The aprevo™ anterior lumbar interbody fusion and aprevo™M lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo™ anterior lumbar interbody fusion and aprevo™ lateral lumbar interbody fusion devices are 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 devices are 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. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

Device Description

The aprevo™ ALIF and LLIF devices 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. Aprevo™ devices are additively manufactured and made from Titanium Alloy (Ti-6Al-4V) per ASTM F3001, and have a cavity intended for the packing of bone graft.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "aprevo™ Intervertebral Body Fusion Device." This document focuses on demonstrating substantial equivalence to legally marketed predicate devices through mechanical performance testing, rather than a study evaluating device performance against pre-defined clinical acceptance criteria.

Therefore, many of the requested elements for a study proving device performance (such as sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) are not applicable or cannot be extracted from this document, as it pertains to a mechanical device and not an AI/diagnostic software.

Here's an analysis based on the available information:

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

The document does not specify quantitative acceptance criteria in terms of clinical outcomes or performance metrics for the device in a clinical setting. Instead, it relies on demonstrating mechanical properties that are sufficient for its intended use and comparable to predicate devices. The "reported device performance" refers to the results of various mechanical tests.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Static axial compression strength sufficient for intended use	Results demonstrate sufficient mechanical performance per ASTM F2077.
Static compression shear strength sufficient for intended use	Results demonstrate sufficient mechanical performance per ASTM F2077.
Dynamic axial compression durability sufficient for intended use	Results demonstrate sufficient mechanical performance per ASTM F2077.
Dynamic compression shear durability sufficient for intended use	Results demonstrate sufficient mechanical performance per ASTM F2077.
Resistance to subsidence for intended use	Results demonstrate sufficient mechanical performance per ASTM F2267.
Accuracy and Usability (Design Process):
Cadaver accuracy validation acceptable	Results from Cadaver Accuracy Validation and Usability Study were acceptable.
Inter- and Intradesigner variability for segmentation, planning, and implant design acceptable	Results from Inter- and Intradesigner Variability Testing were acceptable.
Substantial Equivalence:
Equivalent to predicate devices in mechanical performance, indications for use, and technological characteristics.	Tested to be substantially equivalent to predicate devices (K191391, K182158, K133455).

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 for Test Set: This information is not explicitly provided in the document. Mechanical tests typically use a certain number of device samples, but the specific quantity is not stated here. For the "Cadaver Accuracy Validation and Usability Study" and "Inter- and Intradesigner Variability Testing," the sample size (e.g., number of cadavers or number of designers/cases) is not detailed.
Data Provenance: Not specified, as the data predominantly refers to mechanical testing of the physical device samples. It is not clinical data from patients or countries.

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 is not applicable as the document describes mechanical testing of an intervertebral body fusion device, not an AI/diagnostic software that requires expert ground truth for image interpretation or diagnosis. The "Cadaver Accuracy Validation" likely involved medical professionals, but their number and specific qualifications are not detailed.

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

This is not applicable for the type of mechanical device testing described.

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 is not applicable. The device is a physical implant, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a physical implant, not an algorithm. The "patient-specific adaptable features" and "individualized surgical correction plan" are developed using patient CT scans, which implies a human-in-the-loop design process based on AI/software, but the core device performance evaluation is mechanical.

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

For mechanical testing, the "ground truth" is typically defined by engineering standards (e.g., ASTM standards) and the physical properties of the material and design. For the "Cadaver Accuracy Validation," anatomical landmarks or surgical measurements would serve as the "ground truth." For the "Inter- and Intradesigner Variability Testing," consistency and deviation from a "gold standard" design or a human expert's optimal design would be evaluated. Detailed specifics are not provided in the document.

8. The sample size for the training set

This is not applicable as the document is about a manufactured medical device and its mechanical properties, not an AI/machine learning model that requires a "training set." While the device design process involves patient CT scans to create patient-specific implants, these likely serve as input data for design software (which may incorporate AI), rather than a training set for algorithm development that is being evaluated in this 510(k).

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

This is not applicable for the same reasons as #8.

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.

December 3, 2020

Carlsmed, Inc. % Meredith May Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K202034

Trade/Device Name: aprevoTM Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 29, 2020 Received: November 2, 2020

Dear Ms. May:

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.

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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) 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 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 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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INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug 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) K202034 Device Name

aprevo™ Intervertebral Body Fusion Device

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's Name:	Carlsmed, Inc.
Submitter's Address:	4250 Executive Sq., Ste. 200La Jolla, CA 92037
Submitter's Telephone:	760-205-1195
Contact Person:	Meredith May MSEmpirical Testing Corp.719-337-7579mmay@empiricaltech.com
Date Summary was Prepared:	29-Oct-2020
Trade or Proprietary Name:	aprevo™ Intervertebral Body Fusion Device
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

The aprevo™ anterior lumbar interbody fusion and aprevo™ lateral lumbar interbody fusion devices are intended for interbody fusion in skeletally mature patients and are to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The aprevo™ anterior lumbar interbody fusion and aprevo™ lateral lumbar interbody fusion devices are 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 devices are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches may include anterior lumbar interbody fusion or lateral lumbar interbody fusion.

TECHNOLOGICAL CHARACTERISTICS

The aprevo™ Intervertebral Body Fusion Device is made from titanium alloy that conforms to ASTM F3001. The subject and predicate devices have nearly identical technological

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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 ●
o Sizes
Materials of manufacture ●
Patient specific adaptable features ●
Mechanical functionality o

Table 5-1 Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K191391	HEDRON™ Lumbar Spacers	Globus Medical Inc.	Primary
K182158	UNiD Patient-matched PLIF Cage	Medicrea International S.A.	Additional
K133455	CROSSFUSE II CORONAL TAPER	Pioneer Surgical Technology, Inc.	Additional

PERFORMANCE DATA

The aprevo™ Intervertebral Body Fusion Device 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
Cadaver Accuracy Validation and Usability Study ●
Inter- and Intradesigner Variability Testing for Segmentation, Planning, and Implant Design ●

The results of this non-clinical testing show that the mechanical performance of the aprevo™ IBFD 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™ Intervertebral Body Fusion Device 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.