative studies as would be seen for new, high-risk devices or AI-driven diagnostics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or detailed ground truth establishment.

Instead, the submission focuses on non-clinical performance testing and comparison to a predicate device to demonstrate substantial equivalence.

Here's what can be extracted and why the other information is not present:

Key Findings from the Document:

• Device Name: Acid Etchant

• Predicate Device: E Dental Products e-1 Etchants (K152110)

• Regulatory Class: Class II (Product Code KLE)

• Indications for Use: "Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials."

• Clinical Performance Testing: "No clinical performance testing has been conducted." (Page 5-3, Section "Clinical Performance Testing")

• Non-Clinical Performance Testing: The following tests were conducted:

  1. Performance Test in Accordance with ISO 29022:2013
  2. Viscosity Testing
  3. pH and Acid Content Testing
  4. Compatibility Testing

• Basis for Substantial Equivalence:

  • Same intended use.
  • Same technological characteristics (delivery system, flow behavior, consistency, % Phosphoric Acid, pH, and similar materials).

• Performance Data Reported (Non-Clinical Bench Testing):

  Device Name	Average Bond Strength [N/mm²]	Viscosity (Pas):	Calculated pH:	% Phosphoric Acid:
  Acid Etchant (Gel)	27.20	10.8	1.6	37.5
  Acid Etchant (Liquid)	26.91	0.54	1.6	37.6
  E Dental Products e-1 Etchants (Predicate)	26.71	7-4.7	1.6	37*
  *Stated value from manufacturer

Explanation of Missing Information:

1. Acceptance Criteria & Device Performance Table (as requested for clinical validation): The document does not provide clinical acceptance criteria because no clinical performance testing was conducted. The "performance data" table above reflects non-clinical bench testing comparing physical and chemical properties, not clinical outcomes or AI performance metrics.
2. Sample Size for Test Set & Data Provenance: Not applicable, as no clinical test set was used for validating clinical performance or AI. The non-clinical tests would have their own sample sizes (e.g., number of bond strength tests), but these are not explicitly detailed in the summary beyond the reported averages.
3. Number of Experts & Qualifications / Adjudication Method: Not applicable, as no human expert-based ground truth was established for a clinical or AI performance study.
4. MRMC Comparative Effectiveness Study: No MRMC study was done, as explicitly stated "No clinical performance testing has been conducted." This device is a chemical etchant, not an AI or imaging diagnostic requiring human-in-the-loop evaluation.
5. Standalone (Algorithm Only) Performance: Not applicable. This is a dental material, not an AI algorithm.
6. Type of Ground Truth Used: For the non-clinical tests, the "ground truth" is laboratory measurement against specified standards (e.g., ISO 29022:2013 for bond strength, direct chemical measurements for pH and acid content). There is no "expert consensus" or "pathology" ground truth as would be used for diagnostic devices.
7. Sample Size for Training Set & How Ground Truth for Training Set Was Established: Not applicable. This device is not an AI/ML product requiring training data.

In summary, this document is a 510(k) for a dental material (Acid Etchant), demonstrating substantial equivalence through non-clinical bench testing and material comparisons, not through clinical trials or AI performance evaluations that would involve the detailed criteria requested in the prompt.

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American Orthodontics' BracePaste™ Adhesive is intended for use as an orthodontic bonding agent for Metal Brackets, Ceramic Brackets and Buccal Tubes to the tooth's surface.

BracePaste™ Adhesive is a light-curing adhesive used as an orthodontic bonding agent for metal brackets, ceramic brackets and buccal tubes. The adhesive will be offered in syringe and carpule containers which will allow a precise volume to be dispensed during orthodontic treatment.

The flow consistency (medium viscosity) of the adhesive allows for easy manipulation, yet does not allow bracket "drift" during placement. The flowable consistency also allows for precise dispensing and application of the adhesive.

The adhesive contains Bis GMA and Bis EMA as resin fillers. A combination of silanized strontium aluminum boron silicate glass and silanized silica is used as fillers (Silane Treated Quartz; Silane Treated Silica). The inorganic loading is approximately 72% by weight.

