Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.

Device Description

Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.

AI/ML Overview

The provided document describes the 510(k) premarket notification for the "Cartiva® SCI Disposable Instrumentation Set". This device is orthopedic surgical instrumentation, and the 510(k) is for a modification to allow for a single-use, disposable option, with minor material changes.

It is important to note that this 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Cartiva SCI Instrumentation) by showing that the modifications do not raise new questions of safety or effectiveness. Therefore, the "acceptance criteria" and "device performance" in this context refer to the successful completion of various tests to confirm that the disposable set retains the safety and performance of the original, reusable device. There isn't a direct "performance metric" in the typical sense of diagnostic or AI device studies (e.g., sensitivity, specificity).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance/Conclusion
Biocompatibility	- Cytotoxicity (ISO 10993-5)	"All data demonstrated that the safety and performance of the Cartiva SCI Instrumentation is not affected by the modification to allow for disposable, single-use instrumentation." (Implies successful completion of these tests, meeting ISO 10993-1 requirements.)
	- Sensitization (ISO 10993-10)
	- Irritation (ISO 10993-10)
	- Toxicity (ISO 10993-11)
	- Pyrogenicity (ISO 10993-11)
Sterility & Shelf Life	- Terminal sterilization via Gamma radiation	"The Cartiva SCI Disposable Instrumentation Sets are terminally sterilized via Gamma radiation."
	- Sterilization validation per ISO 11137 and ISO 11737 (Method VDmax25)	"Sterilization validation methodology per ISO 11137 and ISO 11737, Method VDmax25. Sterility Assurance Level is 10-6."
	- Sterility Assurance Level (SAL)	"Sterility Assurance Level is 10-6."
	- Non-pyrogenic claims verified through ISO Materials Mediated Rabbit Pyrogen testing	"Non-pyrogenic claims for the Cartiva SCI Disposable Instrumentation Sets were verified through ISO Materials Mediated Rabbit Pyrogen testing."
	- Shelf-Life testing (accelerated aging per ASTM F 1980)	"Shelf-Life testing was established as 5 years through accelerated aging per ASTM F 1980. Realtime testing is ongoing to assure stability."
Performance/Functional	- Simulated Use Testing of aged product in beyond use conditions to demonstrate functionality	"Simulated Use Testing of aged product in beyond use conditions to demonstrate functionality." "All data demonstrated that the safety and performance of the Cartiva SCI Instrumentation is not affected by the modification to allow for disposable, single-use instrumentation." "the single use set has been demonstrated to provide the same level of performance as the predicate reusable device."
	- Ship studies per ASTM D4169	"Ship studies per ASTM D4169." "All data demonstrated that the safety and performance of the Cartiva SCI Instrumentation is not affected by the modification to allow for disposable, single-use instrumentation." "the single use set has been demonstrated to provide the same level of performance as the predicate reusable device."

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

The document does not specify exact sample sizes for each test (e.g., number of units tested for biocompatibility, sterility, or functional testing). The provenance of the data (country of origin, retrospective/prospective) is not mentioned beyond the fact that testing was "carried out" and the manufacturer is based in Alpharetta, Georgia, USA. These are laboratory/bench tests, not clinical studies involving patient data.

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

This question is not applicable. For a device like surgical instrumentation, "ground truth" as it relates to expert consensus on clinical findings is not relevant. The ground truth for these tests is defined by established scientific and regulatory standards (e.g., ISO, ASTM standards) and the physical/chemical properties of the materials and device.

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

This question is not applicable. The tests conducted are laboratory-based, objective measurements against established standards, not studies requiring human interpretation or adjudication in the sense of clinical image analysis or diagnosis.

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

This question is not applicable. This device is surgical instrumentation, not an AI, diagnostic, or imaging-related device. There was no MRMC study or AI component. The document explicitly states: "A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are all preserved."

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

This question is not applicable. This device is surgical instrumentation. There is no algorithm or AI component involved.

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

For the various tests, the "ground truth" is defined by the established scientific and regulatory standards themselves (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization, ASTM F 1980 for accelerated aging, ASTM D4169 for shipping). The device's performance is measured against the specifications and requirements outlined in these standards.

8. The sample size for the training set

This question is not applicable. This device is surgical instrumentation; there is no "training set" in the context of machine learning or AI.

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

This question is not applicable. As there is no AI component or training set, this information is irrelevant.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

June 20, 2018

Cartiva, Inc. Tanya Eberle Senior Director, Regulatory Affairs and Quality Assurance 6120 Windward Parkway Suite 220 Alpharetta, Georgia 30005

Re: K181348

Trade/Device Name: Cartiva® SCI Disposable Instrumentation Set Regulation Number: 21 CFR 888.4505 Regulation Name: Orthopedic surgical instrumentation designed for osteochondral implants with pressfit fixation Regulatory Class: Class II Product Code: QBO Dated: May 18, 2018 Received: May 21, 2018

Dear Ms. Eberle:

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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 Statement

510(k) No. (if known):	K181348
Device Name:	Cartiva® SCI Disposable Instrumentation Set
Indications for Use:	Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.

