The PROPEL device is indicated for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including initiation holes for drill bits, implants, screws, plates and other orthodontic appliances.

Device Description

The PROPEL Device is intended for use in dental operative procedures involving the preparation of tissue and bone. The PROPEL Device can be used manually as a bone cutting instrument in accordance with the FDA regulation 21 CFR Sec. 872.4120. It CANNOT be attached to any powered driver.

The PROPEL Device has a stainless steel drill tip that can be manually adjusted to the length needed for treatment or cutting depth. The plastic handle incorporates a retractable plastic tube over the cutting drill instrument. This enables the drill tip to be locked into a specific depth at 3. 5. or 7mm, thus preventing the drill tip from penetrating the bone bevond the targeted depth when used during orthodontic and dental operative procedures. The handle contains a red LED. operated by batteries. The LED is illuminated when the tip of the drill tip reaches the set depth. There is no motor in the device. The batteries are only for signaling when the prescribed depth has been achieved.

The device is provided sterile and is for single use only.

AI/ML Overview

The document provided does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the typical format of a clinical trial or performance study with detailed statistical results. Instead, it is a 510(k) Premarket Notification from the FDA to Propel Orthodontics, LLC, confirming substantial equivalence of their PROPEL Device to a predicate device.

The information primarily focuses on comparing the PROPEL device's features to a predicate device (Synthes 90° Screwdriver, K082649) to demonstrate substantial equivalence, rather than setting specific performance acceptance criteria and then validating against them with a dedicated study.

However, based on the provided text, I can extract information related to "acceptance criteria" in the sense of compliance with standards and "reported device performance" from bench testing, and information about the evidence used to support substantial equivalence.

Here's an analysis based on the structure of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, "acceptance criteria" here refer more to compliance with recognized standards and successful completion of bench tests, rather than explicit numerical thresholds for clinical performance.

Acceptance Criteria Category (Compliance/Test Type)	Reported Device Performance (Summary)
Biocompatibility	In compliance with ISO 10993-1 and ISO 7405.
Sterilization	Validated according to ISO 11137-1, -2, and -3 to ensure a Sterility Assurance Level (SAL) of 10-6.
Shelf-life	Validated according to ASTM F1980-07 for a 2-year shelf-life.
Electrical Safety	In compliance with IEC 60601-1 and IEC 60601-1-2.
Bench Testing (General)	Demonstrated compliance with product specifications, medical community expectations, and product labeling.
Bench Testing (Specific)	Bit reliability (deflection resistance, hole depth repeatability)
	Various tensile and compression tests of components
	Dial and bit depth reliability
	LED light reliability
Clinical Literature	Documented ability to create holes through gum tissue into alveolar bone in humans.

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific sample sizes for test sets in the context of clinical performance evaluation (e.g., number of patients or cases). The "supporting data" section refers to:

Bench testing: Conducted to demonstrate performance, but no sample sizes (e.g., number of devices tested for reliability) are provided.
Clinical literature article: Only one article is cited ("Alikhani M, Rapis M, Soldan B, et al. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 144:639-48; 2013."). The provenance of data within this article (country of origin, retrospective/prospective) is not specified in the 510(k) summary. This is presented as existing published literature, not a study specifically commissioned for this 510(k) submission with a freshly collected test set.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The document does not describe a process of establishing ground truth by experts for a specific test set. The clinical literature cited (Alikhani et al.) would have its own methodology and expert involvement, but this is not detailed in the 510(k) summary.

4. Adjudication Method

Not applicable. There is no mention of a ground truth adjudication method as there is no specific test set undergoing expert review described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. The document presents a comparison of the PROPEL device to a predicate device (Synthes 90° Screwdriver) for substantial equivalence based on technological characteristics and intended use, not a comparative effectiveness study involving human readers with and without AI assistance. This device is a manual drilling tool, not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only) Performance

No. This is a physical medical device (a manual drill), not an algorithm or AI system.

7. Type of Ground Truth Used

For the non-clinical tests (biocompatibility, sterilization, shelf-life, electrical safety, bench tests), "ground truth" is defined by compliance with established international and national standards (ISO, ASTM, IEC) and the device's own product specifications.

For the claim of being able to create holes in alveolar bone, the "ground truth" is supported by a citation to published clinical literature.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is relevant for AI models, not for traditional medical devices like a manual bone drill.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 18, 2015

Propel Orthodontics, LLC c/o Mr. Craig J. Coombs Coombs Medical Device Consulting, Inc. 1193 Sherman Street Alameda. California 94501

Re: K150392

Trade/Device Name: PROPEL Device Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZJ Dated: August 18, 2015 Received: August 19, 2015

Dear Mr. 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. 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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Page 2 - Mr. Craig J. Coombs

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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for Erin I. Keith, M.S. 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) K150392

Device Name PROPEL Device

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for Propel Orthodontics. The word "PROPEL" is written in a large, sans-serif font in blue. Below the word "PROPEL" is the word "ORTHODONTICS" in a smaller, sans-serif font, also in blue. Above the word "PROPEL" is a series of blue arcs that form a semi-circle.

