(88 days)
The Pioneer Lumbar Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The Pioneer Lumbar Plate System is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (LI -S1) spine instability as a result of the following: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, and failed previous spine surgery.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The Pioneer Lumbar Plate System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Implants are composed of titanium alloy Ti6Al4V (ISO 5832-3) ELI, the same as predicate device.
The provided document is a 510(k) premarket notification for a medical device called the "Pioneer Lumbar Plate System." It describes the device's intended use and demonstrates its substantial equivalence to previously marketed predicate devices.
However, the document does not contain the kind of information typically associated with complex AI/ML device evaluations, such as detailed acceptance criteria, reported performance metrics (like accuracy, sensitivity, specificity), sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.
Instead, the performance data presented focuses on mechanical testing and comparison to predicate devices' performance data, materials, indications, and design/function. This is standard for spinal implant devices where the primary concern is the physical and structural integrity and biocompatibility of the implant.
Therefore, for aspects 2 through 9 of your request, the answer will largely be "Not applicable" or "Not specified in this document" because this type of evaluation is not relevant to a spinal plate system.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from "Guidance for Spinal Systems 510(k')s", May 3, 2004) | Reported Device Performance | Study Proving Acceptance |
|---|---|---|---|
| Mechanical Performance | In accordance with "Guidance for Industry and FDA Staff. Guidance for Spinal Systems 510(k')s", May 3, 2004 standards for spinal systems. | Device performance data (exact metrics not detailed in this summary) was compared to predicate devices K063158 & K041167. | Mechanical testing |
| Material Composition | Biocompatibility and structural integrity of Titanium alloy Ti6Al4V (ISO 5832-3) ELI. | Implants composed of titanium alloy Ti6Al4V (ISO 5832-3) ELI, the same as predicate device. | Material comparison and potentially material testing (implied) |
| Indications for Use | Substantial equivalence to predicate device's indications. | Pioneer Lumbar Plate System indications are substantially equivalent to predicate devices K063158 and K041167. | Comparison of indications for use |
| Design/Function | Substantial equivalence to predicate device's design and function. | Design and function are substantially equivalent to predicate devices K063158 and K041167. | Comparison of design/function |
Additional Information Not Relevant for this Device Type:
- Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device (spinal plate system), not a diagnostic algorithm or AI/ML product that uses a "test set" of data in the typical sense. Mechanical testing typically uses a certain number of physical samples to establish performance. The document doesn't specify the number of samples for mechanical testing, nor does it refer to "data provenance" in this context.
- 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): Not applicable. "Ground truth" in the context of device performance for this product refers to established engineering standards for mechanical strength, fatigue, material properties, and clinical utility as defined by the predicate devices. It doesn't involve expert consensus on image interpretation or similar.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" for performance is defined by established mechanical engineering standards (e.g., ISO standards for implants, ASTM standards for materials testing) and the performance characteristics of the legally marketed predicate devices. The "Guidance for Spinal Systems 510(k')s" document likely outlines specific mechanical tests and performance benchmarks (e.g., fatigue strength, static strength, wear resistance).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary: The Pioneer Lumbar Plate System demonstrated substantial equivalence by meeting mechanical performance standards and by having comparable materials, indications for use, and design/function to its predicate devices (K063158 & K041167), as outlined in the "Guidance for Spinal Systems 510(k')s". The evaluation process did not involve the types of studies or criteria typically applied to AI/ML software as a medical device.
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Summary of Safety and Effectiveness Information . 3.0
| Sponsor: | Pioneer Surgical TechnologyAPR 2 8 2009375 River Park CircleMarquette, MI 49855(906) 226-4812Contact: Jonathan M. Gilbert |
|---|---|
| Device Name: | Pioneer Lumbar Plate System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Number: | Regulation Number: 888.3060Product Code: KWQ; Panel Code: 87 |
| Description: | The Pioneer Lumbar Plate System consists of an assortment ofplates and screws. The system also contains Class 1 manualsurgical instruments and cases that are considered exempt frompremarket notification. Implants are composed of titanium alloyTi6Al4V (ISO 5832-3) ELI, the same as predicate device. |
| Intended Use: | The Pioneer Lumbar Plate System is intended for use via thelateral or anterolateral surgical approach above the bifurcation ofthe great vessels or via the anterior surgical approach, below thebifurcation of the great vessels. The Pioneer Lumbar PlateSystem is indicated as an adjunct to fusion in the treatment oflumbar and lumbosacral (LI -S1) spine instability as a result ofthe following: fracture (including dislocation and subluxation),tumor, degenerative disc disease (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed bypatient history and radiographic studies), pseudoarthrosis,spondylolysis, spondylolisthesis, scoliosis, lordotic deformitiesof the spine, spinal stenosis, and failed previous spine surgery.Warning: This device is not intended for screw attachment orfixation to the posterior elements (pedicles) of the cervical,thoracic, or lumbar spine. |
| Performance Data:Performance and SEDetermination: | Mechanical testing in accordance with the "Guidance forIndustry and FDA Staff. Guidance for Spinal Systems 510(k')s",May 3, 2004 is presented.Comparisons of device performance data, materials, indicationsand design/function to predicate devices, K063158 &K041167,were provided in making a determination of substantialequivalence. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 its wings spread, 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
Pioneer Surgical Technology % Mr. Jonathan M. Gilbert 375 River Park Circle Marquette, Michigan 49855
APR 2 8 2009
Re: K090222
Trade/Device Name: Pioneer Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: March 13, 2009 Received: March 16, 2009
Dear Mr. Gilbert:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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- Mr. Jonathan M. Gilbert
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Mabel N. Malloy
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: 2.0 Indications for Use Statement
Pioneer Lumbar Plate System
510(k) Number (if known): K090222
Device Name:
Indications:
The Pioneer Lumbar Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The Pioneer Lumbar Plate System is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (LI -S1) spine instability as a result of the following: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, and failed previous spine surgery.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mavare Richards A. MKM
Division Sign-Off
Division of General. Hestorative. and Neurological Devices
510(k) Number K090220
§ 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.