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The Invisalign Palatal Expander System is indicated for the orthodontic treatment of malocclusion. The system is used for rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw, dental arch and tooth, palate) with primary, mixed, or permanent dention during orthopedic treatment in children or adolescents. In adults, it is to be used in conjunction with surgery or other interventions when necessary.

The subject device, Invisalign Palatal Expander (IPE) System (hereafter referred to as the IPE System) is a modification to the legally marketed multiple predicate devices. Invisalign System (Class II; Product Code: NXC; K220287) as Primary and Dentaurum Expansion Screws/Hyrax Expander – Hyrax ® and Hyrax neo® (Class I, Product Code: DYJ, K935154) as Secondary.

The IPE System consists of the Invisalign Palatal Expanders, Invisalign Palatal Holders, the Attachment Template and the proprietary 3D Shape generation software.

Invisalign Palatal Expanders are a staged series of removable orthodontic devices designed to expand the patient's skeletal and/or dental narrow maxilla (upper jaw, dental arch, teeth and palate) in small increments to an optimal position determined by the doctor. Once the desired clinical outcome of the expansion phase has been achieved, patients progress to the holding phase.

The Invisalign Palatal Holder is a copy of the last stage of the expansion phase designed to hold the maxilla post active expansion, to allow the maxilla to stabilize before the patient progresses to the next phase of treatment (retention, phase 2 or other treatment).

The proprietary Align internal personnel-facing 3D software enables Align's computer-aided design (CAD) designers to generate the shape and quantity/stages of the device. Using this software, CAD designers create digital files for the incremental stages of the doctorprescribed expansion amount and the design and quantity of holders per the prescribed holding duration. Each device in the series is fabricated via additive manufacturing (3D printing).

The Attachment Template (also a component of the primary predicate device, the Invisalign System) enables correct placement and bonding of attachments made of dental composite (material provided by doctor) to the tooth surface for IPE engagement and retention.

The provided text is a 510(k) Premarket Notification for the Invisalign Palatal Expander System. It outlines the device's indications for use, comparison to predicate devices, and performance data. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a study proving the device meets those criteria for an AI/software component, particularly around metrics like sensitivity, specificity, or reader performance with and without AI.

The document mentions "proprietary 3D Shape generation software" and "includes software algorithms that are used to determine the shape and calculate the quantity of devices required." It also states "successful software verification and validation (V&V) testing at the unit, integration, and system level was performed to qualify the orthodontic software component of the subject device." This suggests that the software is a design and manufacturing tool, generating device shapes based on clinician prescriptions and patient scans, rather than an AI performing diagnostic or assistive tasks that would typically require the comparative performance studies you're asking about (e.g., MRMC studies, standalone performance with ground truth labels).

Therefore, based on the provided text, I can only provide information related to the device's overall performance and safety testing, not specific AI acceptance criteria and studies as if it were a diagnostic AI.

Here's what can be extracted and inferred from the document:

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

The document doesn't provide a table of quantitative acceptance criteria (e.g., specific thresholds for force, retention, etc.) for the various tests. Instead, it states that the test results "met the acceptance criteria and performed as intended" or were "found to be adequately designed."

Regarding the study that proves the device meets the acceptance criteria (specifically concerning the software component, as that's where AI concepts typically apply):

The document describes the software as a "proprietary, 3D Shape generation software" that "enables Align's computer-aided design (CAD) designers to generate the shape and quantity/stages of the device." It clarifies that this is an "internal Align facing only shape generation software which includes software algorithms that are used to determine the shape and calculate the quantity of devices required per the doctor prescribed expansion distance and holding duration." This is a software that designs the physical device based on inputs, not an AI that interprets medical images, flags abnormalities, or assists in diagnosis, which would typically involve the detailed study characteristics you've requested.

Therefore, many of your questions related to multi-reader studies, expert ground truth adjudication for a test set, effect sizes of human improvement with AI, and specific ground truth types (pathology, outcomes data) are not applicable to the description of the software provided in this 510(k) summary, as it's not a diagnostic or AI-assisted diagnostic tool in the typical sense.

