(142 days)
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.
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.
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.
{0}------------------------------------------------
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
page 1 of 2
{1}------------------------------------------------
Orthosis. Spinal Pedicle Fixation is MNI. These device classifications are reviewed by the Orthopedic Devices Branch.
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.
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.
page 2 of 2
{2}------------------------------------------------
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
{3}------------------------------------------------
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
{4}------------------------------------------------
510(k) Number (if known):
Device Name: SSP Pedicle Screw System
Indications for 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 tumor, pseudoarthrosis, and failed previous fusion.
| 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 |
|---|---|
| --------------- | --------- |
page 1 of 1
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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 the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.