The 3D Printed PEEK Interbody System (ALIF) is intended for spinal fusion procedures in the lumbosacral spine at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral body fusion device. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device must be used with supplemental fixation and is intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is to be implanted via an anterior approach.

The 3D Printed PEEK Interbody System (Cervical) is intended for spinal fusion procedures in the cervical spine at one or two contiguous levels from C2 to T1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device must be used with supplemental fixation and is intended for use with autograft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The device is to be implanted via an anterior approach.

Device Description

The 3D Printed PEEK Interbody System devices are spinal fusion implants that are inserted into the intervertebral body space of the spine to act as disc spacers and hold bone graft. These devices are manufactured from PEEK OPTIMA™ LT1AMR5 with tantalum radiographic markers and are offered in multiple footprint, height, and lordotic angle options.

AI/ML Overview

This document, a 510(k) Premarket Notification from the FDA, does not describe the acceptance criteria and study proving a software device meets acceptance criteria. Instead, it details the substantial equivalence of a physical medical device, the "3D Printed PEEK Interbody System," to existing legally marketed predicate devices.

Therefore, many of the requested points for describing an AI/software device's acceptance criteria and study (especially points 2, 3, 4, 5, 6, 7, 8, and 9) are not applicable to the information provided in this document. The document focuses on mechanical and physical properties rather than algorithmic performance.

However, I can extract the relevant information regarding the non-clinical testing performed for this physical device and structure it to the best of my ability, highlighting what is present and what is not.

Acceptance Criteria and Study for 3D Printed PEEK Interbody System (Physical Device)

This document describes the non-clinical testing performed to demonstrate the substantial equivalence of the "3D Printed PEEK Interbody System." The acceptance criteria are implicitly defined by meeting or exceeding the performance of the predicate devices according to established ASTM standards and internal lab protocols.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the non-clinical testing demonstrates the subject devices "have at least equivalent mechanical strength as the predicates and are as safe, as effective, and perform as well or better than these legally marketed devices." Specific numerical acceptance criteria and reported performance values are not provided in this summary. The tests performed are listed as follows:

Test Name	Applicable Device(s)	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Static and Dynamic Torsion per ASTM F2077	Cervical devices	Meet or exceed performance of predicate devices per ASTM F2077.	"At least equivalent mechanical strength as the predicates... as safe, as effective, and perform as well or better."
Static and Dynamic Axial Compression and Compression Shear per ASTM F2077	Cervical and ALIF devices	Meet or exceed performance of predicate devices per ASTM F2077.	"At least equivalent mechanical strength as the predicates... as safe, as effective, and perform as well or better."
Subsidence per ASTM F2267	Cervical and ALIF devices	Meet or exceed performance of predicate devices per ASTM F2267.	"At least equivalent mechanical strength as the predicates... as safe, as effective, and perform as well or better."
Expulsion Testing	Cervical and ALIF devices	Prevent expulsion under defined conditions.	"At least equivalent mechanical strength as the predicates... as safe, as effective, and perform as well or better."
Impaction Testing per lab protocol	Cervical and ALIF devices	Meet performance requirements of internal lab protocol (and implicitly, predicate performance).	"At least equivalent mechanical strength as the predicates... as safe, as effective, and perform as well or better."

Applicability Note: The questions below are typically relevant for AI/software medical devices and are largely not applicable to this 510(k) submission for a physical medical device. Where possible, I will state "Not Applicable" or explain why the information isn't present for a physical device.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in this 510(k) summary. For mechanical bench testing, sample sizes are typically defined by the relevant ASTM standards or internal validation plans, but these details are not disclosed in the public summary.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of benchtop mechanical testing for a physical device. The testing is performed in a laboratory setting.

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

Not Applicable. For mechanical testing, "ground truth" is established by the physical properties and performance metrics measured according to established engineering standards (ASTM). No human experts are used to interpret images or diagnose conditions for AI ground truth.

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

Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in AI studies or clinical trials, not for direct mechanical property testing.

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 physical device, not an AI device designed to assist human readers.

