ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

Device Description

ALTAPORE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicate-substituted calcium phosphate phase of ALTAPORE is similar to human cancellous bone and is intended to support bone growth with macroand micro- porosity. ALTAPORE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si). ALTAPORE is supplied in a sterile applicator and contains ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable aqueous gel carrier. ALTAPORE docs not set in-situ following implantation. ALTAPORE is available in 1.5ml, 2.5ml, 5ml, 10ml, and 20ml configurations.

AI,TAPORE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary. the product can be mixed with Bone Marrow Aspirate (BMA) or autologous bone at the discretion of the surgeon.

ALTAPORE is bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect.

ALTAPORE is osteoconductive based on in vivo animal studies that show it achieves bony healing in a critical defect model as confirmed with radiographic, histolopatholgical, histomorphometric, and mechanical analyses. ALTAPORE undcrgocs ccll-mediated remodeling and is replaced by natural bone.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the ALTAPORE device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for ALTAPORE primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting specific quantifiable acceptance criteria that are then met by performance metrics. The "acceptance criteria" here are implied by the comparison to predicate devices and the general safety and effectiveness requirements for bone void fillers.

Acceptance Criteria (Implied)	Reported Device Performance (ALTAPORE)
Composition: Silicate-substituted calcium phosphate, composed of elements naturally found in bone (Ca, P, O, H, Si).	Reported: Silicate-substituted calcium phosphate, composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si).
Physical Structure: Granules with porosity similar to cancellous bone.	Reported: Granules with a porosity similar to cancellous bone.
Nominal (Total) Porosity: Comparable to predicate.	Reported: 82.5 ± 2.5% (Predicate: 80.0 ± 2.5%, indicating comparable performance).
Strut Porosity: Microporous.	Reported: Microporous.
Sterility: Terminal irradiation.	Reported: Terminal irradiation.
Bioactivity: Forms a surface apatite-layer in simulated body fluid.	Reported: Bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid.
Osteoconductivity and Bony Healing: Achieves bony healing in a critical defect model, replaced by natural bone.	Reported: Osteoconductive based on in vivo animal studies that show it achieves bony healing in a critical defect model as confirmed with radiographic, histolopathological, histomorphometric, and mechanical analyses. Undergoes cell-mediated remodeling and is replaced by natural bone.
Biocompatibility: Meets ISO 10993-1.	Reported: Biocompatibility established in accordance with ISO 10993-1.
Safety and Effectiveness: As safe and effective as predicate devices.	Reported: Non-clinical testing included benchtop material characterization, dissolution, and mechanical; as well as in-vitro bioactivity. Critical size defect implantation in-vivo animal studies have demonstrated that ALTAPORE is efficacious as a standalone bone graft substitute, mixed with Bone Marrow Aspirate (BMA), or mixed with autologous bone. Concluded to be as safe and effective, and performs as well or better than predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a numerical count of subjects or defects. The text refers to "in vivo animal studies" and "critical size defect implantation in-vivo animal studies" but does not provide specific numbers for the animals or defects studied.
Data Provenance: The studies mentioned ("in vivo animal studies") suggest prospective animal studies. The country of origin for the data is not specified in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The concept of human "experts" establishing ground truth for evaluating the device's performance in a diagnostic or interpretive context (e.g., radiologists interpreting images affected by AI) is not applicable to this device. ALTAPORE is a bone void filler, and its performance is assessed through objective biological and material properties, as well as animal studies. Evaluation methods mentioned include radiographic, histopathological, histomorphometric, and mechanical analyses, which typically involve trained professionals interpreting results, but not in the context of defining "ground truth" for a labeling or classification task.

4. Adjudication Method for the Test Set

Not applicable in the context of this device's evaluation. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert opinions during diagnostic AI evaluations. This device's evaluation relies on objective measurements and scientific analysis in animal models.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers are involved in interpreting medical images or data. ALTAPORE is a medical device (bone void filler), and its performance is not assessed through human reader interpretation of AI output.

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

Not applicable. This device is not an algorithm or AI system. It is a physical bone void filler. The "standalone" performance here refers to the device's inherent properties and biological interactions as assessed in in vitro and in vivo (animal) studies, without human intervention in its function. The studies evaluate the material itself.

7. The Type of Ground Truth Used

The "ground truth" for evaluating ALTAPORE's performance in animal studies was established through a combination of objective scientific analyses:
- Radiographic analysis: Imaging confirming bone formation.
- Histopathological analysis: Microscopic examination of tissue to assess new bone growth and remodeling.
- Histomorphometric analysis: Quantitative microscopic analysis of tissue structures.
- Mechanical analysis: Testing the strength and integrity of the repaired bone.
- In vitro studies: Demonstrating apatite layer formation in simulated body fluid.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. ALTAPORE is a physical medical device, not an AI or algorithm that requires training data.

9. How the Ground Truth for the Training Set was Established

Not applicable. As mentioned above, there is no "training set" for this device.