When exposed to light by a photoinitiator system, the methacrylate functionalities of the resin and fillers undergo a polymerization reaction which hardens or "cures" the adhesive. The adhesive in turn will create a "bond" to which the orthodontic appliance becomes attached to etched enamel surface.

The American Orthodontics' BracePaste™ Adhesive is an orthodontic bonding agent intended for use with metal brackets, ceramic brackets, and buccal tubes to the tooth's surface. The submission includes performance testing to demonstrate its substantial equivalence to the predicate device, Transbond™ XT (K880393).

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly uses the performance of the predicate device, Transbond™ XT, as the acceptance criteria for the BracePaste™ Adhesive. The study aims to show comparable performance.

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

The document does not explicitly state the sample sizes for each non-clinical performance test (e.g., number of specimens tested for bond strength, Young's Modulus, etc.).

The data provenance is from non-clinical bench testing performed by American Orthodontics and "side-by-side comparison performed by the original manufacturer." This suggests the data is prospective in nature, as it was generated specifically for this submission. The country of origin of the data is not specified, but it's generated by American Orthodontics, a U.S.-based company.

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

This question is not applicable as the described tests are non-clinical (bench testing) and do not involve human interpretation or subjective assessments that would require experts to establish ground truth. The "ground truth" for these tests is the quantitative measurement obtained through standardized test methods (e.g., ISO, DIN standards).

4. Adjudication Method for the Test Set:

This question is not applicable for the same reasons as point 3. Bench tests do not involve 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:

This question is not applicable. The device is an orthodontic adhesive, not an AI-powered diagnostic tool, and therefore, an MRMC study is not relevant. The testing conducted is non-clinical performance testing.

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

This question is not applicable. The device is an orthodontic adhesive, not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical performance tests, the "ground truth" is the quantitative measurements obtained through standardized physical and mechanical testing protocols (e.g., ISO 29022:2013, DIN 13990-1, DIN 13990-2, ISO 4049:2009, ISO 10993-5). The predicate device's performance serves as a comparative benchmark for these measurements.

8. The Sample Size for the Training Set:

This question is not applicable. The BracePaste™ Adhesive is a physical medical device (an adhesive), not a machine learning model, so there is no "training set."

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

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

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Wire Sterilization Package with Indicators is intended to be used to enclose and package American Orthodontics' line of Orthodontic Arch Wires. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. The indicators will display a visual color change to steam or ethylene oxide gas and distinguish between processed and unprocessed wire.

American Orthodontics' Wire Sterilization Package with indicators is manufactured from bleached surgical paper and plastic film with external chemical process indicators. This packaging is a pouch that is enclosed on all four sides and contains a single arch wire. These packages are shipped unsterile and for single-use only. This packaging offers the health provider (trained dental professional and/or Orthodontist) the option of sterilizing the enclosed arch wire using steam or ethylene oxide gas. Upon completion of the sterilization process, the enclosed arch wire is intended to be used immediately.

This packaging is not offered as a stand-alone product, but is strictly used for the packaging of American Orthodontics' Arch Wires (Classification Code: DZC; 510(k) Exempt).

The bleached surgical paper conforms to the FDA 21CFR186.1673 and can be sterilized using steam or ethylene oxide gas.

The plastic film is sealed to the bleached surgical paper and conforms to 21CFR177.1630 (Polyester), 21CFR175.105 (Adhesive) and 21CFR177.1520 (Polypropylene).

The process indicators meet the performance requirements of AAMI/ANSI/ISO 11140-1:2014.

The given document is a 510(k) premarket notification for a medical device called "Wire Sterilization Package with Indicators." This document does not describe the acceptance criteria and study for an AI/ML device, but rather for a physical sterilization packaging with chemical indicators. Therefore, many of the requested categories are not applicable.

Here's the relevant information based on the provided text, adapted to the questions where possible:

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

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

The document does not explicitly state specific sample sizes for each test in terms of number of units. It refers to "samples" being processed and tested. The data provenance (country of origin, retrospective/prospective) is not specified. It can be inferred that these are prospective bench tests conducted for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI/ML diagnostic tool that requires human expert interpretation for ground truth. The "ground truth" for the indicators is defined by the chemical reaction and color change under specific sterilization parameters, which is a physical and chemical phenomenon, not a human interpretation. The validation was against established standards (e.g., AAMI/ANSI ISO 11140-1) and biological indicators.

