K Number

Validate with FDA (Live)

Device Name

SSP PEDICLE SCREW SYSTEM

Manufacturer

SPECIALTY SPINE PRODUCTS, LLC

Date Cleared

2006-06-08

(142 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

The SSP Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

The SSP Pedicle Screw System also is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal turnor, pseudoarthrosis, and failed previous fusion.

Device Description

The SSP Pedicle Screw System is an internal fixation device for spinal surgery consisting of rods, pedicle screws and transverse links. To enable close conformance to patient anatomy, pedicle screws and rods are available in various lengths, diameters, and/or contours. A series of manual surgical instruments (not a subject of this submission) intended to assist the insertion and placement of the implants are provided in an instrument tray.

AI/ML Overview

This submission is a 510(k) premarket notification for a Class II medical device, the SSP Pedicle Screw System. The primary purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific acceptance criteria through a clinical study. Therefore, the information requested regarding acceptance criteria and a study proving device performance in the context of clinical efficacy, reader studies, and ground truth establishment is not typically found in a standard 510(k) summary for this type of device.

510(k) submissions for pedicle screw systems usually focus on:

Substantial Equivalence: Comparing the new device's indications for use, technological characteristics, and performance data (often mechanical testing) to a predicate device.
Mechanical Testing: Demonstrating that the device meets established ASTM or ISO standards for strength, fatigue, and other biomechanical properties.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of clinical performance or diagnostic accuracy, as this is a surgical implant. The acceptance criteria for a 510(k) of this nature would primarily be the demonstration of substantial equivalence to a predicate device and satisfactory mechanical testing results (which are not detailed in this summary).
Reported Device Performance: The document states, "Specialty Spine Products, LLC has submitted information to demonstrate that... the SSP Pedicle Screw System is substantially equivalent in indications and design principles to predicate devices..." This "performance" is in the context of equivalence, not a clinical outcome measure described by a specific metric (sensitivity, specificity, etc.).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for clinical studies in this 510(k). This is not a diagnostic device or an AI-based system that would typically have a "test set" in the sense of patient data for performance evaluation. If a "test set" were to be considered, it would refer to the samples used in mechanical testing (e.g., number of screws tested for fatigue), but this specific information is not provided in the summary.

3. 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. This device is a surgical implant, not a diagnostic tool requiring expert interpretation of results to establish ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This relates to clinical or diagnostic study outcomes, which are not detailed here.

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 device does not involve human "readers" or AI assistance.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for a medical implant like this is usually established through adherence to engineering design specifications, material properties, and mechanical performance standards, compared against predicate devices and relevant ASTM/ISO standards. Clinical efficacy would be demonstrated in post-market surveillance or larger clinical trials, which are beyond the scope of a 510(k) that establishes substantial equivalence.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI device for this submission.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" for an AI device.

Summary of available information relevant to acceptance criteria and study:

The 510(k) summary provided mostly pertains to regulatory and administrative information, device description, intended use, and the declaration of substantial equivalence. The "study" mentioned is the submission of information to demonstrate substantial equivalence to predicate devices, which is the core requirement for a 510(k) clearance. This equivalence relies on comparing indications for use, technological characteristics (materials, design, manufacturing methods), and typically includes mechanical testing data (though not detailed here) to ensure the new device performs at least as safely and effectively as the predicate.

For devices like this, the "acceptance criteria" are predominantly those defined by FDA guidance documents for pedicle screw systems and relevant mechanical testing standards (e.g., ASTM F1717-96 for spinal implant constructs, ASTM F1798 for fatigue testing of pedicle screw systems), against which the device's mechanical performance would be evaluated to ensure it meets acceptable safety and integrity thresholds. The document explicitly states the FDA reviewed the information and "determined the device is substantially equivalent." This determination is the "proof" that the device meets the regulatory acceptance criteria for 510(k) clearance.

Summary

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510(k) Summary

Specialty Spine Products SSP Pedicle Screw System

JUN - 8 2006

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Specialty Spine Products, LLC4121 Tigris WayRiverside, CA 92503Telephone (951) 687-2808Fax (951) 734-7594
Official Contact:	Angela Carlson
Representative/Consultant:	Floyd G. LarsonPaxMed International, LLC11234 El Camino Real, Suite 200San Diego, CA 92130Telephone (858) 792-1235FAX (858) 792-1236

DEVICE NAME

Classification Name:	Orthosis, Spondylolisthesis Spinal FixationOrthosis, Spinal Pedicle Fixation
Trade/Proprietary Name:	SSP Pedicle Screw System
Common Name:	Pedicle screw spinal system

ESTABLISHMENT REGISTRATION NUMBER

Specialty Spine Products will submit Establishment Registration to FDA prior to marketing the SSP Pedicle Screw System.

DEVICE CLASSIFICATION

Pedicle screw spinal systems are classified as Class II devices (21 CFR 888.3070). The product code for Orthosis, Spondylolisthesis Spinal Fixation is MNH. The product code for

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Orthosis. Spinal Pedicle Fixation is MNI. These device classifications are reviewed by the Orthopedic Devices Branch.

INTENDED USE

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

Specialty Spine Products, LLC has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the SSP Pedicle Screw System is substantially equivalent in indications and design principles to predicate devices that have been determined by FDA to be substantially equivalent to preamendment devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2006

Specialty Spine Products, LLC c/o Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K060118

Trade/Device Name: SSP Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: May 16, 2006 Received: May 19, 2006

Dear Mr. Larson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 -- Mr. Floyd G. Larson

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Hubert Lemerno

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: SSP Pedicle Screw System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

AND/OR

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

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number	K060118
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Regulation Number and Section

N/A