Here's an attempt to answer the relevant questions based on the provided text, and state when information is not applicable or provided:

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

• Test Set Sample Size: For the physical device performance tests (durability, stiffness, retention, etc.), specific sample sizes are not provided, only that testing was conducted and met acceptance criteria. For the "Early Feasibility Study," the number of subjects is not specified, only that "desired active expansion of the upper jaw width was observed in all the subjects." For the "real-world data," the sample size is not provided.
• Data Provenance: The document does not specify the country of origin. The "Early Feasibility Study" is mentioned, implying a prospective collection for that specific study. The "real-world data" is described as from "commercially available product," suggesting it is retrospective post-market data.

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 because the software's function is for device design generation, not for generating 'ground truth' for medical interpretations or diagnoses that would require expert labeling and adjudication. The "doctor-prescribed expansion amount" is the input to the software, implying the clinician dictates the "ground truth" for the device design.

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

• Not applicable for the software as described. The software's output is a device design based on physician input, not a diagnostic finding 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 MRMC study was done or reported for this device's software. The software's role is not described as an AI assisting human readers in diagnostic tasks.

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

• The software's function is described as enabling "CAD designers to generate the shape" based on "doctor-prescribed expansion amount." It's an internal design tool, not a standalone diagnostic algorithm whose performance would typically be evaluated without human input. Software verification and validation (V&V) was performed, which assesses if the software functions as designed from a technical standpoint.

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

• For the software, the "ground truth" for its operation is the "digital scan and doctor/dental practitioner's prescription." The software takes these inputs to generate a 3D model. Clinical performance was evaluated by observing "desired active expansion... in all the subjects" and "no unanticipated or serious adverse events reported," which relates to patient outcomes after using the physical device.

8. The sample size for the training set:

• Not applicable or provided. The document describes software that generates device shapes based on given inputs, rather than a machine learning model that would require a dedicated training set.

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

• Not applicable. The software's function as described does not involve a "training set" in the machine learning sense, where ground truth labels would be established. It is a deterministic design software.

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The Signature Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.

The Signature Orthodontic System (SO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patientmatched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, and modifying cases. Signature Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.

The document provided focuses on the substantial equivalence of the "Signature Orthodontic System" to predicate devices, primarily through non-clinical performance testing. It does not contain information about a study proving the device meets acceptance criteria in the way this request is typically framed for AI/algorithm performance (e.g., sensitivity, specificity, or reader study metrics).

Instead, the provided text describes bench testing to demonstrate performance equivalence of orthodontic brackets, which is a different type of "acceptance criteria" and "study."

Here's an analysis based on the provided text, addressing the points where information is available or noting where it is not:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

Note: The above criteria are for the physical properties and biocompatibility of the orthodontic brackets, not for the performance of a software algorithm in terms of diagnostic accuracy or reader improvement.

Additional Information based on the provided text:

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

   • Sample Size: Not explicitly stated for each bench test. The text mentions "average value" and "statistically significant differences," implying multiple units were tested in each category.
   • Data Provenance: Not applicable in the context of bench testing for physical devices. The testing was non-clinical.

2. 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. The ground truth for bench tests is the physical measurement based on standardized testing procedures, not expert consensus interpreting data.

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

   • Not applicable, as this refers to human review of diagnostic data.

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

   • No MRMC study was done. The document explicitly states: "No clinical performance testing was conducted on SO System brackets." The "Signature Orthodontic System" includes "treatment planning software," but the performance testing described only relates to the physical brackets.

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

   • Not described as such. The "treatment planning software" is mentioned as part of the system, but its standalone performance (e.g., accuracy of treatment planning suggestions) is not detailed or evaluated in the provided performance data. The performance section focuses exclusively on the physical brackets.

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

   • Bench Test Measurements: The "ground truth" for the physical bracket tests would be the direct measurements obtained using calibrated instrumentation according to standardized test methods (e.g., for shear bond strength, torque strength, tensile strength, friction, and fracture strength). For biocompatibility, it's compliance with ISO 10993-1.

7. The sample size for the training set

   • Not applicable. This device is a physical orthodontic system and associated software, not an AI model requiring a training set in the typical sense of machine learning. The software aids in treatment planning but is not described as a learning algorithm that undergoes "training."

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

   • Not applicable, as there is no "training set" for an AI algorithm described in this context.

