(29 days)
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
The subject EXPEDIUM™ Spine System components are designed to accept a 4.5mm rod and are available in various geometries and sizes.
The provided text describes a Special 510(k) Submission for additions to the EXPEDIUM Spine System. This document is a premarket notification for a medical device and thus concerns the regulatory approval process rather than a study proving the device meets acceptance criteria through clinical or AI-related performance metrics.
The "Performance Data" section explicitly states: "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification." ASTM F1717 is a standard specification for spinal implant constructs in a vertebrectomy model, which tests mechanical properties like static and fatigue strength. This indicates that the "acceptance criteria" here are likely related to meeting specific mechanical performance standards as defined by ASTM F1717, rather than clinical or "AI-related" performance criteria.
Therefore, many of the requested details in your prompt (such as sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, and training set information) are not applicable or cannot be extracted from this type of regulatory submission. The device described is a physical spinal implant system, not an AI-powered diagnostic or therapeutic device.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Mechanical Performance | "Performance data per ASTM F 1717 were submitted" to "characterize the subject EXPEDIUM™ Spine System components." |
Explanation: The document does not provide specific numerical acceptance criteria values or detailed performance results (e.g., maximum load, cycles to failure). It only states that data per the ASTM F1717 standard were submitted, implying the device met the requirements of this standard for mechanical characterization.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. ASTM F1717 outlines testing methodologies, which typically involve a specified number of samples for mechanical testing, but the exact number used for this submission is not detailed.
- Data provenance: The testing was conducted to characterize the "subject EXPEDIUM™ Spine System components," implying in-vitro mechanical testing of the device itself.
- Country of origin: Not explicitly stated, but the submission is to the U.S. FDA by DePuy Spine, Inc. (a U.S.-based company), suggesting the testing was likely conducted in the U.S. or by a lab that adheres to U.S. regulatory standards.
- Retrospective or prospective: This is mechanical (in-vitro) testing of hardware, not clinical data, so the terms "retrospective" or "prospective" are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth. The "ground truth" for mechanical performance is defined by the physical properties measured according to the ASTM F1717 standard.
4. Adjudication method for the test set
Not applicable. This is not a clinical study involving human judgment or adjudication.
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 is a physical spinal implant system, not an AI-powered system that would 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 device is a physical spinal implant system, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device is the objective, measurable mechanical properties determined through standardized in-vitro testing (ASTM F1717).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
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JUN 2 9 2007
Special 510(k) Submission – Additions to EXPEDIUM Spine System
510(K) SUMMARY 5.
| Submitter: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767 |
|---|---|
| Contact Person: | Christopher KlaczykRegulatory Project ManagerVoice: (508) 828-2852Fax: (508) 828-3797E-Mail: cklaczyk@dpyus.jnj.com |
| Date Prepared: | May 25, 2007 |
| Device Class: | Class III |
| Classification Name: | Pedicle screw spinal fixationper 21 CFR §888.3070Spinal interlaminar fixation orthosisper 21 CFR §888.3050Spinal intervertebral body fixation orthosisper 21 CFR §888.3060 |
| Classification Panel: | Orthopedics |
| FDA Panel Number: | 87 |
| Product Code(s): | NKB, MNH, MNI, KWP, KWQ |
| Proprietary Name: | EXPEDIUM Spine System |
| Predicate Devices: | EXPEDIUM 5.5mm Spine System (K033901)MOSS® Miami Spine System (K011182)EXPEDIUM SFX Cross Connector System (K062196) |
| Device Description: | The subject EXPEDIUM™ Spine System components aredesigned to accept a 4.5mm rod and are available in variousgeometries and sizes. |
| Intended Use: | The EXPEDIUM Spine System is intended to provideimmobilization and stabilization of spinal segments inskeletally mature patients as an adjunct to fusion in the |
treatment of acute and chronic instabilities or deformities
of the thoracic, lumbar and sacral spine.
DePuy Spine, Inc., a Johnson & Johnson Company
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| The EXPEDIUM™ Spine System is intended fornoncervical pedicle fixation and nonpedicle fixation for thefollowing indications: degenerative disc disease (defined asback pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies);spondylolisthesis; trauma (i.e., fracture or dislocation);spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/orlordosis); tumor; pseudarthrosis; and failed previous fusion. | |
|---|---|
| Materials: | Manufactured from ASTM F 136 implant grade titaniumalloy. |
| Performance Data: | Performance data per ASTM F 1717 were submitted tocharacterize the subject EXPEDIUM™ Spine Systemcomponents addressed in this notification. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol of a person embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2007
DePuy Spine % Mr. Christopher Klaczyk Regulatory Project Manager 325 Paramount Drive Raynham, Massachusetts 02767
Re: K071495
Trade/Device Name: EXPEDIUM™ Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNH, MNI, KWQ Dated: May 25, 2007 Received: May 31, 2007
Dear Mr. Klaczyk:
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 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.
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Page 2 - Mr. Christopher Klacyzk
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
for
Mark N. Melkerson
Director
DRP
Diserse
617562
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Submission - Additions to EXPEDIUM Spine System
INDICATIONS FOR USE STATEMENT 4.
510(k) Number (if known): K071495
Device Name:
EXPEDIUM Spine System
Indications For Use:
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
Prescription Use >< (Part 21 CFR 801 Subpart D) AND/OR
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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510 Number_ L01498
Page 4-1
§ 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.