The aprevo™ Transforaminal interbody device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo™ Personalized Interbody device is indicated for use as an adjunct to fusion at one or more levels of the lumbar spine in patients having an ODI >40 and diagnosed with severe symptomatic adult spinal deformity (ASD) conditions. These patients should have had six months of non-operative treatment. The device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches.

Device Description

The aprevo™ Transforaminal IBF, including the aprevo™ transforaminal curved lumbar interbody fusion (TLIF-C) and the aprevo™ transforaminal oblique lumbar interbody fusion (TLIF-O), are designed to stabilize the lumbar spinal column and facilitate fusion. The personalized aprevo™ devices incorporate patient specific features to allow the surgeon to tailor the deformity correction to the individual needs of the patient. The individualized surgical correction plan and device configurations are developed using patient CT scans. The aprevo™ devices are manufactured from Titanium Alloy (Ti-6Al-4V) per ASTM F3001. The aprevo™ TLIF-C and aprevo™ TLIF-O devices have a cavity intended for the packing of bone graft.

AI/ML Overview

The provided text describes a medical device, the aprevo™ Transforaminal IBF, and its regulatory clearance. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria related to its performance in a clinical or diagnostic setting. Instead, the document focuses on mechanical testing and a "Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy" to demonstrate substantial equivalence to predicate devices for regulatory purposes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I describe studies that prove the device meets such criteria based on the provided text.

The closest information provided related to "performance data" is for mechanical testing and usability, not for a diagnostic or clinical performance study.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Cannot provide. The document only lists "test modes" for mechanical testing (Static axial compression per ASTM F2077, Static compression shear per ASTM F2077, Dynamic axial compression per ASTM F2077, Dynamic compression shear per ASTM F2077, Subsidence per ASTM F2267) and one "TR-056 Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy." It states, "The results of this non-clinical testing show that the mechanical performance of the aprevo™ Transforaminal IBF is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." No specific quantitative acceptance criteria or numerical performance results are provided for any of these tests.

2. Sample size used for the test set and the data provenance:

Cannot provide. The document mentions a "TR-056 Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy" but provides no details on the sample size (number of patients/cases), data provenance (country, retrospective/prospective), or methodology of this "clinical evaluation."

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

Cannot provide. This information would typically be part of a clinical or diagnostic performance study, which is not detailed here.

4. Adjudication method for the test set:

Cannot provide. This information would typically be part of a clinical or diagnostic performance study, which is not detailed 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:

Cannot provide. This document describes an interbody fusion device, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a physical implant, not an algorithm, although its design involves patient CT scans for personalization. The document refers to the device being tested, not an algorithm.

7. The type of ground truth used:

Cannot provide. For mechanical testing, the "ground truth" would be the standard test parameters. For the "Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy," the nature of the "ground truth" for "usability, fit, and accuracy" is not specified (e.g., surgical observation, post-operative imaging, patient outcomes).

8. The sample size for the training set:

Not applicable. This document describes a physical medical device (Transforaminal IBF), not an AI algorithm that would have a "training set." While the device design uses patient CT scans for personalization, this is part of the manufacturing process for a patient-specific device, not an AI model training a diagnostic algorithm.

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

Not applicable. As above, there is no "training set" in the context of an AI algorithm described in this document.

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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 30, 2021

Carlsmed, Inc. Karen Liu VP Quality and Regulatory 4250 Executive Sq., Ste. 675 La Jolla, California 92037

Re: K210542

Trade/Device Name: aprevo™ Transforaminal IBF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 29, 2021 Received: June 30, 2021

Dear Karen Liu:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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,

Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known)	K210542
Device Name	aprevo™ Transforaminal IBF

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff

PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displavs a currently valid OMB number. '

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(K) SUMMARY

Submitter's Name:	Carlsmed, Inc.
Submitter's Address:	4250 Executive Sq., Ste. 675La Jolla, CA 92037
Submitter's Telephone:	760-766-1926
Contact Person:	Karen Liu, VP Quality and RegulatoryCarlsmed, Inc.760-766-1926regulatory@carlsmed.com
Date Summary was Prepared:	29-Jun-2021
Trade or Proprietary Name:	aprevo™ Transforaminal IBF
Common or Usual Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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K210542 Page 2 of 2

TECHNOLOGICAL CHARACTERISTICS

The aprevo™ Transforaminal IBF is made from titanium alloy that conforms to ASTM F3001. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

Indications for use ●
Technological characteristics
. Sizes
Materials of manufacture .
Patient specific adaptable features .
Mechanical functionality ●

Table 5-1 Predicate Devices

510kNumber	Trade or Proprietary or ModelName	Manufacturer	Predicate Type
K190092	UNiD Patient-specific 3Dprinted TLIF cage	MedicreaInternational	Primary
K182158	UNiD Patient-matched PLIFcage	MedicreaInternational	Additional
K202034	aprevo™ Intervertebral BodyFusion Device	Carlsmed, Inc.	Additional

PERFORMANCE DATA

The aprevo™ Transforaminal IBF has been tested in the following test modes:

Static axial compression per ASTM F2077
Static compression shear per ASTM F2077 ●
Dynamic axial compression per ASTM F2077
. Dynamic compression shear per ASTM F2077
Subsidence per ASTM F2267 .
. TR-056 Clinical Evaluation of Transforaminal Implant Usability, Fit, and Accuracy

The results of this non-clinical testing show that the mechanical performance of the aprevo™ Transforaminal IBF is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall indications for use, technology characteristics, and mechanical performance data lead to the conclusion that the aprevo™ Transforaminal IBF is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.