Ultrasonic Osteotomy Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:

Otolaryngology
Oral/maxillofacial
Hand and foot
Neurosurgery
Spine
Plastic/reconstructive.

Device Description

Ultrasonic Osteotomy Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the cutting tip insert. The tips are used to fragment and reshape bone tissue through longitudinal vibration at high frequency and small amplitude.

Ultrasonic Osteotomy Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of cutting tips, wrench and torque wrench, a foot switch and irrigation set (liquid-flow tube and liquid-flow sleeve).

The console has a color LCD touch screen user interface for the selection/visualization of device functional parameters. The console activates and controls the ultrasound vibration, controls irrigation flow and displays system condition.

The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are simultaneously activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.

AI/ML Overview

The provided text describes an Ultrasonic Osteotomy Surgical System and its 510(k) summary for FDA clearance. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" as typically understood for AI/ML performance (e.g., accuracy, sensitivity, specificity, or human reader improvement) does not apply directly in this context.

Instead, for this type of device (an ultrasonic surgical system), "acceptance criteria" relates to demonstrating that the new device is as safe and effective as its predicate device. This is primarily done through non-clinical performance data (bench testing) and demonstrating substantial equivalence in design, materials, and intended use. Clinical studies for performance improvements relative to human readers or AI algorithms are not relevant to this device type or regulatory pathway.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the AI/ML sense, nor information on sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not relevant to the information provided in the document for this specific medical device.

However, I can extract what the document presents as evidence for "meeting acceptance criteria" in the context of a medical device 510(k) submission, focusing on Non-Clinical Performance Data and Substantial Equivalence.

1. "Acceptance Criteria" (in the context of a 510(k) for this device) and Reported Device "Performance":

For this device, "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and showing that differences do not raise new questions of safety and effectiveness, supported by non-clinical testing. The "reported device performance" is the successful outcome of these non-clinical tests, showing the device operates within expected parameters and safely.

Acceptance Criteria Category (Implied for 510(k))	Method of Proof / Reported "Performance"
Substantial Equivalence to Predicate Device (K172464)	Demonstrated through detailed comparison (Table 1) showing: - Same manufacturer, composition, indications for use, user interface, ultrasonic vibration activation, tip material, frequency, maximum flow, ultrasound output mode, electrical safety classification, power supply, power cord length, and operating/shipping/storage conditions. - Minor differences (irrigation system pump placement, wrench type, sterilization method) are discussed and deemed to not impact safety or effectiveness.
Sterilization Efficacy and Shelf Life	Single Use Disposable Components: EO sterilization validation tests for sterile package, sterile barrier testing, device performance testing on sterilized components, simulated shipment testing, accelerated and natural aged testing to support claimed shelf life. Reusable Components: Cleaning and sterilization testing performed for each reusable component (moist heat).
Functional / Bench Performance	Successful completion of: - Ultrasound Performance Testing - Irrigation Performance Testing - Cutting Efficiency and Thermal Testing - Mechanical Testing for Torque Wrench
Safety and Effectiveness	"Safety and performance testing have demonstrated the Ultrasonic Osteotomy Surgical System is as safe and effective as the predicate device."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in terms of patient data. The testing is primarily bench testing and validation studies for sterilization, shelf-life, and functional performance. It would involve specific numbers of device units or components tested to statistical significance, but these specifics are not detailed in this summary.
Data Provenance: Not applicable in the context of clinical data. For non-clinical validation, the testing was performed by SMTP Technology Co., Ltd. in China. The data would be prospective in the sense that the tests were specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is not an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device revolves around objective engineering and performance specifications (e.g., frequency output, flow rate, sterilization efficacy, cutting efficiency) which are measured against established physical standards and predicate device performance characteristics, not expert consensus on medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human reader interpretation or clinical adjudication.

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:

No, a MRMC comparative effectiveness study was not done. This device is an ultrasonic surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this device is not an algorithm. It is a physical surgical system. "Standalone performance" in this context refers to the device's functional performance metrics (e.g., frequency output, flow rate, cutting ability) which are detailed as "Non-Clinical Performance Data."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance validation is based on engineering specifications, international standards (e.g., for sterilization), and direct comparison to the physical and functional characteristics of the predicate device. It relies on objective quantitative measurements (e.g., 39 kHz±4kHz frequency, 120ml/min±20% flow rate) and validated processes (e.g., EO sterilization efficacy). It does not involve medical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.

