The PrimeLOC Attachment System is designed to facilitate patient removal of a dental prosthesis for use with full arch overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

Device Description

The PrimeLOC Attachment System consists of abutments and device-specific accessories (retention inserts and denture housings) to serve in a similar function to LOCATOR® abutments for resilient attachment of prostheses to endosseous dental implants. All PrimeLOC abutments are made of titanium alloy and have the same coronal ridge retention design that attaches to the overdenture component by an interference (snap) fit. The threaded apical end of the abutment connects to the implant and is specific to each compatible implant system and diameter. The PrimeLOC Attachment System is designed to accommodate a path of insertion divergence of up to 20° per implant and no more than 40° of divergence between implants. PrimeLOC abutments are provided with a titanium nitride (TiN) coating and are available in cuff heights up to 6 mm, with an implant interface diameter of 3.5 mm. Retention inserts are fixed within a metal denture housing which is embedded in an overdenture prosthesis. The retention inserts allow for varying levels of retention. This connection allows the denture to be retained on the abutments while the majority of loading is supported by the contact of the denture with the gingival tissue surrounding the mandibular and maxillary ridges. The PrimeLOC Attachment System are compatible with OEM implants, specifically Tapered Screw-Vent 3.5 mm platform dental implants manufactured by Zimmer Dental, Inc. Compatibility is based on agreements with the OEM to ensure that the abutments are designed to fit the corresponding implants. All interfaces of the subject device have been designed and verified by the OEM implant manufacturer. This ensures that the interface of the subject device with the identified compatible implants is appropriate. A thin titanium nitride coating is applied to the PrimeLOC abutments in the area that contacts gingival tissue and in the area that contacts the retention inserts. The denture attachment housing, which sits within the denture, may be colored through a titanium anodization process. This system includes instruments used for seating and removing abutments and retention inserts, and processing inserts, impression copings, and laboratory components used to facilitate the fixation of the retention insert and denture housing in the appropriate position within the denture. These components are endosseous dental implant accessories considered Class I 510(k)-exempt devices as defined in 21 CFR 872.3980.

AI/ML Overview

The provided text describes the 510(k) summary for the PrimeLOC Attachment System, a dental device. It outlines the device's administrative information, classification, predicate devices, indications for use, description, and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, the provided text does not contain information about "acceptance criteria" and how the device's performance measured against those criteria in a structured, quantitative table, as would be typical for an AI/ML medical device submission. The performance data section describes non-clinical testing for areas like sterilization, biocompatibility, mechanical testing (dynamic loading, removal force), and MRI compatibility. It does not mention any clinical study involving a test dataset, ground truth established by experts, or metrics like accuracy, sensitivity, or specificity that would be relevant for an AI/ML device in the context of an "acceptance criteria" table.

Therefore, I cannot fulfill parts 1-9 of your request as the information is not present in the provided document. The document describes a traditional medical device (dental attachment system) clearance, not an AI/ML device that would typically involve the type of study design and data points you're asking about.

To answer your request based on the provided document, the following points are addressable:

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

Not Applicable. The document describes non-clinical performance characteristics (sterilization, biocompatibility, mechanical properties) and demonstrates substantial equivalence to a predicate device. It does not present quantitative acceptance criteria for clinical performance in the manner of an AI/ML device (e.g., accuracy, sensitivity, specificity) against a test set. The "Performance Data" section discusses:
- Sterilization validation (ISO 17665-1, ISO 17665-2)
- Biocompatibility testing (ISO 10993-5, ISO 10993-12)
- Mechanical testing (ISO 14801 for dynamic loading; testing removal force of retention insert)
- Non-clinical worst-case MRI review (using scientific rationale and published literature)

Regarding the study that proves the device meets "acceptance criteria" (interpreting "acceptance criteria" in the context of this traditional device as demonstrating substantial equivalence through non-clinical testing):

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

Not Applicable/Not Provided. The performance data mentioned are non-clinical tests (e.g., sterilization, biocompatibility, mechanical testing). These are laboratory/benchtop tests, not a clinical "test set" in the context of patient data for an AI/ML algorithm. The document does not specify typical sample sizes for these tests (e.g., how many abutments were tested for removal force), nor data provenance (as it's not patient-derived data).

