The Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., 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); and/or
• spondylolisthesis.
The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate) is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., 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); and/or
· spondylolisthesis.
The Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., 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); and/or
• spondylolisthesis.
The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1).

The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., 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); and/or
· spondylolisthesis.
The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

Device Description

The Minuteman MIS Fusion Plate Implants consist of bilateral Plates and a Body/Post that connects the Plate components include several gripping features for attachment of the spinous processes. The Minuteman MIS Fusion Plate Implants are available in multiple sizes to accommodate varying patient anatomy. The Minuteman MIS Fusion Plate Implants are made from Ti6A4V and Ti6A4V ELI. The HA Minuteman MS Fusion Plate have an additional hydroxyapatite coating on the distal regions of the device.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for a spinal fusion plate. It describes the device, its intended use, and states that non-clinical evaluations were performed to support substantial equivalence to a predicate device.

However, the document does not contain any information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or specific performance metrics typically associated with studies proving device performance against acceptance criteria for an AI/ML medical device.

The essential conclusion from the document is that:

The device is a physical medical device (spinal fusion plate), not an AI/ML-based software device.
Substantial equivalence was established through non-clinical evaluations against a predicate device, not through a study involving acceptance criteria and performance metrics described in the prompt.

Therefore, I cannot provide the requested information from the given text because it is not relevant to the type of device and evaluation described in the document.

To directly answer your prompt, based on the provided text:

A table of acceptance criteria and the reported device performance: Not applicable. The document refers to physical device testing for "substantial equivalence" to a predicate, not performance against specific acceptance criteria for an AI/ML output.
Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No test set or data provenance for an AI/ML device is mentioned.
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. No ground truth establishment for an AI/ML device is mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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January 18, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spinal Simplicity LLC Adam Rogers Vice President of Regulatory and Engineering 6363 College Blvd Suite 320 Overland Park. Kansas 66211

Re: K234051

Trade/Device Name: Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: December 19, 2023 Received: December 21, 2023

Dear Adam 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 (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 OS 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 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,

Eileen
Digitally signed
by Eileen Cadel -S
Date: 2024.01.18
Cadel -S 15:22:51-05'00'
for
ODT 11ID

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

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Indications for Use

Submission Number (if known)

K234051

Device Name

Minuteman G5 MIS Fusion Plate;

Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate);

HA Minuteman G3-R MIS Fusion Plate;

Minuteman G3/HA Minuteman G3 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); and/or

· spondylolisthesis.

The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

· 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); and/or

· spondylolisthesis.

The Minuteman G1 (Posterior Fusion Plate/HA Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

• 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); and/or

• spondylolisthesis.

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The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1).

· 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); and/or
· spondylolisthesis.
The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

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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K234051 - Page 1 of 2

K234051 - Page 1 of 2
Prepared on: 2023-12-21

Contact Details
21 CFR 807.92(a)(1)
Applicant Name	Spinal Simplicity LLC
Applicant Address	6363 College Blvd Ste 320 Overland Park KS 66211 United States
Applicant Contact Telephone	913-451-4414
Applicant Contact	Mr. Adam Rogers
Applicant Contact Email	arogers@spinalsimplicity.com
Device Name
21 CFR 807.92(a)(2)
Device Trade Name	Minuteman G5 MIS Fusion Plate;Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate);HA Minuteman G3-R MIS Fusion Plate;Minuteman G3/HA Minuteman G3 MIS Fusion Plate
Common Name	Spinous Process Plate
Classification Name	Spinous Process Plate
Regulation Number	888.3050
Product Code	PEK
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K233527	Minuteman MIS Fusion Plate Implants	PEK
Device Description Summary
21 CFR 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

• 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); and/or

• spondylolisthesis.

The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

{5}------------------------------------------------

The Minuteman G1 (Posterior Fusion Plate) is a posterior, non-pedicle fusion device, intended for use a a single interspace in the non-cervical spine (T1-S1), It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:

• Lumbar spinal stenosis;

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

• spondylolisthesis.

The Minuteman G1 (Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., 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); and/or

• spondylolisthesis.

The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1).

The Minuteman G3/HA Minuteman G3 MS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., 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); and/or

• spondylolisthesis.

The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

Indications for Use Comparison

The Indications for Use are identical to the predicate devices.

Technological Comparison

The Minuteman MIS Fusion Plate Inc same technological characteristics (same design, material composition, packaging, principles of operations) as the cleared predicate devices.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Non-Clinical evaluations were performed to support substantial equivalence of the Minuteman MIS Fusion Plate Include tests were not performed for this submission. The data provided in this submission was sufficient to establish the substantial equivalence of the subject devices.

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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.