(103 days)
The Stryker Spine XIA® III Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA®III Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: Degenerative disc disease (DDD) (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. The Ø5.5mm rods from the Stryker Spine Radius™ Spinal System and Ø6.0 mm Vitallium rods from XIA® Spinal System are intended to be used with the other components of Xia® III Spinal System.
The Stryker Spine Xia® III Spinal System is comprised of monoaxial & polyaxial bone screws, blocker (as a locking mechanism), rods, hooks, and connectors. The implants are manufactured from Ti6Al4V alloy, and CPTi. The subject system also offers MoCoCr alloy (Vitallium) rods.
The Stryker Spine Xia® III Spinal System is a spinal fixation system. The provided text indicates that its performance was assessed through testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004. This testing demonstrated substantial equivalent performance characteristics to the predicate device systems.
However, the provided document does not contain detailed information regarding specific acceptance criteria, reported device performance metrics, sample sizes, data provenance, expert ground truth establishment, adjudication methods, or specific study types (MRMC or standalone AI studies).
Therefore, I can only provide the information that is explicitly stated or can be inferred from the text.
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with numerical values or detailed reported device performance. It generally states:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device systems based on FDA Guidance for Spinal System 510(k)'s May 3, 2004. | Demonstrated substantial equivalent performance characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document. It's important to note that this is a spinal implant, and "ground truth" may not be established by medical experts in the same way it would be for an AI diagnostic device. Instead, performance is typically assessed through mechanical and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be applicable for this type of medical device (a spinal implant). MRMC studies are typically performed for diagnostic imaging devices where human interpretation is involved, often with AI assistance. This device is an implant for surgical use.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a spinal implant, not an algorithm or AI system. Its performance is assessed through various engineering and biocompatibility tests, not algorithmic output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Given that this is a spinal implant, the "ground truth" for its performance would likely be based on engineering standards, materials testing results (e.g., strength, fatigue, biocompatibility), and potentially pre-clinical data on mechanical stability and integration. The document mentions "testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004," which would involve these types of evaluations. Expert consensus, pathology, or outcomes data are not explicitly mentioned as the primary ground truth for its performance in this 510(k) summary for substantial equivalence.
8. The sample size for the training set
This information is not provided and is not applicable as this is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as this is not an AI or machine learning device requiring a training set.
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Stryker Spine Xia® III Spinal System
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| 510(k) Summary of Safety and EffectivenessStryker Spine Xia® III Spinal System | AUG 27 2007 | |
|---|---|---|
| Submitter: | Stryker Spine2 Pearl CourtAllendale, New Jersey 07401 | |
| Contact Person | Ms. SIMONA VOICREGULATORY AFFAIRS PROJETC MANAGERTELEPHONE: 201-760-8145FAX: 201-760-8345EMAIL: simona.voic@stryker.com | |
| Date Prepared | May 14, 2007 | |
| Trade Name | Stryker Spine Xia® III Spinal System | |
| Proposed Class | Class III and II | |
| Classification Nameand Number | Pedicle Screw Spinal System21 CFR 888.3070Spinal Interlaminal Fixation Orthosis21 CFR 888.3050 | |
| Product Code | NKB, MNH, MNI, and KWP | |
| Predicate Devices | Stryker Spine Xia® Spinal Systems: 510(k) #K060361,K060979, and #K013823,Stryker Spine Radius™ Spinal System: 510(k) # K062270,DePuy's Moss Miami Spinal System: 510(k) #K950697. | |
| Device Description | The Stryker Spine Xia® III Spinal System is comprised of monoaxial & polyaxial bone screws, blocker (as a locking mechanism), rods, hooks, and connectors. The implants are manufactured from Ti6Al4V alloy, and CPTi. The subject system also offers MoCoCr alloy (Vitallium) rods. | |
| Intended Use | The Stryker Spine XIA® III Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle and non-pedicle fixation system, the XIA®III Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:Degenerative disc disease (DDD) (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. The Ø5.5mm rods from the Stryker Spine Radius™ Spinal System and Ø6.0 mm Vitallium rods from XIA® Spinal System are intended to be used with the other components of Xia® III Spinal System. | |
| Summary of theTechnologicalCharacteristics | Testing in compliance with FDA's Guidance for Spinal System510(k)'s May 3, 2004 was performed for the Xia® III SpinalSystem, and demonstrated substantial equivalent performancecharacteristics to the predicate device systems. |
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K071373
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071373
Stryker Spine Xia® III Spinal System
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401
AUG 27 2007
Re: K071373
Trade/Device Name: Xia® III Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWP Dated: August 1, 2007 Received: August 2, 2007
Dear Ms. Voic:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 -- Ms. Simona Voic
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
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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Indications for Use
510(k) Number (if known): K 07 1373 Device Name: Stryker Spine Xia® III Spinal System
Indications For Use:
The Stryker Spine XIA® III Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA "III Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
- . Degenerative disc disease (DDD) (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. .
The Ø5.5mm rods from the Stryker Spine Radius™ Spinal System and Ø6.0 mm Vitallium rods from XIA® Spinal System are intended to be used with the other components of Xia "III Spinal System.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
Page 1 of 1
(Division Sign-Ola)
Division of General. Restorative,
and Neurological Devices
510(k) Number K071373
§ 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.