(73 days)
Blue Sky Bio Computerized Orthodontic Bracket System is a software system intended for use as an aid in orthodontic treatment planning to correct malocclusions in orthodontic patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. Blue Sky Bio Computerized Orthodontic Bracket System is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the dental professional to place multiple brackets at the same time.
The device consists of proprietary software that calculates the ideal position of the dental brackets based on the dental impressions and or 3D models supplied by the patient's orthodontist. Commercially available brackets are used as part of the system.
The Blue Sky Bio Computerized Orthodontic Bracket System is a software system intended to aid in orthodontic treatment planning. The information provided outlines the device's substantial equivalence to a predicate device, but does not provide specific acceptance criteria or a dedicated study proving performance against those criteria. Instead, it describes general testing for accuracy and software verification.
Here's a breakdown of the available information based on your questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy of Data Transfer | "All samples met the performance criteria."Verified by scanning and digitizing physical models and comparing scanned 3D models with 3D models generated by the software. |
| Accurate Bracket Placement | "Testing was conducted verifying that the treatment plan performed in the software resulted in accurate placement of the brackets and corresponded to the treatment plan in Blue Sky Bio software." |
| Software Verification and Validation | "Software verification and validation testing were conducted... Documentation was provided as recommended by FDA's Guidance..." (The software was considered a "moderate" level of concern). |
Note: The document does not explicitly state numerical acceptance criteria (e.g., specific thresholds for deviation in bracket placement). The performance is reported as meeting general criteria or being confirmed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the performance testing or software verification and validation. It only mentions "All samples met the performance criteria." The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided. The method for establishing ground truth for the "accurate bracket placement" or "accuracy of data transfer" testing is not detailed in terms of expert involvement or qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided. The document describes internal testing and software verification, but no external expert adjudication process is detailed.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being performed. The device is a software system for treatment planning, not an AI for diagnostic interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance testing described ("Testing was conducted verifying that the treatment plan performed in the software resulted in accurate placement of the brackets") appears to be a standalone assessment of the software's ability to generate an accurate treatment plan. However, the system is always intended for use by dental professionals "as an aid in orthodontic treatment planning," implying that human-in-the-loop is part of its intended use. The "accuracy of data transfer" testing also seems to be a standalone evaluation of the software's data handling.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies the ground truth for the "accuracy of data transfer" was established by comparison with scanned physical models and 3D models generated by the software, likely based on predetermined, ideal bracket positions. For the "accurate bracket placement," the ground truth was also based on the "treatment plan in Blue Sky Bio software," suggesting an internal consistency check against the planned outcome, which is initially informed by the clinician's detailed treatment plan. There's no mention of external validation against pathology or patient outcomes data.
8. The sample size for the training set
This information is not provided. The document focuses on performance testing and software verification, not on the details of algorithm training. Given it's a "Computerized Orthodontic Bracket System" and not explicitly termed an "AI" or "machine learning" system, it might be a rules-based or CAD-like system, rather than one requiring a large training dataset for a learning algorithm.
9. How the ground truth for the training set was established
This information is not provided, as details about a training set are absent.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
Blue Sky Bio % Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K182338
Trade/Device Name: Blue Sky Bio Computerized Orthodontic Bracket System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: DYW, NJM,ELF Dated: August 22, 2018 Received: August 28, 2018
Dear Dave Yungvirt:
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.
November 9, 2018
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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, | |
|---|---|
| Mary S. | Digitally signed by Mary S. |
| Runner -S3 | Runner -S3 |
| Date: 2018.11.09 12:38:39 | |
| -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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Section 4 Indications for Use
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Indications for Use
510(k) Number (if known)
Device Name
Blue Sky Bio Computerized Orthodontic Bracket System
Indications for Use (Describe)
Blue Sky Bio Computerized Orthodontic Bracket System is a software system intended for use as an aid in orthodontic treatment planning to correct malocclusions in orthodontic patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. Blue Sky Bio Computerized Orthodontic Bracket System is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the dental professional to place multiple brackets at the same time.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5 510(k) Summary or Statement
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510(k) Summary
March 26, 2018
Blue Sky Bio Computerized Orthodontic Bracket System
Blue Sky Bio LLC 888 E Belvidere Rd Suite 212 Grayslake. IL 60030
718-376-0422
Contact Person: Albert Zickmann
| General Information | |
|---|---|
| Trade Name | Blue Sky Bio Computerized OrthodonticBracket System |
| Common Name | Accessory for orthodontic bracket |
| Product Codes | DYW (Orthodontic plastic bracket),NJM (Orthodontic Ceramic Bracket), andELF (Orthodontic Metal Bracket) |
| Regulation No. | 21CFR 872.5470 Orthodontic PlasticBrackets |
| Classification | Class II |
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Predicate 510k: Exceed Computerized Precision Bracket Placement Solution K151702
Indications for Use:
Blue Sky Bio Computerized Bracket System is a software system intended for use as an aid in orthodontic treatment planning to correct Malocclusions in Orthodontic Patients. For use by dental professionals trained in orthodontic treatment, including radiographic analyses and treatment planning. Blue Sky Bio Computerized Orthodontic Bracket System is intended for use with commercially available brackets currently used in standard orthodontic treatment. The end product is an indirect bonding tray for use by the Dental professional to place multiple brackets at the same time.
