The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radios. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion, is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

AFT is intended for use as a bone void filler in the extremities, spine, intervertebral disc space, and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury. When used in intervertebral body fusion procedures, AFT must be used on its own with an intervertebral body graff containment device cleared by FDA for use with a bone void filler.

Device Description

The OptiMesh Multiplanar Expandable Interbody Fusion System is an intervertebral body graft containment device that is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

AFT Allograft Filler Tube is composed of human demineralized bone matrix, human nondemineralized bone, and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "OptiMesh Multiplanar Expandable Interbody Fusion System" with the addition of "AFT Allograft Filler Tube" as a compatible allograft. It outlines the purpose of the submission, device descriptions, indications for use, technological characteristics, and non-clinical/clinical testing. However, the document does not provide specific acceptance criteria or detailed study results in the format requested.

The FDA 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific, quantifiable acceptance criteria with a detailed study report. The non-clinical and clinical data presented here are used to support this claim of substantial equivalence.

Based on the provided text, I can infer some aspects and highlight what is not present:

Inferred Information:

Acceptance Criteria (Implied): The implied acceptance criteria revolve around demonstrating that the OptiMesh device with AFT performs comparably to the predicate device and the reference devices in terms of mechanical performance and biological impact, without introducing new safety or effectiveness concerns. This means that:
- Mechanical performance of OptiMesh + AFT should be "as intended" and comparable to the reference device and ISO 23089-2 data.
- Biological impact of AFT should be comparable to the reference bone graft.
- Biocompatibility, pyrogenicity/endotoxin, sterilization, packaging, and shelf-life should be acceptable and comparable.
- The risk profile should not be altered, and new safety/effectiveness issues should not arise.
Study Proving Acceptance Criteria: The study used to demonstrate this is primarily a critical engineering and clinical comparison to a bone graft used in a prospective, multi-center, non-randomized, FDA and IRB approved performance goal clinical investigation.

Information NOT present explicitly in the document:

Specific quantifications of acceptance criteria.
A table of acceptance criteria and reported device performance with numerical values.
Sample sizes used for the test set (e.g., number of patients/data points in the clinical investigation for comparison).
Data provenance (country of origin, retrospective/prospective for the comparison study). While it mentions a "prospective" clinical investigation for the reference bone graft, it doesn't specify if the comparison itself involved new prospective data or a retrospective analysis of the existing investigation's data.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
MRMC comparative effectiveness study details (effect size, human reader improvement). This type of study is more common for diagnostic imaging AI than for interbody fusion systems.
Standalone algorithm performance (algorithm only without human-in-the-loop). This is a physical device, so "standalone algorithm performance" is not applicable in the typical AI/software sense.
Type of ground truth used (pathology, outcomes data, etc.) beyond "clinical data" and "performance goal clinical investigation."
Sample size for the training set. There's no mention of a "training set" in the context of an AI/machine learning model. This submission is for a physical medical device.
How the ground truth for the training set was established. (Not applicable for this type of device submission).

Given these limitations, here is the best possible answer based only on the provided text, heavily inferring the "acceptance criteria" based on the substantial equivalence claims:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from Substantial Equivalence)	Reported Device Performance (Summary from Submission)
Mechanical Function and Performance: Device with AFT performs "as intended" and comparably to reference device and ISO 23089-2 mechanical performance data.	"Benchtop mechanical ASTM testing and comparison confirmed that the OptiMesh device with AFT performs as intended in comparison to the reference device and ISO 23089-2 mechanical performance data." (Specific numerical performance values not provided).
Biological Impact: AFT's impact on bone biology is comparable to the reference bone graft.	"A critical comparison between AFT bone void filler and the reference bone graft and its impact on bone biology was conducted and assessed." (Specific comparative biological data not provided).
Biocompatibility, Pyrogenicity/Endotoxin, Sterilization, Packaging, Shelf-life: These aspects are acceptable and comparable to the predicate/reference devices.	"Biocompatibility, pyrogenicity / endotoxin monitoring, sterilization, packaging, and shelf-life were compared and assessed." (Specific details of these assessments and their outcomes, other than "compared and assessed," are not provided).
Risk Profile: No alteration of the risk profile; no new issues of safety or effectiveness compared to the predicate device.	"A risk assessment was performed and confirmed that the OptiMesh device with AFT does not alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate device." (Details of the risk assessment and specific findings not provided).
Clinical Performance & Safety: Performance and safety of OptiMesh with AFT are supported by clinical data demonstrating equivalence to a historically studied bone graft.	"Clinical data has been utilized to demonstrate the performance and safety of the addition of AFT as a compatible allograft for use with the OptiMesh Multiplanar Interbody Fusion System. The clinical data includes evaluation through a critical engineering and clinical comparison to a bone graft that was used in a prospective, multi-center, non-randomized, FDA and IRB approved performance goal clinical investigation." (Specific clinical outcomes not provided).