A. Device Information:
Category	Comments
Sponsor:	Propel Orthodontics, LLC.384 South Abbott AvenueMilpitas, CA 95035Company Contact: Bryce WayChief Executive OfficerTel: 408-394-5851Email: BW@PropelOrtho.com
Correspondent ContactInformation:	Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140Fax: 510-337-0416
Device Common Name:	Manual Bone Drill
Device Classification Number& Name:	21 CFR 872.4120Bone Cutting Instrument and Accessories
Device Classification &Product Code:	Class II,DZJ
Device Proprietary Name:	PROPEL Device

Section 5: 510(k) Summary

Predicate Device Information:

Predicate Device:	90° Screwdriver
Predicate Device Manufacturer:	Synthes
Predicate Device Common Name:	Manual Screwdriver & Bone Drill
Predicate Device Premarket Notification #	K082649
Predicate Device Classification & Name:	21 CFR 872.4120Bone Cutting Instrument and Accessories
Predicate Device Classification &Product Code:	Class II,DZJ

B. Date Summary Prepared

14 September 2015

C. Description of Device

The PROPEL Device has a stainless steel drill tip that can be manually adjusted to the length needed for treatment or cutting depth. The plastic handle incorporates a retractable plastic tube

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Image /page/4/Picture/0 description: The image shows the logo for Propel Orthodontics. The word "PROPEL" is written in a large, sans-serif font in blue. Below it, the word "ORTHODONTICS" is written in a smaller, sans-serif font, also in blue. Above the word "PROPEL" is a semi-circular design made of several curved lines that get progressively shorter from left to right.

over the cutting drill instrument. This enables the drill tip to be locked into a specific depth at 3. 5. or 7mm, thus preventing the drill tip from penetrating the bone bevond the targeted depth when used during orthodontic and dental operative procedures. The handle contains a red LED. operated by batteries. The LED is illuminated when the tip of the drill tip reaches the set depth. There is no motor in the device. The batteries are only for signaling when the prescribed depth has been achieved.

The device is provided sterile and is for single use only.

D. Indications for Use

E. Comparison to Predicate Device

The PROPEL device is substantially equivalent in intended use, technology, design, materials, and physician use as that found in the predicate Synthes 90° Screwdriver (K082649).

Product Code Equivalence

Both the subject PROPEL device and the predicate Synthes 90° Screwdriver have identical product codes: DZJ.

Indications for Use Equivalence

The subject device is indicated "for manually drilling holes in tissue and bone for orthodontic and dental operative procedures including initiation holes for drill bits, implants, screws, plates and other orthodontic appliances."

The predicate device is indicated "for the manual and powered pre-drilling and insertion of bone fixation screws in oral/maxillofacial surgery."

Both devices are bone-cutting devices for initiation holes for screws and other devices. The PROPEL device is a manual drill, whereas the predicate device is a powered drill. The subject device does not have a screwdriver function like the predicate. As a result, the subject device is indicated for a subset of performance features of the predicate device.

Because subject device features are a subset of the predicates, they do not raise new questions of safety or efficacy; they allow the conclusion of substantial equivalence between the Indications for Use.

Technological Equivalence

Both devices use rotating steel drill bits to cut holes in the bone of the upper or lower jaw. They differ in that the predicate device is a pneumatically powered drill, and the subject device is a manually powered drill.

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Image /page/5/Picture/0 description: The image shows the logo for Propel Orthodontics. The word "PROPEL" is written in a sans-serif font in blue. Below the word "PROPEL" is the word "ORTHODONTICS" in a smaller, gray sans-serif font. Above the word "PROPEL" is a series of blue lines that form an arc.

