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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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