(261 days)
Not Found
No
The document mentions image processing for generating and interpreting images of teeth states, but it does not explicitly mention the use of AI, ML, or related terms like DNN. The performance studies focus on material properties and software validation against specifications, not on the performance of an AI/ML algorithm.
Yes
The device is indicated for the "treatment of tooth malocclusion," which is a medical condition, and it functions by "positioning teeth by way of continuous gentle force" through "removable orthodontic appliances (aligners)," directly acting on the body to achieve a therapeutic effect.
No
This device is for the treatment of tooth malocclusion, not for diagnosis. The software generates images to plan treatment, but it does not diagnose medical conditions.
No
The device description explicitly states that the device consists of "a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners)." These aligners are physical components, not software. While software is used in the design and planning process, the final medical device delivered to the patient is a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of tooth malocclusion by physically moving teeth. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a series of physical appliances (aligners) that apply force to teeth. This is a physical intervention, not a test performed on a biological sample to provide diagnostic information.
- Input: While it uses scans of impressions or digital scans, these are used to design the physical treatment, not to analyze biological samples for diagnostic purposes.
- Anatomical Site: The device interacts with the mouth and mucosal membranes, which is consistent with a therapeutic dental device, not an IVD which typically analyzes samples like blood, urine, or tissue.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
Smart Moves Complete consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners). The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. Smart Moves Complete is intended as an alternative to conventional bracket technology and fixed appliances for the treatment of patients with malocclusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mouth; mucosal membranes
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
prescription use device by order of a Dentist or Orthodontist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
- Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, and irritation.
- Software verification and validation testing using FDA's guidance document confirmed acceptance to required specifications.
- Tensile strength: sample of base materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile strength yield.
- Aligner elongation: sample of based materials used for fabrication of aligners were tested and analyzed showing acceptable results in comparison of break point.
- Tensile stress: sample of base materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile stress at break point.
- Modulus: tested for the base materials used for fabrication of aligners to show acceptable results between the samples tested.
- Load of materials: found acceptable results when tested and analyzed for samples of base material tested used for fabrication of aligners.
- Water absorption: found acceptable results when tested and analyzed for fabricated aligners.
- Durometer testing of thermoplastic forming material: 80 +/- 3 Shore D: Acceptable.
- Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output and work model and aligner were tested and compared. Aligners met the specifications of this testing.
Clinical Performance Data:
There was no clinical testing performed to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence is supported by non-clinical testing and the comparative table, so this is not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K113618, ClearCorrect System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Great Lakes Orthodontics Ltd Mr. David Graver Director of Logistics 200 Cooper Ave Tonawanda, New York 14150
Re: K172765
Trade/Device Name: Smart Moves Complete Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: April 30, 2018 Received: May 2, 2018
Dear David Graver:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
June1, 2018
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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. Runner -S
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) K172765
Device Name Smart Moves Complete
Indications for Use (Describe)
Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (1.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.
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)
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510(k) Summary
Smart Moves Complete
K172675
Sponsor
Great Lakes Orthodontics Ltd
200 Cooper Ave.
Tonawanda, NY 14150
Contact person:
Dave Graver
Director of Logistics
Date Prepared: May 31, 2018
Device Identification
Trade/Proprietary name: Smart Moves Complete Regulation Number: 21CFR 872.5470 Regulation Name: Aligner Sequential/ Orthodontic Plastic Bracket
Panel: Dental
Product Class: II
Product Code: NXC
Legally Marketed Predicate Device
K113618, ClearCorrect System, ClearCorrect Inc.
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Indications for Use
Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.
Background
Orthodontic treatment is conventionally performed using brackets and archwires. A bracket is bonded to each tooth and a wire is inserted with the goal of moving each tooth to a desired final treatment position. An alternative to traditional bracket treatment has been in existence for the past 20 years. This alternative treatment uses clear plastic aligners to gradually move the teeth. The aligners are designed in a series of incremental stages. A patient wears each aligner stage for a period of two weeks to accomplish the programmed tooth movement. Once tooth movement has been accomplished for a given stage the current aligner is removed and the next aligner in the sequence is worn. This method of orthodontic treatment is popular with patients because it provides a virtually invisible appliance and avoids the appearance of braces on the teeth.
