(29 days)
OSW Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
The OSW Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners progressively move the patient's teeth in small increments from their original state to a final treated state. The OSW Aligner System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion. The 3D software generates the model of a provisional treated state and then creates a series of models that represent intermediate teeth states. The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the setup prior to approving it for aligner fabrication. Once the doctor approves the setup, the series of custom-made aligners are manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.
The OSW Aligner System is an orthodontic device. The provided text indicates that no clinical testing or bench testing was performed due to the established performance of sequential aligners and the difficulty of evaluating this device type in a lab.
Here's the information regarding acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| OSW OrthoSetup Software Verification | PASS (meets FDA Guidance) |
| OSWDP System and Software Verification | PASS (meets FDA Guidance) |
| Biocompatibility - Cytotoxicity (ISO 10993-5) | PASS |
| Biocompatibility - Irritation (ISO 10993-10) | PASS |
| Biocompatibility - Sensitization (ISO 10993-10) | PASS |
| Biocompatibility - Acute Systemic Toxicity (ISO 10993-11) | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify a separate "test set" in the context of clinical performance or data provenance from patient studies. The performance reported is from non-clinical performance tests for software verification and biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported tests are non-clinical and did not involve expert-established ground truth in the context of medical image analysis or clinical outcomes. The software verification tests would have their own internal verification process, but details on experts are not provided.
4. Adjudication method for the test set within a clinical context
Not applicable. No clinical test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done. The device description does not position it as an AI-assisted diagnostic tool for human readers but rather as a system for generating aligners based on a practitioner's treatment plan.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The software verification tests represent a standalone evaluation of the software components (OSW OrthoSetup and OSWDP). The results indicate these components passed their respective verification criteria. The "algorithm" in this context is the 3D software that generates treatment plans and models for aligner fabrication. Its performance was verified, but specific metrics beyond "PASS" are not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests:
- Software Verification: The "ground truth" would be established by following FDA Guidance for software verification and validation, ensuring the software performs as intended according to its specifications.
- Biocompatibility Testing: The "ground truth" is adherence to ISO standards (ISO 10993 series) for evaluating biological responses to medical devices.
8. The sample size for the training set
Not applicable. This document describes the clearance of a device that includes 3D software for orthodontic planning and aligner manufacturing, not a machine learning or AI model that requires a distinct "training set" in the conventional sense for medical image analysis. The software's development would involve internal testing and validation, but this is not typically referred to as a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a "training set" as understood in machine learning/AI development in this document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2019
OSW Manufacturing, LLC % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K191990
Trade/Device Name: OSW Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: July 24, 2019 Received: July 25, 2019
Dear Mark Job:
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.
{1}------------------------------------------------
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K191990
Device Name OSW Aligner System
Indications for Use (Describe)
OSW Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary (K191990)
| 510(k) Owner | OSW Manufacturing, LLC35778 Elk Lane,Murrieta, CA 92563Phone: 408.621.1152 |
|---|---|
| Contact person | Ian KitchingOSW Manufacturing, LLC35778 Elk Lane,Murrieta, CA 92563Phone: 408.621.1152ian@oswaligner.com |
| Date Prepared | August 23, 2019 |
| Product Code: | |
| Common Name | Orthodontic Plastic Brackets |
| Trade Name | OSW Aligner System |
| Classification Name | aligner, sequential |
| Regulation | 872.5470 |
| Class | Class II |
| Panel | Dental |
| Product Code | NXC |
| Primary Predicate | K171674Angel Align System |
Description
The OSW Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners progressively move the patient's teeth in small increments from their original state to a final treated state.
The OSW Aligner System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion.
The 3D software generates the model of a provisional treated state and then creates a series of models that represent intermediate teeth states. The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to
{4}------------------------------------------------
reject or request modifications to the setup prior to approving it for aligner fabrication. Once the doctor approves the setup, the series of custom-made aligners are manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.
