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)
Tumor
The Affix II Spinous Process Plate System is not intended for stand-alone use.

Device Description

The Affix II Spinous Process Plate System 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 the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use. When the Affix II Plate is used as supplemental fixation in interbody fusion procedures, its use is limited to the treatment of degenerative disc disease (DDD) of the lumbosacral spine (L2-S1).

AI/ML Overview

Here's an analysis of the provided text regarding the Affix® II Spinous Process Plate System.

Please Note: The provided document is a 510(k) summary for a medical device (an orthopedic implant), not an AI algorithm or diagnostic tool. Therefore, many of the requested points, especially those related to AI-specific studies (e.g., MRMC studies, training sets, ground truth establishment for AI), are not applicable to this type of submission. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Acceptance Criteria and Device Performance (Non-Clinical Testing)

The "acceptance criteria" for this device are implicitly demonstrating substantial equivalence to predicate devices through non-clinical biomechanical performance testing. The reported device performance indicates that these tests were successfully passed, showing equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Static axial compression performance equivalent to predicate.	Results demonstrate substantial equivalence to predicate.
Dynamic axial compression performance equivalent to predicate.	Results demonstrate substantial equivalence to predicate.
Static torsion performance equivalent to predicate.	Results demonstrate substantial equivalence to predicate.
Static post distraction performance equivalent to predicate.	Results demonstrate substantial equivalence to predicate.
Material composition equivalent to predicate.	Was shown to have equivalent technological characteristics to predicate.
Design equivalent to predicate.	Was shown to have equivalent technological characteristics to predicate.
Labeling/intended use equivalent to predicate.	Was shown to have equivalent technological characteristics to predicate.
Function equivalent to predicate.	Was shown to have equivalent technological characteristics to predicate.

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

Sample Size: Not specified for the non-clinical tests. These are typically bench tests conducted on a sufficient number of devices to ensure statistical validity, but the exact N is not disclosed in this summary.
Data Provenance: Not applicable in the context of clinical data. This refers to non-clinical, benchtop mechanical testing performed in a lab setting.

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

Not applicable. "Ground truth" in the context of clinical studies or AI algorithm evaluation is not relevant here. The "truth" for these non-clinical tests is based on objective measurements against established engineering standards and comparison to a predicate device's known performance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical data labeling. This document details non-clinical, objective biomechanical testing.

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 medical device (implant), not an AI system or diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This is a medical device (implant), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance data is the performance characteristics of the predicate device (NuVasive Spinous Process Plate System K073278 and NuVasive Affix Spinous Process Plate System K131238) and general engineering standards for spinal fixation devices. The goal was to prove "substantial equivalence" to these established devices.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is a physical medical device, not a machine learning model.

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

Not applicable. There is no training set for a physical medical device.

Summary

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Image /page/0/Picture/2 description: The image shows the Nuvasive logo. The logo consists of a stylized abstract shape on the left, followed by the word "NUVASIVE" in capital letters. Below "NUVASIVE" is the tagline ": Speed of Innovation" in a smaller font. The logo appears to be in black and white.

Affix® II Spinous Process Plate System July 31, 2013

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitted by: A.

Olga Lewis Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: July 31, 2013

Device Name B.

Trade or Proprietary Name: Common or Usual Name: Classification Name:

Device Class: Classification: Product Code: Spinal interlaminal fixation orthosis Spinal interlaminal fixation orthosis

Affix® II Spinous Process Plate System

Class II 21 CFR § 888.3050 РЕК

C. Predicate Devices

The subject Affix II Spinous Process Plate System is substantially equivalent to the predicate device, NuVasive Spinous Process Plate System (K073278) and NuVasive Affix Spinous Process Plate System (K131238).

Device Description D.

Intended Use E.

Degenerative disc disease (DDD) defined as back pain of discogenic origin with t degeneration of the disc confirmed by history and radiographic studies.
. Spondylolisthesis
Trauma (i.e., fracture or dislocation) .
Tumor

The Affix II Spinous Process Plate System is not intended for stand-alone use.

CONFIDENTIAL

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Technological Characteristics F.

As was established in this submission, the subject Affix II Spinous Process Plate System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject Affix II Spinous Process Plate System is substantially equivalent to other predicate devices. The following testing was performed:

Static and dynamic axial compression .
Static torsion .
Static post distraction ●

The results demonstrate that the subject Affix II Spinous Process Plate System is substantially equivalent to the predicate.

H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject Affix II Spinous Process Plate System has been shown to be substantially equivalent to legally marketed predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2013

NuVasive, Incorporated Ms. Olga Lewis Specialist Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K132411

Trade/Device Name: Affix® II Spinous Process Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: October 28, 2013 Received: October 29, 2013

Dear Ms. Lewis:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Olga Lewis

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark Nielkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K132411

510(k) Number (if known):

Device Name: Affix® II Spinous Process Plate System

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.
Spondvlolisthesis . �
. Trauma (i.e., fracture or dislocation)
Tumor o

The Affix II Spinous Process Plate System is not intended for stand-alone use.

AND/OR

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132411

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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.