CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the bony structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Description

CarriGen Porous Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. CarriGen PF is a mixing syringe pre-filled with the previously cleared CarriGen Porous Bone Substitute Material. The CarriGen PF system eliminates the need to transfer the CarriGen powder to the mixing syringe. After mixing, CarriGen is administered to the treatment site by manual application. The material can be shaped into a desired form in situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. CarriGen Porous Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

AI/ML Overview

This document describes a 510(k) premarket notification for CarriGen® PF, a resorbable calcium salt bone void filler device. The information provided demonstrates the device's substantial equivalence to predicate devices, but it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and performance studies for an AI/ML medical device.

Specifically, this document does not describe:

A table of acceptance criteria and reported device performance in the context of an AI/ML algorithm. The acceptance criteria mentioned are for the physical properties of a bone void filler.
Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI/ML test set.
MRMC or standalone studies for an AI/ML algorithm.

Therefore, I can only provide the information that is available in the document, which primarily pertains to the physical and chemical properties of the bone void filler, not an AI/ML device.

Here's an analysis of the provided text based on your request, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance (Based on Device Type - Bone Void Filler)

The document primarily focuses on the physical and chemical performance characteristics of the CarriGen® PF bone void filler, not an AI/ML algorithm.

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

The document states that "The information summarized in the Design Control Activities Summary demonstrates that the CarriGen PF meets the pre-determined acceptance criteria for the verification activities." However, it does not provide a table with specific acceptance criteria values and corresponding reported performance values. It only lists the types of performance testing conducted:

Test Type	Description / Purpose	Reported Performance
Simulated Use/Extrusion Testing	Demonstrated the device's performance in a simulated use environment.	"Meets pre-determined acceptance criteria." (Specific values not provided)
Working Time	Time the material remains workable after mixing.	"Meets pre-determined acceptance criteria." (Specific values not provided)
Setting Time	Time for the material to harden.	"Meets pre-determined acceptance criteria." (Specific values not provided)
Compression Strength	Mechanical strength of the hardened material.	"Meets pre-determined acceptance criteria." (Specific values not provided)
Biocompatibility Evaluation	Ensures the material is safe for biological contact.	"Meets pre-determined acceptance criteria." (Specific values not provided)
Bacterial Endotoxin Test (BET)	To establish that the device meets pyrogen limit specifications.	"Meets pyrogen limit specifications." (Specific values not provided)

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

Sample Size for Test Set: Not specified in the provided text. The testing mentioned is for the physical and chemical properties of the material, not a data-driven AI test set.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable or not specified, as this is for material testing, not patient data for an AI/ML algorithm.

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

Not applicable. This information is relevant for AI/ML performance studies involving human expert interpretations of data (e.g., medical images). The document describes testing of a physical medical device.

4. Adjudication method for the test set

Not applicable. This information is relevant for AI/ML performance studies involving multiple human readers.

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 document describes a traditional medical device (bone void filler), not an AI/ML software.

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

Not applicable. This document describes a traditional medical device (bone void filler), not an AI/ML software.

7. The type of ground truth used

For material properties: The ground truth for the performance testing (e.g., working time, setting time, compression strength, biocompatibility, endotoxin levels) would be established by standardized testing methods and specifications (e.g., ASTM standards, ISO standards, USP monographs for biocompatibility and endotoxin). The "truth" is determined by the physical and chemical measurements aligning with the pre-defined acceptable ranges for these properties.
For AI/ML: Not applicable in this document.

8. The sample size for the training set

Not applicable. This document describes a traditional medical device (bone void filler), which does not have a "training set" in the context of an AI/ML algorithm. Its properties are inherent to its formulation and manufacturing process.

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

Not applicable. No training set for an AI/ML algorithm is mentioned.

In summary, the provided FDA 510(k) clearance letter and summary describe the regulatory review of a physical medical device (a bone void filler). It details the device's indications for use, description, predicate devices, and the types of performance testing conducted to demonstrate substantial equivalence of its physical and chemical properties. It does not contain any information relevant to the development, testing, or performance of an artificial intelligence or machine learning-based medical device.

Summary

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August 31, 2018

ETEX Corporation % Stacy Hutchens Scientific Affairs Manager Zimmer Biomet 1800 West Center Street, MS 1901 Warsaw, Indiana 46580

Re: K182107

Trade/Device Name: CarriGen® PF Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, FMF Dated: August 3. 2018 Received: August 3, 2018

Dear Ms. Hutchens:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

Indications for Use

510(k) Number (if known) K182107

Device Name CarriGen® PF

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

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510(k) Summary

Manufacturer:	ETEX Corporation38 Sidney StreetCambridge, MA 02139
Contact:	Ms. Stacy HutchensScientific Affairs ManagerZimmer Biomet1800 West Center Street, MS 1901Warsaw, IN 46580Phone: 574.253.5514Fax: 574.371.8760Email: stacy.hutchens@zimmerbiomet.com
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1050 K Street, NW, Suite 1000Washington, DC 20001Phone: 202.552.5800
Date Prepared:	August 3, 2018
Device Trade Name:	CarriGen® PF
Common Names:	Bone void fillerPiston Syringe
Regulations:	21 CFR 888.3045 – Resorbable calcium salt bone void filler device21 CFR 880.5680 – Piston syringe
Classification:	Class II
Product Codes:	MOV, FMF

Indications for Use:

CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Description:

CarriGen Porous Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. CarriGen PF is a mixing syringe pre-filled with the previously cleared CarriGen Porous

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Bone Substitute Material. The CarriGen PF system eliminates the need to transfer the CarriGen powder to the mixing syringe. After mixing, CarriGen is administered to the treatment site by manual application. The material can be shaped into a desired form in situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. CarriGen Porous Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

Predicate Devices:

OssiPro (ETEX Corp., K062630) and CarriGen® Porous Bone Substitute Material (ETEX Corp., K093447 and K101557) serve as predicate devices with the ETEX Mixing and Delivery System (ETEX Corp., K141245) serving as a reference predicate device.

Performance Testing:

All necessary testing has been performed to assure the substantial equivalence of CarriGen PF to the predicate devices, and demonstrate the device performs as intended.

The following performance testing was performed:

Simulated Use/Extrusion Testing ●
Working Time ●
Setting Time
Compression Strength
Biocompatibility Evaluation
Bacterial Endotoxin Test (BET) to establish that the device meets pyrogen limit ● specifications

Substantial Equivalence:

The modified CarriGen PF is substantially equivalent to the predicate devices based on indications for use, technological characteristics, design, material, mechanical performance testing, packaging and sterilization. Predicate devices K062630. K093447 and K101557 are synthetic calcium phosphate bone graft substitutes; the subject device chemical composition and manufacturing processes are identical to those of the predicate devices. The mixing syringe component and method of application of the subject device are substantially equivalent to that of the reference predicate (K141245). The information summarized in the Design Control Activities Summary demonstrates that the CarriGen PF meets the pre-determined acceptance criteria for the verification activities.

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.