The restor3d lumbar cages are intended to be used as an intervertebral body fusion device with bone graft for use in lumbar spine. They are indicated for use in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels from L2-S1. DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Implants are used to facilitate fusion in the lumbar spine using autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbar spine.

Device Description

The restor3d TiDAL Lumbar Interbody Fusion System are additively manufactured Titanium Alloy (Ti-6AL-4V per ASTM F2924) implants, designed for use as a lumbar interbody fusion device. They are provided sterile-packed. The system is comprised of various sizes to accommodate individual patient anatomy as well as multiple designs to support several surgical techniques (PLIF, ALIF, OLIF, LLIF). Each approach includes several offerings that vary by footprint (width and depth/length), height, and lordotic angle. All sizes have a large central window(s) for packing autogenous bone graft and/or allogenic bone graft. The inferior and superior faces have endplate surface lattices as well as teeth to resist migration when placed in between the vertebral bodies.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "restor3d TiDAL Lumbar Interbody Fusion System." It's essentially an application to the FDA to market a new device by demonstrating that it's "substantially equivalent" to an already legally marketed device (the predicate device).

The request asks about acceptance criteria and a study that proves the device meets those criteria, typically found in the context of AI/ML-driven medical devices or diagnostic tools. However, the provided text describes a spinal implant (a physical device for interbody fusion in the lumbar spine), not an AI/ML-driven diagnostic or assistive technology. As such, the concepts of "acceptance criteria" and a "study that proves the device meets acceptance criteria" for AI performance metrics (like accuracy, sensitivity, specificity, expert consensus, MRMC studies, etc.) are not applicable to this type of medical device as described in the provided document.

Instead, for a physical implant like the restor3d TiDAL Lumbar Interbody Fusion System, "acceptance criteria" are related to mechanical properties, biocompatibility, sterilization, and manufacturing quality. The "study that proves the device meets acceptance criteria" would involve performance testing (e.g., mechanical testing to prove strength and durability, sterilization validation, cleaning validation, and biocompatibility testing).

Let's break down what is provided and why the requested information isn't directly present in the context of an AI/ML device:

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

Not applicable in the AI/ML sense. For this implant, "acceptance criteria" would relate to standards for its material properties, manufacturing tolerances, and mechanical performance (e.g., compression strength, fatigue life). The document states that performance testing was conducted:
- Cleaning per ISO 17664-1, AAMI TIR30, and ASTM F565.
- Sterilization per ISO 17665-1, ISO 17665-3, AAMI TIR 12, ISO 11737-1, ISO 11737-2, and ASTM F565.
- Biocompatibility per ISO 10993-1.
The reported device performance is implicitly that it met the requirements of these standards, allowing the FDA to determine substantial equivalence. The document doesn't provide specific numerical results from these tests (e.g., actual measured compression strength in Newtons) but rather states the standards followed.

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

Not applicable in the AI/ML sense. There isn't a "test set" of images or patient data for an algorithm. The testing involves physical prototypes of the implant. The sample size for mechanical testing (e.g., how many implants were tested) is not specified in this summary but would be detailed in the full submission.

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

Not applicable. This relates to clinical or image-based ground truth for AI. For an implant, ground truth is established through adherence to engineering standards and material science.

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

Not applicable. This refers to consensus reading for AI ground truth.

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 type of clinical study for diagnostic devices (often AI-assisted). This document is for a physical implant.

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

Not applicable. No algorithm is being assessed.

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

For a physical implant, the "ground truth" for performance is defined by established international and national standards (e.g., ISO, ASTM, AAMI) for mechanical properties, material safety, and manufacturing quality. Meeting these standards serves as the "ground truth" for device safety and effectiveness.

8. The sample size for the training set:

Not applicable. No AI algorithm is being trained.

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

Not applicable. No AI algorithm is being trained.

Summary with respect to the provided document:

The provided document is a 510(k) summary for a physical medical implant (lumbar interbody fusion system), not a software or AI-driven device. Therefore, most of the questions, which are tailored to evaluating AI/ML medical devices, are not applicable.