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

Not Applicable. This question pertains to AI algorithm performance.

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

Not Applicable directly. For mechanical testing, the "ground truth" refers to the quantitatively measured physical properties and performance values (e.g., strength, stiffness, deformation) obtained through validated test methods (ASTM standards, internal protocols). Comparative performance against predicate devices serves as a benchmark.

8. The sample size for the training set:

Not Applicable. This device is a physical product, not a machine learning model; therefore, it does not have a "training set."

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

Not Applicable. As there is no training set for a physical device, no ground truth needed to be established in this context.

Summary

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September 17, 2024

Nvision Biomedical Technologies, Inc. % Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry, Inc. (dba SpiTrex 3D) 1815 Aston Ave., STE 106 Carlsbad, California 92008

Re: K240250

Trade/Device Name: 3D Printed PEEK Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: August 16, 2024 Received: August 19, 2024

Dear Jeffrey Brittan:

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.

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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" (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 (QS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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,

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director 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

Submission Number (if known)

K240250

Device Name

3D Printed PEEK Interbody System

Indications for Use (Describe)

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

DATE PREPARED

September 16, 2024

CONTACT DETAILS

Applicant

Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: (210) 545-3713 Applicant Contact: Diana Langham, Director of Regulatory and Corporate Compliance

Correspondent / Consultant

Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry, Inc. (dba SpiTrex 3D) Telephone: (714) 287-6780 Email: jeffbrittan(@spitrexorthopedics.com

DEVICE NAME

Device Trade Name

3D Printed PEEK Interbody System

Common Name Intervertebral body fusion device

Classification Name, Regulation Number & Product Code

Intervertebral Fusion Device with Bone Graft, Lumbar Intervertebral Fusion Device with Bone Graft, Cervical Regulation: 21 CFR 888.3080 Product Code: MAX (lumbar), ODP (cervical)

LEGALLY MARKETED PREDICATE DEVICES

The subject device is substantially equivalent to the following predicates:

510(k) #	Manufacturer & Predicate Device Name	Predicate
K193645	Nvision Biomedical Technologies nva, nvp, and nvt (MAX)	Primary Predicate
K190380	Nvision Biomedical Technologies nvc (ODP)	Additional Predicate
K213030	Curiteva Porous PEEK Cervical Interbody Fusion System (ODP)	Additional Predicate

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DEVICE DESCRIPTION SUMMARY

INTENDED USE / INDICATIONS FOR USE

INDICATIONS FOR USE COMPARISON

The subject device has the same intended use / indications for use as the predicates. Although phrasing may differ slightly, there are no significant differences between the subject device and predicates with respect to indications. The subject and predicate devices are equivalently indicated for spinal fusions using bone graft and supplemental fixation at the same spinal levels in the same patient populations.

TECHNOLOGICAL COMPARISON

The subject device has equivalent technological characteristics as the predicates. The subject devices are designed in the same sizes and geometries with equivalent features as the Nyision predicates but are 3D printed, which allows inclusion of porous latticed areas that provide additional surface for interfacing with bone. Inclusion of these porous features is equivalent to the Curiteva predicate, which is also 3D printed. The subject device ALIF also includes a porous central bridge feature that provides additional surface for device-tissue contact but does not change the function or performance of the device and maintains at least equivalent graft area for bony fusion.

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NON-CLINICAL TESTS SUMMARY & CONCLUSIONS

Bench top mechanical testing was performed, which addresses recommendations from the FDA Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.

. Static and dynamic torsion per ASTM F2077 (Cervical devices)
Static and dynamic axial compression and compression shear per ASTM F2077 (Cervical . and ALIF devices)
Subsidence per ASTM F2267 (Cervical and ALIF devices) ●
. Expulsion testing (Cervical and ALIF devices)

Impaction testing per lab protocol was also performed (Cervical and ALIF devices).

Clinical testing was not applicable for this submission.

The non-clinical testing demonstrates that the subject devices have at least equivalent mechanical strength as the predicates and are as safe, as effective, and perform as well or better than these legally marketed devices.

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.