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/ML device where expert radiologists or similar professionals would establish ground truth for a test set. The "ground truth" for the non-clinical tests would be the established standards for sterilization, biocompatibility, and mechanical properties.

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

Not Applicable. Not a clinical study requiring adjudication of expert readings.

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-assisted device.

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

Not Applicable. This is not an AI algorithm.

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

Not Applicable / Pre-defined standards. For the non-clinical tests:
- Sterilization: Ground truth is defined by the requirements of ISO 17665-1 and 17665-2.
- Biocompatibility: Ground truth is defined by the requirements of ISO 10993-5 and 10993-12.
- Mechanical Testing: Ground truth is defined by the requirements of ISO 14801 for dynamic loading, and internal company specifications for retention force (compared to the predicate).
- MRI Review: Ground truth is based on scientific rationale and published literature for material properties in an MR environment.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/ML device.

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

Not Applicable. There is no "training set."

In summary, the provided FDA 510(k) clearance letter and summary are for a traditional Class II dental device (an attachment system for dental implants), not an AI/ML medical device. Therefore, the questions related to AI/ML specific study design elements (test sets, ground truth by experts, MRMC studies, training sets) are not applicable to the content of this document.

Summary

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Innovative Product Brands, Inc. % Melissa Burbage Senior Regulatory Specialist PaxMed International. LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K220612

Trade/Device Name: PrimeLOC Attachment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 9, 2022 Received: May 9, 2022

Dear Melissa Burbage:

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 (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-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.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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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Indications for Use

510(k) Number (if known)

K220612

Device Name

PrimeLOC Attachment System

Indications for Use (Describe)

PrimeLOC Attachment Implant Compatibility
Implant	Configurations
Zimmer Biomet DentalTapered Screw-Vent Implant	3.5mm Platform (3.7mm and 4.1mm bodydiameters)

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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510(k) Summary

K220612

PrimeLOC Attachment System

Innovative Product Brands, Inc.

June 6, 2022

ADMINISTRATIVE INFORMATION

Manufacturer Name	Innovative Product Brands, Inc.
	7045 Palm Avenue
	Highland, CA 92346
	Telephone: +1 909-864-7477
	Fax: +1 909-864-7232

Official Contact	Chris Gervais, Chief Scientific Officer
Representative/Consultant	Melissa Burbage
	Kevin A. Thomas, PhD; Floyd G. Larson, MS, MBA
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone: +1 858-792-1235
	Fax: +1 858-792-1236
	Email: mburbage@paxmed.com kthomas@paxmed.com; flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Device Name	PrimeLOC Attachment System
Common Name	Dental implant abutment
Classification Name	Endosseous dental implant abutment
Regulation Number	21 CFR 872.3630
Regulation Name	Endosseous dental implant abutment
Regulatory Class	Class II
Product Code	NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

PREDICATE DEVICE INFORMATION

Primary Predicate Device K083324, LOCATOR Implant Anchor Attachment System, Zest Anchors, Inc.

Reference Device K133339, Tapered Screw Vent Implant, Zimmer Dental Inc.

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INDICATIONS FOR USE STATEMENT

The PrimeLOC Attachment system is designed to facilitate patient removal of a dental prosthesis for use with full arch overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

PrimeLOC Attachment Implant Compatibility
Implant	Configurations
Zimmer Biomet Dental Tapered Screw-Vent Implant	3.5mm Platform (3.7mm and 4.1mm bodydiameters)

SUBJECT DEVICE DESCRIPTION

Retention inserts are fixed within a metal denture housing which is embedded in an overdenture prosthesis. The retention inserts allow for varying levels of retention. This connection allows the denture to be retained on the abutments while the majority of loading is supported by the contact of the denture with the gingival tissue surrounding the mandibular and maxillary ridges.

