The Longbow Ti Expandable Lateral Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Device Description

The Longbow Ti Expandable Lateral Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. The implant is hollow to permit packing with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Longbow Ti Expandable Lateral Spacer System components with components from any other system or manufacturer. The Longbow Ti Expandable Lateral Spacer System components should never be reused under any circumstances.

AI/ML Overview

This 510(k) premarket notification is for the LongBow Ti Expandable Lateral Spacer System, an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information about clinical performance studies is not present.

Here's an analysis based on the provided text:

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

The document does not specify quantitative acceptance criteria for clinical performance that an AI device would typically have (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to existing predicate devices through mechanical testing and comparison of design, materials, and indications for use.

Acceptance Criteria Category	Reported Device Performance (LongBow Ti)
Mechanical Performance	- Testing Conducted: Static and Dynamic Compressive Shear, Subsidence, Expulsion.- Conclusion: Presented to demonstrate equivalent mechanical performance to the Life Spine LongBow (K133717). The specific results or numerical acceptance criteria for these tests are not provided in this summary, but the claim is that they demonstrate equivalence.
Material Equivalence	- Material: Titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.- Conclusion: This is the same material used in the predicate devices (Life Spine LongBow K133717 and Life Spine TiBow K170919).
Design Equivalence	- Conclusion: Shown to be substantially equivalent to the predicate systems in terms of design (e.g., expandable mechanism, hollow for bone graft, superior/inferior teeth).
Indications for Use	- Conclusion: The Indications for Use are identical to the predicate devices.
Function Equivalence	- Conclusion: Shown to be substantially equivalent to the predicate systems in terms of function (e.g., intervertebral body fusion device, allows for in-situ expansion).
Sizing Equivalence	- Conclusion: Shown to be substantially equivalent to the predicate systems in terms of sizing (available in a range of sizes and footprints to suit individual pathology).

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

This submission does not involve a clinical test set in the way an AI/software device would. The "testing" referred to is mechanical performance testing on the device itself. Therefore, a sample size for a clinical test set and its provenance are not applicable or provided.

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 this is a physical medical device (intervertebral body fusion device) and the "testing" is mechanical. Ground truth from experts is not established for a clinical test set in this context.

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

Not applicable for the same reasons as above.

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 not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm or AI device.

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

For mechanical testing, the "ground truth" would be established by the physical testing equipment and adherence to ASTM standards (ASTM F2077 & F2267). For the comparative claims, the ground truth is the established properties and performance of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

In summary: The provided document is a 510(k) summary for a physical orthopedic implant. Its acceptance criteria and proof focuses on demonstrating substantial equivalence to already cleared predicate devices through mechanical testing and comparison of design, materials, and intended use, rather than clinical performance against specific metrics like accuracy, sensitivity, or specificity that would be typical for an AI/software as a medical device (SaMD).

Summary

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November 14, 2019

Life Spine Inc. Angela Batker RA/OA Specialist 13951 S Quality Drive Huntley, Illinois 60142

Re: K190721

Trade/Device Name: LongBow Ti Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 13, 2019 Received: October 29, 2019

Dear Angela Batker:

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/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,

for

Brent Showalter Assistant Director (Acting) 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

510(k) Number (if known) K190721

Device Name LongBow Ti

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary LongBow Ti

Submitted By:	Life Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Angela BatkerLife Spine, Inc.13951 S. Quality DriveHuntley, IL 60142Telephone: 847-884-6117Fax: 847-884-6118
Date Prepared:	September 13th, 2019
Trade Name:	LongBow Ti
Common Name:	Intervertebral Body Fusion Device
Classification:	MAX, CFR 888.3080, Class II
Primary Predicate:	Life Spine LongBow (K133717)
Additional Predicate:	Life Spine TiBow (K170919)

Device Description:

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Indications for Use Statement:

The Longbow Ti Expandable Lateral Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Technological Characteristics:

The LongBow Ti System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.

Material:

This submission seeks clearance of a device made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. This this is the same material used in the predicate devices.

Performance Data:

Testing according to ASTM F2077 & F2267 included Static and Dynamic Compressive Shear, Subsidence, Expulsion, was presented to demonstrate equivalent mechanical performance to the to the Life Spine LongBow K133717.

Substantial Equivalence:

The LongBow Ti was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.

Conclusion:

The information presented demonstrates the substantial equivalency of The LongBow Ti.

Regulation Number and Section

N/A