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Illusion Aligners Pro are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

Illusion Aligner Flx are indicated for use in the alignment teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

A dental health professional (e.g., an orthodontist or a dentist) prescribes the Illusion Aligners Pro and Illusion Aligner Flx are based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes either the intraoral scans or physical impressions of the patient's teeth, determines the required corrections to align the teeth, and 3Shape's Ortho System is used for treatment planning. Illusion Aligners Pro and Illusion Aligner Flx are intraoral thermoplastic appliances that are worn 20 to 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning. Illusion Aligners Pro and Illusion Aligner Flx are fabricated using a three- step process.

The first step is to obtain the dimensions and details of the patient's dentition. This is generally done using an intraoral scan or a physical impression. This scanned data (digital CAD/CAM models or patient models) is imported into specialized dental software for treatment planning.

The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, Illusion Aligners Pro and Illusion Aligner Flx utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. The treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the models needed for each treatment step to provide the surface around which the aligner is thermoformed.

The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using standard thermoforming equipment and the appropriate material as specified. The trays are provided to the dental health care professional who provides them to the patient in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment the first aligner is delivered to when the final aligner is finished, and treatment is complete

The provided text is a 510(k) Summary for the devices Illusion Aligner Pro and Illusion Aligner Flx. It details the safety and effectiveness assessment based on substantial equivalence to predicate devices, rather than a study proving the device meets specific performance criteria.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, ground truth establishment, expert involvement, adjudication, MRMC studies, standalone performance), and training set information are not present in this document.

The document explicitly states: "No clinical study was conducted." This is a key piece of information that means the device's performance was not evaluated through clinical trials or comparative effectiveness studies described in points 2-7 of your request.

Here's a breakdown of the available information based on your request, highlighting what is not provided:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics from a study. The acceptance is based on demonstrating substantial equivalence to predicate devices.
• Reported Device Performance: No quantitative performance data is present as no clinical or comparative performance study was conducted. The "performance tests" mentioned are likely non-clinical (e.g., material properties, dimensional accuracy relative to the manufacturing process), but specific metrics are not detailed.

The comparison tables (Table-1 and Table-2) focus on technological characteristics and intended use alignment with predicate devices, not on quantifiable performance metrics of the subject devices themselves.

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

• Not provided. No test set or data provenance from a performance study is mentioned, as no clinical study was conducted.

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

• Not applicable/Not provided. No test set or associated ground truth established by experts is mentioned.

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

• Not applicable/Not provided. No test set or adjudication process is mentioned.

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. This device is an orthodontic aligner, not an AI-assisted diagnostic tool for human readers. The document explicitly states, "No clinical study was conducted."

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

• Not applicable/Not provided. This is a physical medical device (aligner), not an algorithm.

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

• Not applicable/Not provided. No ground truth for a performance study is mentioned.

8. The sample size for the training set:

• Not applicable/Not provided. This document describes a physical medical device (aligner) requiring traditional substantial equivalence demonstration, not a machine learning model that would have a "training set."

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

• Not applicable/Not provided. As above, this concept does not apply to the type of device and submission described.

Summary of what the document does provide regarding acceptance and proof:

The acceptance criteria and proof of safety and effectiveness for Illusion Aligner Pro and Illusion Aligner Flx derive from demonstrating Substantial Equivalence (SE) to legally marketed predicate devices, as per the FDA 510(k) pathway.

• Acceptance Criteria (Implicit via Substantial Equivalence):

  • Same Indications for Use: The subject devices align with the predicate devices in their indication for "alignment of permanent teeth (i.e., all second molars) through orthodontic treatment of misalignment and malocclusion."
  • Similar Technological Characteristics: The devices share fundamental design principles and mode of action (applying continuous gentle force for tooth movement).
  • Equivalent Materials: Illusion Aligner Pro uses polyurethane, matching its predicate DailyMate. Illusion Aligner Flx uses co-polyester and polyurethane composite, matching its predicate Smylio Invisible Clear Aligners.
  • Biocompatibility: The devices must meet ISO 10993 standards for permanent tissue-contacting mucosal membrane devices (contact > 30 days).

• Study Proving Acceptance (Method of Proof):

  • The primary method of proof is comparison to predicate devices and non-clinical testing.
  • Biocompatibility Testing: The devices were evaluated for:
    • In Vitro Cytotoxicity (ISO 10993-5:2009)
    • Skin Sensitization (ISO 10993-10:2021)
    • Intracutaneous Reactivity (ISO 10993-23:2021)
  • Performance Tests: General statement that "Performance tests were conducted to demonstrate that the subject device is as effective as its predicate device." However, no specific metrics or data from these tests are provided in this summary. These tests likely relate to physical properties and manufacturing quality control rather than clinical outcomes.
  • Animal Study: The conclusion mentions "animal study provided in this submission," but no details of such a study are present in the extract provided.
  • No Clinical Study: Explicitly stated, "No clinical study was conducted."