Indications for Use
OSW Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Technological Characteristics
The predicate and the OSW Aligner System were compared in the following areas and found to have similar technological characteristics and to be equivalent:
{5}------------------------------------------------
| Device Comparison Table | ||
|---|---|---|
| OSW Aligner System | K171674 | |
| Indications forUse Statement | The OSW Aligner System is indicatedfor the alignment of teeth duringorthodontic treatment ofmalocclusion. | The Angel Align System isindicated for the alignment ofteeth during orthodontic treatmentof malocclusion. |
| 3-D SoftwareDescription | The OSW Manufacturing 3-DSoftware uses a scan of a PVSimpression or a digital scan (whichrepresents an untreated state) togenerate the image of a final,provisional treated state and theninterprets a series of images thatrepresent intermediate teeth states.The dental practitioner then reviewsthese images and has the option toreject or request modifications to theset-up prior to approving it foraligner fabrication. Once the dentalpractitioner approves the treatmentplan, the software converts the filesto produce the series of custom-made aligners | The Angel 3-D Software uses ascan of a PVS impression or adigital scan (which represents anuntreated state) to generate theimage of a final, treated state andthen interprets a series of imagesthat represent intermediate teethstates. The dental practitioner thenreviews these images and has theoption to reject or requestmodifications to the set-up prior toapproving it for aligner fabrication.Once the dental practitionerapproves the treatment plan, thesoftware converts the files toproduce the series of custom-madealigners |
| Mode ofOperation for 3-DSoftware | OSW Aligner System 3-D softwareperforms the following operations:Produce 3D-model file of thePVS impression or digitalscan. Identifies the individualteeth that will requiretreatment (i.e.repositioning). Creates a treatment plan (i.e.3-D models that representthe treatment plan). Thetreating dental practitionerreviews these images usingOSWDP software and hasthe option to reject orrequest modifications to theset-up prior to approval. | Angel Align System 3-D softwareperforms the following operations:Produce 3D-model file ofthe PVS impression ordigital scan. Identifies the individualteeth that will requiretreatment (i.e.repositioning). Creates a treatment plan(i.e. 3-D models thatrepresent the treatmentplan). The treating dentalpractitioner reviews theseimages using iOrthosoftware and has theoption to reject or requestmodifications to the set-upprior to approval. |
| Material | 0.03" thick, thermoformedpolyurethane | 0.03" thick, thermoformedpolyurethane |
| Mode of Use | Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence. | Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence. |
| Description of Appliance Application | Removable | Removable |
| Manufacturing Method | A digital model of the patient's teeth is created from either scanning a PVS impression or directly from an intraoral scan of the patient's teeth. From the digital model, following a dental practitioner's prescription, the software generates model transforms describing the provisional final, treated state and then interpolates a series of model transforms that represent intermediate states of alignment. The resulting computer "setups" relay this information to rapid prototyping machines that produce physical positive models. The aligners are produced by thermoforming on each physical model to fabricate the sequence of aligners. | A digital model of the patient's teeth is created from either CT scanning a PVS impression or directly from an intraoral scan of the patient's teeth. From the digital model, following a dental practitioner's prescription, the software generates model transforms describing the final, treated state and then interpolates a series of model transforms that represent intermediate states of alignment. The resulting computer "setups" relay this information to rapid prototyping machines that produce physical positive models. The aligners are produced by thermoforming on each physical model to fabricate the sequence of aligners. |
Device Comparison Table
{6}------------------------------------------------
Technological Characteristic Differences
There are no major technological characteristic differences when comparing the subject device and the predicate device, with only differences in location of manufacturing. Non-clinical performance testing mitigated any concerns regarding this difference.
Non-Clinical Performance Testing
The following non-clinical performance tests were conducted:
| Report Name | Standard | Result |
|---|---|---|
| OSW OrthoSetup Software Verification Report | N/A (FDA Guidance) | PASS |
| OSWDP System and Software Verification Report | N/A (FDA Guidance) | PASS |
| Biocompatibility testing of device - Cytotoxicity | ISO 10993-5 | PASS |
| Biocompatibility testing of device - Irritation | ISO 10993-10 | PASS |
| Biocompatibility testing of device - Sensitization | ISO 10993-10 | PASS |
| Biocompatibility testing of device - Acute Systemic Toxicity | ISO 10993-11 | PASS |
{7}------------------------------------------------
Clinical Testing
The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the OSW Aligner System to the predicate device.
Bench Testing
Bench testing of the aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. There is sufficient information available from the scientific literature and from the predicate device to demonstrate substantial equivalence of the OSW Aligner System to the predicate device.
Substantial Equivalence Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Based on the comparison and analysis above, the OSW Aligner System is determined to be substantially equivalent to the referenced primary predicate device.
§ 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.