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.

Device Description

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.

AI/ML Overview

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:

Acceptance Criteria (Implied)	Reported Device Performance
Material Safety (Biocompatibility)	Compliance with ISO 10993: Demonstrated through testing for cytotoxicity and sensitization. The use of PETG, a material already "commonly used for dental appliances and in other aligners," including the reference device (Smart Moves Complete, K172765), further supports safety.
Functional Performance (Mechanical/Clinical Effectiveness)	Compliance with pertinent standards and specifications: Bench testing demonstrated the device meets "the expectations of the dental community and the product labeling." The device's "mode of action" and "mode of use" are identical to predicate devices, implying similar functional outcomes.
Manufacturing Process Reliability	Validated Manufacturing Process: Straight Smile "validated the manufacturing process of the Byte aligners, demonstrating that the process can adequately render the final device as specified by appropriate FDA-cleared design software."
Shelf Life/Stability	2-year Shelf Life: Validated with real-time testing.
Clinical Equivalence (Indications for Use, Intended Population)	Identical Indications and Intended Population: The Byte Aligner System has "identical Indications for Use" and "Intended Population" to the predicate (ClearCorrect System, K113618) and reference devices (Smart Moves Complete, K172765), implying comparable clinical application and expected outcomes.

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.

Summary

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Straight Smile, LLC % Craig Coombs President Coombs Medical Device Consulting, Inc. 1193 Sherman St Alameda, California 94501

February 19, 2019

Re: K180346

Trade/Device Name: Byte Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 24, 2018 Received: November 26, 2018

Dear Craig Coombs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Mary S. Mary S. Runner -S3 Runner - S3 Date: 2019.02.19
19:02:26 -05'00'

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180346

Device Name Byte Aligner System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K180346: 510(k) Summary

A. Device Information:

Category	Comments
Sponsor:	Straight Smile, LLC; dba: Byte370 Alabama St., Ste KRedlands, California 92373Office phone: 1.818.231.2363Fax Number: 1.512.727.0429E-mail: sabbasi@byteme.comContact: Sepi Abbasi, Managing Member
Correspondent ContactInformation:	Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140Fax: 510-337-0416
Device Common Name:	Sequential Aligners
Device Classification Number:	21 CFR 872.5470
Device Classification &Product Code:	Class II,NXC
Device Proprietary Name:	Byte Aligner System

Predicate Device Information:

Predicate Device:	ClearCorrect System
Predicate Device Manufacturer:	ClearCorrect, Inc
Predicate Device Common Name:	Sequential Aligners
Predicate Device Premarket Notification #	K113618
Predicate Device Classification:	21 CFR 872.5470
Predicate Device Classification &	Class 2,
Product Code:	NXC

Reference Device Information:

Reference Device:	Smart Moves Complete
Reference Device Manufacturer:	Great Lakes Orthodontics Ltd
Reference Device Common Name:	Sequential Aligners
Reference Device Premarket Notification #	K172765
Reference Device Classification:	21 CFR 872.5470
Reference Device Classification &Product Code:	Class 2,
	NXC

B. Date Summary Prepared

11 February 2019

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C. Description of Device

D. Indications for Use

E. Comparison to Predicate/Reference Devices

The Straight Smile Byte Aligner System is substantially equivalent in intended use, indications for use, mode of action, mode of use, design and materials to the predicate ClearCorrect System (K113618).

Both devices have identical Indications for Use, except for the device name, which implies they have the same intended use.

Both devices have the same modes of action and use. Both are a sequential series of rigid aligners that gently pressure the teeth to move in a desired manner. The patient transitions to the next aligner in the series approximately every two weeks. After completing the series, the user's teeth should conform to the desired position.

The application and predicate aligners are made from different base materials. The predicate aligners are made from thermoplastic polyurethane. The Byte aligners are made from thermoplastic PETG. PETG has been used in other dental appliances and aligners, including the reference device Smart Moves Complete sequential aligners (K172765). Straight Smile conducted testing that demonstrated that the PETG material can be manufactured into aligners and meet the same safety and performance criteria as the predicate and reference devices.

The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.

Straight Smile concludes that the predicate ClearCorrect System (K113618) and the application Byte Aligner System are substantially equivalent.

