Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Device Description

Z5m(t) is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). It has a tapered implant body, a double thread design in the coronal third of the implant and a self-tapping apex. The Z5m(t) endosseous surface is laser modified, identical to the Z5m surface cleared under K120793. Z5m(t) and Z5m utilize the same prosthetic components. Z5m(t) is designed for single or multiple tooth restorations and provided in two diameters (4.0, and 5.0 mm), each in three lengths (8. 10, and 12 mm). The Z5m(t) implant system is suitable for patients with metal allergies and the chronic diseases resulting from them.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a dental implant system called Z5m(t). It does not describe an AI medical device or a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, AI performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and standalone AI performance cannot be extracted from this document.

However, I can extract the general "performance data" that was submitted for this non-AI device:

Performance Data for Z5m(t) Dental Implant System (Non-AI device)

This device is not an AI/ML device, so much of the requested information (AI performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies) is not applicable. The document describes performance data for the dental implant itself, focusing on physical and biological aspects, not a diagnostic or prognostic AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device (dental implant) and not an AI algorithm, the "acceptance criteria" are related to product standards and validation rather than diagnostic performance metrics. Similarly, "reported device performance" refers to the validation results against these standards.

Acceptance Criteria (Standard / Test)	Reported Device Performance / Compliance
Sterilization Validation (according to ISO 14937: Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices)	Sterilization parameters have been validated to a Sterility Assurance Level (SAL) of 10-6.
Biocompatibility Evaluation (according to ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process)	No new biocompatibility testing was performed. The materials and manufacturing methods are identical to those used for the predicate device, which was previously evaluated for biocompatibility.
Static and Dynamic Compression-Bending Testing (according to ISO 14801: Dentistry - Implants -Dynamic fatigue test for endosseous dental implants)	The subject device does not represent a new worst-case in mechanical testing compared to the predicate. (Implies it meets or exceeds the predicate's performance).
Software Validation (Implicit for any embedded software, though not detailed)	Software validation was conducted (details not provided).

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

Sample Size: Not applicable in the context of typical AI/ML test sets. The tests mentioned (sterilization, biocompatibility, mechanical) involve specific numbers of device units or biological assays per standard, but are not usually referred to as "test sets" in the AI sense.
Data Provenance: Not applicable in the context of this type of device submission. The data would be generated in laboratories according to international standards (ISO).

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)

Not applicable. This is not an AI device that requires expert-established ground truth for diagnostic accuracy.

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

Not applicable. This is not an AI device that requires expert adjudication for a ground truth dataset.

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

Not applicable. This is not an AI device, and no human reader comparative effectiveness studies are mentioned.

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

Not applicable. This is a physical dental implant, not an algorithm.

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

Not applicable. For this device, "ground truth" would be established by physical and biological measurements against regulatory and industry standards (e.g., a device is sterile if it meets the SAL, it is biocompatible if it passes ISO 10993 tests, it is mechanically sound if it passes ISO 14801 fatigue tests).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm. No training set is used.

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

Not applicable. This is a physical device, not an AI algorithm. No training set or ground truth for a training set is relevant.

Summary

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

July 31, 2015

Z-systems Ag c/o Ms. Linda Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K150021

Trade/Device Name: Z5m(t) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 29, 2015 Received: July 1, 2015

Dear Ms. Schulz:

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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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 devicerelated 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Tina
Kiang-S

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150021

Device Name

Z5m(t)

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Summary

Z-Systems AG

Z5m(t)

July 23, 2015

ADMINISTRATIVE INFORMATION

Manufacturer Name	Z-Systems AG
	Bittertenstrasse 15
	CH-4702 OensingenSwitzerland
	Telephone	+41 62 388 69 69
	Fax	+41 62 388 69 70
Official Contact	Thomas Hug, PhD
Representative/Consultant	Linda K. Schulz, BSDH, RDH
	Kevin A. Thomas, PhD
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone	+1 (858) 792-1235
	Fax	+1 (858) 792-1236
	Email	lschulz@paxmed.com
		kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Z5m(t)
Common Name	Dental Implant
Classification Name	Implant, endosseous, root-form
Classification Regulations	21 CFR 872.3640, Class II
Product Code	DZE
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

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INDICATIONS FOR USE

PREDICATE AND REFERENCE DEVICES

Z-Systems AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Z5m(t) is substantially equivalent in indications and design principles to the following legally marketed devices:

Primary Predicate Z-Systems AG, Z-Look3 Evo SLM, K120793 Reference Devices Z-Systems AG, Z5c, K132881; and Implant Direct Sybron Manufacturing LLC, Legacy3 6 mm Length Implants, K131097.

