Calcigen™-S Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from a traumatic injury to the bone. Calcigen™-S Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Device Description

Calcigen™-S Bone Void Filler is a bone filler that resorbs and is replaced with bone during the healing process. The product is available in two forms, paste and granuales.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Calcigen™-S Bone Void Filler. This document describes a medical device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain any information about a clinical study with acceptance criteria and reported device performance related to diagnostic accuracy or clinical outcomes as would be expected for a diagnostic or AI-powered device.

Instead, the submission focuses on:

Non-Clinical Testing: Material properties (set time, exothermic temperature, purity, porosity, mass/volume ratio), biocompatibility (non-toxic, non-mutagenic, non-hemolytic, non-cytotoxic, non-pyrogenic), and comparative testing with a predicate device for dissolution rate and surface pH.
Animal Testing: Demonstrated equivalence with the predicate device in an in vivo situation (histologically and mechanically).
A statement explicitly saying: "Clinical Testing: none provided".

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance in the context of diagnostic accuracy, AI involvement, or human reader improvement, as this information is not present in the provided text.

Based on the available information, here is what can and cannot be answered:

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

Not Applicable / Not Provided: The document does not present acceptance criteria or reported performance for clinical accuracy or diagnostic capabilities. The non-clinical and animal testing results (e.g., set time, dissolution rate, biocompatibility, histological equivalence) are presented to demonstrate substantial equivalence to a predicate device, not to meet specific clinical performance metrics.

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 / Not Provided: No clinical test set involving human data is mentioned. Animal testing was conducted, but specific sample sizes and provenance are not detailed beyond "an in vivo situation."

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 / Not Provided: No human test set or ground truth establishment by experts is described as there was no clinical testing provided.

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

Not Applicable / Not Provided: No human test set requiring adjudication is mentioned.

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

No: No MRMC study was done, and no AI component is described.

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

No: No standalone algorithm performance is described, as the device is a bone void filler, not an AI or diagnostic algorithm.

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

Not Applicable / Not Provided: For the non-clinical and animal testing, "ground truth" would be established by standard analytical methods for material properties and histological/mechanical assessments in animal models. No human ground truth is referred to.

8. The sample size for the training set

Not Applicable / Not Provided: There is no training set mentioned, as this is a physical medical device, not a machine learning model.

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

Not Applicable / Not Provided: As there is no training set, this question is not applicable.

Summary

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K013790

UN 1 1 2002

CORPORA ARTERS

Summary of Safety and Effectiveness

Applicant/Sponsor:	Biomet Orthopedics, Inc.56 Bell DriveP.O. Box 587Warsaw, Indiana 46581-0587
--------------------	-----------------------------------------------------------------------------------------

Contact Person: Patricia Sandborn Beres Telephone: (219) 267-6639 Fax: (219) 372-1683

Calcigen™-S Bone Void Filler Proprietary Name:

Calcium Sulfate Dihydrate Common Name:

Filler, Calcium Sulfate (Unclassified) Classification Name:

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Calcigen™-S Bone Void Filler is substantially equivalent to Wright Plaster of Paris Pellets (OsteoSet® Pellets) (K960978, K963562, K963587) and Wright Plaster of Paris Bone Void Filler Kit (CaSor powder)(K963587) manufactured by Wright Medical Technology, Inc., Arlington, TN.

Device Description: Calcigen™-S Bone Void Filler is a bone filler that resorbs and is replaced with bone during the healing process. The product is available in two forms, paste and granuales.

Intended Use: Calcigen™-S Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from a traumatic iniury to the bone. Calcigen™ -S Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.

Summary of Technologies: Similar to the predicate device. Calcigen™-S Bone Void Filler is a resorbable. radiopaque, osteoconductive, isothermic calcium sulfate based material intended for identical indications.

Non-Clinical Testing: Non-clinical testing included material properties such as set time, exothermic temperature, purity, porosity and mass/volume ratio. Biocompatability testing showed the montoxic, non-mutagenic, non-hemolytic, non-cytotoxic, and non-pyrogenic. Comparative testing with the predicate device showed equivalence in terms of dissolution rate, and surface pH. Animal testing demonstrated equivalence with the predicate in an in vivo situation both histologically and mechanically.

Clinical Testing: none provided

All trademarks are owned by Biomet, Inc .except for the following: OsetoSet is a trademark of Wright Medical Technology, Inc.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

1

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

Image /page/0/Picture/19 description: The image shows the word "FAX" in bold, centered above a phone number. The phone number is "219.267.8137" and is located directly below the word "FAX". The text is in a simple, sans-serif font and is likely part of a document or letterhead.

E-MAIL biomet@biomet.com

000352

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Image /page/1/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 or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

JUN 1 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. P.O Box 587 Warsaw, Indiana 46581-0587

Re: Re: K013790 Trade Name: Calcigen-S Bone Void Filler Regulatory Class: unclassified Product Code: MQV Dated: March 12, 2002 Received: March 14, 2002

Dear Ms. Beres:

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 Mav 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.

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.

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Page 2 - Ms. Patricia Sandborn Beres

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Mark A. Millbern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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510(k) Number (if known): K013790

Device Name: Calcigen™-S Bone Void Filler

Indications For Use:

Mark A. Mikkelsen

(Division Sign-Off) Division of General, Restorative and Neurological Devices KO13790

510(k) Number -

(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 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

000003

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.