Search Results

The Byte Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Byte Aligner System positions teeth by way of continuous gentle force.

The Byte Aligner System consists of a sequential series of aligners fabricated of clear, thin, lightweight and flexible thermoformed polyethylene terephthalate glycol (PETG) [copolyester] plastics. The mechanism of action of the proposed Byte Aligner System is mechanical in nature; that is, tooth movement induced by orthodontic force application using continuous gentle forces. The aligners are made from elastic thermoplastic material that applies continuous gentle force to the teeth for treatment of tooth malocclusion. Treatment plans are modeled using CAD-CAM (computer-aided-design and computer-aided-manufacturing) software. Model archforms are created using rapid prototyping techniques like stereo-lithography. The aligners are thermoformed over the model archforms and are not themselves 3D printed. With the aligners seated on the patient's upper and/or lower dental arches, the teeth are progressively and gradually straightened over time by mechanical forces that are delivered via minor, incremental changes in tooth positions in each subsequent set of aligner trays that have been customized for the patient, delivered as a sequential series of trays to progressively reposition the teeth. The mechanics of how this happens is based on the forces caused by the elastic deformation of the aligner when worn by the patient. The forces are applied to the teeth, and also to the roots, causing pressure to the periodontium in the direction of the desired movement. Each aligner moves the patient's teeth in small increments from their original state.

The furnished document is a 510(k) Summary for the Byte Aligner System (K230199). It is a declaration of substantial equivalence to a predicate device, not a report detailing a clinical study with acceptance criteria for an AI-powered device. Therefore, the information required to answer the prompt regarding acceptance criteria and a study proving a device meets these criteria is not present in the provided text.

Specifically:

• No acceptance criteria or device performance report: The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for device performance, nor does it present reported device performance metrics against such criteria.
• No test set details: There is no mention of a test set size, data provenance, or whether the study was retrospective or prospective.
• No expert adjudication details: The document does not discuss the number or qualifications of experts used for establishing ground truth, nor does it specify any adjudication methods.
• No MRMC study: There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted or any effect size for human readers improving with AI assistance.
• No standalone performance: The document does not report on the standalone performance of an algorithm without human intervention.
• No ground truth type: The type of ground truth used (e.g., expert consensus, pathology, outcomes data) is not specified because a study of this nature was apparently not performed.
• No training set details: There is no information about the sample size of a training set or how ground truth for a training set was established.

The 510(k) Summary primarily focuses on demonstrating substantial equivalence of the modified Byte Aligner System (K230199) to its predicate device (K180346) and reference devices by comparing their intended use, indications for use, technological characteristics, and safety aspects (biocompatibility, shelf-life, material review). It explicitly states: "No data from human clinical studies was included to support the substantial equivalence of the proposed Byte Aligner System." Therefore, it's not possible to extract the requested information from this document.

Ask a specific question about this device

The Invisalign System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent), or permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition.

The subject device, Invisalian System with Mandibular Advancement Featuring Occlusal Blocks (Invisalign System, MAOB) is a modification to the predicate device, Invisalign System (K220287, cleared on April 07, 2022) and the reference device. Invisalign System with Mandibular Advancement Features (K181739, cleared on October 26th, 2018). The Invisalign System, MAOB (subject device) consists of removable orthodontic appliances (aligners with mandibular advancement features including occlusal blocks), proprietary treatment planning 3D software (doctor facing - ClinCheck and Align employee facing -Treat) and attachment templates.

The provided text describes a 510(k) premarket notification for a medical device (Invisalign System with Mandibular Advancement Featuring Occlusal Blocks) and its substantial equivalence to a predicate device. However, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria, particularly concerning AI or software performance characteristics.

The document primarily focuses on:

• Regulatory Clearance: The FDA's substantial equivalence determination.
• Device Description: What the device is and how it functions.
• Comparison to Predicate: How the modified device compares to existing, cleared devices.
• Testing Summary: High-level statements about bench testing, biocompatibility, and software V&V.

**Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance (since specific performance metrics and acceptance thresholds for the software are not detailed).
2. Sample sizes for a test set or data provenance (no specific AI performance study data is presented).
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used for specific AI performance.
8. Sample size for the training set.
9. How ground truth for the training set was established.**

The document states:

• Software Testing: "In accordance with IEC 62304, Medical device software - Software life cycle processes; successful software verification and validation (V&V) testing at the unit, integration, and system level was performed to qualify the modified software with the subject device." This indicates that standard software V&V was performed, but details on specific acceptance criteria for performance related to image analysis or treatment planning accuracy that would typically be associated with an AI/ML device are not provided. The phrase "proprietary, 3D treatment planning software" is mentioned, but no performance claims or supporting study data for this software's accuracy are included in this FDA letter/summary.
• No Animal or Clinical Testing: "No animal or clinical testing was required or performed for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks." This further indicates that the detailed performance study you are asking for, especially involving human observers or patient outcomes, was not part of this specific submission.

