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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.

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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 is a series of Byte dental aligners fabricated of clear, thin thermoformed polyethylene terephthalate glycol (PETG) plastic to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a modified position in each subsequent aligner.

This document is a 510(k) summary for the Byte Aligner System (K180346), indicating its substantial equivalence to predicate devices for the treatment of tooth malocclusion. It focuses on demonstrating that the Byte Aligner System, particularly its use of PETG material, is as safe and effective as existing devices.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the typical sense of a clinical trial. Instead, it relies on demonstrating compliance with recognized standards and a comparison to predicate devices, particularly regarding materials and manufacturing processes.

However, based on the provided text, we can infer some "performance" aspects and how they were addressed indirectly:

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

The document discusses bench testing and biocompatibility testing. It does not specify a "sample size for the test set" in terms of clinical cases or patient data.

• For biocompatibility testing (cytotoxicity, sensitization), no specific sample size (e.g., number of test samples) is provided. The tests were performed to demonstrate compliance with ISO 10993, which outlines methods for such testing.
• For bench testing to demonstrate compliance with standards and specifications, no specific sample size (e.g., number of aligners tested mechanically) is provided.
• For shelf-life testing, "real-time testing" was conducted, but the sample size is not specified.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." All described testing (biocompatibility, bench, shelf-life, manufacturing validation) would be conducted internally by the manufacturer or by a contracted laboratory to generate data for this submission. This is pre-market data, not clinical trial data on patients.

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

This document does not describe a study involving human experts establishing "ground truth" for a test set. This type of submission (510(k)) primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices, rather than a de novo clinical validation against an expert-derived ground truth. The "ground truth" here is implied to be widely accepted dental and medical device standards and the performance of predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no human-expert-adjudicated test set is described.

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. The Byte Aligner System is a physical dental device (aligners) for orthodontic treatment, not an AI software/diagnostic tool that would involve human "readers" or an "AI assistant."

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 or AI system.

7. The Type of Ground Truth Used

The "ground truth" implicitly used in this 510(k) submission is:

• Compliance with recognized standards: ISO 10993 for biocompatibility and "pertinent standards and specifications" for bench testing.
• Performance of predicate and reference devices: The Byte Aligner System is deemed safe and effective because its materials, design, indications for use, and mode of action are comparable to devices already cleared by the FDA (ClearCorrect and Smart Moves Complete). The fact that PETG is used in the reference device (Smart Moves Complete, K172765) reinforces its acceptability.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable.

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