The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Device Description

The Duo Lumbar Interbody Fusion Device is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum. The Duo implant is available in varying lengths and heights with two lordotic configurations, and is provided sterile. The device is designed with a porous central cavity for graft containment, rounded nose to aid implant insertion, and ridged teeth to resist migration.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the Duo™ Lumbar Interbody Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics typically associated with AI/ML devices or novel diagnostic tools.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission. This document describes a modification to an existing device, not a performance study comparing a device's output to a ground truth with specific acceptance criteria.

Here's an breakdown of why most sections cannot be filled, and what information is available:

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

Not Applicable. This document does not establish performance acceptance criteria in the way a diagnostic or AI device would (e.g., sensitivity, specificity, accuracy). Its purpose is to demonstrate that modifications to an already-cleared device do not alter its safety or effectiveness compared to its predicate. The "performance" being assessed is a comparison to the predicate device, not against absolute clinical metrics.

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

Not Applicable. There is no "test set" in the context of clinical data for this type of submission. The document refers to "verification testing" for surgical instrumentation and "review of design changes" and "risk assessment" for the implant, but these are engineering and design control activities, not clinical studies with patients.

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. No ground truth established by experts for a test set is mentioned.

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

Not Applicable. No test set or related 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 is not an AI/ML device, and no MRMC study is mentioned.

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 concensus, pathology, outcomes data, etc)

Not Applicable. No ground truth in the clinical sense is discussed. The "ground truth" relevant to this submission is the expectation that the modified device remains functionally and safely equivalent to the predicate, based on engineering analysis and non-clinical testing.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device; there is no training set.

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

Not Applicable. No training set or ground truth for it.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical "acceptance criteria and study" format for an AI/diagnostic device, here's what can be extracted relevant to the device's assessment:

Device Details:

Device Name: Duo™ Lumbar Interbody Fusion Device
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX
Predicate Device: K160074 Rampart™ D Lumbar Interbody Fusion Device (Spineology Inc.)

Purpose of Submission:

To obtain FDA clearance for modifications to the Duo Lumbar Interbody Fusion Device, including:
* Name change
* Updated surgical instrumentation
* Updated product labeling (no change to indications or contraindications)
* Minor modifications to the Duo implant
* Shelf life extension

Confirmation of Equivalence (rather than "performance against acceptance criteria"):

The core of this submission is to demonstrate substantial equivalence to the predicate device. The following points confirm that the device meets the criteria for substantial equivalence, rather than providing numerical performance metrics:

Duo Implantable Devices:
- A review confirmed modifications do not alter the primary device design, introduce new technological characteristics, or alter the intended use.
- A risk assessment confirmed modifications do not alter the risk profile or present new issues of safety or effectiveness.
Duo Surgical Instrumentation:
- Verification testing was performed to support modifications.
- A review confirmed modifications do not present new technological characteristics or alter the intended use of these devices.
- For instruments interfacing with the implant, the implant/instrument interface remained unchanged.
- Design changes aimed to improve ergonomics and usability but do not alter the primary control mechanism or operating principle.
- A risk assessment confirmed modifications do not alter the risk profile or present new issues of safety or effectiveness.

Comparison to Predicate (Criteria for Substantial Equivalence):

When compared to the predicate device, the modified Duo System has the same or equivalent:

Intended Use
Indications for Use
Fundamental Scientific Technology
Principle of Operation
Device Design
Materials of Construction
Risk Profile

Conclusion:

Based on the review of modifications, Spineology has demonstrated that the modified Duo System is substantially equivalent to the predicate device.

In essence, this document is an administrative and engineering review to ensure that minor changes to an already-cleared device do not negatively impact its safety or effectiveness, thus maintaining its "acceptance" based on the predicate device's prior clearance.

Summary

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August 18, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Spineology, Inc. Ms. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street N.. Suite 600 St. Paul. Minnesota 55128

St. Paul, Minne

Re: K171660 Trade/Device Name: Duo™ Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 21, 2017 Received: July 24, 2017

Dear Ms. Hauge:

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. 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 (reporting of medical device-

Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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)

K171660

Device Name Duo™ Lumbar Interbody Fusion Device

Indications for Use (Describe)

The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be sketally mature and six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

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

Spineology, 44
----------------	--

Date Prepared:	July 20, 2017
Submitter:	Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128Establishment Registration Number: 2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs ManagerPhone: 651.256.8534Fax: 651.256.8505Email: jhauge@spineology.com
Device Name and Classification
Trade Names:	Duo™ Lumbar Interbody Fusion Device
Common Name:	Intervertebral body fusion device
Product Code:	MAX
Regulatory Class:	Class II
Regulation Number:	21 CFR 888.3080
Panel:	Orthopedic
Primary Predicate Device:	K160074 Rampart™ D Lumbar Interbody Fusion Device(Spineology Inc.)

A. Purpose of Submission

The purpose of this submission is to obtain FDA clearance for the following modifications to the Duo Lumbar Interbody Fusion Device (formerly known as Rampart D Lumbar Interbody Fusion Device):

Name change ●
Updated surgical instrumentation
Updated product labeling (no change to indications or contraindications) ●
Minor modifications to the Duo implant
. Shelf life extension

B. Device Description

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C. Indications for Use

The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Duo device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

D. Comparison to Predicate

When compared to the predicate device, the modified Duo System has the same or equivalent:

Intended Use
Indications for Use
. Fundamental Scientific Technology
Principle of Operation

E. Non-Clinical Testing

Duo Implantable Devices: New performance testing was not required to support the modifications to the Duo implantable device.

. A review of the design changes to the Duo implantable device was performed and confirmed that these modifications do not alter the primary device design, introduce new technological characteristics, or alter the intended use of the device.
A risk assessment was performed and confirmed that the modifications to the Duo implant do ● not alter the risk profile for the device or present new issues of safety or effectiveness.

Duo Surgical Instrumentation: Where applicable, verification testing was performed to support modifications to the Duo surgical instrumentation.

. A review of the design changes to the Duo surgical instrumentation was performed and confirmed that these modifications do not present new technological characteristics or alter the intended use of these devices.
. For surgical instruments which are intended to interface with the Duo implant, the implant/instrument remained unchanged.
. The design changes included modifications to maintain or improve surgical instrument ergonomics and usability but do not alter the primary control mechanism or operating principle of the instrument.
. A risk assessment was performed and confirmed that the modifications to the Duo surgical instruments do not alter the risk profile for the device or present new issues of safety or effectiveness.

F. Conclusion

Based on individual and collective review of the modifications to the Duo implant and surgical instruments, Spineology has demonstrated that the modified Duo System is substantially equivalent to the predicate device.

Device Design
Materials of Construction
Risk Profile

Regulation Number and Section

N/A