In summary, the provided text is a regulatory clearance document, not a detailed technical report on AI/ML model performance. It confirms that the device's modifications (addition of occlusal blocks and associated software updates) were deemed substantially equivalent to a predicate device based on bench testing, biocompatibility, and general software V&V, without specific performance metrics or studies relating to AI/ML accuracy or efficacy as you've requested.

Ask a specific question about this device

The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligner positions teeth by way of continuous gentle force.

The Custom-made Invisible Aligners System is a series of dental aligners that fabricated of clear, thin thermoformed plastic to progressively reposition the teeth. The product is made from a composite multilayer material with thermoplastic polyurethane and polyethylene terephthalate-1, 4-cyclohexanedimethanol ester (TPU+PETG). Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

The provided text is a 510(k) summary for a medical device called "Custom-made Invisible Aligners." This document describes the device, its intended use, comparison to predicate devices, and the non-clinical testing performed to establish substantial equivalence.

However, the 510(k) summary explicitly states:
"H. Clinical Test Conclusion: No clinical study is included in this submission."

Therefore, based on the provided text, there is no information available regarding acceptance criteria based on clinical performance, nor any study proving the device meets such criteria through human clinical data. The document focuses solely on non-clinical testing to demonstrate performance and safety.

Even though the request asks for specific details about the study that proves the device meets the acceptance criteria, the provided document does not contain this information because no clinical studies were performed or included in the submission.

To directly address the request while accurately reflecting the content of the document:

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

Based on the non-clinical testing described, the acceptance criteria relate to material properties, manufacturing accuracy, and biocompatibility.

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

• Sample Size: For manufacturing accuracy validation, aligners from "12 different patient case" were evaluated. No other specific sample sizes are mentioned for the general performance or biocompatibility testing (e.g., number of material samples for tensile strength).
• Data Provenance: Not explicitly stated, but the applicant (Zhejiang Yinchili Medical Technology Co., Ltd.) is based in China, suggesting the testing was likely conducted in China or by labs contracted by a Chinese company.
• Retrospective/Prospective: Not applicable, as these were non-clinical bench and lab tests, not clinical studies involving patients.

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

• Not applicable. The "ground truth" for non-clinical tests is established by adherence to recognized standards (e.g., ISO 10993) and pre-established specifications, not by expert consensus on clinical findings.

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

• Not applicable. Adjudication methods like 2+1 are used in clinical studies for interpretation of results, especially imaging. This document describes non-clinical testing.

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. The document explicitly states, "No clinical study is included in this submission." This device is a physical medical device (aligners), not an AI-based diagnostic or assistive software.

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

• No. This section is generally relevant for AI/ML devices. The device described is a physical aligner. While there is software for ordering/processing, its V&V focused on its function in facilitating the device, not its standalone diagnostic performance.

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

• For material performance and manufacturing accuracy: Ground truth was established by pre-established specifications, engineering principles, and compliance with recognized standards (e.g., ISO for biocompatibility).
• For biocompatibility: Ground truth was based on the results of specific biological tests (cytotoxicity, irritation, sensitization, sub chronic systemic toxicity, genotoxicity) interpreted against the requirements of ISO 10993.

8. The sample size for the training set:

• Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set of data.

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

• Not applicable (see point 8).

Ask a specific question about this device

Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

The Clear Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state.

The Clear Aligners are fabricated by thin thermoformed polyurethane or thermoformed multilayer copolyester and polyurethane composite (TPU +PETG) plastic. The corrective forces are generated via differences between current teeth arrangement and each step's aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

The traction accessory, also called "Angel Button", made of thermoplastic polyurethane can be selected and will be bonded to the outer surface of the aligner by adhesive made of acrylic polyurethane.

The provided text describes the regulatory clearance of a medical device, the "Clear Aligner," and summarizes the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain the detailed information requested regarding acceptance criteria and the study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or accuracy, which are typical for studies involving diagnostic AI/ML devices.

The document focuses on:

• Biocompatibility testing
• Software validation & risk analysis
• Performance Testing of the traction accessory and shelf life
• Real-world data for the traction accessory's effectiveness and adverse event analysis.

Based on the provided text, I can only extract information related to the non-clinical tests and their general acceptance criteria. There is no mention of a device that requires performance metrics against specific acceptance criteria like sensitivity/specificity or accuracy in the way described in your request. The device in question is a clear aligner for orthodontic treatment, not an AI/ML-driven diagnostic tool.

Therefore, many of your specific numbered requests cannot be directly answered from this document.

Here's an attempt to answer based on the available information, noting where information is missing:

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

Ask a specific question about this device