Summary

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SMTP Technology Co., Ltd Songtao Zhan Contact Address1F&4F, Building A, Emerging Industry Incubation Center Zhangjiagang, Jiangsu 215634 China

Re: K201274

Trade/Device Name: Ultrasonic Osteotomy Surgical System Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachments Regulatory Class: Class II Product Code: JDX Dated: January 9, 2021 Received: January 21, 2021

Dear Songtao Zhan:

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 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.

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

February 19, 2021

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device reporting (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website assistance/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,

For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201274

Device Name

Ultrasonic Osteotomy Surgical System

Indications for Use (Describe)

Otolaryngology
Oral/maxillofacial
Hand and foot
Neurosurgery
Spine
Plastic/reconstructive.

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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Ultrasonic Osteotomy Surgical System 510 (k) Summary

1. Date Prepared

February 19th, 2021

2. Submitter's Information

Company Name:	SMTP Technology Co., Ltd.
Company Address:	1F&4F, Building A, Emerging IndustryIncubation Center, Zhangjiagang Free TradeZone, 215634, Jiangsu Province, CHINA
Fax:	+86 10 88572898 ext. 8005
Contact Person:	Songtao ZhanCTOTel: +86 10 88572898zhansongtao@smtpmed.com

3. Trade Name, Common Name, Classification

Trade Name:	Ultrasonic Osteotomy Surgical System
Classification Name:	Sonic Surgical instrument andaccessories/attachments
Product Code:	JDX
Regulation Number:	21 CFR 888.4580
Device Class:	Class II

4. Identification of Predicate Devices(s)

The identification of predicate device within this submission is as follow:

Manufacturer:	SMTP Technology Co., Ltd.
Trade Name:	XD880A Ultrasonic Osteotomy SurgicalSystem
Product Code:	JDX

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Classification Name:

Regulation Number: FDA 510 (k) #:

Sonic Surgical instrument and accessories/attachments 21 CFR 888.4580 K172464

5. Description of the Device

6. Indications for Use

-Otolaryngology
-Oral/maxillofacial
-Hand and foot
-Neurosurgery
-Spine
Plastic/reconstructive -

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7. Substantial Equivalence

Most the features and characteristics of proposed Ultrasonic Osteotomy Surgical System (subject device) are identical to those of the predicate device (K172464), and where there are differences, such differences do not have impact on the safety or effectiveness of the subject device.

The following table compares the subject device Ultrasonic Osteotomy Surgical System to the predicate device.

