FM-02 Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. FM-02 is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone.

FM-02 Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis and posterolateral spine), and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Device Description

FM-02 Bone Graft Substitute is a resorbable porous bone void filler for the repair of bony defects. It is an osteoconductive, porous implant with a trabecular structure that resembles the multidirectional interconnected porosity of human cancellous bone. The implant is >70% porous and the pore diameters range from 1 um to 1000 um.

FM-02 Bone Graft Substitute guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When FM-02 Bone Graft Substitute is placed in direct contact with host bone, new bone grows in apposition to the surfaces of the implant. As the implant resorbs, bone and other connective tissues grow into the space previously occupied by the scaffold.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (FM-02 Bone Graft Substitute). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study demonstrating performance against specific acceptance criteria for AI or diagnostic imaging.

Therefore, the requested information elements related to AI/algorithm performance (acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document.

However, I can describe the performance data provided in the document which supports the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The device is a bone graft substitute, and its "performance" is assessed against physical and biological standards required for such materials, rather than diagnostic accuracy metrics. The acceptance criteria are essentially meeting the requirements of specific ASTM standards and demonstrating characteristics comparable to the predicate device.

Acceptance Criteria / Standard Met	Reported Device Performance
ASTM F 1088-04a: Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation	FM-02 is a medical grade beta-tricalcium phosphate which fulfills the requirements of ASTM F 1088-04a.
Biocompatibility requirements (ISO 10993-1)	Biocompatibility of the implant has been established in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing.
Comparative Testing (vs. Predicate Device)	Comparative testing included: - Wettability - Fluid retention - Wash away resistance - Homogeneity - Radiopacity - Bioactivity - SEM comparisons These tests demonstrated that FM-02 is "substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness."
Physical/Chemical Characterization (vs. Predicate Device)	Evaluation of: - XRD (X-ray diffraction) - FTIR (Fourier-transform infrared spectroscopy) - ICP (Inductively coupled plasma atomic emission spectroscopy) - Porosity (These were evaluated for the predicate device, implying FM-02 shared similar characteristics or was evaluated against these established parameters for comparison.)

Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical performance testing to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance. The study described focuses on characterizing the material and comparing its properties to a legally marketed predicate device and to established material standards.

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

Sample Size for Test Set: Not applicable in the context of a bone graft substitute material characterization study. The "test set" would refer to samples of the FM-02 material itself, tested in laboratory settings. The number of samples per test (e.g., how many specimens for wettability) is not specified.
Data Provenance: Not specified in terms of country of origin. This would be laboratory testing conducted by Orthovita, Inc. or a contracted lab. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission.

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. "Ground truth" in this context would refer to the true physical/chemical properties of the material, which are determined by objective laboratory measurements and adherence to scientific standards (e.g., ASTM, ISO). Expert consensus is not relevant for establishing the "truth" of these material properties.

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

Not applicable. This is not a study requiring expert adjudication of results, but rather objective laboratory testing.

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 device is a bone graft substitute, not an AI or diagnostic imaging device.

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

Not applicable. This device is a bone graft substitute, not an AI or diagnostic imaging device.

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

The "ground truth" for the performance data presented is based on objective laboratory measurements against established standards (ASTM F 1088-04a, ISO 10993-1) and comparison of physical/chemical properties to a predicate device. This involves analytical chemistry techniques (XRD, FTIR, ICP), microscopy (SEM), and various physical property tests (wettability, fluid retention, etc.).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study.

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

Not applicable. This is not an AI/machine learning study.

Summary

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Orthovita, Inc. FM-02 Bone Graft Substitute Special 510(k)

510(k) SUMMARY FM-02 Bone Graft Substitute October 26, 2010

510(k) Number (if known): K102545

OCT 2 7 2010

Contact Person

Deborah L. Jackson, RAC Senior Regulatory Affairs Specialist (e-mail) djackson(@orthovita.com

Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355 (t) 610-640-1775 - (f) 484-323-8803

2. Device Name and Classification

Product Name:	FM-02 Bone Graft Substitute
Classification Name:	Resorbable calcium salt bone void filler device
Common or Usual Name:	Bone Void Filler
Classification Panel:	Orthopedic
Regulation Number:	888.3045
Device Class:	Class II
Product Code:	MQV

3. Predicate Device(s)

Vitoss Bioactive Foam Bone Graft Substitute (K072184) Vitoss Bioactive Foam Bone Graft Substitute STRIP and PACK (K081439) Vitoss Bioactive Foam Bone Graft Substitute STRIP and PACK (K083033)

4. Device Description

5. Intended Use / Indications for Use

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6. Performance Data

FM-02 is a medical grade beta-tricalcium phosphate which satisfies the requirements of ASTM F 1088-04a. Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. Comparative testing included wettability, fluid retention, wash away resistance, homogeneity, radiopacity, bioactivity, and SEM comparisons. XRD, FTIR ICP and porosity were evaluated for the predicate device. Biocompatibility of the implant has been established in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing. Data supplied demonstrate that FM-02 Bone Graft Substitute is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.

7. Substantial Equivalence

FM-02 Bone Graft Substitute, subject of the Special 510(k), is a product line extension to the Vitoss Bioactive Foam product line. FM-02 Bone Graft Substitute has the same intended uses and indications, technological characteristics, and principles of operation as its predicate device. The minor differences between FM-02 Bone Graft Substitute and the predicate device raise no new issues of safety or effectiveness. Thus, FM-02 Bone Graft Substantially equivalent to Vitoss Bioactive Foam.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Orthovita, Inc. % Ms. Deborah L. Jackson, RAC Senior Regulatory Affairs Specialist 45 Great Valley Parkway Malvern, Pennsylvania 19355

OCT 2 7 2010

Re: K102545

Trade Name: FM-02 Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 1, 2010 Received: October 4, 2010

Dear Ms. Jackson:

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. Iisting 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.

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

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Page 2 - Ms. Deborah L. Jackson, RAC

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH0ffices/ucm1115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFF) Pact 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Meller for

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

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Orthovita, Inc. FM-02 Bone Graft Substitute Special 510(k)

Indications for Use Statement

510(k) Number (if known): 〈につってく

Device Name:

FM-02 Bone Graft Substitute

OCT 2 7 2010

Indications for Use:

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

Signature

(Division Sign. Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102545

Page 1 of 1

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.