The PrimeLOC Attachment System are compatible with OEM implants, specifically Tapered Screw-Vent 3.5 mm platform dental implants manufactured by Zimmer Dental, Inc. Compatibility is based on agreements with the OEM to ensure that the abutments are designed to fit the corresponding implants. All interfaces of the subject device have been designed and verified by the OEM implant manufacturer. This ensures that the interface of the subject device with the identified compatible implants is appropriate.

A thin titanium nitride coating is applied to the PrimeLOC abutments in the area that contacts gingival tissue and in the area that contacts the retention inserts. The denture attachment housing, which sits within the denture, may be colored through a titanium anodization process.

This system includes instruments used for seating and removing abutments and retention inserts, and processing inserts, impression copings, and laboratory components used to facilitate the fixation of the retention insert and denture housing in the appropriate position within the denture. These components are endosseous dental implant accessories considered Class I 510(k)-exempt devices as defined in 21 CFR 872.3980.

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PERFORMANCE DATA

Non-clinical testing data submitted to demonstrate substantial equivalence included:

sterilization validation according to ISO 17665-1 Sterilization of health care products -. Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO 17665-2 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1
. biocompatibility testing according to ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-12 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
mechanical testing according to ISO 14801 Dentistry Implants Dynamic loading ● test for endosseous dental implants
testing of each different type of retention insert in a denture housing to measure removal ● force from an abutment over multiple sets of insertion/removal cycles compared to the predicate device
. non-clinical worst-case MRI review to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the subject device components and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque

The subject abutment-implant interface of the PrimeLOC Attachment System is verified to be compatible through either OEM signed abutment drawings, OEM implant drawings, and/or established compatibility demonstrated through mutual agreements with the OEM. Once the specifications and tolerances have been identified, the subject device have been designed and verified by the OEM implant manufacturer. This ensures that the interface of the subject device with the identified compatible implants is appropriate.

EQUIVALENCE TO MARKETED DEVICES

The indications for use statement of the subject device is similar to that of the primary predicate device. The subject device has the added text, "designed to facilitate patient removal of a dental prosthesis for use with full arch overdenture ... , " whereas the primary predicate states, "appropriate for use with overdentures…." This added text only provides more information on how the device is used and does not affect the intended use of the device.

The subject device abutment diameter and abutment cuff height are similar to those of the predicate in that they are within the range of the predicate device. The subject device connection is similar to the internal hex connection of the predicate device, but the subject device is not offered with the additional connections offered by the predicate device. Any differences in technological characteristics were supported by fatigue testing and retention testing to demonstrate substantial equivalence.

Reference Device K133339 is included for the compatible implant body.

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Comparison	Subject Device	Primary Predicate Device	Conclusion
	PrimeLOC AttachmentInnovative Product Brands, Inc.	K083324LOCATOR Implant AttachmentSystemZest Anchors, Inc.
Indications	The PrimeLOC Attachment system isdesigned to facilitate patient removalof a dental prosthesis for use with fullarch overdentures or partial denturesretained in whole or in part byendosseous implants in the mandibleor maxilla.	The LOCATOR Implant AnchorAbutment for Endosseous DentalImplants is appropriate for use withoverdentures or partial denturesretained in whole or in part byendosseous implants in the mandibleor maxilla.	Similar
Design
Abutment Diameter,mm	3.5	3.25 to 6.5	Similar
Abutment CuffHeight, mm	1 to 6	0 to 8	Similar
AbutmentAngulation	Straight	Straight	Same
Abutment/ImplantInterface	Internal Hex	Conical, External Hex, Internal Hex,Internal Multi Lobe	Similar
DivergenceAllowance	20°/40°	20°/40°	Same
ProsthesisAttachment Type	Nylon Insert retained in DentureAttachment Housing	Nylon Insert retained in DentureAttachment Housing	Same
Material
Abutment	Ti 6Al-4V ELI	Ti 6Al-4V ELI	Same
Abutment CoronalSurface Coating	Titanium Nitride	Titanium Nitride	Same
Prosthetic RetentionComponent	Nylon	Nylon	Same

CONCLUSION

The subject devices and the primary predicate device have the same intended use and similar technological characteristics. They encompass a similar range of physical dimensions, are manufactured from the same materials, and are to be sterilized using identical methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)