The HI TECH IMPLANT and HT PHYSIO IMPLANT consist of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes. The unit also houses the peristaltic pump. The HI TECH IMPLANT and HT PHYSIO IMPLANT provide electronic control of velocity and torque. The HI TECH IMPLANT and HT PHYSIO IMPLANT can be programmed and retain programs into memory. The HI TECH IMPLANT and HT PHYSIO IMPLANT are fully operational from foot pedal.

AI/ML Overview

The provided text describes a 510(k) submission for the BY DENTAL Hi-Tech Implant/HT Physio Implant. This is a medical device for preparing intraoral bone for implantology procedures, a surgical micromotor system. The submission focuses on demonstrating substantial equivalence to a predicate device and compliance with various safety and electrical performance standards.

Here's an analysis of the provided text, addressing your specific questions, though it's important to note that the description of a medical device submission, particularly for a traditional 510(k), primarily focuses on engineering and performance characteristics against established standards, rather than clinical efficacy studies involving human readers or sophisticated AI performance metrics that are common in more recent AI/ML device submissions.

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are adherence to specific international and European standards for medical electrical equipment and dental handpieces. The reported device performance is that the device complies with all these standards.

Acceptance Criteria (Standards)	Reported Device Performance
IEC 55011 EMC Conducted RF emissions	Complies
IEC 60529 Degrees of protection provided by enclosures (IP Code)	Complies
IEC 60601-1 Medical Electrical Equipment Part 2, "General Safety Norms"	Complies
IEC 60601-1-2 Medical Electrical Equipment Part 1 EMC	Complies
IEC 61000-4-2 EMC Electrostatic Discharge Immunity	Complies
IEC 61000-4-3 Radiated RF immunity	Complies
IEC 61000-4-4 Fast Transient Immunity	Complies
IEC 61000-4-5 Pulse immunity	Complies
IEC 61000-4-6 Conducted RF immunity	Complies
IEC 61000-4-11 Supply Voltage Hole Immunity	Complies
IEC 61558-1 Transformer safety	Complies
IEC 61558-2-6 Transformer safety-Particular prescriptions	Complies
ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors	Complies

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not specify a "test set" in the context of clinical data or image-based AI testing. The "tests" performed were engineering and electrical safety evaluations of the physical device. Therefore, typical notions of sample size and data provenance for clinical studies do not apply here. The evaluation was performed by a "Notified Laboratory" (presumably in Italy, given the manufacturer's location).

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 type of information is not relevant to this 510(k) submission. The "ground truth" for compliance with electrical and safety standards is defined by the standards themselves, and testing is performed by qualified technicians/engineers at a certified laboratory, not medical experts.

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

Adjudication methods for clinical interpretation or data labeling are not applicable to the technical performance tests described in this 510(k). The compliance is determined by the test results against the specified standard requirements.

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 such study was conducted or mentioned. This 510(k) is for a surgical micromotor system, which is a physical tool, not an AI-powered diagnostic or assistive technology for human readers.

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

No "standalone" algorithm performance testing was done, as this device is not an algorithm. It is a physical medical electrical device.

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

The "ground truth" for this device's performance is established by the specifications and criteria outlined in the various international and European technical standards (e.g., IEC 60601-1, ISO 11498:1997). Compliance is objectively measured during laboratory testing against these predefined technical benchmarks, not against clinical outcomes or expert consensus.

8. The sample size for the training set

There is no concept of a "training set" for this type of medical device submission. The device is a hardware system, not a machine learning model.

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

As there is no training set, this question is not applicable.

Summary

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091913

BY DENTAL: Hi-Tech Implant/HT Physio Implant 510(k): Original Submission Traditional

SECTION 14: SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMD 1990 and CFR 807.92. OCI 3 0 2009

SUBMITTER INFORMATION 14.1

BY DENTAL SRL a. Company Name Via Vecchia Prov.le Lucchese Company Address b. 47/F 51030 Serravalle Pistoiese Italy +39 0573 994 355 Company phone C. +39 0573 919 480 Company fax Contact Person Daniele Poli d. President Date Summary Prepared June 22, 2009 e.

DEVICE IDENTIFICATION 14.2

a.	Trade/Proprietary Names: HI TECH IMPLANT /HTPHYSIO IMPLANT
----	----------------------------------------------------------------

Dental Handpieces and b. Classification Name: Accessories 21 CFR 872.4200 Surgical Micromotor for Common Names: C.

IDENTIFICATION OF PREDICATE DEVICE 14.3

Company	Device	510(k) No.	Date Cleared
ATR	Implant System	K033597	25 Nov. 2003

implantology

DEVICE DESCRIPTION 14.4

The HI TECH IMPLANT and HT PHYSIO IMPLANT consist of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes.

