The EL CAPITAN Anterior Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). EL CAPITAN system implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The EL CAPITAN spacer and plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws.

When used with anchors only the zero plate may be used and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

Hyperlordotic interbody devices (>20° lordosis), Oblique interbody devices and EL CAPITAN X must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for use in the lumbar spine.

The EL CAPITAN X spacer may only be used with titanium alloy screws.

Device Description

The EL CAPITAN Anterior Lumbar Interbody Fusion devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). The Spacers are a modular design which allows for interchangeable plate and spacer components. The plate and spacer components contain interlocking features in addition to a spring-loaded latch mechanism which allows for intraoperative assembly prior to implantation. The spacer components are available in a range of footprints and heights, and the plates are offered in multiple fixation types and sizes to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).

AI/ML Overview

The provided text describes the EL CAPITAN Anterior Lumbar Interbody Fusion device and its substantial equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about a study proving the device meets specific acceptance criteria based on performance in a clinical or diagnostic context.

The document discusses the regulatory clearance (K222554) of an intervertebral body fusion device and summarizes the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. However, this is not a study that proves a device meets acceptance criteria in the sense of a clinical performance study with defined metrics for accuracy, sensitivity, or specificity. Instead, it's a regulatory summary demonstrating mechanical and material equivalence.

Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as they are not applicable to the type of information presented.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not in terms of performance metrics like accuracy, sensitivity, or specificity as would be relevant for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the successful completion of the non-clinical tests listed, demonstrating mechanical and material equivalence to predicate devices. The "reported device performance" is that it passed these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Static Compression ASTM F2077	Passed / Results indicate equivalence to predicate devices
Dynamic Compression ASTM F2077	Passed / Results indicate equivalence to predicate devices
Static Compression Shear ASTM F2077	Passed / Results indicate equivalence to predicate devices
Dynamic Compression Shear ASTM F2077	Passed / Results indicate equivalence to predicate devices
Subsidence ASTM F2267	Passed / Results indicate equivalence to predicate devices
Expulsion	Passed / Results indicate equivalence to predicate devices

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

Sample Size for Test Set: Not applicable. The tests are non-clinical (mechanical, material, etc.), not based on a "test set" of patient data for performance evaluation.
Data Provenance: Not applicable. These are laboratory test results, not clinical data from patients.

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

Not applicable. "Ground truth" in the context of expert consensus or pathology is relevant for clinical or diagnostic studies. For these non-clinical mechanical tests, the "ground truth" is defined by the ASTM standards and engineering principles. The tests themselves provide the data.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication process for these non-clinical mechanical tests as there would be for subjective clinical assessments. The results are objective measurements against defined standards.

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

No, an MRMC comparative effectiveness study was not done. The device is an intervertebral body fusion device, not a diagnostic tool or AI-assisted system for human readers.

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.

7. The type of ground truth used

Not applicable in the conventional sense (expert consensus, pathology, outcomes data). For these non-clinical mechanical tests, the "ground truth" is implied by the established ASTM standards and measurable physical properties.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 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.

January 19, 2023

Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063

Re: K222554

Trade/Device Name: EL CAPITAN Anterior Lumbar Interbody Fusion Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: December 20, 2022 Received: December 20, 2022

Dear Parker Kelch:

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

{1}------------------------------------------------

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 Showalter -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K222554

Device Name

EL CAPITAN Anterior Lumbar Interbody Fusion

Indications for Use (Describe)

The EL CAPITAN Anterior Lumbar Interbody Fusion is indicated for intervertebral body fusion procedures in sketally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). EL CAPITAN system implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. The EL CAPITAN spacer and plate assembly are an integrated interbody fusion device intended for stand-alone use when used with all titanium alloy screws.

When used with anchors only the zero plate may be used and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

The EL CAPITAN X spacer may only be used with titanium alloy screws.

