BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process. When used in the posterolateral spine, osteoSPAN Morpheus must be used as a bone graft extender, mixed in a one to one ratio with autogenous bone graft.

Device Description

osteoSPAN Morpheus is a moldable, osteoconductive bone graft substitute composed of 1-2mm osteoSPAN granules suspended in a resorbable organic binder. The osteoSPAN granules used in osteoSPAN Morpheus are a composite of calcium carbonate with a thin calcium phosphate layer, in the form of hvdroxvapatite, coating on all the surfaces of the interconnected porosity. The interconnected pores are approximately 500 microns in diameter and occupy approximately 65% of the volume. The biocompatible, organic binder used in osteoSPAN Morpheus facilitates placement and containment of the implant and is rapidly resorbed in-situ, leaving behind the osteoSPAN granules without affecting their osteoconductive or resorbable properties.

AI/ML Overview

The provided document is limited in scope and only describes the OsteoSPAN Morpheus device and its expanded indication for use. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study proving the device meets those criteria.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided text.

However, I can extract what is available and indicate what information is missing.

Here's a summary based on the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device through supplementary preclinical performance testing. The reported performance is a qualitative assessment of this equivalence.

Performance Metric	Acceptance Criteria (Not explicitly stated numerically, but implied as "substantially equivalent" to predicate)	Reported Device Performance (Summary of findings)
Bone Ingrowth	Substantially equivalent to predicate osteoSPAN in a posterolateral spine model.	Confirmed substantially equivalent to its predicate osteoSPAN when used in a posterolateral spine model.
Tissue Reaction	Substantially equivalent to predicate osteoSPAN in a posterolateral spine model.	Confirmed substantially equivalent to its predicate osteoSPAN when used in a posterolateral spine model.
Mechanical Strength	Substantially equivalent to predicate osteoSPAN in a posterolateral spine model.	Confirmed substantially equivalent to its predicate osteoSPAN when used in a posterolateral spine model.
Residual Material	Substantially equivalent to predicate osteoSPAN in a posterolateral spine model.	Confirmed substantially equivalent to its predicate osteoSPAN when used in a posterolateral spine model.
Osteoconductive	Identical to osteoSPAN predicate device (K093342).	The osteoSPAN predicate device (K093342), which is the primary component, has identical osteoconductive potential to the current device.
Resorbable Properties	Unaffected by organic binder.	The organic binder does not affect the osteoSPAN granules' resorbable properties.

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

The document states "Supplementary preclinical performance testing confirmed..." but does not provide details on the sample size for this testing. It only mentions the "posterolateral spine model."

The data provenance is within the context of a 510(k) submission to the FDA, suggesting the data was generated specifically for supporting this regulatory submission. It does not specify the country of origin of the data or whether it was retrospective or prospective.

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

Not applicable/Not provided. The document describes preclinical performance testing in a "posterolateral spine model," implying animal or in-vitro models were used, rather than human data requiring expert ground truth establishment for diagnostic purposes.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As the testing appears to be preclinical performance testing, an adjudication method for human interpretation of results is not relevant or described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not mention any MRMC study or any study involving human readers with or without AI assistance. This device is a bone void filler, not an imaging or diagnostic AI device.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical device (bone void filler), not an algorithm or AI. The concept of "standalone performance" for an algorithm does not apply here.

7. Type of Ground Truth Used

For the preclinical performance testing, the "ground truth" would likely be based on:

Histopathology/Microscopic analysis: To assess bone ingrowth and tissue reaction in the experimental models.
Mechanical testing standards: For measuring mechanical strength.
Material analysis techniques: For determining residual material.

However, the specific methods for establishing this "ground truth" are not detailed in the document beyond stating "preclinical performance testing confirmed."

8. Sample Size for the Training Set

Not applicable/Not provided. This device is a physical medical device and does not involve AI or machine learning models that require a "training set."

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

Not applicable/Not provided. (See point 8).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 15, 2015

Biogennix, LLC % Ms. Elaine Duncan President Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082

Re: K142828

Trade/Device Name: osteoSPAN Morpheus Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: December 18, 2014 Received: December 19, 2014

Dear Ms. 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. 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

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Page 2 - Ms. Elaine Duncan

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K142828

Device Name

osteoSPAN Morpheus

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(K) SUMMARY

Submitted on behalf of:

Company Name:	BIOGENNIX, LLC
Address:	18011 Sky Park Circle, Ste MIrvine, CA 92614
Telephone:	949-253-0094
Fax:	949-266-5800
by:	Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082
Telephone:	715-549-6035
Fax:	715-549-5380
CONTACT PERSON:	Elaine Duncan
DATE PREPARED:	January 14, 2015
TRADE NAME:	osteoSPAN Morpheus
COMMON NAME:	bone void filler
CLASSIFICATION NAME:	21 CFR 888.3045;Resorbable calcium salt bone void-filler device
PRO CODE:	MQV

DESCRIPTION of the DEVICE:

This submission expands the indication for use to include posterolateral spine.

INDICATIONS FOR USE:

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filler that resorbs and is replaced with bone during the healing process. When used in the posterolateral spine, osteoSPAN Morpheus must be used as a bone graft extender, mixed in a one to one ratio with autogenous bone graft.

SUMMARY of HOW TECHNOLOGICAL CHARACTERISTICS COMPARE:

The subject device is IDENTICAL to osteoSPAN Morpheus cleared under K132377, except for an expanded indication for use in posterolateral spine fusion and updated instructions for use which now include quidelines for use in posterolateral spine fusion. The osteoSPAN predicate device (K093342) is the primary component of osteoSPAN Morpheus and has not been altered in any way: therefore, both devices have identical osteoconductive potential.

Product	Calcium Salt	GranuleSize	Porosity	PolymerBinder	Osteo-conductive
osteoSPANMorpheusK132377	Calcium carbonate/calcium phosphatecomposite	1-2mm	65%	Yes	Yes
osteoSPAN(K093342)	Calcium carbonate/calcium phosphatecomposite	1-4mm	65%	No	Yes

SUBSTANTIALLY EQUIVALENT TO:

The contents of this submission have demonstrated that osteoSPAN Morpheus is substantially equivalent to OsteoSPAN when used as a bone graft extender in posterolateral spine cleared under K093342 (primary predicate); and is identical to the predicate osteoSPAN Morpheus cleared under K132377. This submission does not change any aspect of the osteoSPAN Morpheus. This submission only adds the additional indication for use for osteoSPAN Morpheus.

CONCLUSION FROM TESTING:

Supplementary preclinical performance testing confirmed that osteoSPAN Morpheus has substantially equivalent bone ingrowth, tissue reaction, mechanical strength and residual material as its predicate osteoSPAN when used in a posterolateral spine model; therefore, osteoSPAN Morpheus is substantially equivalent to the predicate device osteoSPAN when used in posterolateral spinal fusion indications.

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.