Prescription Use:(Part 21 CFR 801 Subpart D)	AND/OR	Over-the-Counter Use(21 CFR 801 Subpart C)
X

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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CARTIVA

510(k) Summary

SUBMITTER'S INFORMATION

Owner:	Cartiva, Inc.
Address:	6120 Windward Parkway, Suite 220, Alpharetta, GA 30005
Phone:	770-754-3800
Fax Numbers:	770-754-3808
Contact Person:	Tanya Eberle, Sr. Director, Regulatory Affairs
Date Summary Prepared:	May 18, 2018
DEVICE INFORMATION
Name of Device:	Cartiva SCI Disposable Instrumentation Set
Common/Usual Name:	Orthopedic Surgical Instrumentation
Classification Name:	Orthopedic Surgical Instrumentation designed for osteochondralimplants with press-fit fixation (Product Code QBO)
Predicate Device(s):	Cartiva SCI Instrumentation (Product Code QBO, Regulation Number21 CFR 888.4505)
Device Description:	Orthopedic surgical instruments designed for osteochondral implantswith press-fit fixation are hand-held devices intended to manipulatebone and cartilage tissue or the implant for the positioning, alignment,defect creation, and placement of press-fit osteochondral implants thatutilize no additional means of fixation (e.g., suture fixation, adhesives).This type of device includes instruments specific to the geometry of theimplant.
Indication for Use:	Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicatedfor use in the press-fit fixation of the implantable medical deviceproducts manufactured by Cartiva, Inc.
TechnologicalCharacteristics:	The minor changes to the material of the Cartiva SCI DisposableInstrumentation do not do not raise new questions of safety oreffectiveness. All technological aspects of press-fit fixation arepreserved.
Comparison to PredicateDevice:	The Cartiva SCI Disposable Instrumentation Set intended use andperformance characteristics are not altered by this modification to allowfor a single-use option.

6120 Windward Parkway, Suite 220 Alpharetta, GA 30005

Tel | 877.336.4616 Fax | 770.754.3808 www.cartiva.net Page 1 of 2

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Performance Data:

Testing of the Cartiva SCI Disposable Instrumentation Set was carried out. including:

Biocompatibility per ISO 10993-1

Cytotoxicity (ISO 10993-5) ●
Sensitization (ISO 10993-10)
Irritation (ISO 10993-10) .
. Toxicity (ISO 10993-11)
Pyrogenicity (ISO 10993-11) ●

Sterility and Shelf Life

The Cartiva SCI Disposable Instrumentation Sets are terminally ● sterilized via Gamma radiation.
. Sterilization validation methodology per ISO 11137 and ISO 11737, Method VDmax25.
Sterility Assurance Level is 10-6. ●
Non-pyrogenic claims for the Cartiva SCI Disposable ● Instrumentation Sets were verified through ISO Materials Mediated Rabbit Pyrogen testing.
. Shelf-Life testing was established as 5 years through accelerated aging per ASTM F 1980. Realtime testing is ongoing to assure stability.

Performance/Functional Testing

Simulated Use Testing of aged product in beyond use ● conditions to demonstrate functionality.
Ship studies per ASTM D4169. .

All data demonstrated that the safety and performance of the Cartiva SCI Instrumentation is not affected by the modification to allow for disposable, single-use instrumentation.

A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are all preserved.

This modification falls within the FDA regulations for 510(k) review. The indication for use, intended use, principles of operation, and performance have not been altered. The minor change in technological characteristics (material) of the next-generation disposable instrumentation do not raise any new questions of safety or effectiveness and the single use set has been demonstrated to provide the same level of performance as the predicate reusable device. The Cartiva SCI Disposable Instrumentation Set with next-generation instrumentation is substantially equivalent to the predicate device (Cartiva SCI Instrumentation, Product Code QBO, Regulation Number 21 CFR 888.4505).

The Cartiva SCI next-qeneration disposable instrumentation, as modified by this 510(k), do not raise any new issues regarding safety or effectiveness, and therefore is suitable for commercial sale.

6120 Windward Parkway, Suite 220 Alpharetta, GA 30005

Tel | 877.336.4616 Fax | 770.754.3808 www.cartiva.net Page 2 of 2

Rationale for Substantial Equivalence:

Conclusion:

Regulation Number and Section

§ 888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.

(a)
Identification. Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9. The special controls for this device are:(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position and place the implant.
(2) The patient contacting components of the device must be demonstrated to be biocompatible.
(3) Labeling must include:
(i) Identification of implant(s) and instruments which have been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.