The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The FABC devices are used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

When used with the two fixation screws, the FABC System is a stand-alone system and requires no additional supplemental fixation. When used without the fixation screws, the FABC System should be used with supplemental fixation cleared for use in the lumbar spine. When only one device is implanted, the FABC System must be used with supplemental fixation cleared for use in the lumbar spine.

Device Description

The Fixated Asfora BULLET CAGE® (FABC) System is comprised of a threaded titanium alloy interbody fusion cage and two optional fixation screws. The implants are available in an assortment of diameter and length combinations to accommodate a variety of anatomic requirements. The instrumentation for implantation is manufactured from medical grades of stainless steel per ASTM F899 with some having silicone handles.

AI/ML Overview

This document is a 510(k) premarket notification for the Fixated Asfora BULLET CAGE® (FABC) system, an intervertebral body fusion device. The focus is on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria for an AI/ML device or conducting a study to prove it meets them. Therefore, many of the requested categories related to AI/ML device performance and ground truth establishment are not applicable.

Here's the information that can be extracted from the provided text, categorized as per your request, with "N/A" for those not relevant to this type of submission:

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

Acceptance Criteria (related to substantial equivalence)	Reported Device Performance
Mechanical testing of worst case FABC System devices according to ASTM F2077 (static & dynamic compression, static & dynamic compression shear, static torsion).	Mechanical test results demonstrate that FABC System performance is substantially equivalent to the predicate devices.
Evaluation of subsidence properties according to ASTM F2267.	Subsidence properties were evaluated according to ASTM F2267.
Evaluation of expulsion according to the ASTM draft standard.	Expulsion was evaluated according to the ASTM draft standard.
Intended use: Same as predicate devices.	The FABC System possesses the same intended use as predicate devices.
Basic design: Similar to predicate devices (cage with integrated fixation).	The FABC System possesses a similar basic design to predicate devices.
Material: Same as predicate devices (titanium alloy).	The FABC System is made of titanium alloy (ASTM F136), same material as predicate devices.
Sizes: Comparable to those offered by predicate systems.	The FABC System offers sizes comparable to those offered by the predicate systems.
Differences from predicate devices: Must not raise new questions of safety and effectiveness.	Differences were shown not to raise new questions of safety and effectiveness.

2. Sample sized 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 refers to mechanical testing of "worst case FABC System devices." The specific number of devices tested is not provided in this summary.
Data Provenance: The document does not specify the country of origin of the data or whether the mechanical testing was retrospective or prospective. It is generally understood that such testing would be conducted in a laboratory setting by the manufacturer.

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)

N/A. This is a medical device (implant) submission, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for this device's performance is derived from standardized mechanical testing.

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

N/A. As this is not an AI/ML device with human interpretation, an adjudication method is not relevant.

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

N/A. This is not an AI-assisted device.

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

N/A. This is a physical medical implant, not an algorithm.

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

For the performance testing, the "ground truth" is established by adherence to recognized ASTM (American Society for Testing and Materials) standards for mechanical performance of intervertebral body fusion devices (ASTM F2077, ASTM F2267, and an ASTM draft standard for expulsion). These standards define the methods and criteria for evaluating the physical properties of the device.

8. The sample size for the training set

N/A. This is not an AI/ML device requiring a training set.

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

N/A. This is not an AI/ML device.

Summary

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September 26, 2018

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

Medical Designs, LLC Kristi Vondra VP of Operations 6709 S. Minnesota Ave. Suite 204 Sioux Falls. South Dakota 57108

Re: K181591

Trade/Device Name: Fixated Asfora BULLET CAGE® (FABC) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: August 15, 2018 Received: August 17, 2018

Dear Kristi Vondra:

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

Brent Showalter -S

for 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

510(k) Number (if known) K181591

Device Name Fixated Asfora BULLET CAGE® (FABC)

Indications for Use (Describe)

The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The FABC devices are used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

