The Paradigm Interspinous Fusion Plate is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1 - S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

Device Description

The Paradigm Interspinous Fusion Plate is a spinous process fixation device that stabilizes the spinous processes and spine to act as an adjunct to fusion. It consists of a single, U-shaped component, fabricated from medical grade titanium alloy (Ti6A14V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

AI/ML Overview

This 510(k) submission (K093438) describes the Paradigm Interspinous Fusion Plate, a spinal implant, and focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics for acceptance criteria and a detailed study report for meeting those. Instead, it relies on preclinical and clinical data comparisons.

Here's an breakdown based on the provided text, addressing your questions where possible and noting limitations due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantified acceptance criteria in the format you've requested (e.g., "Accuracy > X%", "Sensitivity > Y%"). Instead, it states that "Performance testing demonstrated Paradigm Interspinous Fusion Plate is substantially equivalent to predicate devices."

The performance is described as:

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Mechanical Performance	Demonstrated substantial equivalence to predicate devices in:Static tensionStatic compressionStatic torsionDynamic compressionDynamic compression-tensionScrew loosening and tightening
Clinical Performance	Demonstrated substantially equivalent performance to predicate devices through clinical data.

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

Test Set Sample Size: Not specified. The submission mentions "clinical data was provided" but does not give the number of patients or cases in any comparative clinical study.
Data Provenance: Not specified. It's unclear if the clinical data was retrospective or prospective, or the country of origin. Given the typical nature of 510(k) submissions, especially for an implant like this, the "clinical data" likely refers to evidence gathered on the predicate devices or general clinical performance related to the indication, rather than a dedicated new clinical trial for this specific device.

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

This information is not provided in the submission. For a device like an interspinous fusion plate, "ground truth" for the test set would typically relate to clinical outcomes (fusion rates, pain reduction, adverse events) as evaluated by clinicians (surgeons, radiologists) over time. However, the details of how this was established for this specific device's clinical data are not present.

4. Adjudication Method for the Test Set

This information is not provided.

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

No, an MRMC comparative effectiveness study was not done, as this device is a physical implant (spine plate), not an AI/imaging diagnostic tool that would typically involve human readers interpreting output.

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

This question is not applicable as the device is a physical implant and does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used

For the preclinical testing, the ground truth was based on engineering standards and measurements of mechanical properties (tension, compression, torsion, etc.).

For the clinical data, the "ground truth" implicitly relates to clinical outcomes (e.g., successful fusion, symptom resolution, absence of device failure or adverse events), typically assessed by surgeons, radiologists, and patient reports. However, the specific methodology for establishing this ground truth is not detailed for this particular device's submission.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical implant and does not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable for the same reason as above.

Summary of the Study that Proves Substantial Equivalence:

The submission leverages preclinical (bench) testing and clinical data comparison to demonstrate substantial equivalence.

Preclinical Testing: This involved a series of mechanical tests—static tension, static compression, static torsion, dynamic compression, dynamic compression-tension, screw loosening, and tightening. The "study" here involved performing these tests on the Paradigm Interspinous Fusion Plate and comparing the results to those obtained for the predicate devices (Medtronic SPIRE (K032037), Lanx Spinous Process Plate (K071877), and NuVasive Spinous Process Plate System (K073278)). The implicit "acceptance criteria" for these tests were that the Paradigm plate's performance should be comparable to or better than the predicates, thus establishing substantial equivalence in mechanical properties.
Clinical Data: The submission states that "clinical data was provided to demonstrate substantially equivalent performance of the subject device to predicate devices." This likely involved referencing existing clinical data or literature on the predicate devices and demonstrating that the Paradigm plate, with its similar design, function, and materials, would be expected to achieve similar clinical outcomes (e.g., fusion rates, complication profiles) as observed with the predicates. It is highly improbable that a new, dedicated clinical trial was conducted solely for this 510(k) submission for this type of device. The exact nature and scope of this clinical data are not detailed.

In essence, the "study" for this 510(k) approval was a comparison against established, cleared devices (predicates) across both mechanical performance and expected clinical outcomes, rather than a de novo investigation with its own distinct acceptance criteria and study endpoints.

Summary

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K093438

OCT 6 2010

510(k) Summary according to 807.92(c)

Contact:	Justin EggletonDirector, Spine Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005(202) 552-5800
Date Prepared:	August 10, 2010
Trade Name:	Paradigm Interspinous Fusion Plate
Common Name:	Spinous Process Plate
Device Regulatory Class:	Spinal interlaminal fixation orthosis21 CFR §888.3050, Class II
Product Code:	KWP

Indications for Use:

Device Description:

Predicate Device(s):

The Paradigm Interspinous Fusion Plate was shown to be substantially equivalent to previously cleared devices (e.g., Medtronic SPIRE (K032037), Lanx Spinous Process Plate (K071877), and NuVasive Spinous Process Plate System (K073278)) and has the same indications for use, design, function, and materials used.

page 1 of 2

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K093438

Performance Standards:

Performance testing demonstrated Paradigm Interspinous Fusion Plate is substantially equivalent to predicate devices. Preclinical testing (Static tension, static compression, static torsion, dynamic compression, dynamic compression-tension, screw loosening and tightening) demonstrated substantial equivalence to predicate devices. In addition, clinical data was provided to demonstrate substantially equivalent performance of the subject device to predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

OCT 0 6 2010

Paradigm Spine, LLC % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K093438

Trade/Device Name: Paradigm Interspinous Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: August 11, 2010 Received: August 12, 2010

Dear Mr. Eggleton:

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.

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Page 2 - Mr. Justin Eggleton

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
for DEP Dir
Ruma

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Paradigm Interspinous Fusion Plate

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

H
_**_, and the text is not readable.

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Ko93438 510(k) Number_

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.