In essence, the "proof" is that the new devices are sufficiently similar to already legally marketed devices in terms of materials, intended use, and fundamental mode of action, and they meet relevant non-clinical safety standards (biocompatibility). The FDA assumes that if these similarities hold, the new device is as safe and effective as the predicate.

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The Illusion Aligners indicated for use in the alignment of permanent teeth (i.e. all second molars) through orthodontic treatment of misalignment and malocclusion.

Illusion Aligners are intraoral thermoformed plastic aligners that are worn at least 22 hours per day and are designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligners are to be removed for eating and for cleaning. Illusion Aligners are fabricated using a ten-step process.

The Step 1 is to obtain the dimensions and details of the patient's baseline dentition. This is generally done using an oral scan data or a physical impression. Step 3, the scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. In the Step 3, Laxmi Dental Exports Pvt Ltd, Inc. utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. Step 4, the treatment plan is sent to the doctor for approval. Upon approval, a 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed. Step 5 is the printing of 3D models of the treatment plan for use in Step 7 thermoforming. The thermoforming process is accomplished using a standard thermoforming equipment and the appropriate material as outlined in this submission.

The provided document, K211010, describes a 510(k) premarket notification for "Illusion Aligners." This document primarily focuses on establishing substantial equivalence to a predicate device (Smylio Invisible Clear Aligner, K173784) rather than presenting a detailed study proving the device meets specific performance acceptance criteria in the manner of a clinical trial for a novel AI/software medical device.

Therefore, the information required for a comprehensive answer regarding acceptance criteria and a study proving device performance (especially for an AI/ML device) is largely not present in this document.

However, I can extract the information that is available and explain why other requested information is missing.

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

This document does not present quantitative acceptance criteria or reported device performance for a software-driven clinical outcome in the format typically seen for AI/ML devices. Instead, it focuses on demonstrating equivalence through material properties and manufacturing processes.

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 document describes non-clinical physical and biocompatibility testing of the material itself, not a clinical study on patient outcomes with a "test set" of patient data. The "testing" referred to is laboratory testing of the material. There is no mention of a test set for assessing algorithmic performance on patient data.

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

This information is not applicable/not provided. There is no "test set" with ground truth established by experts described in this 510(k) summary relating to clinical performance or AI/ML algorithm output. The document focuses on material properties and manufacturing process equivalence.

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

This information is not applicable/not provided. No adjudication method for a test set is mentioned.

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 information is not applicable/not provided. This device is a physical orthodontic aligner. While its manufacturing process involves software for treatment planning, the document does not describe it as an AI-assisted diagnostic or decision-support tool that would undergo an MRMC study comparing human performance with and without AI assistance. The software mentioned (3Shape) is for designing the aligners, not for interpreting medical images or providing clinical diagnoses.

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

This information is not applicable/not provided. This device is not an algorithm-only standalone diagnostic or treatment device. It is a physical aligner whose design process uses software. The software, 3Shape, is referred to as "FDA 510K cleared," indicating it has its own clearance. The current submission is for the physical aligners.

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

This information is not applicable/not provided in the context of an AI/ML device performance study. The "ground truth" here would relate to the physical and biocompatibility properties of the material, which are measured directly by laboratory tests (e.g., precise measurements for ASTM standards, cellular responses for ISO 10993).

8. The sample size for the training set

This information is not applicable/not provided. Since this is a submission for a physical medical device (aligners) and not a de novo AI/ML algorithm, there is no mention of a "training set" in the context of machine learning. The "training" here would refer to the historical data and experience used to develop the manufacturing process and material selection.

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

This information is not applicable/not provided for the same reasons as #8.

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A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Model 1: Natural Latex Powder Free Polymer Coated Examination Gloves, with Vanilla Scent
Model 2: Orange Latex Powder Free Polymer Coated Examination Gloves, with Citric Scent
Model 3: Pink Latex Powder Free Polymer Coated Examination Gloves

I am sorry, but the provided text is a 510(k) premarket notification for "ILLUSION Powder Free Latex Examination Gloves." This document does not contain information about acceptance criteria or a study that proves a device meets such criteria for an AI or medical imaging device. It is a regulatory approval document for disposable medical gloves.

Therefore, I cannot extract the specific details you requested regarding acceptance criteria and study information for an AI/imaging device from this text.

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A patient examination glove is a disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination, contagious issue by the world. In the dentistry field.

Patient Examination Glove Oleicon Powder free polymer coated berce Cot Bubblegum ssented NR latef

The provided text is a 510(k) premarket notification letter from the FDA regarding "Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue)". This document is a regulatory approval for a medical device and does not contain any information about a study proving the device meets acceptance criteria.