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 required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary: EL CAPITAN Anterior Lumbar Interbody Fusion

Date Prepared	August 23, 2022
Submitted By	Astura Medical4949 W Royal LnIrving, TX 75063
Contact	Parker Kelch4949 W Royal LnIrving, TX 75063Phone: 469-501-5530 x503Email: quality@asturamedical.com
Trade Name	EL CAPITAN Anterior Lumbar Interbody Fusion
Common Name	Intervertebral body fusion device
Classification Name	Intervertebral body fusion device - lumbar
Class	II
Product Code	OVD
CFR Section	21 CFR section 888.3080
Device Panel	Orthopedic
Primary Predicate Device	EL CAPITAN Anterior Lumbar Interbody Fusion (K192492)
Additional PredicateDevice(s)	Half Dome (K163481, K182877)SIRION (K192006)
Device Description	The EL CAPITAN Anterior Lumbar Interbody Fusion devices are implantsdeveloped for the substitution of the classical autogenous bone graftblocks. The cages assist to avoid complications related to the bone graftdonation site (chronic pain, hematoma, infection, bone removal from thedonor site making it impossible to remove bone again, quality of the iliacbone, accessing a healthy donor site that may become an unhealthy site,hernias by the incision). The Spacers are a modular design which allowsfor interchangeable plate and spacer components. The plate and spacercomponents contain interlocking features in addition to a spring-loadedlatch mechanism which allows for intraoperative assembly prior toimplantation. The spacer components are available in a range offootprints and heights, and the plates are offered in multiple fixationtypes and sizes to suit the individual pathology and anatomical conditionsof the patient. The implants have a hollow center to allow placement ofautogenous bone graft. The superior and inferior surfaces are open topromote contact of the bone graft with the vertebral end plates, allowingbone growth (arthrodesis).
Materials	Tantalum per ASTM F560Titanium Alloy (Ti6-AL4-V ELI) per ASTM F136Nitinol #1 per ASTM E2063
Substantial EquivalenceClaimed to PredicateDevices	The EL CAPITAN X device is substantially equivalent to the predicatedevices in terms of intended use, design, materials used, mechanicalsafety and performances.
Indications for Use	The EL CAPITAN Anterior Lumbar Interbody Fusion is indicated forintervertebral body fusion procedures in skeletally mature patients withdegenerative disc disease (DDD) of the lumbar spine at one or twocontiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic painwith degeneration of the disc confirmed by history and radiographicstudies. These DDD patients may also have up to Grade I spondylolisthesisor retrolisthesis at the involved level(s). EL CAPITAN system implants areto be used with autogenous bone graft and supplemental fixation.Patients should have at least six (6) months of non-operative treatmentprior to treatment with an intervertebral cage. The EL CAPITAN spacerand plate assembly are an integrated interbody fusion device intended forstand-alone use when used with all titanium alloy screws.When used with anchors only the zero plate may be used and theassembly is intended for use with additional supplemental fixation thathas been cleared by the FDA for use in the lumbar spine.Hyperlordotic interbody devices (>20° lordosis), Oblique interbody devicesand EL CAPITAN X must be used with supplemental fixation (e.g. posteriorfixation) that has been cleared by the FDA for use in the lumbar spine.The EL CAPITAN X spacer may only be used with titanium alloy screws.
Non-clinical TestSummary	The following analyses were conducted:Static Compression ASTM F2077Dynamic Compression ASTM F2077Static Compression Shear ASTM F2077Dynamic Compression Shear ASTM F2077Subsidence ASTM F2267Expulsion
	The results of these evaluations indicate that the EL CAPITAN X implantsare equivalent to predicate devices.
Clinical Test Summary	Clinical data were provided as ancillary evidence of substantialequivalence.
Conclusions: Non-Clinicaland Clinical	Astura Medical considers the EL CAPITAN Anterior Lumbar InterbodyFusion system to be equivalent to the predicate devices listed above. Thisconclusion is based upon the devices' similarities in principles ofoperation, technology, materials and indications for use.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

{4}------------------------------------------------

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.