State	Subject Device	Predicate Device	Comparison
General Description
Manufacturer	SMTP Technology Co., Ltd.	SMTP Technology Co., Ltd.	Same
Composition	The device consists of a console,foot switch and accessories. Theaccessories include handpiece,liquid-flow tube,liquid-flowsleeve, wrenchandanassortment of cutting tips.	The device consists of a console,foot switch and accessories. Theaccessories include handpiece,liquid-flow tube,liquid-flowsleeve, wrenchandanassortment of cutting tips.	Same
Indications forUse	Ultrasonic Osteotomy SurgicalSystem is an ultrasonic surgicalsystem consisting of a handpieceand associated tips for cuttingbone, osteotomy, osteoplastyand drilling in a variety ofsurgical procedures, includingbut not limited to:	Ultrasonic Osteotomy SurgicalSystem is an ultrasonic surgicalsystem consisting of a handpieceand associated tips for cuttingbone, osteotomy, osteoplastyand drilling in a variety ofsurgical procedures, includingbut not limited to:
	- Otolaryngology- Oral/maxillofacial- Hand and foot- Neurosurgery- Spine- Plastic/reconstructive	- Otolaryngology- Oral/maxillofacial- Hand and foot- Neurosurgery- Spine- Plastic/reconstructive	Same
User Interface	The functional parameters aredisplayedandcontrolledthrough a console with touch	The functional parameters aredisplayedandcontrolledthrough a console with touch	Same
	screen.	screen.
Ultrasonicvibrationactivation	Foot switch connected to thedevice control unit by means ofa cord.	Foot switch connected to thedevice control unit by means ofa cord.	Same
			Similar
IrrigationSystem	Peristaltic pumpThe placement of pump isvertical	Peristaltic pumpThe placement pump ishorizontal	The subject device hasthe same type peristalticpump with the predicatedevice. The difference isplacement direction ofthe pump. The directionchange does not impactthe flow rate parameter.
Wrench type	Torque wrench; Normal wrench	Normal wrench	SimilarThe new torque wrenchhas the same materialand function with thenormal wrench. Thetorque wrench does notcontact patients.
Tip material	Titanium alloy	Titanium alloy	Same
SterilizationMethod	EO for disposable componentsMoist heat for reusablecomponents	Moist heat	SimilarThe subject deviceprovides sterilizedpackaging by EOsterilization fordisposable components.The sterilizationmethods andparameters of allcomponents have beenverified and confirmed.
Performance Description
Frequency	39 kHz±4kHz	39 kHz±4kHz	Same
Maximumflow	120ml/min±20%	120ml/min±20%	Same
Ultrasoundoutput mode	Continuous or pulsed mode	Continuous or pulsed mode	Same
Electrical Description
ElectricalSafetyClassification	Class I, Type BF Applied Part	Class I, Type BF Applied Part	Same
Power supply	100-240 VAC, 50/60 Hz.	100-240 VAC, 50/60 Hz.	Same
Power cordlength	About 3m	About 3m	Same
Conditions Description
Operatingenvironmentconditions	Environment Temperature:10 °C~30°CRelative Humidity: 30%~~75%,no condensationAtmospheric pressure:700hPa~~1060hPa	Environment Temperature:10 °C~30°CRelative Humidity: 30%~~75%,no condensationAtmospheric pressure:700hPa~~1060hPa	Same
Shipping andstorageconditions	Environment Temperature:30°C~~50°CRelative Humidity: ≤ 90%, nocondensationAtmospheric pressure:700hPa~~1060hPa	Environment Temperature:30°C~~50°CRelative Humidity: ≤ 90%, nocondensationAtmospheric pressure:700hPa~~1060hPa	Same

Table 1 – Comparison of Characteristics

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Discussion of Substantial Equivalence:

Comparison of General information, Product performance, Electrical characteristics, and Conditions between the predicate device and the subject device Ultrasonic Osteotomy Surgical System, minor differences with the Predicate device was identified. The differences were supported with safety and performance testing, as appropriate, and are not likely to affect device safety and performance. The subject device has same indications for use. The technological characteristics differences listed in the above table between the subject device and the predicate device do not raise any new questions of safety and effectiveness.

Non-Clinical Performance Data:

SMTP completed the following non-clinical tests to demonstrate safety and effectiveness of Ultrasonic Osteotomy Surgical System and to show substantial equivalence to the predicate device, the test results confirm that the design inputs and performance specifications for the Ultrasonic Osteotomy Surgical System are met.

Sterilization and Shelf Life

Single Use Disposable Components – Sterile packaging provided

Cutting tip, liquid-flow tube and liquid-flow sleeves are provided sterile and are for single use. The submission includes EO sterilization validation tests for sterile package.

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The submission also includes sterile barrier testing, device performance testing on sterilized, simulated shipment testing, accelerated and natural aged testing to support the claimed shelf life.

Reusable Components – End user cleaned and sterilized

The reusable handpiece and wrenches are cleaned and sterilized by end user before each use. The cleaning and sterilization testing for each reusable component are performed.

Bench Testing

. Ultrasound Performance Testing
Irrigation Performance Testing
Cutting Efficiency and Thermal Testing
Mechanical Testing for Torque Wrench

Clinical Performance Data:

Clinical evaluation is not applicable for the proposed device.

8. Conclusion

The Ultrasonic Osteotomy Surgical System has the same intended use as the predicate device, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Safety and performance testing have demonstrated the Ultrasonic Osteotomy Surgical System is as safe and effective as the predicate device. Based on the information contained within this submission, it is concluded that the Ultrasonic Osteotomy Surgical System is substantially equivalent to the predicate device which is already in commercial distribution in the United States.

Regulation Number and Section

§ 888.4580 Sonic surgical instrument and accessories/attachments.

(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.