(87 days)
The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS PL PEEK Spacers are to be implanted via posterior approach.
The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
The AVS PL Peek Spacers are intervertebral body fusion devices intended for use as an aid in spinal fixation. The AVS PL PEEK Spacers are rectangular shaped, hollow frame implants with lateral fenestrations. The spacers incorporate two (2) Tantalum marker pins to aid in radiographic visualization.
The AVS PL PEEK Spacers are available in a variety of sizes, from 6 mm to 13 mm in height, two lengths: 30 mm and 33 mm and one width: 11 mm. There are also 0° and 4° wedge shaped options that allow the surgeon to best choose the size suited to the patient's anatomy and pathology.
The device described is the Stryker Spine AVS PL PEEK Spacers, an intervertebral body fusion device. The submission is a Traditional 510(k) Premarket Notification (K073470).
The provided text describes a medical device submission (510(k)) and its clearance. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing specific performance acceptance criteria for a new, innovative diagnostic device that requires rigorous clinical study with statistical endpoints.
Therefore, many of the requested elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or could not be extracted from the provided document. The document describes a device for spinal fusion, not a diagnostic AI device. The "study" mentioned is a set of bench tests to confirm mechanical and material properties, rather than a clinical trial to assess diagnostic accuracy or algorithm performance.
Here's an attempt to answer the questions based on the available information, noting the limitations:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in the format typically seen for diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for a medical implant like this are related to its material properties, mechanical strength, and biocompatibility, ensuring it functions as intended and is safe. The performance is reported in terms of meeting the requirements of recognized standards.
| Acceptance Criteria Category | Reported Device Performance (Summary from document) |
|---|---|
| Mechanical Performance | Substantial equivalent performance characteristics to identified predicate device systems. |
| Material Properties | Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed. |
Note: The document references compliance with a Class II Special Controls Guidance Document for Intervertebral Body Fusion Devices. This guidance document would outline the specific benchmarks and testing methodologies (e.g., static and dynamic compression, subsidence, expulsion, torsional testing) that the device must meet to demonstrate substantial equivalence to legally marketed predicates. The provided text confirms that such testing was performed and demonstrated substantial equivalent performance, but does not list the specific quantitative criteria or results.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of a diagnostic dataset. The "test set" for this device would refer to the physical prototypes subjected to bench testing. The document does not specify the number of individual spacers tested, but rather states that "Testing... was performed."
- Data Provenance: Not applicable in the context of diagnostic data. The "data" pertains to engineering and material testing results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical and material properties is established through standardized engineering tests and measurements, often conducted by engineers or technicians, rather than clinical experts or radiologists.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions for ground truth establishment. For device performance based on engineering tests, the results are objectively measured against predefined standards.
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 device is an intervertebral body fusion spacer, not an AI-powered diagnostic tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be established engineering standards, material specifications, and biomechanical performance requirements as outlined in relevant ASTM/ISO standards and the FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device." It's based on objective measurements from bench testing to ensure mechanical integrity, biocompatibility, and functional equivalence to predicate devices.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable.
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MAR - 6 2008
Stryker Spine AVS PL PEEK Spacers
Traditional 510(k) Premarket Notification
510(k) Summary: AVS PL PEEK Spacers
| Submitter: | Stryker Spine2 Pearl CourtAllendale, New Jersey 07401 |
|---|---|
| Contact Person | Ms. Simona VoicRegulatory Affairs Project ManagerPhone: 201-760-8145FAX: 201-760-8345Email: simona.voic@stryker.com |
| Date Prepared | March 3, 2008 |
| Trade Name | Stryker Spine AVS PL PEEK Spacers |
| Proposed Class | Class II |
| Classification Nameand Number | Intervertebral body fusion device, 21 CFR 888.3080 |
| Product Code | MAX |
| Predicate Devices | Stryker Spine Ray Threaded Fusion Cage (TFC)TM withinstrumentation: P950019;DePuy AcroMed, Inc. Lumbar I/F Cage® with VSP SpineSystem: P960025.Synthes Spine SynFixTM - LR: K072253. |
| Device Description | The AVS PL Peek Spacers are intervertebral body fusion devicesintended for use as an aid in spinal fixation. The AVS PL PEEKSpacers are rectangular shaped, hollow frame implants withlateral fenestrations. The spacers incorporate two (2) Tantalummarker pins to aid in radiographic visualization.The AVS PL PEEK Spacers are available in a variety of sizes,from 6 mm to 13 mm in height, two lengths: 30 mm and 33 mmand one width: 11 mm. There are also 0° and 4° wedge shapedoptions that allow the surgeon to best choose the size suited tothe patient's anatomy and pathology. |
| Intended Use | The Stryker Spine AVS PL PEEK Spacers are intervertebralbody fusion devices indicated for use with autogenous bone graftin patients with degenerative disc disease (DDD) at one level ortwo contiguous levels from L2 to S1.DDD is defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies. The DDD patients may also have up to Grade Ispondylolisthesis at the involved level(s). These patients shouldbe skeletally mature and have six months of nonoperativetherapy.The AVS PL PEEK Spacers are to be implanted via posteriorapproach.The AVS PL PEEK Spacers are intended to be used withsupplemental spinal fixation systems that have been cleared foruse in the lumbosacral spine (i.e., posterior pedicle screw androd systems). |
| Summary of theTechnologicalCharacteristics | Testing in compliance with FDA's June 12, 2007 "Class IISpecial Controls Guidance Document: Intervertebral BodyFusion Device" was performed for the AVS PL PEEK Spacersand demonstrated substantial equivalent performancecharacteristics to the identified predicate device systems. |
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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 stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Spine % Ms. Simona Voic 2 Pearl Court Allendale, NJ 07401
MAR - 6 2008
Re: K073470
Trade/Device Name: Stryker Spine AVS PL PEEK Spacers Regulation Number: 21 CFR 888.3080 Regulation Names: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: December 7, 2007 Received: December 10, 2007
Dear Ms. Voic:
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 - 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Miller
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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Stryker Spine AVS PL PEEK Spacers
Indications for Use
510(k) Number (if known): K ( 73470 Device Name: Stryker Spine AVS PL PEEK Spacers
Indications For Use:
The Stryker Spine AVS PL PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The AVS PL PEEK Spacers are to be implanted via posterior approach.
The AVS PL PEEK Spacers are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems).
Prescription Use X (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)
Neil R R Qde for nxm
Division of General, Restorative and Neurological Devices
Page 1 of 1
510(k) Number K073470
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.