Cove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cove Strip resorbs and is replaced with bone during process. Cove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.

Device Description

Cove Strip is comprised of a ceramic granule consisting of a ratio of 70:30 Beta-Tricalcium Phosphate (B-TCP): Hydroxyapatite (HA) combined with highly purified Type-1 collagen. The collagen scaffold contains ceramic granules throughout, providing osteoconductive substrates that support new bone formation. Cove Strip combined with autograft in a 1:1 ratio, is intended to be placed in the posterolateral spine. The implant is provided sterile and non-pyrogenic for single use in a double blister tray configuration.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Cove Strip device.

It's important to note that the provided text is an FDA 510(k) clearance letter and its summary. These documents focus on establishing substantial equivalence to a legally marketed predicate device rather than presenting a detailed new performance study with acceptance criteria in the way one might find for a novel AI/software device. The "acceptance criteria" here are implicitly tied to the performance of the predicate devices.

Re-interpretation for a medical device (not AI/software):

Since the device is a medical implant (bone void filler) and not an AI/software device, the questions about "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," MRMC studies, and ground truth for training sets are not applicable in their original context. The FDA 510(k) process for this type of device relies on demonstrating equivalence to predicate devices through design, material, non-clinical (e.g., biocompatibility, sterilization, animal study), and sometimes clinical data.

Here's the information extracted and re-contextualized for the Cove Strip bone void filler:

1. Table of Acceptance Criteria and Reported Device Performance

For this particular medical device (Cove Strip, a bone void filler), "acceptance criteria" are not explicitly defined in terms of specific performance metrics with numerical thresholds in the same way they would be for a diagnostic test or an AI algorithm. Instead, acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices in terms of:

Intended Use/Indications for Use: The subject device must be similar to the predicate.
Technological Characteristics: Design, materials, manufacturing, labeling, sterility, etc.
Non-Clinical Performance: Including biocompatibility, sterilization, and in vivo performance.

Acceptance Criterion (Implicitly based on Predicate Device Performance)	Reported Device Performance (Cove Strip)
Biocompatibility: Safe for biological contact.	Compliant with ISO 10993-1.
Bacterial Endotoxin Limit: Meeting safety standards.	Testing complies with AAMI ST72, USP<85>, and USP<161>. Validated to ensure a BET limit of ≤20 EU/Device.
Sterility: Achieving a required sterility assurance level (SAL).	Sterilization complies with ISO 11135 (Ethylene Oxide) to ensure a SAL of 10^-6^. (Equivalency was established with a predicate device of identical product sizing and packaging, allowing adoption of its sterilization validation).
In Vivo Performance (Resorption, Remodeling, Fusion Rates): Comparable biological response to predicate.	An in vivo (animal) study demonstrated comparable resorption, remodeling, and rates of fusion when compared to a legally marketed predicate. Assessed per ISO 10993-6:2016 for local effects after implantation. (Specificity on what constitutes "comparable" and the exact metrics/thresholds found comparable are not detailed in this summary, but are part of the full submission).

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

The primary "test set" described for performance is an animal study (in vivo).

Sample Size: Not explicitly stated (e.g., number of animals). The document only mentions "An in vivo (animal) study."
Data Provenance: An animal study, likely conducted in a preclinical lab setting. No country of origin is specified. It is a prospective study as it was conducted to evaluate the subject device.

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

This concept is not directly applicable in the context of this 510(k) submission for a bone void filler, which relies on physical and biological testing:

For the in vivo animal study, "ground truth" would be established by standard histological, radiographic, and surgical evaluation techniques. The "experts" would be veterinary surgeons, pathologists, histologists, and radiologists involved in the animal study, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable in the AI/software sense (e.g., 2+1, 3+1 for image interpretation). Adjudication for in vivo studies typically involves consensus among experienced histopathologists, radiologists, and surgeons regarding outcomes like fusion, resorption, and local effects. The specific adjudication method is not mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done...

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices or AI-assisted interpretation, which is not the nature of the Cove Strip device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done (for AI/software devices)

Not applicable. The Cove Strip is a physical implant, not an AI algorithm.

7. The Type of Ground Truth Used

For the in vivo animal study, the ground truth would be based on:

Histopathology: Microscopic examination of tissue samples to assess bone formation, resorption, and inflammation.
Radiography/Imaging: To assess bone healing and fusion.
Gross observation/Surgical evaluation: Direct assessment during necropsy or follow-up surgeries.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model, so there is no "training set" in that sense. The foundational data for its design and manufacturing would come from material science research, biological studies, and engineering principles, but not a "training set" for an algorithm.

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

Not applicable. (See point 8).