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 14937 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; Biocompatibility evaluation according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process: software validation: and static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants.

Sterilization parameters have been validated to an SAL of 10 . ·
. No new biocompatibility testing has been performed, as the materials and manufacturing methods used for the subject device are identical to those used for the predicate device.
The subject device does not represent a new worst case in mechanical testing. •
No clinical data were included in this submission.

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	Subject Device	Primary PredicateDevice	Reference Devices
Comparison	Z-Systems AG	Z-Systems AG	Z-Systems AG	Implant Direct SybronManufacturing LLC
	Z5m(t)	Z-Look3 Evo SLM	Z5c	Legacy3 6 mm LengthImplants
		K120793	K132881	K131097
Indicationsfor Use	Z5m(t) implants aredesigned for surgicalimplantation into theupper and lower jaw forthe attachment ofprosthodontic appliancesto replace missing teeth.The Z5m(t) implantsystem is also suitable forpatients with metalallergies and the chronicdiseases resulting fromthem.	Z-Look3 Evo SLMimplants are designed forsurgical implantation intothe upper and lower jawfor the attachment ofprosthodontic appliancesto replace missing teeth.The Z-Look3 Evo SLMimplant system is alsosuitable for patients withmetal allergies and thechronic diseases resultingfrom them.	Z5c implants are designedfor surgical implantationinto the upper and lowerjaw for the attachment ofprosthodontic appliancesto replace missing teeth.Z5c implant system isalso suitable for patientswith metal allergies andthe chronic diseasesresulting from them. Z5cimplants are intended fordelayed loading.	Lcgacy3 6mm Lengthconsists of two-pieceimplants for one-stage ortwo-stage surgicalprocedures. Theseimplants are intended foruse in partially and fullyedentulous upper andlower jaws in support ofsingle or multiple-unitrestorations and terminalor intermediate abutmentsupport for fixedbridgework. Implants canbe indicated forimmediate loading whengood primary stability hasbeen achieved and withappropriate occlusalloading.
Design	One-piece,implant/abutment	One-piece,implant/abutment	Two-piece,implant/abutment	Two-piece,implant/abutment
ImplantDiameter, mm	4.0, 5.0	3.6, 4.0, 5.0	4.0, 5.0	3.7, 4.2, 4.7, 5.2, 5.7, 7.0
ImplantLength, mm	8, 10, 12	8, 10, 11.5, 13	8, 10, 12	6
Material
Implant,Abutment	Y-TZPLaser treated surface	Y-TZPLaser treated surface	Y-TZPLaser treated surface	Titanium

This submission expands the Z-System Implant line to include a tapered version of the Z5m (previously named Z-Look3 Evo SLM) originally cleared in K120793. The modification includes a tapered implant body, a double thread design and a self-tapping apex. The primary predicate has a straight body and a single thread design. Both the subject device and the predicate device have the same abutment portion of the one-piece implant.

Z5m(t) diameters and lengths are the same as the reference device Z5c implant diameters and lengths cleared in K132881. The implant body, thread design and self-tapping feature of the Z5m(t) are substantially equivalent to the design of the reference device Legacy3 implant cleared

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510(k) Summary K150021

in K131097. Z5m(t) is different from the reference devices in that it is a one piece implant and abutment, where the reference devices are a two-piece implant and abutment configuration.

The subject device and the predicate and reference devices have intended use, the same technological characteristics, and encompass the same range of physical dimensions and characteristics, including implant diameter, length, and surface treatment.

CONCLUSION

Overall, the subject device has the following similarities to the predicate and reference devices:

has the same intended use,
uses the same operating principle,
incorporates the same basic design, ●
incorporates the same or very similar materials, and
has similar packaging and is sterilized using the same materials and processes.

The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.