This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DMETEC Ultrasonic Surgery Machine:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device (EMS Piezon Master Surgery) rather than defining explicit, quantitative acceptance criteria for de novo performance. The acceptance criteria are implicitly met by showing that the DMETEC device is "similar in functions and efficiency" and has "similar specification and performance" to the predicate.

Here's a table comparing the DMETEC device's reported performance against the predicate, which serves as the de facto "acceptance criteria" through substantial equivalence:

Characteristic	Predicate Device (EMS Piezon Master Surgery) Acceptance Criteria (Implicit)	DMETEC Device (Surgy Star, AIC Surgery) Reported Performance
Indications for Use	Surgical dentistry procedures including osteotomy, osteoplasty, periodontal surgery, and implantation.	Surgical procedure including osteotomy, osteoplasty, periodontal surgery, and implantation.
Supply Voltage	100-240 V AC	24V DC
Power Consumption (max)	105 VA	50W max
Maximum Output Power (load)	25W	50W
Frequency Range Available	24-32 kHz	24-32 kHz
Transformer Input	100/220 VAC/50-60Hz	100-240 VAC, 50-60Hz
Transformer Output	24V AC/ 1.25A	24V DC/ 3.75A
Main Components	1 Unit Body, 1 Hand-piece, 5 Tips	1 Unit Body, 1 Hand-piece, 10 Tips
Tip Material	Stainless steel	Stainless steel

Note: The differences, particularly in supply voltage and output power, are acknowledged, but the submission argues for substantial equivalence based on the overall functional similarity and safety.

Study Information

The document does not describe a classic clinical study with an explicit test set and detailed performance metrics as one might expect for novel technology. Instead, it relies on demonstrating substantial equivalence through non-clinical testing and comparison to post-market experience of the predicate device.

Sample size used for the test set and the data provenance:
- No specific sample size for a clinical "test set" is mentioned in the context of device performance evaluation.
- Data provenance: The document mentions "post market experience" of the predicate device. This suggests retrospective data from the market performance of the EMS Piezon Master Surgery. No specific country of origin is mentioned for this "post market experience."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a defined "test set" requiring expert ground truth establishment for clinical performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set requiring adjudication is described.
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:
- Not applicable. This device is a surgical instrument, not an imaging or diagnostic AI device. Therefore, MRMC studies and "human readers" improving with/without AI are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for substantial equivalence appears to be derived from documented performance and safety records of the predicate device (EMS Piezon Master Surgery), as well as compliance with recognized standards (IEC 60601-1, ISO 10993). For biocompatibility, lab tests (in vitro cytotoxicity, skin sensitization, oral mucosa irritation) served as the basis for assessing safety.
The sample size for the training set:
- Not applicable. As this isn't an AI/machine learning device, there is no "training set."
How the ground truth for the training set was established:
- Not applicable, for the same reason as above.

Summary of Non-Clinical Tests Conducted:

Biocompatibility Tests:
- In vitro cytotoxicity test (ISO 10993-5 criteria: evaluated as Grade 0, no cell lysis or toxicity).
- Skin sensitization test (scores were zero, 0% sensitization rates at 24 hours).
- Oral mucosa irritation test (no mortality, no body weight changes, no differences between saline and test group).
Electric Safety and Electromagnetic Compatibility:
- Tested according to EN 60601-1 and IEC 60601-1-2. Device met the requirements.
Software Validation:
- A software validation report indicated the device "performs as it should" and is substantially equivalent.

Overall Conclusion of Studies:

The manufacturer concludes that the DMETEC Ultrasonic Surgery Machine (Surgy Star, AIC Surgery) is substantially equivalent to the predicate device based on:

Similar intended use.
Similar specifications and performance, despite some numerical differences (e.g., output power).
Successful completion of non-clinical tests (biocompatibility, electrical safety, electromagnetic compatibility, software validation) demonstrating safety.
Comparison to the post-market experience of the predicate device to infer similar functions and efficiency.