The FDA letter grants substantial equivalence based on the device's similarity to a legally marketed predicate device, not on specific performance studies detailed in this document. Therefore, I cannot provide the requested information.

The document indicates:

• Device Name: Illusion Powder Free-Polymer Coated Bubble Gum Scented NR Latex Examination Gloves (Blue)
• Regulation Number/Name: 880.6250 / Patient Examination Glove
• Regulatory Class: I
• Product Code: LYY
• Indications for Use: A disposable device intended for medical purposes worn on the hands to prevent contamination and eliminating contagious issue by the wearer. Suitable for use in medical examination and in the dentistry field.

To answer your specific questions, one would need access to the full 510(k) submission documentation, which would include the raw data and study reports if they were required and submitted. The letter itself only confirms the FDA's decision based on that submission.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner. Suitable for use in medical examination, diagnostic and therapeutic procedures, as well as in the dentistry field.

Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)

This document is a 510(k) premarket notification letter from the FDA regarding "Illusion Powder Free Polymer Coated Blue Scented (Grape) Latex Examination Glove with Protein Content Labeling Claim (50 Micrograms or Less)."

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. It is an approval letter for a medical device (patient examination gloves), confirming that the device is substantially equivalent to legally marketed predicate devices. The letter primarily details the regulatory classification, general controls, and compliance requirements for the manufacturer.

Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text.

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ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) system, and is intended for the cementation of porcelain and composite inlays, onlays, crowns and veneers. ILLUSION can also be used for conventional cementation of metallic inlays, onlays, crowns and fixed partial dentures.
Intended Use of ILLUSION: dental resin cement

ILLUSION, a universal, dual-cured resin cement, is based on an opacity/translucency (value) system, and is intended for the cementation of porcelain and composite inlays, onlays, crowns and veneers. ILLUSION can also be used for conventional cementation of metallic inlays, onlays, crowns and fixed partial dentures.

The provided text describes a 510(k) summary for a dental resin cement called ILLUSION. It aims to establish substantial equivalence to a predicate device, "Choice™," and lacks detailed information typically found in a study report, particularly regarding acceptance criteria and performance data for a medical device that would involve human subjects or complex algorithms.

However, based on the provided information, I can extrapolate the "acceptance criteria" and "device performance" relating to the physical and mechanical properties of the dental cement as these are explicitly compared to the predicate device.

Here's the breakdown of the information as requested, using the available data:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (dental resin cement), the "acceptance criteria" are implied by the performance of the legally marketed predicate device, Choice™. The new device, ILLUSION, is deemed "substantially equivalent" if its performance falls within a comparable range to the predicate device, demonstrating similar safety and effectiveness for its intended use.

Study Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) Summary, which typically references internal testing reports rather than providing them in full detail. The "study" mentioned here refers to the testing conducted by Bisco, Inc. to compare ILLUSION's properties against its predicate. The FDA reviewed these undisclosed test results and determined substantial equivalence.

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

• Sample Size for Test Set: The table indicates numerical values followed by a number in parentheses (e.g., "49 MPa (8)"). This "(8)" or "(6)" likely represents the number of samples or measurements taken for that specific physical property test (e.g., 8 samples for diametrical tensile strength, 6 for compressive strength). This is a very small sample size for a "test set" in the context of clinical studies, but common for material property testing.
• Data Provenance: The data is generated by Bisco, Inc., a company located in Schaumburg, IL, USA. This would be considered experimental/laboratory data rather than clinical data, and it is prospective in the sense that the testing was performed specifically to characterize the new device. There is no information regarding the country of origin of the data beyond the company's location.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of submission. For dental cements, "ground truth" is typically established through standardized material property testing, according to recognized ASTM or ISO standards, rather than expert interpretation or clinical consensus. There are no "experts" in the sense of clinicians establishing ground truth for physical properties like tensile strength or hardness, but rather skilled technicians performing tests according to methods.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader interpretations (e.g., radiology images) to resolve discrepancies among experts. For physical property testing, results are quantitative and typically averaged or analyzed statistically; there's no "adjudication" in this sense.

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. MRMC studies are typically used for diagnostic devices involving human interpretation of clinical data (e.g., radiologists reading images). This 510(k) is for a dental material (cement), and its assessment relies on material properties rather than diagnostic performance or human reader interaction.

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 concept applies to AI/software as a medical device. ILLUSION is a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the physical and mechanical properties of the dental cement is established by standardized testing methods (e.g., ISO, ASTM standards for dental materials) that yield quantitative measurements. The predicate device's performance provides the benchmark against which the new device's properties are compared. There is no pathology, outcomes data, or expert consensus used for these specific material properties.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. For a physical medical device like a dental cement, there is no "training set" in this context. The characteristics of the material are inherent to its composition and manufacturing process, optimized through formulation development and testing.

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

This information is not applicable, as there is no "training set" for this type of device.

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