(84 days)
The Pioneer Poise Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Pioneer Poise Anterior Cervical Plate System consists of an assortment of plates and screws. The screws are used to secure the plates to the vertebral bodies of the cervical spine through an anterior approach. The Poise system consists of static and dynamic plates in lengths that range from 10-84mm and include one, two, three and four level designs. The dynamic design provides for uni-directional axial movement for postoperative load sharing between the plate and graft. The plates have an integrated screw retention mechanism. Screws range from 10-20mm in length, 4.0 or 4.5mm in diameter, and are available in self tapping or self drilling. The plates and screws are manufactured from Titanium alloy (ASTM F136) and Nitinol (ASTM F2063). The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes the Pioneer Poise Anterior Cervical Plate System, a medical device, and its 510(k) submission. However, it does not include information about a study proving the device meets acceptance criteria related to AI/algorithm performance. The documentation focuses on demonstrating substantial equivalence to predicate devices through traditional mechanical testing and material comparisons.
Therefore, many of the requested sections regarding acceptance criteria and a study proving algorithmic performance cannot be fulfilled from the given text. The device is a physical spinal implant, not an AI or software-as-a-medical-device (SaMD), so the questions about AI performance metrics, ground truth, and reader studies are not applicable.
Here's an analysis based on the provided text, focusing on the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of device are primarily related to its mechanical strength, durability, and material properties, demonstrating that it is substantially equivalent to legally marketed predicate devices. The "performance" here refers to the outcomes of these mechanical tests.
| Acceptance Criteria Category | Specific Test/Property | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static and fatigue compression bending (ASTM F1717) | Tested. Results demonstrate substantial equivalence to predicate devices. (Specific numerical thresholds or values are not provided in the summary, but the conclusion is "substantially equivalent"). |
| Static torsion (ASTM F1717) | Tested. Results demonstrate substantial equivalence to predicate devices. | |
| Axial pullout screw strength (ASTM F543) | Tested. Results demonstrate substantial equivalence to predicate devices. | |
| Screw pull-through plate (internal protocol) | Tested. Results demonstrate substantial equivalence to predicate devices. | |
| Screw retention characteristics (internal protocol) | Tested. Results demonstrate substantial equivalence to predicate devices. | |
| Material Composition | Plates and Screws | Manufactured from Titanium alloy (Ti6Al4V ELI, according to ASTM F136). Identical to predicate devices. |
| Screw-retention mechanism ("spring") | Manufactured from Nitinol (ASTM F2063). | |
| Dimensional Equivalence | Screw lengths (10-20mm) | Identical to predicate devices. |
| Screw diameters (4.0/4.5mm) | Identical to predicate devices. | |
| Overall plate length (10-84mm) | Identical to predicate devices. | |
| Plate types (one, two, three, four level; static & dynamic) | Identical to predicate devices. | |
| Intended Use & Principle of Operation | Indications for Use | Identical to predicate devices (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, failed previous fusion). |
| Principle of Operation | Employs the same principles of operation as predicate devices (anterior cervical fixation, securing plates to vertebral bodies for uni-directional axial movement in dynamic designs). |
Due to the nature of the device (a physical spinal implant) and the content of the provided document (a 510(k) summary focused on substantial equivalence through mechanical testing), the following questions are not applicable to the submitted information.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The "test set" in this context would refer to the samples of the device components used for mechanical testing. The document states "Non-Clinical Mechanical testing was presented to characterize construct and component performance," but does not specify the number of samples tested for each mechanical test. Data provenance like country of origin or retrospective/prospective is not relevant for non-clinical mechanical testing of physical implants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of expert review, is not relevant for pre-market clearance of a physical implant based on mechanical engineering testing. The "ground truth" for mechanical testing is established by recognized ASTM standards and the physical properties observed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically for evaluating subjective interpretations, often in image analysis or clinical assessments, which is not the primary method for demonstrating equivalence of a spinal implant.
