Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

In the posterolateral spine and intervertebral disc space, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender. When used in intervertebral body fusion procedures, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Device Description

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.

The anorqanic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine Achilles tendon.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix". The document confirms FDA clearance and discusses the device's indications for use and substantial equivalence to previously cleared devices.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the traditional sense of a performance study with defined metrics for the device itself.

The document focuses on establishing substantial equivalence to predicate devices. This means that the FDA has determined the new device is as safe and effective as a legally marketed device that does not require premarket approval.

Here's a breakdown of why the requested information cannot be fully provided from this document:

No "AI" or "Algorithm": This is a bone graft matrix, a physical medical device. It's not a software device or an AI-powered system, so concepts like "AI assistance," "human-in-the-loop," "ground truth," "training set," "test set," "experts," or "adjudication methods" are not applicable.
Focus on Substantial Equivalence: The "study" mentioned is not a performance study against acceptance criteria for an AI or software device. Instead, it refers to the comparison of the subject device to predicate devices to demonstrate substantial equivalence.

However, I can extract the relevant information regarding the "study" (in the context of demonstrating substantial equivalence) and the "performance" as described:

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

Since this is not a software/AI device with performance metrics like sensitivity, specificity, or accuracy, a traditional acceptance criteria table is not present. The "performance" is primarily described by its material composition and functional characteristics, and its equivalence to predicate devices.

Acceptance Criteria (Implied for Substantial Equivalence to Predicates)	Reported Device Performance (as described for substantial equivalence)
Material Composition Equivalence: The device's components (anorganic bone mineral, bioactive glass, type I collagen) should meet specified standards and be comparable to predicate devices.	Composed of anorganic bone mineral, bioactive glass, and type I collagen. Anorganic bone mineral meets ASTM F1581 standard. Bioactive glass (45S5 Bioactive Glass) meets ASTM F1538 standard. Purified type I collagen is derived from bovine Achilles tendon. Same basic design characteristics and technological characteristics (design, material, chemical composition, principle of operation) as the secondary predicate device (K231942) and reference device (K182074). Same specification range as secondary predicate K231942 and reference device K182074.
Functional Characteristics Equivalence: The device should be moldable, osteoconductive, bioactive, porous, allow bony ingrowth, and resorb over time to be replaced by new bone. These characteristics should be consistent with predicate devices.	Moldable to fit the bone defect. Osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. Slowly resorbed and replaced by new bone tissue during the natural healing process.
Intended Use/Indications for Use Equivalence & Expansion: The device's intended use should be substantially equivalent to predicate devices, with justified expansion of indications if applicable.	Original/Predicate Indications: Bone void filler for voids or gaps not intrinsic to bony structure (extremities, pelvis, posterolateral spine) for surgically created osseous defects or traumatic injury. Resorbs and is replaced by bone. Expanded Indication (Subject of this 510(k)): Includes use in the intervertebral disc space with an intervertebral body fusion device cleared by FDA. Also combined with autogenous bone marrow or autograft with saline; can be used as a bone graft extender with autograft.
Safety and Efficacy Equivalence: (Implied through non-clinical testing, sterilization, biocompatibility, and manufacturing controls) The device must be shown to be as safe and effective as the predicate devices. This includes demonstrating: * Sterilization: Maintains validated sterilization method and SAL. * Non-pyrogenic: Confirms non-pyrogenic status. * Biocompatibility: No changes to product requiring new biocompatibility testing. * Animal Testing: Existing animal testing from predicate devices is applicable. * Clinical Data: No new clinical data required due to demonstrated equivalence.	Performance Testing: Unchanged from secondary predicate (K231942) and reference device (K182074) as there are no changes to device characteristics, specifications, manufacturing, or composition due to expanded indications. Sterilization: Validated sterilization method and SAL (1x10-6) remain the same as documented in K231942 and K182074. Non-pyrogenic: Subject device is non-pyrogenic; no changes to product. Biocompatibility: No new biocompatibility testing required as there are no changes to the product and performance data is from K231942 and K182074. Animal Testing: No additional animal testing required; animal testing from K231942 and K182074 is applicable. Clinical Performance Data: Not required to determine substantial equivalence.
Absence of New Safety/Efficacy Issues: Differences in technological characteristics should not raise new issues.	Any differences in technological characteristics between subject and predicate devices do not raise new issues or concerns of safety or efficacy.

