DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. DSI implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

Device Description

DSI Dental Implant System is an internal hex implant system with one model of implant at this time, Premium Spiral is a slightly tapered spiral internal hex implant with micro-rings at the implant neck which comes in 3.5, 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. The 6.0 diameter implant does not come in lengths of 13 or 16mm. All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface. Loc-in abutments are anodized. All types of abutments can be used with all implants. Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. The system also includes abutment fixation screws. Straight abutments come in 7, 9, or 11mm lengths and shouldered straight abutments come 1, 2, 3, or 4mm in gingival height. Wide straight shoulder abutments come in gingival heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 7, 9, 11 mm. Straight wide abutments come in lengths of 9 or 11 mm. 15° anatomic angulated abutments come in gingival heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in gingival heights of 1, 2, or 3mm. Straight multi-unit abutments, Loc-in abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Loc-in abutments come in collar heights of 0.5, 1, 2, 3, 4, 5, and 6 mm. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in gingival heights of 0.5, 1.5 mm. Overdenture abutments are used with removable dentures and partial dentures. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Multi-unit abutments are used for fixed restorations. Straight multi-unit mounted dentures can only be removed by the dentures mounted on flat abutments, overdentures or ball attachments can be removed by the patient. The UCLA is 4.5mm in diameter and is for making gold restorations which are taller than 4mm. Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in gingival heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in gingival heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in gingival heights of 2, 3, 4, and 5 mm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DSI Dental Implant System, asserting its substantial equivalence to legally marketed predicate devices. The document details the device, its indications for use, and a summary of testing conducted to support this claim.

It does not describe an AI/ML powered medical device, nor does it present acceptance criteria and a study proving the device meets those criteria in the way typically expected for such products (e.g., performance metrics like sensitivity, specificity, AUC). Instead, the "acceptance criteria" for this dental implant system are framed in terms of demonstrating substantial equivalence to a predicate device, primarily through materials, design, and fatigue performance.

Therefore, many of the requested points regarding AI/ML device performance (like sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document as it pertains to a traditional medical device (dental implants).

However, I can still extract information related to the device's performance testing and comparison to predicates, interpreting "acceptance criteria" in the context of demonstrating substantial equivalence for a non-AI device.

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

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (DSI Dental Implant System)
Mechanical Strength (Fatigue Performance)	Run out limit about the same or higher than other implant systems (predicates).
Biocompatibility	Surface treatment does not adversely change cytotoxicity. Materials are common in dental implants and meet ASTM F136.
Sterilization Efficacy	Implants sterilized according to ISO 11137-1, ISO 11137-2, and ISO 11137-3. Abutment steam sterilization done according to ISO 17665-1 and ISO 17665-2.
Package Integrity & Shelf Life	Package integrity testing and accelerated aging conducted.
Endotoxin Content	Endotoxin testing according to USP 161 conducted.
Indications for Use (Similarity)	Substantially equivalent to SpiralTech Dental Implant System.
Material (Similarity)	Ti6Al4V, same as predicate devices.
Design/Connection (Similarity)	Internal Hex connection, similar to predicate devices. Slight differences in geometry and size are considered minor.

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test (e.g., how many implants were fatigue tested) or the provenance (country of origin, retrospective/prospective) of any clinical data, as this is primarily a non-clinical, performance-based submission. The testing appears to be lab-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in the context of AI/ML evaluation by experts is not relevant here. The evaluation is against engineering standards and comparison to predicate devices, which is typically conducted by engineers and regulatory experts.

4. Adjudication method for the test set
Not applicable for this type of device and submission.

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/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" or reference for evaluating this device's performance is based on recognized international standards (ISO, ASTM, USP) for medical devices, specifically dental implants, and comparison to legally marketed predicate devices. For example, mechanical strength is compared against the run-out limits established by ISO 14801.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore does not have a "training set" in that context.

9. How the ground truth for the training set was established
Not applicable.

Summary

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April 1, 2020

DSI Dental Solutions Ltd % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K200188

Trade/Device Name: DSI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 20, 2020 Received: January 24, 2020

Dear Angela Blackwell:

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 combination 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.

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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 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 (OS) 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-reportingmdr-how-report-medical-device-problems.

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

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200188

Device Name DSI Dental Implant System

Indications for Use (Describe)

DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients and chewing function. DSI implants are intended for single or multiple unit restorations on splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

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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510k Summary April 1, 2020 DSI Dental Implant System

Name and address: DSI Dental Solutions Ltd 59 haAvoda St Light Industrial Zone Ashdod Israel 7706300 Contact Person: Shlomi Krasner Phone Number: +972 2003265 Name of device: DSI Dental Implant System Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA

Device Description: DSI Dental Implant System is an internal hex implant system with one model of implant at this time, Premium Spiral is a slightly tapered spiral internal hex implant with micro-rings at the implant neck which comes in 3.5, 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13 and 16. The 6.0 diameter implant does not come in lengths of 13 or 16mm.