2. Sample size used for the test set and data provenance:
* Sample Size: Not specified in the given text.
* Data Provenance: The clinical data for comparison comes from a "prospective, multi-center, non-randomized, FDA and IRB approved performance goal clinical investigation" involving a reference bone graft. The country of origin is not specified but it's an FDA-approved study, implying it was likely conducted in the US or under FDA oversight for data acceptability.

3. Number of experts used to establish the ground truth for the test set and their qualifications:
* Not specified. The clinical investigation mentioned for comparison would have medical professionals involved, but the text does not detail the "ground truth" establishment process by experts in the context of this submission.

4. Adjudication method for the test set:
* Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
* No, an MRMC study is not mentioned. This type of study is typically for evaluating diagnostic imaging systems where human readers interpret medical images. This submission is for a physical interbody fusion system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* No, this concept is not applicable. The device is a physical medical implant, not an AI algorithm.

7. The type of ground truth used:
* The term "ground truth" is not explicitly used in the context of a dataset for algorithmic evaluation. However, for the clinical performance comparison, the "performance goal clinical investigation" likely established clinical outcomes (e.g., fusion rates, pain reduction, adverse events) as the de facto "truth" against which the subject device's performance (via comparison to a reference bone graft) was evaluated.

8. The sample size for the training set:
* Not applicable. This submission is for a physical medical device, not an AI/machine learning model that would require a training set.

9. How the ground truth for the training set was established:
* Not applicable, as there is no training set for an AI model.

Summary

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November 1, 2023

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 acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.

Spineology Inc. Andrew Adams Group Director of Regulatory & Ouality Affairs 7800 3rd Street North Suite 600 Saint Paul, Minnesota 55128

Re: K230927

Trade/Device Name: OptiMesh Multiplanar Expandable Interbody Fusion System Regulation Number: 21 CFR 888.3085 Regulation Name: Intervertebral body graft containment device Regulatory Class: Class II Product Code: OQB, MBP Dated: March 31, 2023 Received: April 3, 2023

Dear Mr. Adams:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K230927 - Andrew Adams

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Jesse Muir -S Date: 2023.11.01 14:56:03 Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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)

K230927

Device Name

OptiMesh Multiplanar Expandable Interbody Fusion System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 GER 801 Subpart D)	Over-The-Counter Use (21 CER 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Indications for Use

510(k) Number (if known)

K230927

Device Name

AFT Allograft Filler Tube

Indications for Use (Describe)

AFT is intended for single patient use only.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Spineology	510(k) Summary
Date Prepared:	October 25, 2023
Submitter:	Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128Establishment Registration Number: 2135156
Contact Person:	Andrew AdamsGroup Director of Regulatory & Quality AffairsPhone: 651.256.8500Fax: 651.256.8505Email: aadams@spineology.com
Device Name and Classification
Trade Name:	OptiMesh Multiplanar Expandable Interbody Fusion System
Classification Name:	Intervertebral Body Graft Containment Device
Product Codes:	OQB
Regulatory Class:	Class II
Regulation Number:	21 CFR 888.3085
Panel:	Orthopedic
Trade Name:	AFT Allograft Filler Tube
Classification Name:	Resorbable Calcium Salt Bone Void Filler Device
Product Codes:	MBP
Regulatory Class:	Class II
Regulation Number:	21 CFR 888.3045
Panel:	Orthopedic
Predicate Device
Primary:	K203714 Thoracolumbar Interbody Systems andAttrax Putty
Reference:	DEN200010 Spineology Interbody Fusion System
Reference:	K060161 AFT Allograft Filler Tube

