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 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.

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 is a 510(k) premarket notification for a medical device called the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the provided text, the device is an interbody fusion device and the submission is focused on demonstrating its similarity to a previously cleared version of the same product. There is no study provided that establishes specific acceptance criteria or measures the performance of the device against such criteria. Instead, the submission relies on the concept of substantial equivalence.

Here's an analysis based on your requested information points:

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

The provided FDA letter and 510(k) summary do not contain specific acceptance criteria or performance metrics for the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. The submission is based on demonstrating that the modified device has identical uses, indications, technological characteristics, and principles of operation as the predicate device (K181531).

Therefore, a table like the one requested cannot be created from the given text. The "reported device performance" is essentially that it is considered "substantially equivalent" to the predicate, implying it performs equivalently.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no test set described for performance evaluation in the provided document. The submission explicitly states: "Since all modifications to the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices from what was cleared in K181531 are additions to the surgical instrumentation, performance testing is not required." This indicates that the regulatory clearance is based on the equivalence of the device's design and materials, not a new performance study.

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)

Not applicable, as no test set or ground truth establishment study is described for the device's performance.

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

Not applicable, as no test set or adjudication process is 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

Not applicable. This device is a physical implant (interbody fusion device), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness analysis is irrelevant to this submission.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

Not applicable, as no specific performance study requiring ground truth is described. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable, as this is a physical medical device and does not involve a training set for an algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification process itself, which relies on demonstrating substantial equivalence to a previously cleared predicate device.

Acceptance Criteria for Substantial Equivalence: The acceptance criteria are implicitly that the modified device should have:
- Identical indications for use.
- Identical materials of manufacture.
- Identical structural support mechanism.
- Identical principles of operation.
- No new types of safety or effectiveness questions compared to the predicate.
Proof of Meeting Acceptance Criteria: The document explicitly states:

"The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness when compared to the predicate. Specifically, the following characteristics are identical between the subject and predicates: Indications for use, Materials of manufacture, Structural support mechanism, Principles of operation."

"Since all modifications to the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices from what was cleared in K181531 are additions to the surgical instrumentation, performance testing is not required. However, risk analysis was conducted on the additional instruments."

"The modified SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are very similar to previously cleared SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. The subject has identical uses, indications, technological characteristics, and principles of operation as the predicate device. The modifications raise no new types of safety or effectiveness questions when compared with the predicate device. The overall technological characteristics lead to the conclusion that SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are substantially equivalent to the predicate device."

In essence, the "study" is a comparative analysis of the device's design, materials, and intended use against a cleared predicate device (K181531) to assert that the modifications do not introduce new safety or effectiveness concerns and that the device remains substantially equivalent. No experimental performance data on the device itself is presented in this document.

Summary

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March 4, 2019

Image /page/0/Picture/1 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.

SpineEX Inc. % Meredith May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K190193

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: February 1, 2019 Received: February 4, 2019

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,

Melissa Hall -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 HUMANSERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known) K190193

Device Name SpineEX Sagittae® Lateral Lumbar Interbody Fusion Device

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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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:	01 February 2019
Trade or Proprietary Name:	SpineEX Sagittae® Lateral Lumbar Interbody FusionDevices
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX, OVD
Classification Panel:	Division of Orthopedic Devices

510(K) SUMMARY

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.

The indications for use for the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are identical to that of the clearance of K181531.

TECHNICAL CHARACTERISTICS

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The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness when compared to the predicate. Specifically, the following characteristics are identical between the subject and predicates:

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

Table 5-1 Predicate Device

510k Number	Trade or Proprietary or Model Name	Manufacturer
K181531	SpineEX Sagittae® Lateral LumbarInterbody Fusion Devices	SpineEX, Inc.

PERFORMANCE TESTING SUMMARY

Since all modifications to the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices from what was cleared in K181531 are additions to the surgical instrumentation, performance testing is not required. However, risk analysis was conducted on the additional instruments.

CONCLUSION

The modified SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are very similar to previously cleared SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. The subject has identical uses, indications, technological characteristics, and principles of operation as the predicate device. The modifications raise no new types of safety or effectiveness questions when compared with the predicate device. The overall technological characteristics lead to the conclusion that SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are 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.