Summary of the 510(k) Approach for Cove Strip:

The K230486 submission for Cove Strip demonstrates substantial equivalence to predicate devices (MASTERGRAFT Putty and IsoTis Mozaik Strip) through:

Direct Comparison: Similar indications for use, device description, and technological characteristics (materials: B-TCP:HA ceramic granules with Type-1 collagen; design, manufacturing, sterilization).
Non-Clinical Bench Testing: Biocompatibility (ISO 10993-1), bacterial endotoxin, and sterilization (ISO 11135) to ensure safety.
In Vivo Animal Study: Demonstrating comparable performance (resorption, remodeling, fusion rates) to a legally marketed predicate, and local effects as per ISO 10993-6. This animal study serves as the primary "performance study" for this type of device, showing that it functions as intended in a biological environment similar to how the predicate performs.

The FDA explicitly states: "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." This further emphasizes that the clearance relies on non-clinical data and direct comparison to the predicates rather than new human clinical efficacy trials with explicit, quantitative acceptance criteria for superiority.

Summary

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August 21, 2023

SeaSpine Orthopedics Corporation Cindy Toyama Regulatory Affairs Specialist 2 Goodyear Irvine, California 92618

Re: K230486

Trade/Device Name: Cove Strip Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MOV Dated: July 22, 2023 Received: July 24, 2023

Dear Cindy Toyama:

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

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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 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 medical devices and radiation-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,

Image /page/1/Picture/5 description: The image shows the name "Jesse Muir-S" in a large, bold, sans-serif font. The text is black and stands out against a white background. There is a faint, light blue watermark in the background, partially obscuring the text.

Jesse Muir, Ph.D. 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) K230486

Device Name Cove Strip

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

K230486

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(949) 855-7175
Fax number:	(760) 683-6874
Contact Person:	Cindy Toyama, Regulatory Affairs Specialist
Date Prepared:	June 21, 2023

Device Name

Device/Trade Name:	Cove Strip
Common Name:	Bone Void Filler
Classification Name:	Filler, Bone Void, Calcium Compound (21 CFR 888.3045)
Class:	II
Product Code:	MQV

Legally Marketed Predicate Device

510(k) Number	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K140375	MQV	MASTERGRAFT Putty	Medtronic SofamorDanek USA, Inc.
Additional Predicate Device
K063124	MQV	Integra MOZAIK™ BoneRegeneration Matrix — Strip*	Integra LifeSciencesCorporation

*Since the most recently cleared 510(k) for the predicate device, Integra MOZAK™ Osteoconductive Scaffold – Strip (K063124), under contractual agreements between IsoTis OrthoBiologics, Inc. and Integra LifeSciences Corporation, the device has been rebranded under a new trade name for IsoTis OrthoBiologics, Inc., and will herein be referred to as "IsoTis Mozaik Strip". IsoTis Mozaik Strip is legally manufactured by IsoTis OrthoBiologics, Inc.

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Device Description

Indications for Use

Cove Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., posterolateral spine and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cove Strip resorbs and is replaced with bone during the healing process. Cove Strip must be used with autograft as a bone graft extender in the posterolateral spine and pelvis.

Summary of Technological Characteristics

The subject device is identical or similar to the cited predicate devices in regard to intended use/indications for use, device description, technological characteristics (i.e. design, materials, manufacturing, labeling, sterility, etc.), and non-clinical performance (i.e., in vivo performance (animal) study).

Summary of Non-Clinical Testing to Support Substantial Equivalence

Non-clinical testing performed on the subject device includes tests for biocompatibility and bacterial endotoxin to establish safety. Biocompatibility was performed in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Bacterial endotoxin testing complies with AAMI ST72 Bacterial Endotoxins – Test Methods, Routine Monitoring, and Alternatives to Batch Testing, USP<85> Bacterial Endotoxin Test, and USP<161>, Medical Devices – Bacterial Endotoxin and Pyrogen Tests, and has been validated ensure a BET limit of ≤20 EU/Device.

Equivalency was established with a predicate device consisting of identical product sizing and packaging that allowed us to adopt the sterilization validation. Sterilization complies with ISO 11135, Sterilization of health care products-Ethylene Oxide-Requirements to ensure a sterility assurance level (SAL) of 10-6.

An in vivo (animal) study for safety and performance demonstrated comparable resorption, remodeling and rates of fusion when compared to a legally marked predicate. The study employed various analyses and endpoints were assessed at several time points. The subject device was also assessed per ISO 10993-6:2016 Biological evaluation of medical devices – Part 6: Tests for local effects after implantation.

Clinical Testing

Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.

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Conclusions

The submitted data demonstrate that the subject device is substantially equivalent to the cited legally marketed predicate.

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.