The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

Device Description

The Cure™ Lumbar Plate (Cure™ OPEL-L (S)) is available in a range of sizes to coincide with the surgical approach. The Cure™ OPEL-L (S) is similar to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole, the inclusion of a central rib at the through hole location and convexity in the sagittal plane at the screw hole locations. All Cure™ Lumbar Plates continue to be manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Cure™ Lumbar Plate System." It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, the device in question is a spinal implant (Cure™ Lumbar Plate System), not an AI-powered diagnostic or assistive tool. Therefore, the typical acceptance criteria and study designs associated with AI/ML medical devices (such as MRMC studies, standalone performance, training/test sets, expert adjudication of ground truth, etc.) are not applicable here.

The document primarily discusses mechanical testing and an engineering analysis to demonstrate equivalence to a previously cleared predicate device.

Here's how to address the request given the nature of the document:

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

The document describes non-clinical mechanical testing rather than performance in a clinical setting against specific acceptance criteria for diagnostic accuracy. The acceptance criteria relate to mechanical properties and equivalence to the predicate device.

Acceptance Criteria (Mechanical)	Reported Device Performance
Equivalency to predicate device (K171538) in:	An engineering analysis was performed demonstrating equivalence. The Cure™ OPEL-L (S) Lumbar Plates were found to be superior in mechanical function and properties compared to the predicate device.
- Static compression bending (per ASTM F1717)	Met/Exceeded (Implied by superiority claim)
- Static tension (per ASTM F1717)	Met/Exceeded (Implied by superiority claim)
- Dynamic compression bending (per ASTM F1717)	Met/Exceeded (Implied by superiority claim)
Material: Grade 23 Titanium (Ti-6Al-4V ELI)	Confirmed: Manufactured from Grade 23 Titanium (Ti-6Al-4V ELI)
Manufacturing standard: ASTM F136	Confirmed: Manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
Intended Use: (T1-L5 or L1-S1 instability due to fracture, tumor, DDD, scoliosis, lordosis, spinal stenosis, failed previous surgery; temporary fixation until fusion)	Identical to Predicate Device: The identical intended use confirms that the device is suitable for the specified conditions, matching the predicate device. The document explicitly states: "The identical intended use and consistency between the fundamental scientific technology between the Cure™ OPEL-L (S) Lumbar Plate allows that it is substantially equivalent to the predicate device."

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

Sample Size: Not applicable in the context of clinical "test sets" for AI/ML performance. The "testing" here refers to mechanical engineering tests on device prototypes/samples. The document does not specify the number of individual devices tested for mechanical properties, but it's standard engineering practice to test a representative sample.
Data Provenance: Not applicable. This involves lab-based mechanical testing, not patient data.

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. Ground truth for mechanical testing is established by engineering standards (e.g., ASTM F1717) and measurements, not expert clinical consensus.

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

Not applicable. This is relevant for clinical interpretation or subjective assessment, not mechanical properties.

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 device is a passive spinal implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study was performed.

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

Not applicable. This is not an algorithm.

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

Ground Truth: For mechanical testing, the "ground truth" is defined by the objective physical properties and performance measured against established engineering standards (e.g., ASTM F1717) and benchmarks from the predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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May 12, 2020

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Meditech Spine, LLC Mr. Bruce Dunaway Chief Design Engineer 1447 Peachtree St NE Suite 440 Atlanta, Georgia 30309

Re: K201136

Trade/Device Name: Cure™ Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 27, 2020 Received: April 28, 2020

Dear Mr. Dunaway:

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

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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 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 (OS) 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,

Colin O'Neill, M.B.E. Acting 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

510(k) Number (if known) K201136

Device Name Cure™ Lumbar Plate System

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

As required by section 807.92(c)

Meditech Spine, LLC is requesting marketing clearance for the Cure™ OPEL-L (S) Lumbar Plate System

A. Sponsor/Manufacturer: Meditech Spine, LLC Registration Number: 3009405289 Bruce Dunaway, Chief Design Engineer 1447 Peachtree St NE Suite 440 Atlanta, GA 30309 678-974-5287 Phone 404-759-2104 Fax
B. Trade Name: Cure™ Lumbar Plate System Common Name: Spinal Implant Spinal intervertebral body fixation orthosis (21 CFR 888.3060 Class Classification Name: II,Product Code KWQ)
C. Predicate Device: K171538 (Cure™ Lumbar Plate System)
D. Device Description:

All Cure™ Lumbar Plates continue to be manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

E. Indications for Use:
The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine

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Image /page/4/Picture/1 description: The image shows a logo with a stylized letter "M" and a circle. The "M" is formed by two rounded rectangles that overlap each other. The left rectangle is a lighter shade of blue, while the right rectangle and the circle are a darker shade of blue. The circle is positioned to the right of the "M".

instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

F. Technological Characteristics:
The fundamental technological characteristics of the Cure™ OPEL-L (S) is identical to the predicate device.

G. Non-clinical Testing:

An engineering analysis was performed on the Cure™ OPEL-L (S) to demonstrate equivalency to the previously tested predicate device (Cure™ Anterior Lumbar Plate System) with respect to static compression bending, static tension, and dynamic compression bending per ASTM F1717.

Cure™ OPEL-L (S) Lumbar Plates are superior in mechanical function and properties to the predicate device.

H. Conclusion:
The identical intended use and consistency between the fundamental scientific technology between the Cure™ OPEL-L (S) Lumbar Plate allows that it is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.