This is identical to the indications for use of the predicate device.
Device Description:
The device consists of proprietary software that calculates the ideal position of the dental brackets based on the dental impressions and or 3D models supplied by the patient's orthodontist. Commercially available brackets are used as part of the system.
This is identical to the device description for the predicate device.
Mode of Operation
The operating principle for Blue Sky Bio Computerized Orthodontic Bracket System and the Exceed Computerized Precision Bracket Placement Solution is identical. In addition Blue Sky Bio is also introducing an option to print a model that includes printed brackets. The difference between the two procedures is minor and both procedures yield the same result, a tray with the orthodontic brackets attached to it. The dentist will take the tray and apply a commercially available bonding material to the brackets. Subsequently, the tray with the brackets and the bonding material is placed onto the patient's dentition and the brackets are bonded in the position determined by the tray. The tray is removed. The accuracy of the position of the brackets is then visually inspected in the same manner as with traditional orthodontics. In case, that the position of one or more brackets need to be corrected, the dentist can do that in a traditional manner. The orthodontic treatment is then continued in a traditional fashion.
Mechanism of Action:
The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through forces applied to the teeth by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.
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Performance Testing:
Testing was conducted verifying that the treatment plan performed in the software resulted in accurate placement of the brackets and corresponded to the treatment plan in Blue Sky Bio software.
The accuracy of data transfer through the software was confirmed by scanning and digitizing physical models and comparing scanned 3D models with the 3D models generated by the treatment plan in the software. All samples met the performance criteria.
Biocompatibility Testing:
The resin used for printing indirect bonding trays is a legally marketed impression tray resin so no testing was performed. The brackets used with the trays are all 510k exempt or 510k cleared devices so no testing was performed. Indirect bonding trays made using pressure forming are made from a 510k cleared or exempted resin so no testing was performed.
Software Verification and Validation Testing:
Software verification and validation testing were conducted on the Blue Sky Bio Computerized Orthodontic Bracket System software that allows the user to locate the brackets in order to create an indirect bonding tray and export either the bonding tray or a model to form a bonding tray over.
Documentation was provided as recommended by FDA's Guidance for Industry and FDA staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
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Predicate Device Comparison Table
| Blue Sky Bio Computerized OrthodonticBracket System | Exceed Computerized PrecisionBracket Placement Solution | |
|---|---|---|
| Indicationsfor Use | Blue Sky Bio Computerized BracketSystem is a software system intended foruse as an aid in orthodontic treatmentplanning to correct Malocclusions inOrthodontic Patients. For use by dentalprofessionals trained in orthodontictreatment, including radiographicanalyses and treatment planning. BlueSky Bio Computerized OrthodonticBracket System is intended for use withcommercially available brackets currentlyused in standard orthodontic treatment.The end product is an indirect bondingtray for use by the Dental professional toplace multiple brackets at the same time. | eXceed Computerized PrecisionBracket Placement Solution is asoftware system intended for use asan aid in orthodontic treatmentplanning to correct Malocclusions inOrthodontic Patients. For use bydental professionals trained inorthodontic treatment, includingradiographic analyses and treatmentplanning. eXceed ComputerizedPrecision Bracket PlacementSolution is intended for use withcommercially available bracketscurrently used in standardorthodontic treatment. The endproduct is an indirect bonding trayfor use by the Dental professional toplace multiple brackets at the sametime. |
| Key Records | A 3D model is generated from scannedanalog impressions or directly from anintra-oral scan | A 3D model is generated from scannedanalog impressions or directly from anintra-oral scan |
| AdditionalRecords | A panoramic X-ray, facial and intra- oralimages. | A panoramic X-ray, facial and intra-oral images |
| TreatmentPlan | A detailed treatment plan is providedby the clinician as part of casesubmission. | A detailed treatment plan isprovided by the clinician as partof case submission. |
| VirtualBracketPlacementPlan | Using the submitted records and theprescribed treatment plan, a suggestedplacement plan is generated and sent forreview by the clinician. The Clinicianutilizes the Blue Sky Bio software toadjust the plan and later have itapproved. | Using the submitted records and theprescribed treatment plan, asuggested placement plan isgenerated and sent for review bythe clinician. The Clinician utilizesthe eXceed software to adjust theplan and later have it approved. |
| Manufacturing | A working pre-treatment model, whichincludes tooth and bracket-specificlandmarks depicting the position of thebrackets based on the approved plan, isprinted. Brackets are bonded by atechnician within the landmarks.Alternatively, the indirect bonding tray isprinted. | A working pre-treatment model,which includes tooth and bracket-specific landmarks depicting theposition of the brackets based onthe approved plan, is printed.Brackets are bonded by a technicianwithin the landmarks. |
| FinishedProduct | Vacuum forming then follows toproduce patient- specific indirectbonding trays.Alternatively, the indirect bonding trayis printed. | Vacuum forming then follows toproduce patient- specific indirectbonding trays. |
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Conclusion:
Blue Sky Bio Computerized Orthodontic Bracket System is as safe, as effective, and is substantially equivalent to the predicate device in regards to indications for use, design, technological characteristics, mechanism of action, performance, materials and biocompatibility.
§ 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.