Callos® ProModel Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Description

Callos ProModel Bone Void Filler is a moldable and biocompatible calcium phosphate/calcium sulphate composite bone void filler. The single-use Callos ProModel kit contains the necessary components for mixing of the bone void filler. The Callos ProModel sterile kit contains: Calcium Phosphate/Calcium Sulfate Powder, Dilute Sodium Silicate Liquid, a Mixing System (Mixer and Syringe) and a Cannula.

AI/ML Overview

The provided text describes the device "Callos ProModel Bone Void Filler" and its regulatory clearance process, including summaries of non-clinical tests. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in human patients, as would be expected for a device with a focus on AI performance or clinical efficacy against measured outcomes.

Instead, the document states:

"Callos ProModel does not meet the criteria to require clinical testing."
"In vitro and in vivo performance demonstrate that Callos ProModel is substantially equivalent to legally marketed predicate devices."

This indicates that clearance was based on substantial equivalence to existing devices and non-clinical data, not on a clinical effectiveness study with defined acceptance criteria for patient outcomes.

Therefore, I cannot provide the requested table and information as the document does not contain the specific details about acceptance criteria, device performance against those criteria, or a qualifying clinical study.

Based on the provided text, the following points can be addressed, but the core request for acceptance criteria and a study proving their fulfillment cannot be fully met:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics for a clinical effectiveness study in the provided text. The criteria are implied to be "substantial equivalence" to predicate devices based on non-clinical data (biocompatibility, bench testing, animal study).
- Reported Device Performance:
  - "Callos ProModel met the standards set forth in ISO 10993-1. Biological Evaluation of Medical Devices."
  - "radiation sterilization validation is in compliance to ANSI/A AMI/ISO 11137-2:2006."
  - "Bench testing demonstrated that Callos ProModel is substantially equivalent to the marketed predicate devices. The results indicated that the device met performance criteria outlined for its intended use." (Specific numerical performance metrics are not provided).
  - "The animal study provided data that Callos ProModel elicited similar biologic response in a large animal critical size defect model as compared to predicate devices for its intended use." (Specific outcome data or statistical comparisons are not provided).
Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" (human patient data) is described in the context of proving efficacy against acceptance criteria. The non-clinical studies involved bench testing (materials, mechanical properties) and an animal model. The sample size for the animal study is not specified, nor is the provenance of the animals.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert review of clinical cases is described for establishing ground truth, as no clinical effectiveness study requiring such review was conducted.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical "test set" requiring adjudication by multiple experts is described.
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. The device is a bone void filler, not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to this device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a medical implant, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Adherence to ISO standards.
- For sterilization: Compliance with ANSI/AAMI/ISO standards.
- For bench testing: Comparison to predicate device performance (implied physical/mechanical properties). The "ground truth" would be objective measurements of these properties.
- For animal study: Biologic response compared to predicate devices in a large animal model. "Ground truth" would likely involve histological assessment, imaging, or gross observation of bone healing and integration in the animals, as interpreted by veterinary or pathological experts.
The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set. The "development" would involve material science and engineering, not machine learning.
How the ground truth for the training set was established: Not applicable.

Summary

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KI12383 PAGE 2 OF 2

FEB - 7 2012

Image /page/0/Picture/2 description: The image shows the logo for Skeletal Kinetics. The logo consists of a circular graphic to the left of the text "Skeletal Kinetics". The graphic is a circle with a complex network of lines inside, resembling a geodesic dome or a stylized representation of a cell structure. The text "Skeletal Kinetics" is in a bold, sans-serif font.

A COLSON ASSOCIATE

510(k) Summary

General Information as required by 21 CFR 807.92 (a) (1)

Submitters Name/address:	Skeletal Kinetics® LLC10201 Bubb RoadCupertino, CA 95014, USA
Date:	February 2, 2012
Contact Person:	Christine Kuo,Director, Regulatory Affairs and Quality AssurancePhone: (408) 350-5842Fax: (408) 366-1077

Device Name as required by 21 CFR 807.92 (a) (2)

Trade Name:	Callos ProModel Bone Void Filler
Regulation Number:	21 CFR 888.3045
Regulation Name:	Resorbable calcium salt bone void filler device
Regulatory Class:	II
Product Code:	MQV

Predicate Devices as required by 21 CFR 807.92 (a) (3)

The subject device is substantially equivalent to the following legally marketed devices (predicates):MIIG® SR Bone Void Filler (K060011), PRO-DENSE™ Bone Graft Substitute (K070437) and Callos® Bone Void Filler (K051123).

Device Description as required by 21 CFR 807.92 (a) (4)

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Intended Use as required by 21 CFR 807.92 (a) (5)

Callos ProModel is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process

Summary of Technological Characteristics as required by 21 CFR 807.92 (a) (6)

Callos ProModel consists of calcium phosphate/calcium sulfate powder and sodium silicate solution; when mixed together it forms a paste that can be applied directly to the injured bone.

The intended use, operating principles, design features, and materials of Callos ProModel is substantially equivalent to predicate devices.

Summary of Non-clinical Tests as required by 21 CFR 807.92 (b) (1)

The results of biocompatibility testing demonstrated that Callos ProModel met the standards set forth in ISO 10993-1. Biological Evaluation of Medical Devices, and the radiation sterilization validation is in compliance to ANSI/A AMI/ISO 11137-2:2006.

Bench testing demonstrated that Callos ProModel is substantially equivalent to the marketed predicate devices. The results indicated that the device met performance criteria outlined for its intended use.

The animal study provided data that Callos ProModel elicited similar biologic response in a large animal critical size defect model as compared to predicate devices for its intended use.

Summary of Clinical Tests as required by 21 CFR 807.92 (b) (2)

Callos ProModel does not meet the criteria to require clinical testing.

Conclusion as required by 21 CFR 807.92 (3)

In vitro and in vivo performance demonstrate that Callos ProModel is substantially equivalent to legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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, facing right. The eagle is composed of three thick, curved lines. 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

Skeletal Kinectics® LLC % Ms. Christine Kuo Director, Regulatory Affairs and Quality Assurance 10201 Bubb Road Cupertino, California 95014

Re: K112383

Trade/Device Name: Callos® ProModel Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV · Dated: January 17, 2012 Received: January 18, 2012

Dear Ms. Kuo:

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 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 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.

7 2012 FEB

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Page 2 - Ms. Christine Kuo

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you active spective ad 100 boutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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" (21CFR Part nove the regulation unities, 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. Molkerson

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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Section 4: Indications for Use

510(K) Number (if Known):

K112383

Device Name:

Callos® ProModel Bone Void Filler

Indications for Use:

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21CFR 801 Subpart C

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Division Slon-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112383

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.