Design and Use
- This is a prescription use device by order of a Dentist or Orthodontist ●
- Designed for single patient use (2 weeks/aligner)
- Aligners are worn except for eating and brushing teeth. They are removed by the patient for those tasks.
- It is not provide sterile
- It does not contain any drugs or biologic
- Software as part of the system is used by the Dental lab to design the aligners that the ● Dental professional reviews and approves prior to fabrication.
- No clinical studies are included in the submission
Device Description
Aligner System
A dental health professional (e.g. orthodontist or dentist) prescribes Smart Moves Complete based on an assessment of the patient's teeth, takes molds of the patient's teeth, determines a course of treatment to reposition the teeth via gentle, corrective forces in the upper and lower dental arch, and completes a prescription form. Digital information concerning the patient's teeth and the prescription form are then sent electronically to Great Lakes Orthodontics.
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Great Lakes then designs a series of plastic thermoformed aligners in a sequential series intended to gradually realign the patient's teeth in accordance with the physician's prescription using standard dental tooth alignment software. The prescribing physician accesses the doctor-facing portion of the standard dental tooth alignment software to review and approve the model scheme before the thermoformed aligners are produced. Once approved, Great Lakes Orthodontics produces these aligners, which are formed of clear, thin, thermoformed plastic.
The aligners in a sequential series are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period of time, each progression of aligners are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The aligners are held in place by pressure and can be removed by the patient at any time.
| Manufacturer | Great Lakes
Orthodontics, Ltd. | ClearCorrect Inc. | Device Comparison |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Smart Moves Complete | ClearCorrect System | N/A |
| 510(k) Number | K172765 | K113618 | N/A |
| Product Code | NXC | NXC | Same |
| Regulation Number | 872.5470 | 872.5470 | Same |
| Regulation Name | Orthodontic Plastic
Bracket | Orthodontic Plastic
Bracket | Same |
| Indications for Use
Statement | Smart Moves Complete is
indicated for the
treatment of tooth
malocclusion in patients
with permanent
dentition (i.e. all second
molars). Smart Moves
Complete positions teeth
by way of continuous
gentle force. | The ClearCorrect System
is indicated for the
treatment of tooth
malocclusion in patients
with permanent
dentition (i.e. all second
molars). The
ClearCorrect System
positions teeth by way of
continuous gentle force. | Same |
| Device Description | Smart Moves Complete
consists of a series of
doctor-prescribed, thin,
clear plastic removable
orthodontic appliances
(aligners). The aligners
gently move the patient's
teeth in small increments
from their original state
to a more optimal,
treated state. Smart
Moves Complete is
intended as an
alternative to | The ClearCorrect device
is fabricated of clear thin
thermoformed
polyurethane plastic in a
sequential series to
progressively reposition
the teeth. Corrective
force to straighten the
teeth is delivered via
minor changes into a
position in each
subsequent aligner. | Same; the device
performs treatment of
tooth malocclusions in
the same way by
continuous gentle force. |
| | | | |
| | conventional bracket
technology and fixed
appliances for the
treatment of patients
with malocclusion. | | |
| Mode of Action | Orthodontic tooth
movement occurs
through forces applied by
the appliance to the
dentition as each tooth
follows the programmed
displacement based on a
doctor's prescription. | Orthodontic tooth
movement occurs
through forces applied by
the appliance to the
dentition as each tooth
follows the programmed
displacement based on a
doctor's prescription. | Same |
| Anatomy Location | Mouth; mucosal
membranes | Mouth; mucosal
membranes | Same |
| Size | Patient specific | Patient specific | Same |
| Manufacturing Method | Thermoforming | Thermoforming | Same |
| Material | 0.03" Thermoplastic
PETG | 0.03" Thermoplastic
Polyurethane | Similar; these are both
thermoplastic forming
materials that have same
durometer, similar
properties in modulus
that do not raise any
additional questions of
safety or efficacy. |
| Biocompatibility | Passed ISO 10993-1 and
series | Passed ISO 10993-1 and
series | Same |
| Hardness Durometer | $80 \pm 3$ Shore D | $80 \pm 3$ Shore D | Same |
| Material Tensile
Strength/Stress | Strength and stress of
material tensile
produced acceptable
results for base material | Information not available | Base materials of
thermoplastic used to
fabricate aligners uses
similar material used in
these applications gentle
tooth alignment. The
materials are
thermoformed plastics
that are similar in
composition to the
predicate device not
raising any additional
questions of safety or
efficacy. |
| Material Elongation | Elongation at yield and
