(136 days)
The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The Stryker Spine Vertebral Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine Vertebral Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).
The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5). It is intended to replace a collapsed, damaged, or unstable vertebral body resected or excised during total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. It is recommended to pack bone graft material inside the implant. The device is intended for use with supplemental fixation systems such as Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).
The provided document is a 510(k) summary for the Stryker Spine Vertebral Spacer. It discusses the device's intended use, materials, and a comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain information about specific acceptance criteria or a detailed study proving the device met those criteria in the context of performance metrics like accuracy, sensitivity, or specificity, which are typically associated with AI/ML device evaluations.
The "study" referenced in this document is a technological comparison and mechanical testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s. This is a very different type of "study" than what would be conducted to evaluate the performance of an AI/ML powered medical device.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data in the format typically used for AI/ML device evaluations, because this document predates such rigorous performance evaluation requirements for AI/ML devices and describes a different type of medical device (an implant, not an algorithm).
However, I can extract information relevant to the device's regulatory acceptance based on the document.
Here's a breakdown of what can be inferred from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
-
Acceptance Criteria (Inferred from regulatory context, not explicit numerical targets):
- Substantial equivalence to predicate devices in terms of indications for use, materials, design, and principles of operation.
- Compliance with FDA's Guidance for Spinal System 510(k)'s, September 27, 2000.
- Mechanical and biological safety and effectiveness demonstrated through testing (though specific test results are not detailed).
-
Reported Device Performance: The document states that the "Stryker Spine Vertebral Spacer is substantially equivalent to its predicate devices." This is the primary reported "performance" metric in a 510(k) context. Specific quantitative performance data (e.g., in terms of strength, fatigue life, biological compatibility) from the underlying testing mentioned by the company is not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable in the AI/ML sense. This document pertains to a physical implant. The "test set" would typically refer to the samples used in mechanical testing (e.g., number of implants tested for compression, fatigue, etc.) or in-vitro/in-vivo biocompatibility studies. This information is not provided in the 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data provenance. The "data" here would be from mechanical and biocompatibility testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. This device is a physical implant, not an AI/ML algorithm requiring expert interpretation of outputs.
- The FDA reviewers (e.g., Celia M. Witten, Ph.D., M.D., Director, Division of General, Restorative and Neurological Devices) are experts involved in the regulatory approval process, but they are not establishing ground truth for evaluating an algorithm's performance.
4. Adjudication Method for the Test Set:
- Not applicable. This concept relates to resolving discrepancies in expert interpretations for AI/ML ground truth.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This type of study focuses on the impact of an AI algorithm on human reader performance.
6. Standalone Performance:
- Not applicable in the AI/ML sense. The "device" itself (the vertebral spacer) has standalone performance in terms of its mechanical properties and biocompatibility, but this is not typically expressed in terms of metrics like sensitivity/specificity for an algorithm. The 510(k) process ensures the device itself is safe and effective when used as intended.
7. Type of Ground Truth Used:
- For a physical implant, the "ground truth" for its performance would be established through a combination of:
- Mechanical Testing Standards: Adherence to established industry standards for strength, fatigue, etc.
- Biocompatibility Testing: In-vitro and sometimes in-vivo studies to assess material safety.
- Clinical Literature/Experience: Relying on the known performance and safety profiles of similar predicate devices.
- The 510(k) summary indicates compliance with FDA's Guidance for Spinal System 510(k)'s. This guidance would outline the necessary tests and criteria to establish "ground truth" for mechanical and biological safety.
8. Sample Size for the Training Set:
- Not applicable. This is an AI/ML specific term.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is an AI/ML specific term.
In summary, the provided document is a regulatory submission for a physical medical device (vertebral spacer) and addresses "substantial equivalence" to predicate devices rather than the performance metrics typically associated with AI/ML systems. The "study" mentioned refers to engineering and compliance testing against established guidance for spinal implants, not a clinical performance study using a test set of data as would be done for an AI/ML device.
