(75 days)
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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Expedium Spine System components are designed to accept a 5.5mm rod and are available in various geometries and sizes. The Expedium Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification
The provided text is a 510(k) summary for the Expedium Spine System, a medical device. This document focuses on establishing the substantial equivalence of the new device to previously cleared predicate devices, rather than on detailed performance criteria or clinical study results in the context of an AI/ML device.
Therefore, many of the requested elements for describing acceptance criteria and a study that proves a device meets them, particularly those related to AI/ML performance metrics (such as effect size for human readers with AI assistance, standalone algorithm performance, or training set details), are not applicable to this 510(k) submission.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, there are no explicit acceptance criteria or detailed performance metrics reported in the way one would expect for an AI/ML device or a device requiring specific functional performance benchmarks to be met numerically. The 510(k) process for this type of device (spinal fixation system) primarily relies on:
- Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is proving that the new device is substantially equivalent to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics and intended use.
- Mechanical/Material Performance: The "Performance Data" section states that "Performance data were submitted to characterize the additional Expedium Spine System components." While the specific data is not detailed in this summary, it would typically include mechanical testing (e.g., fatigue, static strength, pull-out strength in bone surrogates) to ensure the device meets established engineering standards and comparable performance to the predicate device. However, no numerical acceptance criteria or results are provided in this summary.
2. Sample size used for the test set and the data provenance:
- Not Applicable in the provided text: This type of information (sample size, data provenance for a test set) is typically relevant for clinical studies or performance validation of AI/ML models. This 510(k) summary does not describe such a test set. The "performance data" mentioned would likely be from bench tests on physical devices, not a dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: There is no mention of experts establishing ground truth for a test set. This is a medical implant, not a diagnostic or AI-powered device.
4. Adjudication method for the test set:
- Not Applicable: No test set or adjudication method is described.
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 spinal fixation system, not an AI-powered diagnostic tool. MRMC studies or human reader improvement with AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is a physical medical implant, not an algorithm.
7. The type of ground truth used:
- Not Applicable in the context of software/AI: For a mechanical device, "ground truth" would relate to material properties, design specifications, and mechanical performance standards, which are evaluated through engineering tests and adherence to manufacturing controls.
8. The sample size for the training set:
- Not Applicable: No training set is involved for this type of device.
9. How the ground truth for the training set was established:
- Not Applicable: No training set is involved.
Summary of what is available from the text relevant to the device's assessment:
- Predicate Devices: The device establishes substantial equivalence to the Expedium Spine System (Merlin Spine System) (K033901) and Expedium Spine System (K041119). This implies that a primary "acceptance criterion" is that the new device performs equivalently to these legally marketed devices in terms of safety and effectiveness.
- Performance Data: The document states that "Performance data were submitted to characterize the additional Expedium Spine System components." This would refer to engineering and mechanical testing data, not clinical study results or AI performance metrics. The specific results are not included in this summary.
- Materials: Manufactured from ASTM F-138 implant grade stainless steel and ASTM F-136 implant grade titanium alloy. This implies adherence to established material standards is an "acceptance criterion."
- Intended Use: The device is intended for noncervical pedicle and nonpedicle fixation for various spinal conditions, as detailed in the "Indications for Use" section. This aligns its intended therapeutic purpose.
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| IX. | 510(k) Summary | K051024 |
|---|---|---|
| SUBMITTER: | JUL 6 - 2005DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780 | |
| CONTACT PERSON: | Mary E. Gray | |
| DATE PREPARED: | April 21, 2005 | |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal InterlaminalOrthosis, Spinal Pedicle Fixation, Spinal IntervertebralBody Fixation | |
| PROPRIETARY NAME: | Expedium Spine System | |
| PREDICATE DEVICES: | Expedium Spine System (Merlin Spine System)K033901 and Expedium Spine System K041119 | |
| DEVICE DESCRIPTION: | Expedium Spine System components are designed toaccept a 5.5mm rod and are available in variousgeometries and sizes.The Expedium Spine System also contains Class 1manual surgical instruments and cases that areconsidered exempt from premarket notification | |
| INTENDED USE: | The Expedium Spine System is intended fornoncervical pedicle fixation and nonpedicle fixation forthe following indications: degenerative disc disease(defined as back pain of discogenic origin withdegeneration of the disc confirmed by history andradiographic studies); spondylolisthesis; trauma (i.e.,fracture or dislocation); spinal stenosis; curvatures(i.e., scoliosis, kyphosis, and/or lordosis); tumor;pseudoarthrosis; and failed previous fusion inskeletally mature patients. | |
| MATERIALS: | Manufactured from ASTM F-138 implant gradestainless steel and ASTM F-136 implant gradetitanium alloy. | |
| PERFORMANCEDATA: | Performance data were submitted to characterize theadditional Expedium Spine System components. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 6 - 2005
Mary E. Gray, RAC DePuy Spine, Inc. Sr. Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K051024
Trade/Device Name: Expedium™ Spine System Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedical screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: III Product Code: NKB, MNI, MNH, KWP Dated: June 3, 2005 Received: June 6, 2005
Dear Ms. Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becare in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the entress. 1976, the enactment date of the Medical Device Amendments, or to commerce pror to this) 2005 reclassified in accordance with the provisions of the Federal Food, Drug, de nees mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mererore, mains 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 rr your device to such additional controls. Existing major regulations affecting your device can may or subject to been and 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 r rouse of activer him is to revice complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I 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 - Mary E. Gray, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to organ maining of substantial equivalence of your device to a legally prematication: The PDF interessification 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 If you doon't bpoorne at (240) 276-_. Also, please note the regulation entitled, Connact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
Stupt Clurle
Dr. Michael C. Rivera, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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lll. Indications for Use
| 510(k) Number (if known): | K051024 |
|---|---|
| --------------------------- | --------- |
Expedium™ Spine System Device Name:
Indications For Use:
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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
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)
Styph Curda
Division of General, Restorative,
DePuy Spine, Inc. Special 510K
and Neurologic
Page 5
510(k) Number K051024
§ 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.