(83 days)
The Pioneer Aspect 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 Aspect 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 system consists of static plates in lengths that range from 10-84mm and include one, two, three and four level designs. 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 fixed/variable self-tapping and self-drilling.
The provided text describes a 510(k) summary for the Pioneer Aspect Anterior Cervical Plate System. This is a medical device submission, and the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical testing performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study evaluating AI performance.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (How it compared to predicate) |
|---|---|
| Mechanical Performance: | |
| Static and Fatigue Compression Bending (per ASTM F1717) | "The test results of verification testing demonstrate that the mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is substantially equivalent to the predicate device." (Implies meeting or exceeding predicate's performance or falling within acceptable variations) |
| Static Torsion Testing (per ASTM F1717) | "The test results of verification testing demonstrate that the mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is substantially equivalent to the predicate device." |
| Axial Pullout Screw Strength (per ASTM F543) | "The test results of verification testing demonstrate that the mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is substantially equivalent to the predicate device." |
| Screw Pull Through / Retention Characteristics (internal protocols) | "The test results of verification testing demonstrate that the mechanical performance of the Pioneer Aspect Anterior Cervical Plate System is substantially equivalent to the predicate device." |
| Material Composition | Identical materials used for both subject and predicate plates and screws (Ti6Al4V ELI for plates/screws, Nitinol for screw-retention mechanism). |
| Dimensions | Available 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) are identical to predicate. |
| Indications for Use | Identical to those of the predicate Pioneer Poise system. |
| Principles of Operation | Employs the same principles of operation as the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the number of physical samples (devices or constructs) tested for each mechanical test. ASTM standards for medical device testing often specify minimum sample sizes, but these details are not provided in this summary.
- Data Provenance: The testing was "performed per recognized ASTM F1717, axial pullout screw strength per ASTM F543, and additional testing performed per internal protocols." This indicates the tests were conducted by the manufacturer, Pioneer Surgical Technology, following established scientific and engineering standards. The data is prospective, generated specifically for this submission. The country of origin of the data is implicitly the USA, where Pioneer Surgical Technology is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device. This is a submission for an implantable mechanical device, not an AI or diagnostic device that requires expert-established ground truth from clinical images or data. The "ground truth" for this device's performance is objective mechanical measurements against engineering standards and comparison to a predicate device.
4. Adjudication method for the test set
Not applicable. There's no "adjudication" in the sense of expert review of subjective data. The performance is objectively measured by mechanical testing.
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 device is an implantable surgical plate, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. "Standalone performance" for this device refers to its mechanical properties as a physical implant, which were evaluated.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Objective Mechanical Measurements: Data derived from standardized mechanical testing (ASTM F1717, ASTM F543, and internal protocols) providing quantitative performance metrics.
- Comparison to Predicate Device: The performance of the Pioneer Aspect Anterior Cervical Plate System was compared directly to that of the legally marketed predicate device (Pioneer Poise Anterior Cervical Plate System) to demonstrate substantial equivalence. The predicate device's established performance serves as a benchmark for equivalence.
- Material Specifications: Adherence to material standards (ASTM F136 for Ti6Al4V ELI, ASTM F2063 for Nitinol).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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K111528 Page 1 of $
| 3.0 | 510(k) Summary | |
|---|---|---|
| Sponsor: | Pioneer Surgical TechnologyAUG 2 4 2011375 River Park CircleMarquette, MI 49855(906) 225-5861Contact: Sarah McIntyreDate submitted: June 1, 2011 | |
| Device Name: | Pioneer Aspect Anterior Cervical Plate | |
| Classification Name: | The classification of the Pioneer Aspect Anterior Cervical Plate System is Class II, asper the Code of Federal Regulations, Title 21, Section 888.3060: Spinalintervertebral body fixation orthosis. | |
| Product Codes: | The product code is KWQ. The Panel code is 87. | |
| Predicate Device: | K100708 - Pioneer Poise Anterior Cervical Plate System (SE date 06/04/10) | |
| Description: | The Pioneer Aspect Anterior Cervical Plate System consists of an assortment ofplates and screws. The screws are used to secure the plates to the vertebral bodies ofthe cervical spine through an anterior approach. The system consists of static platesin lengths that range from 10-84mm and include one, two, three and four leveldesigns. The plates have an integrated screw retention mechanism. Screws rangefrom 10-20mm in length, 4.0 or 4.5mm in diameter, and are available infixed/variable self-tapping and self-drilling. | |
| Intended Use: | The Pioneer Aspect Anterior Cervical Plate System is intended for anterior cervicalfixation for the following indications: degenerative disc disease (DDD) (defined asneck pain of discogenic origin with degeneration of the disc confirmed by history andradiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinalstenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor,pseudoarthrosis, and failed previous fusion. | |
| Comparison to PredicateDevices: | The subject device has indications for use identical to those of the predicate PioneerPoise system and employs the same principles of operation. Identical materials areused for both subject and predicate plates and screws. Available screw lengths (10-20mm), screw diameters (4.0, 4.5mm), overall plate length (10-84mm), and platetypes (one, two, three and four level; static) are identical to predicate. | |
| Material: | The Pioneer Aspect Anterior Cervical Plate System plates and screws aremanufactured from titanium alloy (Ti6Al4V ELI, according to ASTM F136). Theplates incorporate a screw-retention mechanism ("spring"), which is manufacturedfrom Nitinol (ASTM F2063). | |
| Non-ClinicalPerformance Data: | Mechanical testing was presented to characterize construct and componentperformance, including static and fatigue compression bending and static torsiontesting per recognized ASTM F1717, axial pullout screw strength per ASTM F543,and additional testing performed per internal protocols to assess screw pull through /retention characteristics. The test results of verification testing demonstrate that themechanical performance of the Pioneer Aspect Anterior Cervical Plate System issubstantially equivalent to the predicate device. | |
| Performance and SEDetermination: | Comparisons of device performance data, materials, indications and design/functionto predicate devices were provided in making a determination of substantialequivalence. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology % Ms. Sarah McIntyre 375 River Park Circle Marquette, Michigan 49855
AUG 24 2011
Re: K111528
Trade/Device Name: Pioneer Aspect Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 22, 2011 Received: July 25, 2011
Dear Ms. McIntyre:
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
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Page 2 - Ms. Sarah McIntyre
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Wilkerson
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 2.0
| 510(k) Number (if known): | K111528 |
|---|---|
| Device Name: | Pioneer Aspect Anterior Cervical Plate |
| Indications for Use: | The Pioneer Aspect 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. |
| 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)
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(Division Sign-Off)_
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111528
§ 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.