Agilon Moldable is indicated for use in voids or gaps of the skeletal system, i.e., the extremities, pelvis, and posterolateral spine, that are not intrinsic to the stability of the bony structure. These osseous defects may be created surgically or from traumatic injury. The product may be used alone in the extremities and pelvis but must be mixed with autograft when used in the posterolateral spine. Agilon Moldable resorbs and is replaced with bone during the healing process.

Device Description

Agilon Moldable collagen enhanced bone graft substitute is a moldable, resorbable osteoconductive bone void filler composed of 1-2mm osteoSPAN granules suspended in a biocompatible orqanic binder to facilitate implant mixing, shaping, and containment. The osteoSPAN granules in the product are approximately 65% porous, biphasic calcium salts with interconnected pores having a nominal cross-section of 500 microns. The primary composition of each granule is calcium carbonate, with a thin layer of calcium phosphate throuqhout its entire porosity. The orqanic binder is a combination of a biocompatible polymer and type I collagen fibers to provide enhanced intraoperative handling. The polymer is rapidly absorbed in-situ, leaving behind osteoSPAN granules and collagen fibers as an osteoconductive scaffold.

AI/ML Overview

The provided text describes a 510(k) submission for the Agilon Moldable device. This document is a premarket notification to the FDA, asserting substantial equivalence to a predicate device. It primarily focuses on the device's characteristics, indications for use, and a summary of performance data rather than a detailed study protocol for acceptance criteria.

The information necessary to fully answer all parts of your request (especially concerning specific acceptance criteria and detailed study designs for proving those criteria) is not comprehensively present in this type of FDA letter. However, I can extract the available information and indicate where details are missing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA letter and associated documents for a 510(k) submission typically don't explicitly list "acceptance criteria" in a table format with numerical targets. Instead, the demonstration of substantial equivalence is based on comparing the subject device's characteristics and performance to a legally marketed predicate device. The performance data presented focuses on equivalence to a predicate device and positive control rather than predefined numerical thresholds for the new device.

From the text, the key performance indicator mentioned is "Fusion rates."

Acceptance Criteria (Implied)	Reported Device Performance
Fusion rates (equivalence to predicate and autograft)	Fusion rates were the same between all treatment groups (Agilon Moldable, predicate, positive control (autograft)) at each time point and consistent with published literature.
Absence of adverse reactions	No adverse reactions were noted at the implant site or in distant organs.
Bone formation, remodeling, and implant resorption	New bone formation, bone remodeling, and implant resorption for the test materials were confirmed with time.

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

Test set sample size: Not explicitly stated. The study involved multiple time points and comparisons between Agilon Moldable, a predicate device (Morpheus), and a positive control (autograft) in an in vivo animal model. However, the exact number of subjects or samples per group is not provided in this summary.
Data provenance: Prospective in vivo animal testing in a validated, clinically relevant, single-level posterolateral spinal fusion model. The country of origin of the data is not specified, but the submission is to the U.S. FDA.

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

Not explicitly stated. The ground truth would likely be established by trained veterinary histopathologists and radiologists/imaging specialists for the animal study. The exact number and qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not explicitly stated. For animal studies, evaluation usually involves standardized scoring by expert histopathologists for histology and morphometry, and radiologists for x-ray and micro-CT. Whether these involve independent assessment or consensus is not 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

Not applicable. This device is a bone void filler, a physical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI is irrelevant to this device.

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

Not applicable. As noted above, this is a physical implant, not an algorithm.

7. The type of ground truth used

The ground truth for the in vivo study included:

Mechanical analysis: Objective quantitative assessments of bone strength/fusion.
Histology and Histomorphometry: Microscopic examination and quantitative measurements of tissue samples, evaluating new bone formation, tissue integration, and implant resorption.
X-ray and Micro-CT analyses: Imaging techniques to assess fusion status, bone volume, and structural characteristics.
Observation of adverse reactions: Clinical and pathological assessment for any negative responses to the implant.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a distinct "training set." The in vivo study involved a test set.

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

Not applicable, as there is no training set for this type of device. The ground truth for the in vivo performance study was established through the various analyses mentioned in point 7.

Summary

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February 13, 2020

Biogennix, LLC. % Elaine Duncan President Paladin Medical, Inc PO Box 560 Stillwater, Minnesota 55082

Re: K193168

Trade/Device Name: Agilon Moldable Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: November 12, 2019 Received: November 18, 2019

Dear Elaine Duncan:

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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose, PhD Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193168

Device Name Agilon Moldable

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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SUBMITTER

Submitted on behalf of:

Company Name:	BIOGENNIX, LLC
Address:	1641 McGaw Ave. Irvine, CA 92614
Telephone:	949-253-0094
Fax:	949-266-5800
by:	Elaine Duncan, M.S.M.E., RAC PresidentPaladin Medical, Inc. PO Box 560Stillwater, MN 55082
Telephone:	715-549-6035
Fax:	715-549-5380
Contact Person:	Elaine Duncan
Date Prepared:	November 12, 2019

SUBJECT DEVICE

Trade Name:	Agilon Moldable
Common Name(s):	Bone void filler, Bone graft substitute, Bone graft extender
Regulation Number:	21 CFR 888.3045
Regulation Name:	Resorbable calcium salt bone void-filler device
Product Code:	MQV
Regulatory Class:	II

PREDICATE DEVICE

The contents of this submission have demonstrated that Agilon Moldable is substantially equivalent to Morpheus (K142828) when used as a bone graft extender in the posterolateral spine.

Morpheus-C, cleared to market as a bone graft substitute (K190371) and now marketed as Agilon Moldable, was used as a reference device.

DEVICE DESCRIPTION

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INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE AND REFERENCE DEVICES

Apart from the type I collagen in the subject device, the function, intended use, and technological characteristics of the subject and predicate devices are identical.

Product	510(k)Number	GranulesComposition	PolymerBinder	Collagen	Osteo-conductive
Morpheus(Predicate Device)	K142828	Calcium Carbonate/Calcium Phosphatecomposite	Yes	No	Yes
Agilon Moldable(Reference Device)	K190371	Identical	Identical	Yes	Yes

PERFORMANCE DATA

Agilon Moldable, the subject device, is IDENTICAL to reference device cleared under K190371. Biogennix followed the "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device: Guidance for Industry and FDA, June 2, 2003", and the company's design controls and risk analysis procedures to ensure the product is safe and effective for use. Biocompatibility testing and other performance characterization prescribed in "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation within a risk management process" was provided in submission K190371.

This submission includes in vivo testing results of the product in a validated, clinically relevant, single-level posterolateral spinal fusion model. Device performance was compared at multiple time points against the predicate and positive control (autograft) using mechanical, histology, histomorphometry, x-ray, and micro-CT analyses. Fusion rates were the same between all treatment groups at each time point and consistent with published literature. No adverse reactions were noted at the implant site or in distant orqans; new bone formation, bone remodeling, and implant resorption for the test materials were confirmed with time.

CONCLUSIONS

The pre-clinical data presented in this submission demonstrate that Agilon Moldable is substantially equivalent to Morpheus when used as an autograft extender in the posterolateral spine.

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.