The Spinal Simplicity Posterior 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:

· 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 Posterior 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 posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).

Device Description

The Posterior Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include several spiked grips at the ends of each Plate for attachment to the spinous processes. The Posterior Fusion Plate device is available in multiple sizes to accommodate varying patient anatomy. The Posterior Fusion Plate is made from Ti6Al4V and Ti6Al4V ELI. The HA Posterior Fusion Plate has an additional hydroxyapatite coating on the distal regions of the device.

AI/ML Overview

The document provided is a 510(k) summary for a medical device called the "Posterior Fusion Plate." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a new AI/software-based device. Hence, most of the requested information regarding acceptance criteria, specific study designs for performance metrics, ground truth, and reader studies is not explicitly available in this document as it pertains to a different type of device and regulatory submission.

However, I can extract the information that is present and indicate where the requested information is not applicable or not provided in this specific context.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (from the document)
Mechanical Performance (based on ASTM F1717 standards):	"The data demonstrate that the subject Posterior Fusion Plate device presents substantially equivalent mechanical performance compared to the predicate device." Specific quantitative criteria and results for each test (Static Axial Compression, Static Torsion, Dynamic Axial Compression) are not provided in this summary but the overall conclusion of meeting substantial equivalence is stated.
Surgical Insertion Technique Suitability:	"Cadaveric device insertion data was presented to demonstrate the suitability of the surgical insertion technique for the device's listed indications. The data demonstrate that the device may be inserted with minimal risk of spinous process fracture."
Device Function and Performance (Surgeon-involved):	"Data from a surgeon-involved cadaveric implantation study was presented to demonstrate suitable device function and performance." (No specific quantitative criteria or outcomes are detailed for this study in the summary).
Clinical Safety (Risk of failure to deploy, spinous process fracture, neurological injuries):	"Survey data from surgeons outside the United States who have implanted the device was also presented and show that none of the surgeons observed any instances of failure to deploy the device wings, spinous process fracture, or neurological injuries."
Clinical Safety (Risk of device migration, dislodgement, spinous process fracture):	"Clinical data were presented to demonstrate that the risk of device migration, dislodgement, and spinous process fracture were sufficiently low." (No specific quantitative data or acceptance thresholds are provided, just the conclusion of "sufficiently low").
Bacterial Endotoxin:	"Bacterial endotoxin testing will be performed on all batches of sterile packed devices." (This is a statement of a future process, implying a standard acceptance criterion that must be met for each batch).

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

Mechanical Testing (ASTM F1717): Not specified. These are typically in-vitro lab tests, not using human data.
Cadaveric Insertion Data: Not specified. This would be a prospective study, likely conducted in a controlled lab setting.
Surgeon-involved Cadaveric Implantation Study: Not specified. Prospective, controlled lab setting.
Survey Data from Surgeons:
- Sample Size: Not specified (number of surgeons).
- Data Provenance: "outside the United States," retrospective from the perspective of the survey, gathering past observations.
Clinical Data (migration, dislodgement, fracture):
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The term "clinical data" implies human patient data, but details are lacking.

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

Mechanical Testing: No human experts establish ground truth for these physical tests. Standards like ASTM F1717 define the methodology.
Cadaveric Insertion Data: The "minimal risk of spinous process fracture" would likely be judged by the testing personnel and/or surgical experts involved in the study. The number and qualifications are not specified.
Surgeon-involved Cadaveric Implantation Study: Similar to above, "suitable device function and performance" would be assessed by the involved surgeons. The number and qualifications are not specified.
Survey Data: The "ground truth" (observations of failures) relies on the reporting surgeons themselves. Their qualifications are implied as surgeons who implant the device, but specific experience levels are not detailed.
Clinical Data: While "clinical data" is mentioned, the method for establishing "ground truth" for risks like migration, dislodgement, and fracture (e.g., by independent medical reviewers, imaging, etc.) is not detailed, nor are the number or qualifications of experts.

4. Adjudication Method for the Test Set

Not specified for any of the studies mentioned.

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

No, this document describes a physical medical device (spinal implant), not an AI/software device that would typically undergo an MRMC study comparing human readers with and without AI assistance. Therefore, this section is not applicable, and no effect size for human readers improving with AI is mentioned.

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

This is not applicable as the device is a physical implant, not an algorithm or AI.

7. The Type of Ground Truth Used

Mechanical Testing: Defined by physical measurements and adherence to ASTM standards.
Cadaveric Data: Observations of physical outcomes (e.g., presence/absence of fracture) during surgical simulation.
Survey Data: Self-reported observations by implanting surgeons.
Clinical Data: Observations of clinical outcomes (e.g., migration, dislodgement, fracture) in patients. Whether this involved expert consensus, pathology, or direct outcome data is not specified.

8. The Sample Size for the Training Set

This concept is primarily relevant for AI/machine learning models. Since this is a physical medical device, there isn't a "training set" in the AI sense. The design and manufacturing process would involve internal testing and refinement, but not a formally labeled "training set" of data.

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

Not applicable for the same reason as above.

Summary

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December 10, 2020

Image /page/0/Picture/1 description: The image shows the logo for 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. Suite 220 Overland Park. Kansas 66211

Re: K200066

Trade/Device Name: Posterior Fusion Plate, HA Posterior Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: November 18, 2020 Received: November 19, 2020

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 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. 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) K200066

Device Name

Spinal Simplicity Posterior Fusion Plate

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

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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510(k) Summarv

Spinal Simplicity's Posterior 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: November 18th, 2020

Name of Device:

Posterior Fusion Plate HA Posterior Fusion Plate

Common / Classification Name:

21 CFR 888.3050: Spinal interlaminal fixation orthosis, Class II Product codes: PEK, Spinous Process Plate

Predicate Devices:

Spinal Simplicity's HA Minuteman G3 MIS Fusion Plate (K151741) - Primary Predicate Spinal Simplicity's Minuteman G3 MIS Fusion Plate (K140046) - Additional Predicate Spinal Simplicity's HA Minuteman G3-R MIS Fusion Plate (K163428) - Additional Predicate

Intended Use / Indications for Use:

· 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.

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Technological Characteristics:

Performance Data:

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

ASTM F1717 Static Axial Compression ●
ASTM F1717 Static Torsion
ASTM F1717 Dynamic Axial Compression

The data demonstrate that the subject Posterior Fusion Plate device presents substantially equivalent mechanical performance compared to the predicate device.

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

Cadaveric device insertion data was presented to demonstrate the suitability of the surgical insertion technique for the device's listed indications. The data demonstrate that the device may be inserted with minimal risk of spinous process fracture.

Data from a surgeon-involved cadaveric implantation study was presented to demonstrate suitable device function and performance.

Survey data from surgeons outside the United States who have implanted the device was also presented and show that none of the surgeons observed any instances of failure to deploy the device wings, spinous process fracture, or neurological injuries.

Clinical data were presented to demonstrate that the risk of device migration, dislodgement, and spinous process fracture were sufficiently low.

Substantial Equivalence:

The Posterior Fusion Plate has the same intended use, the same indications for use, and similar technological characteristics and principles of operation as its predicate device.

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Differences between the subject and predicate device are minor and do not raise any new issues of safety or effectiveness. Performance data further demonstrate that the Posterior Fusion Plate is substantially equivalent to the predicate device.

Conclusions:

The information submitted by Spinal Simplicity in this premarket notification demonstrates that the Posterior Fusion Plate 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.