All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface. Loc-in abutments are anodized. All types of abutments can be used with all implants.

Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. The system also includes abutment fixation screws. Straight abutments come in 7, 9, or 11mm lengths and shouldered straight abutments come 1, 2, 3, or 4mm in gingival height. Wide straight shoulder abutments come in gingival heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 7, 9, 11 mm. Straight wide abutments come in lengths of 9 or 11 mm. 15° anatomic angulated abutments come in gingival heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in gingival heights of 1, 2, or 3mm.

Straight multi-unit abutments, Loc-in abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Loc-in abutments come in collar heights of 0.5, 1, 2, 3, 4, 5, and 6 mm. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in gingival heights of 0.5, 1.5 mm. Overdenture abutments are used with removable dentures and partial dentures. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Multi-unit abutments are used for fixed restorations. Straight multi-unit mounted dentures can only be removed by the dentures mounted on flat abutments, overdentures or ball attachments can be removed by the patient.

The UCLA is 4.5mm in diameter and is for making gold restorations which are taller than 4mm.

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Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in gingival heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in gingival heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in gingival heights of 2, 3, 4, and 5 mm.

Indications for Use: DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. DSI implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments and implants are strong enough for their intended use. Premium Spiral implants exhibited a run out limit about the same or higher than other implant systems. Surface analysis was done to show the surface treatment does not adversely change the cytotoxicity of the materials are ones common in dental implants and abutments are made of titanium alloy which meets ASTM F136. Sterilization was conducted on the implants according to ISO 11137-1, ISO 11137-2, and ISO 11137-3. Abutment steam sterilization was done according to ISO 17665-1 and ISO 17665-2. Package integrity testing and accelerated aging were conducted. Endotoxin testing according to USP 161 was conducted.

Primary Predicate Device: SpiralTech Dental Implant System Esi Hex K170372 Reference Predicates: Cortex K090709 Ditron MPI K140728

Substantial Equivalence:

DSI Dental Implant System is substantially equivalent to SpiralTech Dental Implant System in indications for use, materials, design, and fatigue performance.

Implant SystemComparison Table	DSI Dental ImplantSystemPremium Spiral	SpiralTech DentalImplant SystemK170372ESi Hex	Ditron MPI K140728
Diameter of ImplantsPremium Spiral	3.5, 3.75, 4.2, 5.0, 6.0	ESi Hex 3.3, 3.5, 4.3, 5.0, 6.0	3.3, 3.5, 3.75, 4.2, 5.0, 6.0
Implant Lengths	8, 10, 11.5, 13, 16 (6.0 mm diameter not in 13 or 16 length)	8, 10, 11, 13, 15	6 (4.2, 5 and 6 only), 8, 10, 11.5, 13, and 16
Surface Treatment	SLA	SLA or RBM	Unknown
Sterilization of Implants	Provided sterile by gamma irradiation	Provided sterile by gamma irradiation	Provided sterile by gamma irradiation
Sterilization of abutments	Provided non-sterile with instructions for user to sterilize them	Provided non-sterile with instructions for user to sterilize them	Provided non-sterile with instructions for user to sterilize them
Connection	Internal Hex	Internal Hex	Internal Hex
Spiral Implant Design	Premium Spiral	ESi Hex	MPI
ISO 14801 Fatigue Test	Run out limit is the same or higher than those of other implant systems	Run out limit is comparable to other implant systems.	Run out limit is comparable to other implant systems.
Indications for Use	DSI Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. DSI implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Premium Spiral implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.	The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Spiraltech implants are intended for single or multiple unit restorations on splinted or non-splinted applications. The implants ESi Dynamic and Ultimate are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants [along with Premium and One Piece] can also be used for loading after a conventional healing period. Solo One Piece 3.0 and 3.3 implants, Ultimate (conical) 3.0 implants, and ESi (conical) 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.0 and/or 3.3	Ditron's Dental Implants and Abutments are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. • Two stage: MPI, ULT, API and CPI models • One stage: OPI model The 3.3 and 3.0 mm diameter models for One stage OPI, Two stage MPI, Two stage and API implants are intended only for the incisors and cuspids of the maxilla and mandible. They are also indicated for denture stabilization using multiple

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implants adjacent to oneanother.