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CompleClear appliances are intended for use as a clear, plastic bracket and archwire system to provide orthodontic movement of natural teeth.

CompleClear Plastic Orthodontic Bracket and Wire Appliance is an orthodontic appliance consisting of a polysulfone bracket with two separate components (tooth component and wire component) and an orthodontic wire pre-attached to the wire component of the bracket. The tooth and the wire components are capable of mechanically interlocking to form a detachable and reattachable bracket assembly. The tooth component of the bracket is cemented to the tooth, like regular orthodontic brackets. The wire components are pre-attached at specific positions along the orthodontic wire. The orthodontic wire is customized for each patient by creating various bends and rotations along the wire. This configuration of the customized wire, results in a specific position and orientation of the wire components of the bracket system along the customized wire. This customized orthodontic wire along with the series of pre-attached wire components constitutes the 'aligner'. When the wire components of the 'aligner' are engaged on to the corresponding tooth component cemented on the tooth, the orthodontic wire is activated like a spring. The tooth is gently moved to its desired position due to the elastic recoil of the wire.

The two component bracket assembly of the present device allows moment arms for mesiodistal rotation, labio-lingual inclination and mesio-distal angulations (tip) similar to conventional bracket-wire used in orthodontics.

The treatment uses a series of aligners, each incorporating a predefined amount to tooth movement toward the final desired end goal. The amount of tooth movement incorporated, the type of tooth movement incorporated and the final desired end goal are all determined and approved by the provider.

This document, a 510(k) summary for the CompleClear Plastic Orthodontic Bracket and Wire Appliance (K150830), does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (K110796 and K140807) based on indications for use, materials, aesthetic features, mode of use, physical properties, application, and manufacturing methods.

Here's what can be extracted from the document regarding testing, though it doesn't align with the detailed "acceptance criteria and study" structure you've requested for AI/software devices:

1. Acceptance Criteria and Reported Device Performance (as interpreted from the mechanical testing)

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

• The document does not specify general sample sizes for the mechanical tests. For the shear bond strength testing, it refers to "both CompleClear and Ortho Specialties' brackets" implying a comparison was made but no specific number of samples is given.
• Data provenance is not mentioned (e.g., country of origin, retrospective/prospective).

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

• Not applicable as this is a physical device and the testing described is mechanical, not involving human expert assessment for ground truth.

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

• Not applicable. This type of testing does not involve adjudication by experts.

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/software device and no MRMC study was performed or described.

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

• Not applicable. This is not an AI/software device.

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

• For mechanical tests, the "ground truth" would be established by the physical properties of the materials and the design of the device, measured through standard engineering and materials science testing methodologies. For shear bond strength, it was a direct measurement comparison.

8. The sample size for the training set:

• Not applicable. This is not an AI/software device.

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

• Not applicable. This is not an AI/software device.

In summary, this document is a 510(k) premarket notification for a physical orthodontic device. The "proof" of meeting acceptance criteria is primarily demonstrated through mechanical testing to show equivalency to legally marketed predicate devices, not through studies involving AI performance or human reader analysis as typically required for AI/ML-based medical devices.

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• 1. A device to be used for the treatment of sleep bruxism and
• 2. As an aid in the treatment of associated tension/migraine type headaches in adults.

Not Found

I am sorry, but based on the provided text, there is no information about a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the "Luco Hybrid OSA Appliance." It states that the device is substantially equivalent to legally marketed predicate devices for the indicated uses. However, it does not contain details about a clinical study, acceptance criteria, device performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document primarily covers:

• The FDA's decision to clear the device for marketing.
• The device's trade name and regulation details.
• A reminder about general controls and additional controls for Class II/III devices.
• Contact information for FDA resources.
• The "Indications for Use" for the device, which are:
  1. Treatment of sleep bruxism.
  2. An aid in the treatment of associated tension/migraine type headaches in adults.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text.

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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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Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment. Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional. The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements. There are no accessories or patient contacting components of Insignia Digicast.

The provided document describes the Insignia Digicast, a software product and service that creates digital models of patients' teeth for orthodontic diagnostics.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds for measurements). Instead, it relies on demonstrating substantial equivalence to predicate devices (OrthoCAD iQ and Lava Digital Models) through qualitative comparisons of features and mode of use, and quantitative comparisons of measurement accuracy.