Comparison of Technological Aspects of the Predicate and Application Devices

Characteristic	Predicate Device:Synthes 90° ScrewdriverK082649	Subject Device:Propel Orthodontics, LLCPROPEL Device	How do differences, if any,pertain to justification ofsubstantial equivalence?
OperatingPrinciple	Hand-held powered drill orhand-held manualscrewdriver	Hand-held manual drill	Difference in power modeand lack of screwdriverfunction in application devicedoes not raise new questionsof safety or efficacy.
Drill Angle	Drills holes or inserts screwsat a 90° angle from the handle	Drills holes an a 0° angle(i.e. inline) with the handle	Difference in angle does notdoes not raise new questionsof safety or efficacy for whatthe application device isindicated for
Powered orManual	Screwdriver intended tooperate manually:Drill intended to operateconnected to a mechanicalpower source compatiblewith a Intra couplingaccording to ISO 3964/EN 23964	Manually operated drill	Difference in power mode andlack of screwdriver functionin application device does notraise new questions of safetyor efficacy.
Direct drive orgeared?	2:1 gearing ratio whenturning proximal end	No gearing, device is turnedby rotating proximal end	No clinical difference
Method forcreating holes	Stainless Steel Drill Bit	Stainless Steel Drill Bit	Clinically Identical
Interchangeabledrill bits	Yes	No. Drill bit built-in	Identical result as far ascreating holes
Characteristic	Predicate:Synthes 90° Screwdriver(K082649)	Subject Device:Propel Orthodontics, LLCPROPEL Device	How do differences, if any,pertain to justification ofsubstantial equivalence?
Drill Bit OD	1.0 - 2.4mm	1.6mm	Size available in applicationdevice is a subset of thoseavailable in the predicatedevice
Drill Bit WorkingLength	4 – 18mm	3, 5, or 7 mm	The smaller length availablein the application device areto serve the techniquesdescribed in the Indication forUse. Does not raise newquestions of safety or efficacy
Depth Stops	Yes, buy selecting theappropriate length bit	Yes, by adjusting the depthstop on the drill.	Clinically Identical
Types ofScrewdriver bits	Screwholder bits for screwOD's of 1.5, 2.0 and 2.4mm	None. Device cannot beconverted into a screwdriver	Raises no questions of safetyor efficacy
Indicator ofAchievement ofProper Depth	Head of drill in contact withtissue	LED light comes on toprevent unwarranted pressureon tissue	Clinically Identical
Materials: DrillBits	Stainless Steel	Stainless Steel	Clinically Identical
Materials: devicebody	Metallic	ABS and polycarbonate	Clinically Identical
Single Use?	Reusable	Single Use Only	Clinically Identical
Sterilization	Provided non-sterile, can beresterilized	Provided sterile	Clinically Identical aftersterilization of predicate

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Image /page/6/Picture/0 description: The image shows the logo for Propel Orthodontics. The word "PROPEL" is in a large, sans-serif font and is colored in a light blue. Above the word, there is a series of curved lines that are also light blue, creating an arc shape. Below the word "PROPEL", the word "ORTHODONTICS" is in a smaller, sans-serif font and is colored in gray.

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Image /page/7/Picture/0 description: The image shows the logo for Propel Orthodontics. The word "PROPEL" is in a large, blue, sans-serif font. Below it, the word "ORTHODONTICS" is in a smaller, gray, sans-serif font. Above the word "PROPEL" is a curved, dashed line that resembles an arch.

The subject and predicate devices use steel drill bits to cut holes in the bone of upper or lower jaw. The diameter of the holes created by the PROPEL device are a subset of those available from the predicate device. Both devices allow the user to control the depth of the hole. The predicate uses different length bits to achieve the intended depth. The subject device has a retractable sleeve around its drill bit that allows the physician to preselect the hole depth up to7mm. The predicate device drills holes at a 90° angle to the axis of the handle, whereas the subject device drills holes in-line with the axis of the handle.

Propel Orthodontics, LLC, concludes that the subject PROPEL device and the predicate Synthes 90° Screwdriver are substantially equivalent.

F. Summary of Supporting Data

Biocompatibility data demonstrates that the PROPEL device is in compliance with ISO 10993-1: Biological evaluation of medical devices as described in ISO 7405: Dentistry — Evaluation of biocompatibility of medical devices used in dentistry.

Sterilization validation according to ISO 11137-1, -2, and -3 to ensure a SAL of 10th and shelf-life validation according to ASTM F1980-07 were conducted to validate the 2 year shelf-life of the PROPEL device.

Electrical safety testing demonstrates that the PROPEL device is in compliance with IEC 60601-1: Medical electrical equipment - Part 1: General reauirements for basic safety and essential performance and IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.

Bench testing has demonstrated that the PROPEL is in compliance with its product specifications, the expectations of the medical community and the product labeling. The following bench tests were conducted to demonstrate the Propel device's performance.

Bit reliability, including deflection resistance and hole depth repeatability Various tensile and compression tests of components Dial and bit depth reliability LED light reliability

A clinical literature article has documented that the PROPEL device can create holes through the gum tissue into alveolar bone in humans.

G. 510(k) Summary Conclusion

In accordance with 21CFR807.92(b)(3), it can be concluded from the nonclinical testing and the clinical literature that the PROPEL device is as safe and as effective as the predicate device in the context of its Indications for Use and technological characteristics.

It can be concluded that the PROPEL device is substantially equivalent to the predicate Synthes 90° Screwdriver.

1 Alikhani M, Rapis M, Soldan B, et al. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 144:639-48; 2013.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.