CORTOSS® Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Description

Cortoss is a composite material that functions as a strengthening agent for injection into vertebral bodies with compression fractures or weakened bone stock. This injectable, nonresorbable synthetic material is generically referred to as a resin-based, bis-glycidal dimethacrylate (Bis-GMA) composite.

AI/ML Overview

The provided document is a 510(k) summary for the CORTOSS® Bone Augmentation Material. It describes the device, its indications for use, and claims substantial equivalence to predicate devices based on performance and clinical data. However, the document does not contain acceptance criteria for specific performance metrics, nor does it detail a study that proves the device meets specific acceptance criteria in the way an AI/ML device submission would.

The document refers to "Performance testing was conducted to ensure that Cortoss met its design specifications and performed in a manner substantially similar to the predicate devices. In all instances, Cortoss functioned as intended." and "Human clinical studies were conducted in over 500 patients at 43 clinical sites to demonstrate the safety and effectiveness of Cortoss for the treatment of vertebral compression fractures." These are general statements of testing and clinical studies but do not provide the detailed information requested for an AI/ML device.

Therefore, most of the requested information cannot be extracted from the provided text because it pertains to the evaluation of an AI/ML device, which this product is not.

However, I can extract the information that is present:

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

Acceptance Criteria: Not explicitly stated in the provided text in terms of specific performance metrics with predetermined thresholds. The summary generally states that "Cortoss met its design specifications and performed in a manner substantially similar to the predicate devices."
Reported Device Performance:
- "In all instances, Cortoss functioned as intended."
- Clinical studies (described below) were conducted "to demonstrate the safety and effectiveness of Cortoss for the treatment of vertebral compression fractures."

2. Sample sized used for the test set and the data provenance

Test Set Sample Size:
- U.S.: 40 patients in two pilot studies.
- U.S.: 256 patients (162 Cortoss: 94 control) in a prospective, randomized, multi-center, pivotal, single-blind pivotal study.
- E.U.: over 300 patients in multi-center, single-arm, prospective studies.
Data Provenance:
- U.S. (pilot and pivotal studies)
- E.U.: France, Italy, Sweden, and the UK (multi-center, single-arm, prospective study).
Retrospective or Prospective: All clinical studies mentioned were prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the text. The concept of "ground truth" established by experts is typically relevant for diagnostic AI/ML devices, not for a bone augmentation material where "ground truth" would relate to patient outcomes and treatment efficacy observed by clinicians.

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

This information is not provided in the text. Adjudication methods are typically used to establish ground truth in diagnostic studies, which is not the primary focus of this device. The pivotal U.S. study was "single-blind," implying that patients were unaware of their treatment arm, but it doesn't describe ground truth adjudication.

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

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study is not mentioned as this device is a bone augmentation material and not an AI/ML diagnostic tool meant to assist human readers.

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

Not applicable. This is a medical device (bone augmentation material), not an algorithm or AI system.

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

For a bone augmentation material, "ground truth" refers to patient outcomes related to safety and effectiveness. The clinical data collected in "over 500 patients" demonstrated "safety and effectiveness...for the treatment of vertebral compression fractures." This would involve clinical assessments, imaging, and patient-reported outcomes (e.g., pain reduction, functional improvement), which could be considered the "outcomes data" ground truth for this type of device.

8. The sample size for the training set

Not applicable. This is a medical device (bone augmentation material), not an AI/ML algorithm that requires a training set. The clinical studies mentioned are for validation/demonstration of safety and effectiveness, not for training an algorithm.

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

Not applicable, as there is no mention of an AI/ML training set.

Summary

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510(k) SUMMARY CORTOSS® Bone Augmentation Material

May 28, 2009

510(k) Number (if known): K080108

1. Contact Person

Catherine Moffa Director, Regulatory Affairs (e-mail) cmoffa@orthovita.com

Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 (t) 610-640-1775 - (f) 610-640-1714

2. Device Name and Classification

Product Name:	Cortoss Bone Augmentation Material
Classification Name:	Cement, Bone, Vertebroplasty
Common or Usual Name:	Vertebral Augmentation Material
Classification Panel:	Orthopedic
Regulation Number:	888.3027
Device Class:	Class II
Product Code:	NDN

3. Substantial Equivalence

Cortoss is substantially equivalent to the following medical devices in commercial distribution:

Predicate Device	Company	FDA Clearance Number
Spineplex Radiopaque Bone Cement	Stryker	K032945
Spine-Fix Biomimetic Bone Cement	Teknimed	K043593
Staxx Fx System	Spine Wave	K053336, K063606
Confidence High Viscosity Bone Cement	Disc-O-Tech	K060300

Cortoss has the same intended use and indications, similar technological characteristics, and similar principles of operation as its predicate devices. The minor technological differences between Cortoss and its predicate devices raise no new issues of safety or effectiveness. Performance and clinical data demonstrate that Cortoss is as safe and effective as its predicate devices. Thus, Cortoss is substantially equivalent.

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4. Device Description

5. Indications for Use

CORTOSS Bone Augmentation Material is indicated for the fixation of pathological fractures of the vertebral body using vertebral augmentation. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

6. Performance Data

Performance testing was conducted to ensure that Cortoss met its design specifications and performed in a manner substantially similar to the predicate devices. In all instances, Cortoss functioned as intended.

7. Clinical Data

Human clinical studies were conducted in over 500 patients at 43 clinical sites to demonstrate the safety and effectiveness of Cortoss for the treatment of vertebral compression fractures.

In the U.S., data was collected in 40 patients in two pilot studies and in 256 patients (162 Cortoss: 94 control) in a prospective, randomized, multi-center, pivotal, single-blind pivotal study. In the E.U., data was collected in over 300 patients, including a multi-center, single arm, prospective study. These European studies were conducted in four countries (France, Italy, Sweden and the UK), with follow-up ranging from six months to over three years.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Orthovita, Inc. % Ms. Catherine Moffa Director, Regulatory Affairs 45 Great Valley Parkway Malvern, Pennsylvania 19355

JUN - 5 2009

Re: K080108

Trade/Device Name: CORTOSS® Bone Augmentation Material Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: March 31, 2009 Received: April 1, 2009

Dear Ms. Moffa:

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.

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2- Ms. Catherine Moffa

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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information.regarding.the reporting of adverse events, please go.to http://www.fda.gov/cdrh/mdr/.

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,

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K080108

Device Name:

CORTOSS® Bone Augmentation Material

INDICATIONS FOR USE:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K080108

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”