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

Date:	5 Sept 2018
Sponsor:	Medical Designs, LLC
	6709 South Minnesota Avenue, Suite 204
	Sioux Falls, SD 57108
	Office: 888.276.7271
	Fax: 605.335.3734
Sponsor Contact:	Kristi Vondra, VP of Operations
Proposed Trade Name:	Fixated Asfora BULLET CAGE® (FABC)
Common Name:	Lumbar interbody fusion system with and without fixation
Device Classification:	Class II
Regulation Name,Regulation Number,Product Codes:	Intervertebral body fusion device, 888.3080, MAX & OVD
Device Description:	The Fixated Asfora BULLET CAGE® (FABC) System is comprised of athreaded titanium alloy interbody fusion cage and two optional fixationscrews. The implants are available in an assortment of diameter and lengthcombinations to accommodate a variety of anatomic requirements. Theinstrumentation for implantation is manufactured from medical grades ofstainless steel per ASTM F899 with some having silicone handles.
Indications for Use:	The Fixated Asfora BULLET CAGE® (FABC) is indicated for spinal fusionprocedures in skeletally mature patients for the treatment of degenerativedisc disease (DDD) and instability in the lumbar spine at one or twocontiguous levels from L2 to S1. DDD for lumbar systems is defined asback pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies. The DDD patients may also have up toGrade I spondylolisthesis at the involved level(s). Patients should beskeletally mature and have had at least six (6) months of non-operativetreatment. The FABC devices are used with autograft and/or allograftcomprised of cancellous and/or corticocancellous bone graft.When used with the two fixation screws, the FABC System is a stand-alonesystem and requires no additional supplemental fixation. When used withoutthe fixation screws, the FABC System should be used with supplementalfixation cleared for use in the lumbar spine. When only one device isimplanted, the FABC System must be used with supplemental fixationcleared for use in the lumbar spine.
Materials:	FABC System implants are manufactured from Ti-6AI-4V ELI titanium alloy(ASTM F136).
Primary Predicate:	Primary: S128 Anterior Lumbar Interbody Fusion (ALIF) System (RenovisSurgical Technologies, Inc. - K140106)
Additional Predicates:	Avenue® L Lateral Lumbar Cage and Avenue® T Posterior Lumbar Cage(LDR Holding [now Zimmer Biomet] - K153495), Asfora BULLET CAGE®ABC (Medical Designs - K090048, K112648), STALIF (Centinel Spine, Inc.- K101301), MC+ (LDR Holding - K043479), SynCage-C (Synthes Spine -K024364), Lumbar I/F Cage® (DePuy AcroMed, Inc. - P960025) and AVS®ARIA PEEK Spacers (Stryker Corporation - K143163), TM Ardis®Interbody System (Zimmer Trabecular Metal Technology, Inc. – K113561).
Reference Devices:	ASFORA ANTERIOR CERVICAL PLATE SYSTEM (Medical Designs -K143699)
Performance Data:	Mechanical testing of worst case FABC System devices included static anddynamic compression, static and dynamic compression shear and statictorsion according to ASTM F2077. In addition, the subsidence propertieswere evaluated according to ASTM F2267 and expulsion according to theASTM draft standard.The mechanical test results demonstrate that FABC System performance issubstantially equivalent to the predicate devices.
TechnologicalCharacteristics:	The FABC System possesses the same technological characteristics asone or more of the predicate devices. These include:● intended use (as described above)● basic design (cage with integrated fixation),● material (titanium alloy) and● sizes (dimensions are comparable to those offered by the predicatesystems).While the FABC System is not identical to the predicate devices, thedifferences were shown not to raise new questions of safety andeffectiveness. Therefore the fundamental scientific technology of the FABCSystem is similar to previously cleared devices.
Conclusion:	The FABC System possesses the same intended use and technologicalcharacteristics as the predicate devices. Therefore the FABC System issubstantially equivalent for its intended use.

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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.