   Feature/Measurement	Acceptance Criteria (Implied by Substantial Equivalence)	Insignia Digicast Performance (Reported)
   Teeth Width	Functionally equivalent to predicates	Bench tested, successfully validated
   Space	Functionally equivalent to predicates	Bench tested, successfully validated
   T-J Moyers Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
   Bolton Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
   Arch Measurements	Functionally equivalent to predicates	Bench tested, successfully validated
   Overbite/Overjet	Functionally equivalent to predicates	Bench tested, successfully validated
   Overall Performance	Substantially equivalent to predicate devices	Deemed substantially equivalent

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

   • Sample Size: Not specified in the provided document. The document states "data from bench testing" was used, but does not quantify the number of cases or models tested.
   • Data Provenance: Not explicitly stated. Given it's bench testing, it's likely synthetic data, cadaver models, or a collection of patient impressions, but the origin (e.g., country) is not mentioned. It is a retrospective evaluation against existing (presumably traditional) measurements.

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

   • Not specified. The document indicates that bench testing was used to "evaluate the performance characteristics... compared to the predicate device." It doesn't mention expert involvement in establishing a separate ground truth for the test set beyond the comparisons made with the predicate device's established performance.

4. Adjudication Method for the Test Set:

   • Not specified. This information is typically relevant for human-reader evaluations, which did not occur for this device.

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. The document explicitly states: "Clinical testing has not been conducted on this product."

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

   • Yes, a standalone evaluation was performed. The "Non-Clinical Performance Data" section describes "bench testing" to evaluate the "performance characteristics of Insignia Digicast," which is an algorithm-only assessment. The software was "successfully validated to confirm the performance of the device."

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

   • The "ground truth" for the non-clinical performance evaluation was based on comparisons to the predicate device, OrthoCAD iQ, for characteristics such as teeth width, space, and various analyses (T-J Moyers, Bolton, Arch, Overbite/Overjet). This implies the predicate device's measurements served as the reference or accepted standard.

8. The sample size for the training set:

   • Not specified. The document does not provide any details regarding the training data or its size.

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

   • Not specified. Since no information on the training set is provided, the method for establishing its ground truth is also unknown.

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The Hyperelastic Archwire is indicated for use as an orthodontic arch wire to aid in the movement of teeth during the early phase of orthodontic treatment. The Hyperelostic Archwire may be used in conjunction with metallic, ceramic, or plastic brackets.

Hyperelastic Archwire is a metallic shape memory alloy orthodontic archwire for maxillary and mandibular arches. This alloy exerts low constant forces, retains elastic properties at large strains, with low frictional binding properties.

The provided text describes a 510(k) Pre-market Notification for the "Hyperelastic Archwire." This notification focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data. Therefore, the information typically requested about acceptance criteria and clinical study results for software as a medical device (SaMD) or AI-powered devices is largely not applicable in this context.

Here's an analysis based on the provided text, addressing the requested points where possible, and indicating where information is not available or not relevant for this type of device submission:

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)

This information is not provided in the document. As this submission relies on bench testing of physical properties, traditional "test sets" of patient data are not applicable. The bench tests would have involved specific numbers of archwire samples for each test, but these details are not disclosed.

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

This information is not applicable as this device does not involve human interpretation of medical images or data. Ground truth here refers to the actual physical and mechanical properties measured by scientific instruments and validated methods.

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

This information is not applicable. Adjudication methods are relevant for clinical endpoints or interpretation of ambiguous data, which is not the case for bench testing of material properties.

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 type of study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interact with or are assisted by the AI. The Hyperelastic Archwire is a physical orthodontic device and does not involve AI assistance for human readers.

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

No, a standalone algorithm performance study was not done. This device does not contain an algorithm. The "performance" here refers to the physical and mechanical characteristics of the archwire itself, measured through bench tests.

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

The ground truth used for this device is based on objective measurements of physical and mechanical properties through standardized bench testing methods. This includes measurements of:

• Tensile characteristics (plateau, hysteresis)
• Flexure characteristics (hysteresis)
• Binding force
• Hardness
• Roughness
• Set angle
• Elastic recovery
• Fatigue life
• Biocompatibility (based on established material safety standards)
• Corrosion resistance

8. The sample size for the training set

This information is not applicable. This device is a physical product, not a software or AI model that requires a "training set."

