(89 days)
The Stryker Spine MAPS System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally maturc 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Stryker Spinc MAPS System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the development of a solid fusion mass.
The Stryker Spine MAPS System is also a sacral/iliac screw fixation system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts.
The Stryker Spine MAPS System is also intended to be used in conjunction with the OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Connectors.
The Stryker Spine MAPS System is comprised of screws and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The components will be provided non-sterile.
The provided document is a 510(k) Premarket Notification for the Stryker Spine MAPS System, dated December 10, 2003. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. It does not typically include detailed studies involving AI, human readers, ground truth consensus, or the metrics usually associated with evaluating diagnostic or AI-driven devices.
Here's a breakdown of why many of your requested items cannot be found in this document:
- Device Type: The Stryker Spine MAPS System is a mechanical implant (spinal fixation system), not a diagnostic device or an AI/software-as-a-medical-device (SaMD). Its performance is evaluated through mechanical testing and comparison to predicate devices, not clinical studies involving interpretation of data by human readers or AI algorithms.
- Regulatory Pathway: The 510(k) pathway focuses on demonstrating substantial equivalence to a predicate device in terms of intended use, materials, and design, often supported by non-clinical testing (like mechanical tests). It's not a de novo or PMA pathway that would require extensive clinical efficacy studies with specific performance metrics against a defined ground truth, especially not concerning AI or human reader improvement.
Therefore, many of the requested details are not applicable or present in this type of submission.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (materials, design) | Mechanical testing demonstrated comparable mechanical properties to the predicate devices. |
| Intended use similar to predicate devices | Yes, detailed intended uses are listed and compared for substantial equivalence. |
- Explanation: The "acceptance criteria" for a 510(k) notification are primarily demonstrating substantial equivalence to a legally marketed predicate device. For a mechanical implant, this typically involves showing comparable mechanical strength, fatigue resistance, and biocompatibility. The document explicitly states, "Mechanical testing demonstrated comparable mechanical properties to the predicate devices," implying this was the key performance metric used.
2. Sample size used for the test set and the data provenance
- N/A (Not Applicable/Not Provided): This refers to clinical or diagnostic test sets. Since this is a mechanical implant, the "test set" would be physical samples for mechanical testing, not patient data in the context of AI or diagnostic accuracy. The document does not specify the number of physical samples for mechanical testing or their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A: Ground truth for diagnostic accuracy is not relevant here. The evaluation involves mechanical properties and demonstration of substantial equivalence based on engineering principles and regulatory guidelines for implants.
4. Adjudication method for the test set
- N/A: Adjudication methods are used in studies involving human interpretation or subjective assessments. This is not relevant for the mechanical testing of a spinal implant.
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
- No: This is a mechanical implant, not an AI-driven diagnostic tool. Therefore, MRMC studies are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No: This is a mechanical implant, not an algorithm or AI system.
7. The type of ground truth used
- N/A (Mechanical Standards/Predicate Device Specifications): The "ground truth" in this context would be adherence to established mechanical testing standards (e.g., ASTM or ISO standards for spinal implants) and comparability to the known performance of predicate devices. There is no biological "ground truth" like pathology or outcomes data in the sense of a diagnostic test.
8. The sample size for the training set
- N/A: There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- N/A: There is no "training set" or "ground truth" in the context of machine learning for this mechanical device.
{0}------------------------------------------------
1.62
Stryker Spine MAPS System
DEC 1 0 2003
510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness: Stryker Spine MAPS System
| Proprietary Name: | Stryker Spine MAPS System |
|---|---|
| Common Name: | Spinal Fixation Appliances |
| Classification Name and Reference: | Pedicle Screw Spinal System, 21 CFR 888.3070 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 MNH: Orthosis, Spondyloisthesis Spinal Fixation87 MNI: Orthosis, Spinal, Pedicle Fixation |
| For Information contact: | Karen AriemmaRegulatory Affairs SpecialistHowmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677Telephone: (201) 831-5718Fax: (201) 831-6038Email: karicmma@howost.com |
| Date Summary Prepared: | December 9, 2003 |
Device Description
The Stryker Spine MAPS System is comprised of screws and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The components will be provided non-sterile.
Intended Use
The Stryker Spine MAPS System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion the treatment of the following acute and chronic instabilities or deformities of the thoracic, iumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed provigus fusion (pseudarthrosis).
The Stryker Spine MAPS System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Craces 3 and 4) at the L5-S1 vertebra in sketetsly matured on receiving fusion by autogenous bone graft having implants attached to the lumber and sacral spine (13 to sacrum) with removal of the implants after the development of a solid fusion mass.
The Stryker Spinc MAPS System is also a sacral/iliac screw fixation system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts.
{1}------------------------------------------------
The Stryker Spine MAPS System is also intended to be used in conjunction with the OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Comentors.
Substantial Equivalence
Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed spinal systems. Mcchanical testing demonstrated comparable mechanical properties to the predicate devices.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2003
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K032855
Trade/Device Name: Stryker Spine MAPS System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Codes: MNH, MNI Dated: September 10, 2003 Received: September 12, 2003
Dear Ms. Ariemma:
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 Amendnents. or 10 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 Cl·R 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.
{3}------------------------------------------------
Page 2 - Ms. Karen Ariemma
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 11 you a the Office of Compliance at (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mah Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
०32rsr '11
Page 1 of 1
510(k) Number (if known): K
Device Name: Stryker Spine MAPS System
The Stryker Spine MAPS System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally maturc 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Stryker Spinc MAPS System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the development of a solid fusion mass.
The Stryker Spine MAPS System is also a sacral/iliac screw fixation system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and revision of failed fusion attempts.
The Stryker Spine MAPS System is also intended to be used in conjunction with the OSS/Diapason Rods, Opus Spinal System Rods and the Multi-Axis Cross Connectors.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use (Per 21 CFR 801.109) Prescription Use OR (Optional Format 1-2-96)
R. Mark N. Mcllharron
al, Restorative
Number K032853
§ 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.