The "acceptance criteria" for this device are the successful completion of various performance tests according to recognized standards as listed in Section G:

Cleaning: ISO 17664-1, AAMI TIR30, ASTM F565
Sterilization: ISO 17665-1, ISO 17665-3, AAMI TIR 12, ISO 11737-1, ISO 11737-2, ASTM F565
Biocompatibility: ISO 10993-1

The "study that proves the device meets the acceptance criteria" is the performance testing described in Section G. The outcome of these tests is stated indirectly by the FDA's decision of "substantial equivalence" based on "comparison to the predicate device" and confirmation that the additional components (disc preparation instruments) do "not raise any additional questions of safety and effectiveness."

No details on sample sizes for these physical tests are provided in this summary, nor are specific numerical results, as these are typically part of a more extensive technical file submitted to the FDA rather than the public 510(k) summary.

Summary

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January 22, 2024

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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

restor3d Anika Moorjani Regulatory Engineer 4001 E. NC 54 Highway, Suite 3160 Durham, North Carolina 27709

Re: K234087

Trade/Device Name: restor3d TiDAL Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 22, 2023 Received: December 22, 2023

Dear Anika Moorjani:

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" (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).

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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.

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, Katherine D. Kavlock -S

for 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

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Indications for Use

510(k) Number (if known) K234087

Device Name

restor3d TIDAL Lumbar Interbody Fusion System

Indications for Use (Describe)

The restor3d lumbar cages are intended to be used as an intervertebral body fusion device with bone graft for use in lumbar spine. They are indicated for use in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels from L2-S1. DDD patients may also have up to grade 1 spondylolisthesis at the involved level(s). Implants are used to facilitate fusion in the lumbar spine using autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbar spine.

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

Date Prepared: January 18th, 2024

In accordance with the requirements of 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the restor3d TiDAL Lumbar Interbody Fusion System.

A. 510(k) Sponsor:

restor3d, inc. 4001 E. NC 54 Highway, Suite 3160 Durham, North Carolina, 27709

B. Primary Correspondent:

Anika Moorjani Regulatory Engineer (501) 240-3476 (direct) anika@restor3d.com

C. Premarket Notification:

Trade Name: restor3d TiDAL Lumbar Interbody Fusion System Common Name: Lumbar Interbody Fusion Device Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar Regulation Number: 21 CFR 888.3080 Product Code: MAX Classification: II Review Panel: Orthopedic

D. Indications for Use:

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corticocancellous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbar spine.

E. Predicate Devices:

The Lumbar Interbody Fusion System is substantially equivalent to the following device:

510(k)	Trade Name	Manufacturer
Primary Predicate Device
K220523	restor3d TiDAL LumbarInterbody Fusion Device	restor3d, Inc.

F. Device Description:

G. Performance Testing:

Cleaning per ISO 17664-1 (FDA recognition #14-578), AAMI TIR30, and ASTM F565 (FDA recognition #11-199), sterilization per ISO 17665-1 (FDA recognition #14-333), ISO 17665-3, AAMI TIR 12, ISO 11737-1 (FDA Recognition #14-577), ISO 11737-2 (FDA Recognition #14-540), and ASTM F565 (FDA recognition #11-199), and biocompatibility per ISO 10993-1 to establish substantial equivalence in comparison to the predicate device.

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H. Substantial Equivalence Comparison:

Substantial equivalence of the disc preparation instruments and sterilization tray to the predicate device is based on the following:

o The inclusion of the disc preparation instruments and sterilization tray do not impact the indications for use and intended use of the Lumbar Interbody Fusion Device.
Changes to provide a sterilization tray with disc preparation instruments are not o shown to raise any new questions of safety or effectiveness.

I. Conclusion:

Based on the comparison of the intended use and indications for use, the subject TiDAL Lumbar Interbody Fusion System is substantially equivalent to the predicate TiDAL Lumbar Interbody Fusion System. The addition of the disc preparation instruments provided in the sterilization tray does not raise any additional questions of safety and effectiveness.

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.