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

Not applicable. This is not a study assessing performance of a diagnostic or AI device using a test set of data. The "testing" refers to non-clinical assessments, material characterization, and comparison to predicate devices, not data-driven performance metrics against a "test set."

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)

Not applicable. This is not a study requiring expert-established ground truth for a test set.

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

Not applicable.

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 is not about AI assistance or human reader performance.

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

Not applicable.

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

Not applicable. The "ground truth" for this device's safety and effectiveness is established by its demonstrated equivalence in material, design, and performance characteristics to previously cleared predicate devices through non-clinical testing (e.g., material testing, sterilization validation, biocompatibility) and the absence of new safety/effectiveness concerns.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary

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March 12, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Collagen Matrix, Inc. Daniel Fernandez Regulatory Affairs, Specialist 15 Thornton Road Oakland, New Jersey 07436

Re: K240424

Trade/Device Name: Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: February 12, 2024 Received: February 13, 2024

Dear Daniel Fernandez:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

Sara S. Thompson -S

For

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices

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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) K240424

Device Name

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix

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

1.	Applicant Information
	Applicant Name:Address:Telephone:Fax:	Collagen Matrix, Inc.15 Thornton RoadOakland, New Jersey 07436(201) 405-1477(201) 405-1355
	Contact Person:	Daniel FernandezRegulatory Affairs, Specialistdfernandez@regenity.com
	Date Prepared:	March 6, 2024
2.	Name of the Device
	Device Trade Name:	Mineral Collagen Composite Bioactive MoldableBone Graft Matrix
	Device Common Name(s):	Bone Void FillerBone Graft MatrixBone Graft Substitute
	Device Classification Name:	Filler, Bone Void, Calcium Compound888.3045MQVClass II
3.	Legally Marketed Devices to Which Substantial Equivalence is Claimed
	Predicate Device:	Catalyst Bone Void FillerOssDsign AvK232315
	Secondary Predicate Device:	Mineral Collagen Composite Bioactive ExtraMoldableCollagen Matrix, IncK231942
	Reference Device:	Mineral Collagen Composite Bioactive MoldableCollagen Matrix, IncK182074

4. Description of the Device

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The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

5. Intended Use / Indications for Use

Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

In the posterolateral spine and intervertebral disc space, Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender. When used in intervertebral body fusion procedures. Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

6. Technological Comparison

The subject device has equivalent indications, design principles, and performance characteristics as the predicate device. OssDsign Catalyst Bone Void Filler (510(k) K232315) and secondary predicate Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix (K231942).

The subject device has the same basic design characteristics and technological characteristics (i.e design, material, chemical composition, principle of operation) as the secondary predicate device, K231942 and reference device K182074, with the same specification range.

Any differences in the technological characteristics between the subject and predicate devices do not raise new issues or concerns of safety or efficacy.

7. Non-Clinical and/or Clinical Test Summary and Conclusions

The purpose of this submission is to expand the indications for use of the Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix to include use in the intervertebral disc space in conjunction with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

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Performance testing of the subject device remains unchanged as that submitted for the secondary predicate (K231942) and reference device (K182074). There is no change to the device characteristics and specifications, manufacturing processes or composition resulted from the expanded indications, and the subject device remains identical to the cleared secondary predicate and reference devices K231942 and K182074.

There are no changes to the validated sterilization method and sterility assurance level (SAL 1x10t0) remains the same as documented in the secondary predicated device (K231942) and reference device (K182074).

The subject device is non-pyrogenic. There are no changes to the product and the biocompatibility data remains the same as that submitted in the secondary predicate device (K231942) and reference device (K182074).

Biocompatibility testing of the subject device was not required, as there are no changes to the product and the performance data as submitted for the secondary predicate device (K231942) and the reference device (K182074).

Additional animal testing was not required to determine substantial equivalence. The animal testing conducted and submitted in secondary predicate K231942 and reference device K182074 is applicable for the subject device.

Clinical performance data was not required to determine substantial equivalence.

8. Conclusion

The subject device and the predicate devices have intended use, similar technological characteristics, and are made of similar materials. The subject device and predicate devices share similar packaging and sterilization methods. The data included and referenced in this submission demonstrates substantial equivalence of the subject device to the predicate devices. Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is as safe, effective, and performs as well as the predicate devices.

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.