The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin 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). These patients should be sketally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

Device Description

The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are manufactured out of medical grade Ti-6A1-4V (Grade 5) and Ti-6A-4V (ELI) alloy that conforms to ASTM F1472 and ASTM F136 respectively.

AI/ML Overview

This document, K181531, is a 510(k) Premarket Notification for the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than clinical study data involving AI or human-in-the-loop performance.

Therefore, many of the requested categories related to acceptance criteria for AI performance, clinical study design (sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies), and "how human readers improve with AI" are not applicable to this specific document as it describes a mechanical implant device, not an AI diagnostic tool.

Here's an analysis based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative table for clinical performance. Instead, it outlines the types of non-clinical (mechanical) tests performed and a qualitative conclusion regarding their sufficiency and equivalence.

Non-Clinical (Mechanical) Performance Data:

Acceptance Criteria (Implied)	Reported Device Performance
Sufficient strength for intended use and substantial equivalence to predicate devices under various mechanical loads.	The devices were tested according to: - Static axial compression per ASTM 2077 - Static compressive shear per ASTM 2077 - Dynamic axial compression per ASTM 2077 - Dynamic compressive shear per ASTM 2077 - Subsidence per ASTM F2267 Conclusion: "The results of this non-clinical testing show that the strength of the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are sufficient for their intended use and is substantially equivalent to legally marketed predicate devices."

Acceptance Criteria (Implied)

Reported Device Performance

Sufficient strength for intended use and substantial equivalence to predicate devices under various mechanical loads.

The devices were tested according to: - Static axial compression per ASTM 2077 - Static compressive shear per ASTM 2077 - Dynamic axial compression per ASTM 2077 - Dynamic compressive shear per ASTM 2077 - Subsidence per ASTM F2267 Conclusion: "The results of this non-clinical testing show that the strength of the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are sufficient for their intended use and is substantially equivalent to legally marketed predicate devices."

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

Sample Size for Test Set: Not applicable in the context of clinical images/data for AI. For mechanical testing, the specific number of devices tested is not provided in this summary, but would typically follow ASTM standards.
Data Provenance: Not applicable in the context of clinical images/data for AI. The device itself is manufactured from medical grade Ti-6A1-4V (Grade 5) and Ti-6A-4V (ELI) alloy.

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

Not applicable. This document pertains to a mechanical device, not an AI or diagnostic tool requiring expert interpretation of medical images.

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

Not applicable. This pertains to expert review of medical data for ground truth establishment, which is not relevant for this device.

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

Not applicable. This is a mechanical implant 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. This device does not involve an algorithm.

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

Ground Truth for Mechanical Testing: The "ground truth" here is adherence to mechanical performance standards (ASTM 2077, ASTM F2267) and demonstration of "sufficient strength for intended use" and "substantial equivalence" to predicate devices based on these physical properties.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the machine learning sense.

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

Not applicable. This device does not involve a "training set" or ground truth establishment in the machine learning sense. The "ground truth" for the device's design and material selection would be established through engineering principles, material science, and regulatory standards for implantable medical devices.

Summary

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October 5, 2018

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

SpineEX Inc. % Ms. Meredith May Vice President Empirical Consulting LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K181531

Trade/Device Name: SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 17, 2018 Received: September 20, 2018

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181531

Device Name SpineEX Sagittae (R) Lateral Lumbar Interbody Fusion Devices

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5.510(K) SUMMARY

Submitter's Name:	SpineEX Inc.
Submitter's Address:	4046 Clipper CourtFremont, CA 94538
Submitter's Telephone:	(510) 573-6165
Company Contact Person:	Andrew Rogers
Contact Person:	Meredith Lee May MS, RACEmpirical Consulting LLC719-337-7579MMAy@EmpiricalConsulting.com
Date Summary was Prepared:	08 June 2018
Trade or Proprietary Name:	SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

INDICATIONS FOR USE

The SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin 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). These patients should be skeletally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.

TECHNOLOGICAL CHARACTERISTICS

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:

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Indications for use ●
Materials of manufacture ●
Structural support mechanism ●
Principles of operation ●

Table 5-1: Predicate Devices

510k Number	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K123752	AccuLiF®	CoAlignInnovation	Primary
K123231	Caliber-L	Globus	Additional
K133813	FLXfit IBFD	ExpandingOrthopedics	Additional
K123045	Brigade® Hyperlorditic System	NuVasive®	Additional
K073144	Timberline IBFD	Lanx	Additional

Performance Data

The SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices have been tested in the following test modes:

. Static axial compression per ASTM 2077
Static compressive shear per ASTM 2077 .
Dynamic axial compression per ASTM 2077 ●
Dynamic compressive shear per ASTM 2077 ●
Subsidence per ASTM F2267 .

The results of this non-clinical testing show that the strength of the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are sufficient for their intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are substantially equivalent to the predicate devices.

Regulation Number and Section

N/A