The TheriRidge™ Block device consists of hydroxylapatite material, the primary mineral content of human bone, with porosity and geometric features that encourage tissue in-growth. The device will be available in three (3) basic sizes: small (approximately 10.4 mm x 5.6 x 5.0), medium (approximately 10.4 mm x 10.0 x 5.0), and large (approximately 20.0 mm x 10.0 x 5.0).

AI/ML Overview

The provided text describes Therics' TheriRidge™ Block, a bone graft substitute, and its substantial equivalence to a predicate device, Interpore's Pro Osteon® 200. This is a 510(k) summary, which generally focuses on demonstrating equivalence rather than establishing new acceptance criteria or conducting a comprehensive study with the detailed elements requested in the prompt for AI/diagnostic devices.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of submission.

Here's an analysis based on the provided text, highlighting what is available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific "acceptance criteria" for the device in the context of passing a diagnostic test or achieving a particular performance threshold against a ground truth. Instead, it compares the physical and chemical characteristics of the new device (TheriRidge™) to a predicate device (Pro Osteon® 200) to demonstrate substantial equivalence.

Characteristics	TheriRidge™	ProOsteon 200™
Median Pore Diameter	12 microns	80 microns
Bulk Density	1.7 g/cc	1.3 g/cc
True/Skeletal Density	3.0 g/cc	3.0 g/cc
Porosity	43 % *	57 %
Crystallinity	> 95% HA	> 90% HA
Compressive Strength	4.3 MPa (3 to 6 MPa)	5.8 MPa (4 to 10 MPa)
*Excluding channels

The study proves the device meets the "acceptance criteria" of substantial equivalence to the predicate device, Pro Osteon® 200, based on these physical and chemical characteristics and similar performance in a pre-clinical animal model.

2. Sample Sizes Used for the Test Set and Data Provenance

Test Set Sample Size: The text mentions "Pre-clinical performance testing conducted on TheriRidge™ and Pro Osteon® 200 in a canine animal model." However, the number of animals (sample size) used in this test is not specified.
Data Provenance: "Canine animal model" implies the data is from an animal study, not human patients. The country of origin is not specified. The study is pre-clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the study is pre-clinical performance testing on an animal model, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. The evaluation seems to be based on physical observations and measurements within the animal model, as described in the next point.

4. Adjudication Method for the Test Set

Given the nature of the pre-clinical animal study, an adjudication method in the context of human expert review (e.g., 2+1, 3+1) is not applicable. The assessment was likely made by researchers or veterinary pathologists involved in the animal study based on "handling characteristics, wound healing, implant stability, and the presence of healthy tissue in or adjacent to the devices." No details about specific adjudication protocols are provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance can potentially improve their performance. This submission is for a bone graft substitute, not a diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical bone graft substitute, not an algorithm, and therefore does not have "standalone" algorithm performance.

7. The Type of Ground Truth Used

For the pre-clinical animal study, the "ground truth" was established through direct observation and measurement in the canine animal model regarding "handling characteristics, wound healing, implant stability, and the presence of healthy tissue in or adjacent to the devices." This is essentially a form of outcomes data or histopathological assessment within the animal model.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical bone graft substitute.

Summary

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Attachment – 6

MAR 2 6 2003

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510(k) Summary

Attachment-06-510kSummaryRevised20030318

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THERICS. INC 5 CAMPUS DR ETON, NJ (

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K023998

510(k) SUMMARY

Therics' TheriRidge™ Block

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Submitter's Name:

Umberto V. Parrotta

Telephone: 609.514.7237 or 609.514.7200 (main) Facsimile: 609.514.7219 Contact Person: Umberto V. Parrotta

Date Prepared: December 2, 2002

Name of Device and Name/Address of Sponsor

TRADE/PROPRIETARY NAME OF DEVICE: TheriRidge™ Block, Bone Graft Substitute

ADDRESS:

115 Campus Drive Princeton, New Jersey 08540

Common or Usual Name:

Bone Graft Substitute Hydroxylapatite (HA) Blocks Hydroxyapatite (HA) Blocks Synthetic Bone Substitute

Classification Name

Bone Augmentation Materials

Predicate Devices

Interpore's Pro Osteon® 200

Attachment - 6 Attachment-06-510kSummaryRevised20030318

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THERICS. INC. 115 CAMPUS DRIVE PRINCETON, NJ 08540 TELEPHONE: 609-514-7200 609-514-7219 E-MAIL: therics@therics.com

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Intended Use / Indications for Use

TheriRidge™ Block Bone Graft Substitute is indicated and intended for the augmentation of deficient maxillary and mandibular alveolar ridges.

Technological Characteristics and Substantial Equivalence

A summary of the physical and chemical characteristics of both TheriRidge™ Block and Pro Osteon® 200 is below in Table 1.

Characteristics	TheriRidge™	ProOsteon 200™
Median Pore Diameter	12 microns	80 microns
Bulk Density	1.7 g/cc	1.3 g/cc
True/Skeletal Density	3.0 g/cc	3.0 g/cc
Porosity	43 % *	57 %
Crystallinity	> 95% HA	> 90% HA
Compressive Strength	4.3 MPa (3 to 6 MPa)	5.8 MPa (4 to 10 MPa)

Tahle 1

Excluding channels

Pre-clinical performance testing conducted on TheriRidge™ and Pro Osteon® 200 in a canine animal model according to indication vielded similar results based on handling characteristics, wound healing, implant stability, and the presence of healthy tissue in or adjacent to the devices.

The TheriRidge™ implants have the same intended use and indications, the same or similar principals of operation and technological characteristics, and equivalent performance in an appropriate animal model. Theric's Theric's TheriRidge™ Block is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes representing the feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2003

Mr. Umberto V. Parrotta, Jr. Director of QA & RA Therics, Incorporated 115 Campus Drive Princeton, New Jersey 08540

Re: K023998

Trade/Device Name: TheriRidge™ Block, Bone Graft Substitute Regulatory Class: Unclassified Product Code: LYC Dated: February 24, 2003 Received: February 25, 2003

Dear Mr. Parrotta:

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. Parrotta

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 vour 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 yours,

Susan Juniper

Susan Runner, DDS, MA Interim 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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K023998

CONFIDENTIAL

Attachment - 12

Indications for Use Form

510(k) Number: K023998.

Device Name:

TheriRidge™ Block, Bone Graft Substitute

Indications for Use:

TheriRidge™ Block Bone Graft Substitute is indicated and intended for the augmentation of deficient maxillary and mandibular alveolar ridges.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use

Kein Muluy for MSR

(Optional Format 1-2-96)

inn Sian Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K023998

File: Attachment-12-IndicationsForUseStatementRevised20030318

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.