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| AUG - 5 2004 | 510(k) Summary of Safety and Effectiveness: |
|---|---|
| Stryker Spine Vertebral Spacer |
| Submitter: | Stryker Spine |
|---|---|
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Ms. Simona Voic |
| Regulatory Affairs Project Manager | |
| Phone: 201- 760-8145 | |
| FAX: 201- 760-8345 | |
| Email: Simona.Voic@stryker.com | |
| Date Prepared | March 17, 2004 |
| Trade Name | Stryker Spine Vertebral Spacer |
| Classification Nameand Number | Spinal Vertebral Body Replacement Device,21 CFR 888.3060 |
| Product Code | MQP |
| Predicate Devices | 1) Stryker Spine Vertebral Body Support System (K033837) |
| 2) Spinal Concepts Inc. CadenceTM and TraXisTM (K033517) | |
| 3) PEEK TetrisTM Spinal Implant (K031780) | |
| 4) Stackable CageTM System (K990148) | |
| 5) VERTE-STACKTM Spinal System (K031780) | |
| Intended Use | The Stryker Spine Vertebral Spacer is a vertebral body replacementindicated for use in the thoraco-lumbar spine (T1-L5) to replace acollapsed, damaged, or unstable vertebral body resected or excisedduring total vertebrectomy procedures due to tumor or trauma, toachieve anterior decompression of the spinal cord and neural tissues,and to restore the height of a collapsed vertebral body.It is recommended to pack bone graft material inside the implant.The Stryker Spine Vertebral Spacer is intended for use withsupplemental fixation. The supplemental fixation systems that may |
| be used with the Stryker Spine Vertebral Spacer include, but are not | |
| limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius | |
| 90D, and Trio). | |
| Statement of | The Stryker Spine Vertebral Spacer and its predicate devices have |
| Technological | the same indications for use and are made of the same materials. |
| Comparison | Testing to demonstrate compliance with FDA's Guidance for Spinal |
| System 510(k)'s September 27, 2000 was completed for the Stryker | |
| Spinal Vertebral Spacer. | |
| Conclusion | The Stryker Spine Vertebral Spacer is substantially equivalent to its |
| predicate devices. This conclusion is based upon the fact that this | |
| device is substantially equivalent in terms of indications for use, | |
| materials, design and principles of operation. |
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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 2004
Ms. Simona Voic Regulatory Affairs Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Re: K040731
Trade/Device Name: Stryker Spine Vertebral Spacer Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 23, 2004 Received: June 24, 2004
Dear Ms. Voic:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed 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 encreative to regary the Medical Device Amendments, or to conninered prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices may been recassed require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, manse of the Act include requirements for annual registration, listing of general voltable provision 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 i tease of devised that I wornination that your device complies with other requirements of the Act that I Dr has intact a and regulations administered by other Federal agencies. You must or any I coclar statutes and registements, 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 form in the quand by by of the Actions 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) I his letter will anow you to oegin manceing your manoling of your device to a legally premarket nothCation. The FDA mining of basification 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 desire specific acrice 10. Jour 201) 594-4659. Also, please note the regulation entitled, comact the Office of Complance at (597) vification" (21CFR Part 807.97). You may obtain "Misoranuning by Iciercifec to promance nouiltean and er the Act from the Division of Small other general information on your responsible in the toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Wilkinson
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
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Indications for Use
510(k) Number (if known): K040731
Device Name: Stryker Spine Vertebral Spacer
Indications For Use:
The Stryker Spine Vertebral Spacer is a vertebral body replacement indicated for use in The Stryker Opine Vortobial Opaved, damaged, damaged, or unstable the inoraco-iumbar Spino (11 E8) to reply to tal vertebrectomy procedures due to funnor vertebrail bouy resolou or oxcious anterior of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
It is recommended to pack bone graft material inside the implant.
The Stryker Spine Vertebral Spacer is intended for use with supplemental fixation. The The Unyker Spine Vertebrans that may be used with the Stryker Spine Vertebral Supplemental likation oyetoms warter Spine plate rod or rod systems (XIA, Spiral Radius 90D, and Trio).
× 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 of General, Restorative,
and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K04072
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.