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

This information is not applicable as there is no "training set" for this physical device.

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The ClearArch is indicated for use as an orthodontic archwire to aid in the movement of patient teeth during orthodontic treatment. ClearArch is intended for patients seeking esthetic orthodontic treatment; these are primarily patients being treated with ceramic or polycarbonate braces.

ClearArch is a polymer-based orthodontic archwire for maxillary and mandibular arches. The wire material 1) is more aesthetic than conventional metal wires, 2) can take different shapes, including round, rectangular and square cross-sections, 3) can be bent like TMA and 4) delivers orthodontic forces similar to nickel titanium archwires. This archwire is intended to be used during the first two phases of orthodontic treatment. Its stiffness and strength are similar to the properties of metal orthodontic archwires in order to aid in efficient tooth movement during orthodontic treatment. Therefore, orthodontists can use an esthetic archwire in lieu of a less esthetic metal version without compromising treatment mechanics.

The provided document is a 510(k) summary for the ClearArch orthodontic wire. It focuses on demonstrating substantial equivalence to a predicate device rather than describing a study with a test set, ground truth, or expert involvement in the way AI/ML device studies typically do. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis based on the available information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical or performance study with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it describes characteristics that were evaluated for substantial equivalence.

Study that proves the device meets the acceptance criteria:

The "study" described is a bench testing comparing the ClearArch device to a predicate device (BioMers Translucent Orthodontic Wire) and biocompatibility studies. The purpose of these tests was to demonstrate substantial equivalence for regulatory approval, not to meet specific performance acceptance criteria for a novel clinical outcome in the way an AI/ML device would.

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

This information is not provided in the document. The studies were bench tests, so "sample size" would refer to the number of wire samples tested, not patient data. Data provenance (country of origin, retrospective/prospective) is not applicable to bench testing of material properties.

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

This information is not applicable to this type of device and study. The "ground truth" for material properties like flexural strength, tensile strength, friction, water absorption, and elongation is established by calibrated laboratory equipment and standardized testing methods, not by expert consensus.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where human interpretation of data is required to establish ground truth or resolve discrepancies. Bench testing results are typically quantitative and objective.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging) where human readers interpret medical images, and is not applicable to an orthodontic archwire.

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

No, this is not applicable. The ClearArch is a physical medical device (an orthodontic archwire), not an algorithm or software requiring performance evaluation in a standalone mode.

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

The "ground truth" for the bench testing was based on objective measurements derived from standardized material testing methods and laboratory equipment. For biocompatibility, the ground truth would be established through pre-defined toxicological and biological endpoints according to relevant standards (e.g., ISO 10993).

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical medical device like an orthodontic archwire. Training sets are used in the development of AI/ML algorithms.

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

This is not applicable as there is no training set mentioned or implied for this device.

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An orthodontic arch wire used to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment.

The BioMers Translucent Orthodontic Wire is a translucent arch wire comprised of glass fibers, a polymer composite resin, and a polymer coating. The embedded glass fibers function as the reinforcement, providing the necessary force to straighten teeth. The translucent polymer composite resin serves as the matrix, binding together the individual glass fibers. The outer coating, made of a USP Class VI polycrystalline and amorphous linear polymer, increases theabrasion resistance properties of the wire.

The provided text describes a 510(k) submission for the BioMers Translucent Orthodontic Wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance criteria for safety and effectiveness through extensive human studies. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test/training sets, expert ground truth establishment, and adjudication methods is not typically part of a 510(k) summary for this type of device.

The submission relies on bench testing against established industry standards to demonstrate that the new device has comparable technical characteristics to the predicate device and does not raise new questions of safety or effectiveness.

Here's an attempt to answer the questions based on the provided text, highlighting what is (and isn't) present:

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

The document does not provide a table of explicit acceptance criteria with numerical targets and direct reported device performance against those targets. Instead, it indicates that the device was "designed and tested using the following standards" to assess its technical characteristics. The acceptance criteria are implicitly met if the device's performance, when tested according to these standards, is comparable to or deemed safe and effective given the predicate devices.