implants.Two stage and Onestageimplants fortemporary orlongtermuse: MPI, ULT, API,CPI,OPI are self-tappingtitaniumthreaded screwsindicated for longterm intra bonyapplications. Theypermitimmediate splintstability andlong-term fixationof new orexisting crown,bridge andprosthesis andprotection ofgraft sites.MPI, ULT, API, CPIand OPIdesigns areindicated forimmediate loading(except forMPI and API in6mm length)when good primarystability isachieved and withappropriateocclusal loading.MPI, ULT, API, CPIand OPIare indicated forimmediateloading (except forMPI and APIin 6mm length) insingle toothrestorations when

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			stability is achievedwithappropriateocclusal loading.
Material	Ti6Al4V	Ti6Al4V	Ti6Al4V

	DSI Dental ImplantSystem	SpiralTech DentalImplant SystemK170372	Cortex Dental ImplantSystem K090709
Cover screw	Cover screw	Cover screw
Multi-Unit Abutments*	Multi-unit abutmentsin heights of 1,2,3 and4 mmUsed for fixedrestorations.	Multi-unit abutmentsin heights of 1,2,3 and4 mmUsed for fixedrestorations.
Ball attachments*	Ball attachments inheights of 2,3,4,5, and6mm	Ball attachments inheights of 1,2,3,4,5,and 6mm
Healing Caps 3.8diameter	Healing Cap in 3,4,5,6,7mm height	Healing Abutment in2,3,4,5 and 6 mmheight	Healing abutment7mm height
Healing Caps 4.6diameter	Healing cap in 2,3,4,5,6,and 7mm height	Healing Abutment in2,3,4,5, and 6 mmheight	Healing abutment7mm height
Healing Caps 5.5diameter	Healing cap in 2,3,4,5,6and 7mm height	Healing Abutment in2,3,4,5,and 6mm height	Healing abutment7mm height
Healing Caps 6.3diameter	Healing Caps in 2,3,4and 5 mm height		Healing Abutments in2,3, 4 and 5 mm height
Standard TitaniumAbutment	4.5mm StandardTitanium Abutmentwith heights of 7,9, and11 mm	4.5mm Standard FlatTitanium StraightAbutment with heightof 5,7,9 and 11 mm
Standard NarrowAbutment	3.8mm Standardnarrow abutment withheights of 7,9 and 11mm	3.8mm Narrow FlatTitanium Straightabutment with heightsof 5, 7, 9, and 11mm
Standard WideAbutment	5.5mm Standard wideabutment with heightsof 9 mm	5.5mm Wide FlatTitanium Straightabutment with heightsof 5, 7, 9 and 11 mm

Standard ShoulderAbutment	4.5mm Standardshoulder abutment inheights of 1,2,3 and4mm	4.5mm AnatomicTitanium abutment inheights of 1,2,3 and4mm
Standard WideShoulder Abutment	5.4mm Standard WideShoulder Abutmentwith heights of 1,2,3mm	5.5mm Wide AnatomicAbutment with heightsof 1,2 ,and 3mm
Standard 15°Abutment	Standard 15° Abutmentwith heights of 1,2,3mm	15° Angulated TitaniumAbutment with heightsof 1,2,3 mm
Standard 25°Abutment	Standard 25° Abutmentwith heights of 1,2,3mm	25° Angulated TitaniumAbutment with heightsof 1,2, and 3mm
Loc-In Abutments *	Flat abutment inheights of 1,2,3,4,5,and6 mm	IPI abutment in heightsof 1,2,3,4,5 and 6 mm
Standard OverdentureAbutment*	Overdenture abutmentin 0.5, 1.5, and 2.5 mmheightsUsed for removablerestorations.		Clever clickattachment withheights of 0,1,2,3,4,5mmUsed for removablerestorations.
UCLA	Castable abutments indiameters 4.5mm		Castable abutments4.5mm diameter

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*These models of abutments are not for single crown use.

Conclusion:

DSI Dental Implant System is substantially equivalent to SpiralTech Dental Implant System. They both have similar indications for use, are of the same material, and have internal hex connections. The language regarding small diameter implants in the predicate Indications for Use is not relevant to the subject Indications, as the smallest diameter of subject implants is outside of the precifically indicated range. The reference devices do not include any specific language in their Indications related to the components being compared to the subject system.

Performance testing demonstrates substantial equivalence to the identified predicate devices. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Any abutments not found in the predicate device system are found in the reference device system. The design and size differences between predicate or reference devices and the subject devices are only minor differences in geometry and size so given the use, materials and technology is the same they do not change the substantial equivalence.

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.