break produced
acceptable results for
base material | Information not available | Base materials of
thermoplastic used to
fabricate aligners uses
similar material used in
these applications gentle
tooth alignment. The
materials are
thermoformed plastics
that are similar in
composition to the
predicate device not
raising any additional |
| | | | |
| Material Modulus | Modulus results
produced similar results
for testing of base
material | Information not available | Base materials of
thermoplastic used to
fabricate aligners uses
similar material used in
these applications gentle
tooth alignment. The
materials are
thermoformed plastics
that are similar in
composition to the
predicate device not
raising any additional
questions of safety or
efficacy. |
| Material Load | Load at yield and break
produced acceptable
results for base material | Information not available | Base materials of
thermoplastic used to
fabricate aligners uses
similar material used in
these applications gentle
tooth alignment. The
materials are
thermoformed plastics
that are similar in
composition to the
predicate device not
raising any additional
questions of safety or
efficacy. |
| Dental Tooth Alignment
Software Description | The Smart Moves
Complete 3-D software
uses a scan of a PVS
impression or a digital
scan to generate the
image of a final, treated
state and then interprets
a series of images that
represent intermediate
teeth states. Once the
dental practitioner
approves the treatment
plan, the software
converts the files to
produce the series of
patient specific aligners. | The standard dental
tooth alignment software
uses a scan of tooth
impression or a digital
scan to generate the
image of a final, treated
state and then interprets
a series of images that
represent intermediate
teeth states. Once the
dental practitioner
approves the treatment
plan, the software
converts the files to
produce the series of
patient specific aligners. | Same |
| Healthcare Professional
Review | The dental practitioner
reviews final aligner
series prior to fabrication
and has the option to
reject or request
modifications to the set-
up prior to approving it
for aligner fabrication. | The dental practitioner
reviews final aligner
series prior to fabrication
and has the option to
reject or request
modifications to the set-
up prior to approving it
for aligner fabrication. | Same |
Predicate Device Comparison
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Non-Clinical Performance Testing
As part of demonstrating safety and effectiveness of Smart Moves Complete and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Great Lakes Orthodontics completed a number of non-clinical performance tests. The Smart Moves Complete meets all the requirements for overall design, biocompatibility, and performance results confirming that the design output meets the design inputs and specifications for the device.
The Smart Moves Complete passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- Biocompatibility testing per ISO 10993-1 passed cytotoxicity, sensitization, and irritation .
- Software verification and validation testing using FDA's guidance document confirmed . acceptance to required specifications
- There is no defined specification or standard for tensile strength so a sample of base . materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile strength yield
- . There is no defined specification or standard for aligner elongation which a sample of based materials used for fabrication of aligners were tested and analyzed showing acceptable results in comparison of break point
- . There is no defined specification or standard for tensile stress so a sample of base materials used for fabrication of aligners were tested and analyzed producing acceptable results for tensile stress at break point
- . There is no defined specification or standard for modulus so this was tested for the base materials used for fabrication of aligners to show acceptable results between the samples tested
- There is no defined specification or standard for load of materials which found acceptable ● results when tested and analyzed for samples of base material tested used for fabrication of aligners
- There is no defined specification or standard for water absorption which found acceptable ● results when tested and analyzed for fabricated aligners
- Durometer testing of thermoplastic forming material 80 ± 3 Shore D: Acceptable .
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- Process Flow validation was performed to ensure that the finished device matches the software output specifications. The output and work model and aligner were tested and compared. Aligners met the specifications of this testing.
Clinical Performance Data
There was no clinical testing performed to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence is supported by non-clinical testing and the comparative table, so this is not required.
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 Smart Moves Complete is determined to be substantially equivalent to the referenced predicate device(s).