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1. Purpose

The purpose of this premarket notification is to obtain FDA clearance for the addition of AFT Allograft Filler Tube as a compatible allograft for use with the OptiMesh Multiplanar Interbody Fusion System (formerly branded as Spineology Interbody Fusion System).

2. Device Description

Indications for Use 3.

OptiMesh Multiplanar Expandable Interbody Fusion System

The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion, is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

AFT Allograft Filler Tube

AFT is intended for use as a bone void filler in the extremities, spine, intervertebral disc space, and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury. When used in intervertebral body fusion procedures, AFT must be used on its own with an intervertebral body graft containment device cleared by FDA for use with a bone void filler.

AFT is intended for single patient use only.

4. Technological Characteristics

When compared to the predicate device, the OptiMesh Multiplanar Expandable Interbody Fusion System with AFT has the same intended use and the same or similar technological characteristics, including:

Indications for Use ●
Function / Performance ●
Control Mechanism ●
. Energy Type
Principle of Operation ●
. Use with Compatible Fill Material
Use with Supplemental Fixation Systems .

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Different technological characteristics exist, including:

Materials of Construction ●
Structure of Construction
Mechanism of Mechanical Support ●

The subject OptiMesh interbody device and AFT bone void filler device are identical in technological characteristics to the reference devices. The reference devices support the comparison of the subject device to the primary predicate device, particularly that the differences in technological characteristics do not raise different questions of safety and effectiveness.

ട. Non-Clinical Testing

Non-clinical testing was conducted to support AFT as a compatible allograft for use with the OptiMesh device confirming function and performance.

. Benchtop mechanical ASTM testing and comparison confirmed that the OptiMesh device with AFT performs as intended in comparison to the reference device and ISO 23089-2 mechanical performance data.
A critical comparison between AFT bone void filler and the reference bone graft and its ● impact on bone biology was conducted and assessed.
Biocompatibility, pyrogenicity / endotoxin monitoring, sterilization, packaging, and shelf-● life were compared and assessed.
. A risk assessment was performed and confirmed that the OptiMesh device with AFT does not alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate device.

6. Clinical Performance Data

Clinical data has been utilized to demonstrate the performance and safety of the addition of AFT as a compatible allograft for use with the OptiMesh Multiplanar Interbody Fusion System. The clinical data includes evaluation through a critical engineering and clinical comparison to a bone graft that was used in a prospective, multi-center, non-randomized, FDA and IRB approved performance goal clinical investigation. This evaluation supports the performance of the subject device for its intended use.

7. Conclusion

Based on the intended use, technological characteristics, comparison to the predicate device, and support from the reference devices, the subject addition of AFT Allograft Filler Tube as a compatible allograft for use with the OptiMesh Multiplanar Expandable Interbody Fusion System has been shown to be substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 888.3085 Intervertebral body graft containment device.

(a)
Identification. An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must include an assessment of any adverse events observed during clinical use, as well as intervertebral body fusion, and compare this to a clinically acceptable fusion rate.
(2) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant, as well as the ability of the device to be inserted, deployed, and filled with bone graft consistently.
(3) Device must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components, and device-specific instruments.
(5) Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(6) Labeling must bear all information required for the safe and effective use of the device, specifically including the following:
(i) A clear description of the technological features of the device including identification of device materials, compatible components in the fusion construct, and the principles of device operation;
(ii) Intended use and indications for use, including levels of fixation;
(iii) Identification of magnetic resonance (MR) compatibility status;
(iv) Cleaning and sterilization instructions for devices and instruments that are provided nonsterile to the end user; and
(v) Detailed instructions of each surgical step, including device removal.