The Spinal Simplicity Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions:

· Lumbar spinal stenosis;

· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

· spondylolisthesis;
· trauma (i.e., fracture or dislocation); and/or

• tumor.

The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

Device Description

The Minuteman G5 consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include gripping features on the boneinterfacing surfaces of each Plate for attachment to the spinous processes. The Minuteman G5 device is available in multiple sizes to accommodate varying patient anatomy. The Minuteman G5 is made from titanium alloy Ti6A14V ELI and has a hydroxyapatite coating on the distal regions of the device.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Minuteman G5 MIS Fusion Plate." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with strict acceptance criteria often seen with novel Class III devices or AI/imaging software.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/imaging software device. Specifically, it lacks:

A table of acceptance criteria and reported device performance (for an AI system)
Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods for an AI study.
Information on MRMC comparative effectiveness studies or standalone performance for an AI system.
Details about training sets or how ground truth was established for training (relevant for AI).

Instead, this document focuses on mechanical performance testing for a physical implantable device. The "Performance Data" section discusses:

Mechanical Testing: ASTM F1717 Static Axial Compression, ASTM F1717 Dynamic Axial Compression, Custom Static Plate Dissociation, and Cadaveric Fatigue Testing.
Device Material: Titanium alloy Ti6Al4V ELI with a hydroxyapatite coating.
Comparison to Predicate: The data "demonstrates that the subject Minuteman G5 device presents substantially equivalent mechanical performance compared to the predicate device."

To answer your request based on the provided text, while acknowledging it's not about AI/imaging software and thus most of your specific questions are not applicable:

Acceptance Criteria and Study for Minuteman G5 MIS Fusion Plate (Based on Provided Document)

The "Minuteman G5 MIS Fusion Plate" is a physical implantable medical device, not an AI or imaging software. Its acceptance criteria and study proving it meets them are primarily based on demonstrating substantial equivalence to an existing predicate device through mechanical performance testing, rather than clinical efficacy or accuracy in the way an AI system would be evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific acceptance criteria values (e.g., "Load X must withstand Y N of force") or exact reported performance values. Instead, it indicates that the device's performance in standard mechanical tests was substantially equivalent to the predicate device.

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied)
Mechanical Performance	Substantially equivalent to predicate device (Spinal Simplicity's HA Posterior Fusion Plate (K212781)).
ASTM F1717 Static Axial Compression	Deemed equivalent to predicate.
ASTM F1717 Dynamic Axial Compression	Deemed equivalent to predicate.
Custom Static Plate Dissociation	Deemed equivalent to predicate.
Cadaveric Fatigue Testing	Deemed equivalent to predicate.
Biocompatibility/Sterility	Will undergo bacterial endotoxin testing; made from Ti6Al4V ELI with HA coating.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for the mechanical tests (e.g., number of devices tested for ASTM F1717). The data provenance is implied to be from laboratory mechanical testing and cadaveric testing, typical for orthopedic implants. No country of origin for data is specified, but as an FDA submission, the tests would conform to U.S. or international standards recognized by the FDA. The data is inherently prospective in the context of device testing before market clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This question is not applicable to a physical mechanical device test. There is no concept of "experts establishing ground truth" in the way an AI algorithm analyzes medical images. The "ground truth" for mechanical testing is defined by the physical properties measured under specified test conditions according to ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. Mechanical tests follow predefined protocols and objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

Not applicable. This is a study type for AI/imaging software, not for a physical implantable device.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) was Done

Not applicable. This concept pertains to AI algorithms.

7. The Type of Ground Truth Used

For this device, the "ground truth" is established by objective mechanical performance metrics (e.g., load to failure, fatigue life) measured according to industry-standard test protocols (ASTM F1717, Custom Static Plate Dissociation, Cadaveric Fatigue Testing). The "ground truth" is that the device performs mechanically equal to or better than the predicate device under these standardized conditions.

8. The Sample Size for the Training Set

Not applicable. There is no AI model or "training set" for this physical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable since there is no AI model or training set.

Summary

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March 11, 2022

Image /page/0/Picture/1 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spinal Simplicity LLC Mr. Adam Rogers Director of Regulatory 6600 College Blvd, Ste 220 Overland Park. Kansas 66211

Re: K211880

Trade/Device Name: Minuteman G5 MIS Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: February 7, 2022 Received: February 8, 2022

Dear Mr. Rogers:

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 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

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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 (QS) 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 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-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. 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) K211880

Device Name

Spinal Simplicity Minuteman G5 MIS Fusion Plate

Indications for Use (Describe)

· Lumbar spinal stenosis;

· degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

· spondylolisthesis;
· trauma (i.e., fracture or dislocation); and/or

• tumor.

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

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Spinal Simplicity's Minuteman G5 MIS Fusion Plate

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Spinal Simplicity LLC 6600 College Blvd Suite 220 Overland Park, KS 66211 Phone: (913) 451-4414 Facsimile: (913) 888-0075

Contact Person: Adam Rogers

Date Prepared: February 7, 2022

Name of Device:

Minuteman G5 MIS Fusion Plate

Common / Classification Name:

Spinous Process Plate, 21 CFR 888.3050, Class II

Product codes: PEK

Predicate Devices:

Spinal Simplicity's HA Posterior Fusion Plate (K212781) - Primary Predicate Spinal Simplicity's HA Minuteman G3 MIS Fusion Plate (K212781) Spinal Simplicity's HA Minuteman G3-R MIS Fusion Plate (K212781)

Intended Use / Indications for Use:

lumbar spinal stenosis
degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
spondylolisthesis;

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trauma (i.e., fracture or dislocation); and/or ●
tumor. ●

Technological Characteristics:

Performance Data:

Test data and/or engineering analyses have been provided to describe the performance of the Minuteman G5 in the following test modalities:

ASTM F1717 Static Axial Compression ●
ASTM F1717 Dynamic Axial Compression ●
Custom Static Plate Dissociation ●
Cadaveric Fatigue Testing o

The data demonstrates that the subject Minuteman G5 device presents substantially equivalent mechanical performance compared to the predicate device.

Bacterial endotoxin testing will be performed on all batches of sterile packed devices.

Substantial Equivalence:

The Spinal Simplicity Minuteman G5 MIS Fusion Plate is as safe and effective as the identified predicate device. The Minuteman G5 has the same intended use, indications for use, and similar technological characteristics and principles of operation as its predicate device. Differences between the subject and predicate devices are minor and do not raise any new issues of safety or effectiveness. Performance data further demonstrate that the Minuteman G5 is substantially equivalent to the predicate device.

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Conclusions:

The information submitted by Spinal Simplicity in this premarket notification demonstrates that the Minuteman G5 performs as intended and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.