Summary

{0}------------------------------------------------

KI13152 JUN 1 4 2012

510(k) Summary

Owner Information

Name: DMETEC CO., LTD.
Address: 402-603 Techno-Park, 193 Yakdae-Dong, Wonmi-Ku, Bucheon City, KOREA

1. Phone Number: 82-32-234-0011
1. FAX Number: 82-32-234-1444

Name of Contact Person: Hong-Geun, Lee

1. Date the Summary was Prepared: 05/11/2012

Device Information

1. Common Name: Bone cutting instrument and accessories
1. Trade Name: Ultrasonic Surgery Machine
1. Model Number(s): Surgy Star, AIC SURGERY
1. Classification Name: Drill, Bone, Powered
1. Requlation Number: 872.4120

Predicate Device Information

1. 510(k) Number: K072146
1. Trade Name: EMS Piezon Master Surgery
1. Product Code: DZI

Description of the Device

This product is a device using by purpose of bone cutting, polishing when operate implant for dentist's office using ultrasonic vibration because it is supplied electric and water in outside

{1}------------------------------------------------

KII 3159

Specifications of unit:

Model:

Supply voltage:

Supply frequency:

Power input:

Device life

Output characteristics(Ultrasonic output):

Type of protection against electric shock: Degree of protection aqainst electric shock: Specification of transformer Output characteristics of transformer: Specification of Tip Tip material :

Tin coating method : Coating thickness : Coating Temperature : Surgy Star DC 24V 50 / 60 Hz 24 VA 5years Maximum output power with load:50W Frequency range available: 24-32kHz. Class 1, with transformer Applied part type B AC100-250V, 50-60Hz DC 24V SUS420J2

PVD 8.084pm 500°C

Intended Use

A device intended for use surgical procedure Including osteotomy, osteoplasty, Periodontal surgery and implantation

Product Name : Ultrasonic Surgery Machine
Model : Surgy Star, AIC Surgery

{2}------------------------------------------------

	DMETEC(Surgy Star, AIC Surgery)	EMS(Piezon Master Surgery)
510(k) reference	-	K072146
Indication for use	A device intended for use surgical procedure Including osteotomy, osteoplasty, periodontal surgery and implantation	The EMS Piezon Master Surgery is an ultrasonic bone-cutting instrument for use in surgical dentistry
UNIT
Supply voltage	24V DC	100-240 V AC
Power consumption(max)	50W max	105VA
OUTPUT CHARACTERISTICS
Maximum output power with load	50W	25W
Frequency range available	24-32 kHz	24-32 kHz
TRANSFORMER
Input	100-240 VAC, 50-60Hz	100/220 VAC/50-60Hz
Output	24V DC/ 3.75A	24V AC/ 1.25A
MAIN COMPONENT
	1 Unit Body1 Hand-piece10 Tips	1 Unit Body1 Hand-piece5 Tips
MATERIAL
Tip(contact with patient)	Stainless steel	Stainless steel

Summary of Technical Characteristics Compared to the Predicate Device

{3}------------------------------------------------

Brief Discussion of Nonclinical Tests (if applicable)

For biocompatibility, in vitro cytotoxicity test, skin sensitization test and oral mucosa irritation test were conducted. During the in vitro cytotoxicity test, no evidence of causing cell lysis or toxicity was found and it was evaluated as Grade 0 on the criteria of ISO 10993-5. As for skin sensitization scores were zero and the sensitization rates were observed 0% at 24 hours. As for oral mucosa irritation test, no mortality was observed, no changes in body weight were observed, and there were no differences in saline and test group.

For electric safety and electromaqnetic compatibility, the device was tested according to EN 60601-1 and IEC 60601-1-2 and the device was found to meet the requirements of the standards.

Software validation report shows that the device is substantially equivalent and performs as it should.

Brief Discussion of Clinical Tests (if applicable)

Comparison with the predicate indicates they are similar in functions and efficiency, and the post market experience proves that it is substantially equivalent.

Conclusion from Nonclinical and Clinical Tests (if applicable)

Biocompatibility tests, electric safety test and electromagnetic compatibility test show that the device meets the requirements of those standards.

Literatures and post market experience show that the device is substantially equivalent.

Comparison with the predicate device shows that the device has similar specification and performance.

Thus, we conclude that Surgy Star and AIC Surgery are substantially equivalent to the predicate device.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion.

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

JUN 1 4 2012

DMETEC CO. LTD, C/O Mr. Daniel Nam Pats Corporation 4568 West 1st Street, Suite 104 Los Angeles, California 90004

Re: K113152

Trade/Device Name: Ultrasonic Surgery Machine (Surgy Star, AIC SURGERY) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: II Product Code: DZI Dated: May 22, 2012 Received: May 29, 2012

Dear Mr. Nam:

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.

{5}------------------------------------------------

Page 2 – Mr. Nam

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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): KIBIS2

Device Name: Ultrasonic Surgery Machine (Surgy Star, AIC SURGERY)

Indications For Use: A device intended for use surgical procedure Including osteotomy, osteoplasty,

Periodontal surgery and implantation

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Kunnes
(Division Sign-Off)

(1999-1991) Sign=Oil)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 1 of

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.