The Prodigy System endosseous implants may be used in the mandible and maxilla for fixed single tooth replacement or as abutments for fixed bridgework and denture retention.

Device Description

The Prodigy System dental implants are machined titanium, screw-form implants supplied in 3.5mm, 4mm, 5mm, 6mm diameters across lengths of 9mm, 10.5mm, 12mm and 15mm. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications. The devices are further processed by roughening the surface with tricalcium phosphate blast media, or by applying hydroxylapatite coating conforming to ASTM F 1185, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants, to promote implant fixation. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 108, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization. The Prodigy System is a comprehensive system consisting of dental implants and surgical components.

AI/ML Overview

This document is a 510(k) premarket notification for a dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria for a new device. Therefore, a direct answer to your request in the format you provided is not fully possible.

However, I can extract the relevant information and explain why certain sections of your request cannot be fulfilled based on the provided text.

Here's a breakdown of what can be inferred and what is missing:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report device performance in the way a clinical study would for a new medical device. Instead, it argues for substantial equivalence to existing predicate devices.

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

Not applicable. This is a 510(k) submission, not a clinical study report. There is no "test set" of patient data or clinical outcomes in the provided text. The "test" for the 510(k) is demonstrating that the characteristics of the new device are substantially equivalent to those of legally marketed predicate devices.

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. As this is not a clinical study involving diagnostic accuracy or treatment outcomes, there is no "ground truth" established by experts in this context.

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

Not applicable. No test set or expert adjudication process is described.

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 a medical device (dental implant) and not an AI/imaging device, so MRMC studies or AI assistance are irrelevant to this submission.

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

Not applicable. See point 5.

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

Not applicable. See point 3.

8. The sample size for the training set

Not applicable. This is not a study involving a training set for an algorithm.

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

Not applicable. See point 8.

Summary of Device Comparison (from the provided text):

The core of the 510(k) submission is to demonstrate that the Prodigy System™ Dental Implants are substantially equivalent to BioHorizons The Maestro™ System dental implants. The rationale for equivalence is based on:

Identical fundamental scientific technology: "The fundamental scientific technology of the device is identical to the referenced predicate devices."
Identical materials: "All materials... remain the same as for the predicate BioHorizons Maestro System endosseous implants." (Raw material: titanium alloy as specified in ASTM F 136; HA coating conforming to ASTM F 1185).
Identical packaging and sterilization methods: "packaging and sterilization methods remain the same as for the predicate BioHorizons Maestro System endosseous implants." (Minimum sterility assurance level of 10⁻⁶, validated in compliance to ANSI/AAMI/ISO 11137).
Substantially equivalent design: "The BioHorizons Prodigy System device... and its specifications are substantially equivalent to all features of the products in design, material and intended use."
Identical intended use: "The intended use of The Prodigy System endosseous implants may be used in the human mandible and maxilla for single tooth replacement or as abutments for fixed bridgework and denture retention." This matches the predicate's intended use.
Similar physical characteristics: The document lists various diameters (3.5mm, 4mm, 5mm, 6mm) and lengths (9mm, 10.5mm, 12mm, 15mm) and surface treatments (tricalcium phosphate blast media or hydroxylapatite coating), which are presented as comparable to the predicate.

Conclusion from the document: The FDA letter explicitly states: "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..." This "substantial equivalence" is the "acceptance criteria" and "proof" in the context of a 510(k) submission.

Summary

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SEP 1 6 2004

K042429

510(k) Summary 21 CFR 807.92

Date: Official Contact: Manufacturer:

September 3, 2004 Winston Greer, Director, QA & RA BioHorizons Implant Systems, Inc. One Perimeter Park South Suite 230 South Birmingham, AL 35243 Phone: (205) 967-7880 Fax: (205) 870-0304

Proprietary Name

The Prodigy System™ Dental Implants

Common Name

Screw-type Dental Implant

Classification Name

Endosseous implants, surgical components, and prosthetic attachments

Predicate Devices

Predicate devices are BioHorizons The Maestro™ System dental implants, a screw-type endosseous implant manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) numbers K960026, concurrence date March 28, 1996; K010458, February 15, 2001; K020133, January 15, 2002; and K030463, February 10, 2003.

Device Description

The devices are further processed by roughening the surface with tricalcium phosphate blast media, or by applying hydroxylapatite coating conforming to ASTM F 1185, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants, to promote implant fixation. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 108, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control - Radiation Sterilization.

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The Prodigy System is a comprehensive system consisting of dental implants and The Prodigy System is a complenensive system is a summary of the proposed catalog
surgical components. The following table provides a summing with surgical components. The following table provide Blast Texturing with item of relefence numbers by Sunaoc troutinent (***
tricalcium phosphate media, or HA - hydroxylapatite coating), implant diameter, and lenath.

CatalogREF Number	Surface	Diameter(mm)	Length(mm)	CatalogREF Number	Surface	Diameter(mm)	Length(mm)
PYH3509	HA	3.5	9	PYR3509	RBT	3.5	9
PYH35105			10.5	PYR35105			10.5
PYH3512			12	PYR3512			12
PYH3515			15	PYR3515			15
PGH4009		4	9	PGR4009		4	9
PGH40105			10.5	PGR40105			10.5
PGH4012			12	PGR4012			12
PGH4015			15	PGR4015			15
PBH5009	HA	5	9	PBR5009	RBT	5	9
PBH50105			10.5	PBR50105			10.5
PBH5012			12	PBR5012			12
PBH5015			15	PBR5015			15
PBH6009			9	PBR6009			9
PBH60105	HA	6	10.5	PBR60105	RBT	6	10.5
PBH6012			12	PBR6012			12
PBH6015			15	PBR6015			15

Intended Use

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The intended use of The Prodigy System endosseous implants is in the humants for The intended use of The Fronty Oystom on on single tooth replacement or as abutments for fixed bridgework and denture retention.

Technological Characteristics

ological Characteristics
The fundamental scientific technology of the device is identical to the referenced The fundamental solentino toonnology for sprocessing, packaging and sterilization predicate devices: All materials, Jappredicate BioHorizons Maestro System methous remain the Same as for the prodications are substantially endosseous implants. THS Blonbhichter 10 agy to System device which could affect equivalent to all leatures of the products in design, material and intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of three wavy lines, which represent the department's mission to promote health and well-being. The seal is simple and recognizable, and it is used on official documents and publications of the department.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2004

Mr. Winston D. Greer Director, Quality Assurance & Regulatory Affairs Biohorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 South Birmingham, Alabama 35243

Re: K042429

Trade/Device Name: BioHorizons The Prodigy System™ Endosseous Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: September 3, 2004 Received: September 8, 2004

Dear Mr. Greer:

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 such 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 - Mr. Greer

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Clus

Chiu Lin, Ph.D. 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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BioHorizons Implant Systems, Inc. Bionzons Implant System™ Special 510(k): Device Modification September 3, 2004

Page 1 of 1

K042429 510(k) Number: _

Device Name: BioHorizons The Prodigy System™ Endosseous Implants

Indications for Use:

The Prodigy System endosseous implants may be used in the mandible and maxilla for fixed The Prodigy System endosseous Implants may be assul in the may be abutments for fixed bridgework and dental retention.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, De 510(k) Number:

× Prescription Use (per 21 CFR 801.109) ાર

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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.