(506 days)
The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolithesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:
- Defect of the pars interarticularis .
- Spondylolithesis .
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.
Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.
The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolithesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:
- Defect of the pars interarticularis .
- Spondylolithesis .
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.
Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.
The provided text describes a 510(k) summary for the Pioneer Posterior Cable Screw, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with detailed acceptance criteria and standalone performance evaluations as would be expected for novel devices or software.
Therefore, much of the requested information regarding acceptance criteria, specific study details (sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), and ground truth establishment is not available in the provided document, as it falls outside the scope of a typical 510(k) summary focused on hardware equivalence.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence: Comprised of implant grade stainless steel (ASTM F138 and ISO 5832-1) | Implied to meet this, as the material is stated to be "Implant grade stainless steel (ASTM F138 and ISO 5832-1.)" |
| Mechanical Performance: Equivalent mechanical properties to predicate device. | "Mechanical information was presented to support a determination of PERFORMANCE SE [Substantial Equivalence]." (Specific metrics or thresholds not detailed). |
| Intended Use Equivalence: Similar intended use as predicate device. | "The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolisthesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures." (Matches or is similar to predicate). |
| Design Equivalence: Similar to components of a previously cleared device. | "The Pioneer Posterior Cable Screw system is similar to the components of a previously cleared device." (Specific design details not provided). |
2. Sample Size used for the test set and the data provenance
- Not Applicable/Not Provided. The submission is for a mechanical spinal implant and focuses on substantial equivalence based on material and mechanical properties, not a clinical study on a test set of data (e.g., images for an AI device).
- Data Provenance: Not applicable. Performance is based on material standards and mechanical testing, not a dataset from a specific country or retrospective/prospective study with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Provided. This information is relevant for studies involving human interpretation or clinical outcomes, which are not detailed in this 510(k) summary.
4. Adjudication method for the test set
- Not Applicable/Not Provided. No test set requiring expert adjudication is described.
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 hardware device (spinal implant), not a software/AI device. Therefore, an MRMC study is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a hardware device. "Standalone performance" in the context of AI algorithms is not relevant here. The "standalone" performance would be its mechanical integrity, which is assessed through testing that is not detailed in terms of its specific methodology or standalone vs. human-in-the-loop comparison.
7. The type of ground truth used
- Not Applicable/Not Provided in the typical AI/clinical study sense. For this device, "ground truth" relates to:
- Material composition: Confirmed by adherence to ASTM F138 and ISO 5832-1 standards.
- Mechanical performance: Confirmed through testing (implied by "Mechanical information was presented") against accepted engineering criteria, likely benchmarking against the predicate device.
- Clinical Efficacy/Safety: Not directly proven in this 510(k) summary; rather, it is inferred by substantial equivalence to a device with an established safety and efficacy profile.
8. The sample size for the training set
- Not Applicable/Not Provided. This pertains to AI/machine learning models, which is not the subject of this 510(k). For mechanical testing, the number of samples tested for mechanical properties is not specified.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. As there's no AI "training set" described, this question is not relevant. The "ground truth" for the device's material and mechanical properties would be established through accredited laboratory testing and adherence to recognized material and performance standards.
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K022908 P'//
JAN 2 2 2004
DATA:
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| SPONSOR: | Pioneer Surgical Technology |
|---|---|
| 375 River Park Circle | |
| Marquette, Michigan 49855-1781 | |
| Contact: Jonathan Gilbert |
Pioneer Posterior Cable Screw DEVICE NAME:
The classification of pedicle screw spinal system (§888.3070) and CLASSIFICATION: cerclage (§888.3010) is Class II, as per the Code of Federal Regulations, Title 21. The product codes are MNI and JDQ, respectively.
The ParsFix Cable-Screw System (K003351 - SE 01/24/01, Spinal PREDICATE DEVICE: Concepts, Inc. - Austin, TX)
| DEVICE | Proprietary Name: Pioneer Posterior Cable Screw |
|---|---|
| DESCRIPTION: | Common Name: Posterior Cable Screw |
- The Posterior Cable Screw System is designed as an adjunct to any INTENDED USE: stainless steel, rigid, posterior fixation cleared/approved for trauma and sponylolithesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:
- Defect of the pars interarticularis .
- Spondylolithesis .
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.
Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.
Implant grade stainless steel (ASTM F138 and ISO 5832-1.) MATERIAL:
Mechanical information was presented to support a determination of PERFORMANCE SE.
The Pioneer Posterior Cable Screw system is similar to the BASIS OF components of a previously cleared device. The material is SUBSTANTIAL comprised of implant grade stainless steel. Supplemental fixation EQUIVALENCE: devices are intended for use with the device.
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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 three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2004
Mr. Jonathan Gilbert Director, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855-1781
Re: K022908
Trade/Device Name: Pioneer Posterior Cable Screw Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3010 Regulation Name: Pedicle screw spinal system, Bone fixation cerclage Regulatory Class: II Product Code: MNI, JDQ Dated: November 28, 2003 Received: December 2, 2003
Dear Mr. Gilbert:
We have reviewed your Scction 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 cither 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 - Mr. Jonathan Gilbert
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 (301) 594-4639. 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,
A. Mark A. Milkersson
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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Page 1 of 1
K022908 510(k) Number (if known):
Pioneer Posterior Cable Screw Device Name:
INDICATIONS:
The Posterior Cable Screw System is designed as an adjunct to any stainless steel, rigid, posterior fixation cleared/approved for trauma and spondylolisthesis and is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures. A spinous process Grommet is included as part of the system. The system is designed as an adjunct to any stainless steel, rigid, posterior fixation and is indicated for the following:
- Defect of the pars interarticularis .
- Spondylolithesis .
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum.
Cables and spinous process Grommets may be used for interspinous wiring if additional stability is needed.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Counter Use_
(Per 21 CFR 801.109)
X
OR
Over-The-
for Mark n Wilkerson
Prative
§ 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.