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

The document does not specify sample sizes for the "test set" in terms of clinical or human data. The testing mentioned refers to bench testing against engineering standards. Therefore, concepts like country of origin for clinical data or retrospective/prospective study design are not applicable here.

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

This information is not applicable as the submission relies on bench testing against engineering standards rather than expert-derived ground truth from clinical or image-based data.

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

This information is not applicable as the submission relies on bench testing against engineering standards, not an adjudicated test set.

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 is no mention of an MRMC comparative effectiveness study, nor is "AI" or "human readers" relevant to this device's submission. This is a physical orthodontic wire, not a diagnostic or AI-driven tool.

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 physical orthodontic wire and does not involve an "algorithm" or standalone software performance in the way described.

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

The "ground truth" for this device's performance is established by its compliance with the technical specifications and performance characteristics outlined in the referenced ASTM standards. This is a materials science/engineering-based ground truth, not a clinical or expert-consensus ground truth. The primary ground for acceptance is substantial equivalence to legally marketed predicate devices, supported by bench test data.

8. The sample size for the training set

This information is not applicable. The device is not an AI/ML algorithm requiring a training set.

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

This information is not applicable. The device is not an AI/ML algorithm requiring a training set.

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LingLock is an interlock retainer composed of polycrystalline alumina that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner.

The device is an interlock retainer composed of polycrystalline alumina (aluminum oxide) that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. LingLock is comprised of a set of ceramic attachments (male/female) bonded to the teeth across the contact points of the lower six anterior front teeth; the male component on one side and the female component on the other. When engaged, the ceramic attachments prevent the teeth from shifting out of position, yet have a slight gap which enables patients to floss their teeth interdentally in a regular manner.

The LingLock retainer has an application tool consisting of a ceramic attachment holder (polypropylene) and a guide strip (stainless steel) which ensures an exact positioning of the ceramic attachments both in relation to each other and the teeth to be retained. An orthodontic adhesive is placed on the bonding surface of the ceramic attachments and the guide strip is guided in between two neighbouring teeth. The ceramic attachment holder is brought in contact with the enamel at the lingual surface of the teeth and the orthodontic adhesive is light cured. After curing, the guide strip is removed by pulling it forward in a slight upward rotational movement. The ceramic attachment holder is then removed.

This document describes a medical device submission (K061042) for the LingLock lingual orthodontic retainer. It is a 510(k) summary, which means the manufacturer is claiming substantial equivalence to existing devices, and therefore, an extensive clinical study to prove effectiveness or safety like those required for a PMA (Pre-Market Approval) is typically not required.

Given this context, the document does not describe a detailed study with acceptance criteria and device performance as one might find for a novel or high-risk device requiring extensive clinical trials. Instead, the basis for clearance is substantial equivalence to predicate devices.

Therefore, many of the requested items (e.g., sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

However, I can extract the relevant information regarding the device's intent and the basis for its clearance:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

The "acceptance criteria" in a 510(k) context for a device like this are met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance is "accepted" if it functions similarly to and is intended for the same use as the predicate, and is composed of similar materials and design.

Study Information Overview:

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

   • Not Applicable / Not Provided. This 510(k) submission does not describe a clinical study with a "test set" in the traditional sense of evaluating efficacy against a specific outcome. The submission relies on demonstrating substantial equivalence to predicate devices, implying that their performance is already accepted.

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

   • Not Applicable / Not Provided. No "ground truth" establishment using experts for a test set is described, as a clinical efficacy study was not presented.

3. Adjudication method for the test set:

   • Not Applicable / Not Provided. No test set or adjudication method is described.

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:

   • Not Applicable. The LingLock is a physical dental retainer, not an AI-assisted diagnostic or therapeutic device. This type of study is irrelevant to this device.

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

   • Not Applicable. The LingLock is a physical dental retainer, not an algorithm, so standalone performance in this context is irrelevant.

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

   • Not Applicable. No ground truth for an efficacy study is described. The "ground truth" for the device's market clearance is that it is substantially equivalent to predicate devices that are already deemed safe and effective for their intended use.

7. The sample size for the training set:

   • Not Applicable / Not Provided. No "training set" is relevant or described for this type of physical medical device submission.

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

   • Not Applicable / Not Provided. No training set is relevant or described.

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