Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony you'd or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.

Device Description

Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, non-pyrogenic, and for single use in double peel packages.

AI/ML Overview

This document is a 510(k) premarket notification for the Sorrento™ Bone Graft Substitute. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, extensive study details for a device of this type (a bone graft substitute), and AI-specific metrics (like MRMC studies) cannot be fully extracted from this document, as it outlines a different regulatory approval pathway.

Here's a breakdown of what can be inferred and what cannot, based on the provided text:

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

Acceptance Criteria: While not explicitly stated as "acceptance criteria" in the traditional sense of a performance study with numerical targets, the document establishes "substantial equivalence" as the primary regulatory acceptance criterion. This means the device must perform at least equivalently to the predicate device.
Reported Device Performance: The document states that the Sorrento™ Bone Graft Substitute was compared to the predicate device (Vitoss® Scaffold Foam Bone Graft Material) in a non-clinical rabbit model. The "performance" was observed to be "at least equivalent."

| Criterion                                    | Acceptance Goal                                                                    | Reported Device Performance                                                |
| :------------------------------------------- | :--------------------------------------------------------------------------------- | :------------------------------------------------------------------------- |
| Substantial Equivalence to Predicate Device  | Device performs at least equivalently to the predicate device.                     | Demonstrated to have "at least equivalent performance characteristics" and "substantially equivalent" to the predicate device. |
| Design                                       | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Material Characterization                    | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Biocompatibility                             | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Sterilization                                | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Components of Device (Material)              | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Dimensional Specifications                   | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Physical Form (Sponge)                       | Substantially Equivalent to Predicate                                              | YES                                                                        |
| Radiographic Evaluation (rabbit model)       | Performance comparable to predicate device.                                        | Study data demonstrated "substantially equivalent" with the predicate device. |
| Histomorphometric Evaluation (rabbit model)  | Performance comparable to predicate device.                                        | Study data demonstrated "substantially equivalent" with the predicate device. |
| ASTM F1088 compliance                        | In compliance with standard for beta tricalcium phosphate.                         | Supported by evaluation per ASTM F1088.                                    |
| ASTM F2212 compliance                        | In compliance with standard for collagen.                                          | Supported by evaluation per ASTM F2212.                                    |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document mentions a "Distal femoral defect model in rabbits." However, the number of rabbits or individual defects used in this study (i.e., the sample size) is not specified in the provided text.
Data Provenance: The study was a non-clinical animal model (rabbits). The country of origin is not specified but is typically associated with the submitter (Haider Biologics, LLC, San Diego, California). It is prospective in nature, comparing the subject device to the predicate device following implantation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For a non-clinical animal study involving radiographic and histomorphometric evaluation, experts (e.g., veterinary radiologists, pathologists) would typically be involved, but their number and specific qualifications are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as it pertains more to human reader studies often associated with AI/imaging devices. For an animal study, the evaluation method (e.g., blinded assessment by pathologists) would be relevant but is not described here.

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 imaging devices often involving AI assistance, not for a bone graft substitute.

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

No, this concept does not apply to a bone graft substitute. It's a bio-material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical animal study, the "ground truth" for evaluating the performance was based on:
- Radiographic evaluation: Likely interpreted by experts.
- Histomorphometric evaluation: Involving tissue analysis, which typically uses pathology as the basis for evaluation by experts (e.g., histopathologists).
- Comparison against the established performance of the predicate device.

8. The sample size for the training set

This concept is not directly applicable. This is a medical device (bone graft substitute), not an AI algorithm that requires a "training set." The non-clinical study serves as a "test set" for performance evaluation against the predicate.

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

See point 8; this is not relevant for this type of device.

Summary

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

February 23, 2015

Haider Biologics, LLC Gustavo R. Prado. PhD Vice President of R&D 9930 Mesa Rim Road San Diego, California 92121

Re: K141429

Trade/Device Name: Sorrento™ Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: January 22, 2015 Received: January 26, 2015

Dear Dr. Prado:

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

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Page 2 – Gustavo R. Prado, PhD

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 vours.

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) K141429

Device Name Sorrento™ Bone Graft Substitute

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

Submitter:

Haider Biologics, LLC 9930 Mesa Rim Drive, San Diego, CA 92121

Phone: (858) 202-1540 Fax: (858) 202-1549

Contact: Gustavo R. Prado, PhD Title: Vice President of R&D E-mail: gprado@haiderbiologics.com

Date Prepared:

February 18, 2015

Subject Device:

Trade Name: Sorrento™ Bone Graft Substitute Common Name: Bone Void Filler

Classification Name: Resorbable Calcium Salt Bone Void Filler Device Regulation: 21 CFR 888.3045

Device Class: Class II Product Code: MQV Review Panel: Orthopedic

Predicate Devices:

510(k) #	Trade Name	Product Code
K032288	Vitoss® Scaffold Foam Bone Graft Material(Orthovita, Inc.)	MQV

Device Description:

Indications for Use:

Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony void or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.

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Technological Characteristics:

The subject device is substantially equivalent to the cited legally marketed predicate device. The subject device has the same technological characteristics including design, materials, operating principle and indications for use.

Chart comparing subject device to the predicate device:

Characteristic	Substantially Equivalent?	Impact on Safety &Performance
Design	YES	None
Material Characterization	YES	None
Biocompatibility	YES	None
Sterilization	YES	None
Components of Device (Material)	YES	None
Dimensional Specifications	YES	None
Physical Form (Sponge)	YES	None

Non-Clinical Testing:

Distal femoral defect model in rabbits was used to compare the subject device to the predicate device at 6 and 12 weeks following implantation. Performance was evaluated radiographically and histomorphometrically. Study data demonstrated that the subject device is substantially equivalent with the predicate device.

In addition, substantial equivalence of the Sorrento Bone Graft Substitute was supported by evaluation per ASTM F1088 (for beta tricalcium phosphate) and ASTM F2212 (for collagen).

Clinical Testing:

Clinical performance data were not required to determine substantial equivalence

Conclusions:

Conclusions drawn from the non-clinical tests demonstrated that the subject device possessed at least equivalent performance characteristics as the predicate device, and that overall the subject device is substantially equivalent.

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.