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

Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human readings. The performance of the chemical indicators is evaluated by observing a color change against defined criteria.

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 not an AI/ML diagnostic device.

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

Not applicable. This is not an AI/ML device with an algorithm. The device is a physical product with chemical indicators.

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

The "ground truth" for the Wire Sterilization Package with Indicators is based on:

• Physical/Chemical Reaction: The color change of the chemical indicators, which is a direct physical and chemical response to specific sterilization conditions (temperature, time, chemical exposure).
• Biological Indicators (BIs): Used in performance testing to confirm that the sterilization cycles are effective in achieving the desired Sterility Assurance Level (SAL). BIs contain resistant microorganisms which, if killed, confirm effective sterilization.
• Standardized Test Methods: Adherence to established international and national standards such as AAMI/ANSI ISO 11140-1 for chemical indicators, ISO 15841 for dentistry wires, ISO 10993 for biocompatibility, and USP for cytotoxicity.

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 or ground truth for training.

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Empower Clear brackets are intended for orthodontic movement of teeth as diagnosed by an orthodontist. It is used temporarily and is removed upon completion of orthodontic treatment. Empower Clear brackets are intended to be single use only.

The Empower Clear line of products is single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth. The Ceramic Bracket combines the aesthetics of a ceramic bracket with the versatility and ease of self ligation. These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the tooth and also impart the axial control of the energy from the archwire.

This document is a 510(k) premarket notification for the Empower Clear orthodontic bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with detailed performance metrics. Therefore, it does not contain the kind of information requested in the prompt regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC/standalone studies.

The document primarily provides:

• Device Description: Empower Clear line of single-use devices intended for use in comprehensive orthodontics to control tooth movement.
• Intended Use: Orthodontic movement of teeth as diagnosed by an orthodontist, used temporarily, removed upon completion of treatment, single use only.
• Technological Characteristics: Made of Alumina Oxide [Al2O3], same material as predicate devices (Radiance and In-Ovation C). Clip material for Empower Clear is the same as In-Ovation C.
• Biocompatibility Testing: States that biocompatibility testing was conducted and indicated the bracket material (Aluminum Oxide [Al2O3]) is safe for use, free of harmful extractables, and caused no oral mucosa irritation or skin sensitization. This is the closest approximation to a "study" mentioned, but it lacks specific quantitative acceptance criteria or detailed results suitable for the table requested.
• Substantial Equivalence Analysis: Compares Empower Clear to predicate devices (Radiance and In-Ovation C) based on material, intended use, single use, and non-sterile packaging, concluding they are "Equivalent." This is the core of the 510(k) submission.

Due to the nature of this 510(k) document, I cannot fulfill your request for detailed acceptance criteria and study results as it would be inappropriate to invent or infer data not present in the provided text.

The document's purpose is to show equivalence to existing devices, not to present a de novo study with performance metrics against a defined set of acceptance criteria in the way a medical AI/software device might.

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Radiance is an orthodontic bracket. Orthodontic brackets are prescribed for patients with teeth that are not normally positioned in the mouth.

An orthodontic bracket is a device consisting of a base, an arch wire slot and four tie wings. The bracket bases are attached to a patient's teeth with adhesive. A metal arch wire is placed in the arch wire slot of a set of brackets (typically ten brackets on each of the upper and lower arches) and the wire is held in place in each bracket slot with an elastic o-ring placed under the tie wings and over the arch wire.

This looks like a 510(k) clearance letter for an orthodontic bracket, not a study report for an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device cannot be extracted from this document.

The document discusses the device "Radiance" which is an orthodontic plastic bracket, and the FDA's determination of its substantial equivalence to predicate devices. It does not contain information about software algorithms, performance metrics for AI, test sets, ground truth establishment, or human reader studies.

Therefore, I cannot fulfill the request based on the provided input.

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