The unit also houses the peristaltic pump.

The HI TECH IMPLANT and HT PHYSIO IMPLANT provide electronic control of velocity and torque.

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BY DENTAL: Hi-Tech Implant/HT Physio Implant 510(k): Original Submission Traditional

The HI TECH IMPLANT and HT PHYSIO IMPLANT can be programmed and retain programs into memory.

The HI TECH IMPLANT and HT PHYSIO IMPLANT are fully operational from foot pedal.

SUBSTANTIAL EQUIVALENCE 14.5

The HI TECH IMPLANT and HT PHYSIO IMPLANT are substantially equivalent to the ATR Implant System Surgical Micromotor in commercial distribution by ATR. The fundamental technical characteristics of the HI TECH IMPLANT and HT PHYSIO IMPLANT are similar to those of the predicate device and are listed on the comparison chart provided in this 510(k) submission.

HI TECH IMPLANT and HT PHYSIO IMPLANT and the predicate device have adjustable speed, torque and reduction rates, and are programmable. The micromotor handpiece of HI TECH IMPLANT and HT PHYSIO IMPLANT and the one of the predicate device are autoclavable.

INTENDED USE 14.6

HI TECH IMPLANT and HT PHYSIO IMPLANT are intended for the preparation of intraoral bone for implantology procedures.

14.7 TECHNICAL CHARACTERISTICS

HI TECH IMPLANT and HT PHYSIO IMPLANT were designed and developed to provide a microprocessor controlled surgical system with similar performances compared to predicate device.

HI TECH IMPLANT and HT PHYSIO IMPLANT .
is equivalent in functions to the predicate device, .
has adjustable speeds and torque values (related to the reduction rate of the handpiece ♥ selected) that are fully customisable by the end user,
has automatic motor shutdown system which provides to switch off the motor . whenever set torque is reached,
· has a sterilizable micromotor according the recommended protocols,
can be operated by foot control. .

Any of these feature is found in the predicate device also.

14.8 PERFORMANCE DATA

HI TECH IMPLANT and HT PHYSIO IMPLANT were tested in accordance with the technical requirements of IEC 60601-1 and IEC 60601-1-2.

All evaluation of the HI TECH IMPLANT and HT PHYSIO IMPLANT were performed by Notified Laboratory, and all the results comply to standard listed below.

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BY DENTAL: Hi-Tech Implant/HT Physio Implant 510(k): Original Submission Traditional

The conclusions drawn from the performance test are that HI TECH IMPLANT and HT PHYSIO IMPLANT comply with:

IEC 55011 EMC Conducted RF emissions .
Degrees of protection provided by enclosures (IP Code) IEC 60529 �
Medical Electrical Equipment Part 2,"Genaral Safety Norms" IEC 60601-1 .
IEC 60601-1-2 Medical Electrical Equipment Part 1 EMC .
IEC 61000-4-2 EMC Electrostatic Discharge Immunity .
IEC 61000-4-3 Radiated RF immunity ●
IEC 61000-4-4 Fast Transient Immunity .
IEC 61000-4-5 Pulse immunity .
IEC 61000-4-6 Conducted RF immunity .
IEC 61000-4-11 Supply Voltage Hole Immunity ●
Transformer safety IEC 61558-1 .
IEC 61558-2-6 Transformer safety-Particular prescriptions .
ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors .

and are effective and safe to use.

Declaration of conformity to a standard in Chapter 12.1 of this submission.

510(k) CHECKLIST 14.9

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is composed of three curved lines that suggest the shape of a bird in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Dr. Daniele Poli President By Dental S.R.L. Via Vecchia Prov. le Lucchese 49/FG Serravalle Pistoiese, Pistoia ITALY 51030

OCT 3 0 2009

Re: K091913

Trade/Device Name: Hi-Tech Implant/HT Physio Implant Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories 8Regulatory Class: I Product Code: EKX Dated: September 21, 2009 Received: September 29, 2009

Dear Dr. Poli:

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.

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 - Dr. Poli

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

h for

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

Enclosure

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K091913

BY DENTAL: Hi-Tech Implant/HT Physio Implant 510(k): Original Submission Traditional

INDICATIONS FOR USE

510(k) Number:

To be Assigned by FDA

Device Name:

Hi-Tech Implant/HT Physio Implant

Indications for Use:

Hi-Tech Implant/HT Physio Implant are intended to prepare Intraoral bone for implantology procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

$\times$

· (Per 21 CFR 801.109)

OR Over-The -Counter Use

Kevin Mulvey for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

1 510(k) Number:

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.