PROGENIX® DBM Putty and PROGENIX® Plus may be used alone or in combination with autograft bone and/or autogenous bone marrow for use as a bone graft extender. substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® DBM Putty and PROGENIX® Plus provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.

PROGENIX® DBM Putty and PROGENIX® Plus are intended to be used alone or in combination with autogenous bone and/ or bone marrow aspirate for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of cranial oral maxillofacial and dental intraosseous defects including but not limited to:

Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture

Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

Device Description

The PROGENIX® products contain human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX® is available in two versions: Putty and Plus. The PROGENIX® Plus version contains two different sized demineralized bone particles.

PROGENIX® DBM Putty and PROGENIX® Plus are single use products intended for use in the oralmaxillofacial region. Additionally, these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in readyto-use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown to be osteoinductive in an athymic rat assay. as well as osteoconductive, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Sofamor Danek PROGENIX® device. It describes the product, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain the kind of information requested regarding acceptance criteria and studies that prove the device meets those criteria, especially in the context of device performance metrics like sensitivity, specificity, etc.

The 510(k) process for devices like PROGENIX® (a bone void filler) typically relies on demonstrating substantial equivalence to a predicate device based on similar materials, intended use, technological characteristics, and performance data (which often includes biocompatibility, mechanical properties, and osteoinductivity/osteoconductivity in animal models). It usually does not involve "acceptance criteria" in the sense of predictive algorithm performance (e.g., sensitivity, specificity) against a ground truth, as might be found for AI/ML-driven diagnostic or image analysis devices.

Therefore, I cannot populate the requested table and answer the questions based on the provided text. The document focuses on regulatory approval based on demonstrating equivalence, not on a detailed clinical performance study with acceptance criteria for statistical metrics.

Here's why the information isn't available in the provided text:

Type of Device: PROGENIX® is a medical device (bone void filler) composed of human demineralized bone matrix (DBM) and a biocompatible carrier. It's a biological/material product, not a software algorithm or diagnostic tool that would typically have performance metrics like sensitivity, specificity, or rely on human expert consensus for "ground truth" in the way an AI diagnostic device would.
510(k) Process for this device: The 510(k) summary confirms "substantial equivalence" to previously cleared predicate devices (other DBM products). This means the FDA determined the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This determination relies on demonstrating similar intended use, technological characteristics, and performance data (e.g., osteoinductivity in rats, osteoconductivity, resorption rate). It does not typically involve human reader studies or comparison to an AI algorithm.
Missing Information: The document does not discuss:
- Specific quantitative acceptance criteria (e.g., statistical thresholds for performance).
- Clinical studies designed to measure such criteria in humans (beyond showing it is resorbed and replaced by host bone).
- Test sets, training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies. These are concepts relevant to AI/ML or diagnostic device evaluations, not directly to a bone graft material's regulatory submission as presented here.

In summary, the provided document is a regulatory clearance for a medical device (bone void filler) based on substantial equivalence, not a clinical study report for an AI/ML or diagnostic device with performance metrics and acceptance criteria as outlined in your request.

Summary

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K082463

Medtronic Sofamor Danek PROGENIX® 510(k) Summary August 2008

NOV 10 2008

l. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
- Contact: Ryan Massey Regulatory Affairs Specialist
ll. Proposed Proprietary Trade Name: PROGENIX® Classification Name: Bone Void Filler Product Code: NUN Regulation No .: 872.3930

119. Product Description/Purpose of Application

The purpose of this 510(k) application is to expand the Indication for the PROGENIX® family of products (PROGENIX® DBM Putty and PROGENIX® Plus) so that it may be used alone or in combination with autograft bone and/or autogenous bone marrow for use as a bone graft extender, substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® provides a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process. The subject is identical to previously cleared predicate devices (K081950, SE 7/18/2008, K080462, SE 5/13/2008).

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IV. Indications

PROGENIX® DBM Putty and PROGENIX® Plus may be used alone or in combination with autograft bone and/or autogenous bone marrow for use as a bone graft extender, substitute, and bone void filler in bony voids or gaps, not intrinsic to the stability of the bony structure, of the cranial, oral and maxillofacial region. The voids or gaps may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. PROGENIX® DBM Putty and PROGENIX® Plus provide a bone void filler that is resorbed/remodeled and is replaced by host bone during the healing process.

V. Substantial Equivalence

Documentation is provided that demonstrates PROGENIX® to be substantially equivalent to previously cleared bone void fillers such as PROGENIX® DBM Putty (Medtronic Sofamor Danek, K080462, SE 5/13/2008), PROGENIX® Plus(Medtronic Sofamor Danek, K081950, SE 7/18/2008), and GRAFTON® DBM (Osteotech, Inc., K051188, SE 01/03/2006).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, clutching a caduceus in its talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2008

Mr. Ryan Massey Regulatory Affairs Specialist Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K082463

Trade/Device Name: PROGENIX® Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: August 25, 2008 Received: August 27, 2008

Dear Mr. Massey:

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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Please be advised that FDA's issuance of a substantial cquivalence 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Sasa Quara

Chiu S. Lin. Ph. D Division 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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K082463 510(k) Number (if known):

Device Name: PROGENIX®

Indications for Use:

Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.

Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Pase

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K060463

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.