Summary

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Traditional 510(k) Premarket Notification
K130531 - ALTAPORE

Scetion 5, 510(k) Summary

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5. 510(K) SUMMARY			APR 08 2
DATE SUMMARYPREPARED:	23 January 2013
OWNER:	Baxter Healthcare CorporationOne Baxter WayWestlake Village, CA 91362
CONTACT PERSON:	Jerzy WojcikAssociate Director, Global Regulatory AffairsBaxter Healthcare CorporationOne Baxter WayWestlake Village, CA 91362	Telephone:	224-948-3954
		Fax:	805-372-3082
		Email:	jerzy_wojcik@baxter.com
DEVICE NAME:	Trade Name:	ALTAPORE
	Common Name:	Bone Void Filler
	Classification:	Resorbable calcium salt bone void filler devices have beenclassified by the Orthopedics Device Panel as Class IISpecial Controls per 21CFR888.3045
	Class:	Class II
	Product Code:	MQV
PREDICATEDEVICES	K071206	Actifuse® ABX E-Z-fil Putty Bone Graft Substitute
	K081979	Actifuse® Bone Graft SubstituteActifuse® ABX E-Z-fil Putty Bone Graft SubstituteActifuse® Shape Bone Graft SubstituteActifuse® Flow Bone Graft Substitute
	K082575	Actifuse® Bone Graft SubstituteActifuse® Microgranules Bone Graft SubstituteActifuse® E-Z PrepActifuse® ABX E-Z-fil Putty Bone Graft SubstituteActifuse® MISActifuse® Shape Bone Graft Substitute

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Traditional 510(k) Premarket Notification K130531 - ALTAPORE

DEVICE DESCRIPTION:

STATEMENT OF INTENDED USE:

ALTAPORE is an implant intended to fill bony voids or gaps of the skeletal system i.e., extremities and pelvis. ALTAPORE can be used in combination with autograft as a bone graft extender in the extremities and pelvis. ALTAPORE can be used in combination with autogenous bone marrow aspirate in the extremities and pelvis. These osscous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ALTAPORE resorbs and is replaced with bone during the healing process.

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TECHNOLOGICAL CHARACTERISTICS:

ELEMENT OFCOMPARISON	ALTAPORE	PREDICATE (ABX)
Composition	Silicate-substitutedcalcium phosphatecomposed solely ofelements that existnaturally in normal bone(Ca, P, O, H, Si).	Silicate-substitutedcalcium phosphatecomposed solely ofelements that existnaturally in normal bone(Ca, P, O, H, Si).
PhysicalStructure	Granules with a porositysimilar to cancellous bone	Granules with a porositysimilar to cancellous bone
Nominal (Total)Porosity	$82.5 \pm 2.5%$	$80.0 \pm 2.5%$
Strut Porosity	Microporous	Microporous
Sterility	Terminal irradiation	Terminal irradiation

ASSESSMENT OF NONCLINICAL DATA:

Testing has shown ALTAPORE to meet the requirements of relevant standards for Calcium Salt Bone Void Fillers. Testing has confirmed ALTAPORE to be safe and effective in providing a scaffold for rapid bone repair via hony infiltration of the porous scaffold. Non-clinical testing included benchtop material characterization, dissolution, and mechanical; as well as in-vitro hioactivity . Biocompatibility of the device has been established in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and Testing. Critical size defect implantation in-vivo animal studies have demonstrated that ALTAPORE is efficacious as a standalone bone graft substitute, mixed with Bone Marrow Aspirate (BMA), or mixed with autologous bone.

The conclusions drawn from the non-clinical tests demonstrate that CONCLUSIONS: ALTAPORE is as safe, as cffcctive, and performs as well or better than the predicate devices as a bioactive and osteoconductive bone void filler for osscous defects and is therefore substantially equivalent to the predicate devices. ALTAPORE is efficacious as a standalone bone graft substitute, mixed with Bone Marrow Aspirate (BMA), or mixed with autologous bone. The side-by-side comparative benchtop, in-vitro and in-vivo performance data provided showed no evidence of local or systemic adverse effects related to the device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or waves.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10907 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 8, 2014

Baxter Healthcare Corporation Mr. Jerzy Wojcik Associate Director, Global Regulatory Affairs One Baxter Way Westlake Village, California 91362

Re: K130531

Trade/Device Name: ALTAPORE Regulation Number: 21 CFR 888,3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: March 13, 2014 Received: March 14, 2014

Dear Mr. Wojcik:

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 that I D. And Interes 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 - Mr. Jerzy Wojcik

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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,

Lori A. Wiggins

for

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

Enclosure

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Traditional 510(k) Premarket Notification K130531 - ALTAPORE

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K130531

Device Name:

ALTAPORE

Indication(s) for Use:

তি Prescription Use: 21 CFR 801 Subpart D

Over-the-Counter Use: I 21 CFR 801 Subparı C

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

Page of

(Division Sign-Off) Division of Orthopedia Devices 510(k) Number: K130531

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.