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Substantial Equivalence Justification Table

	PREDICATE DEVICEClearCorrect SystemClearCorrect, Inc.K113618	REFERENCE DEVICESmart Moves CompleteGreat Lakes Orthodontics LtdK172765	APPLICATION DEVICEByte SystemStraight Smile, LLC	Substantial EquivalenceAnalysis
Common Name	Sequential Aligner	Sequential Aligner	Sequential Aligner	Identical to both predicateand reference devices
Classification #	872.5470	872.5470	872.5470	Identical to both
Product Code	NXC	NXC	NXC	Identical to both
Indication for Use	The ClearCorrect System isindicated for the treatment oftooth malocclusion inpatients with permanentdentition (i.e. all secondmolars), The ClearCorrectSystem positions teeth byway of continuous gentleforce.	Smart Moves Complete isindicated for the treatmentof tooth malocclusion inpatients with permanentdentition (i.e. all secondmolars). Smart MovesComplete positions teeth byway of continuous gentleforce.	The Byte Aligner System isindicated for the treatmentof tooth malocclusion inpatients with permanentdentition (i.e., all secondmolars). The Byte AlignerSystem positions teeth byway of continuous gentleforce.	Identical to both, exceptfor device name
Intended Population	Individuals with permanentdentition	Individuals with permanentdentition	Individuals with permanentdentition	Identical to both
Mode of Action	Orthodontic tooth movementoccurs through forces appliedby the device to the dentitionas each tooth follows theprogrammed displacementbased on a doctor'sprescription.	Orthodontic toothmovement occurs throughforces applied by the deviceto the dentition as eachtooth follows theprogrammed displacementbased on a doctor'sprescription.	Orthodontic toothmovement occurs throughforces applied by the deviceto the dentition as eachtooth follows theprogrammed displacementbased on a doctor'sprescription.	Identical to both
Anatomical Site of Use	Oral cavity	Oral cavity	Oral cavity	Identical to both

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510(k) Summary K180346: Byte Aligner System

	PREDICATE DEVICEClearCorrect SystemClearCorrect, Inc.K113618	REFERENCE DEVICESmart Moves CompleteGreat Lakes Orthodontics LtdK172765	APPLICATION DEVICEByte SystemStraight Smile, LLC	Substantial EquivalenceAnalysis
Mode of Use	Each aligner is worn by thepatient as determined by thetreating dental practitioner,generally for 2 weeks prior tobeing replaced by the nextaligner in sequence. This isrepeated for a duration asprescribed by a DentalProfessional.	Each aligner is worn by thepatient as determined by thetreating dental practitioner,generally for 2 weeks prior tobeing replaced by the nextaligner in sequence. This isrepeated for a duration asprescribed by a DentalProfessional.	Each aligner is worn by thepatient as determined by thetreating dental practitioner,generally for 2 weeks prior tobeing replaced by the nextaligner in sequence. This isrepeated for a duration asprescribed by a DentalProfessional.	Identical to both
Application	Removable	Removable	Removable	Identical to both
Raw Material Used	Thermoplastic polymers(polyurathane)	Thermoplastic polymers(polyethylene terephthalateglycol or PETG)	Thermoplastic polymers(polyethylene terephthalateglycol or PETG)	Identical to Referencedevice. Used in same way.
OTC or Rx	Rx	Rx	Rx	Identical to both
Design	Image: ClearCorrect aligner	Image: Smart moves complete aligner	Image: Byte System aligner	Design is developed andfabricated by similar oridentical processes used bypredicate and referencedevices

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F. Summary of Supporting Data

Biocompatibility analysis demonstrates that the Byte Aligner System is in compliance with ISO 10993. Testing included:

Cytotoxicity

Sensitization

Information was provided to demonstrate that PETG is commonly used for dental appliances and in other aligners.

Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling.

Straight Smile validated the manufacturing process of the Byte aligners, demonstrating that the process can adequately render the final device as specified by appropriate FDA-cleared design software.

Straight Smile validated the 2-year shelf life of the aligners with real-time testing.

G. Conclusion

The Byte Aligner System is substantially equivalent to the predicate device (ClearCorrect System: K113618) in indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.