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
- Not applicable. This question pertains to AI/algorithm performance studies, which are not relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI/algorithm performance studies, which are not relevant for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for the mechanical testing of this device is adherence to established ASTM standards and comparable performance to predicate devices' mechanical properties. This is measured objectively, not through human consensus, pathology, or outcomes data in the traditional sense for an AI/diagnostic device.
8. The sample size for the training set
- Not applicable. This device is a physical implant, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model, this question is irrelevant.
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510(k) Summary
| Sponsor: | JUN - 4 2010Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855(906) 225-5602Contact: Emily M. DownsPrepared May 20, 2010 |
|---|---|
| Device Name: | Pioneer Poise Anterior Cervical Plate System |
| ClassificationName: | The classification of the Pioneer Poise Anterior Cervical Plate System isClass II, as per the Code of Federal Regulations, Title 21, Section888.3060: Spinal intervertebral body fixation orthosis. |
| Product Codes: | The product code is KWQ. The Panel code is 87. |
| Predicate Device: | K083663- Pioneer Anterior Cervical (PAC) Plate System (SE 2/25/09)K072703- Pioneer SlimFuse Anterior Cervical Plating System (SE 1/10/08)K053053- Pioneer Anterior Cervical Plate System (SE11/16/05)K043066- Pioneer Anterior Cervical Plate System (SE 2/3/05) |
| Description: | The Pioneer Poise Anterior Cervical Plate System consists of an assortmentof plates and screws. The screws are used to secure the plates to thevertebral bodies of the cervical spine through an anterior approach. ThePoise system consists of static and dynamic plates in lengths that rangefrom 10-84mm and include one, two, three and four level designs. Thedynamic design provides for uni-directional axial movement forpostoperative load sharing between the plate and graft. The plates have anintegrated screw retention mechanism. Screws range from 10-20mm inlength, 4.0 or 4.5mm in diameter, and are available in self tapping or selfdrilling. The plates and screws are manufactured from Titanium alloy(ASTM F136) and Nitinol (ASTM F2063). |
| The system also contains Class 1 manual surgical instruments and casesthat are considered exempt from premarket notification. | |
| Intended Use: | The Pioneer Poise Anterior Cervical Plate System is intended for anteriorcervical fixation for the following indications: degenerative disc disease(DDD) (defined as neck pain of discogenic origin with degeneration of thedisc confirmed by history and radiographic studies), spondylolisthesis,trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures(i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failedprevious fusion. |
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The subject device has indications for use identical to those of the predicate Comparison to Predicate Devices: PAC system and employs the same principles of operation. Identical materials are used for both subject and predicate plates and screws. A vailable screw lengths (10-20mm), screw diameters (4.0/4.5mm), overall plate length (10-84mm), and plate types (one, two, three and four level; static and dynamic) are identical for both systems.
The Pioneer Poise Anterior Cervical Plate System plates and screws are Material: manufactured from titanium alloy (Ti6Al4V ELI, according to ASTM The plates incorporate a screw-retention mechanism ("spring"), F136). which is manufactured from Nitinol (ASTM F2063).
Non-Clinical Mechanical testing was presented to characterize construct and component performance, including testing static and fatigue compression bending and Performance Data: static torsion per recognized ASTM F1717, axial pullout screw strength per ASTM F543, and additional testing performed per internal protocols to assess screw pull through plate and screw retention characteristics. The test results of verification testing demonstrate that the mechanical performance of the Pioneer Poise Anterior Cervical Plate System is substantially equivalent to the predicate devices.
Comparisons of device performance data, materials, indications and Performance and design/function to predicate devices were provided in making a SE Determination: determination of substantial equivalence.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 4 2010
Pioneer Surgical Technology % Ms. Emily M. Downs 375 River Park Circle Marquette, Michigan 49855
Re: K100708
Trade/Device Name: Pioneer Poise Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 13, 2010 Received: April 14, 2010
Dear Ms. Downs:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 - Ms. Emily M. Downs
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Mark M. Mulkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K100708
-Device-Name:
Indications for Use:
The Pioneer Poise Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and
Pioneer-Poise Anterior Cervical Plate
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)
failed previous fusion.
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
K100708 510(k) Number_
§ 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.