(172 days)
The Pioneer Posterior Cervico-Thoracic System is indicated to promote fusion of the cervico- thoracic regions of the spine (C1-T3). The intended indications are as follows:
- Degenerative Disc Disease (as defined by neck or back pain of discogenic origin ー with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis -
- -Spinal Stenosis
- Fracture/ Dislocation -
- -Deformities or Curvature
- -Tumors
- -Pseudoarthrosis
- -Revision of previous cervical and upper thoracic spine surgery
The use of the screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. The screws are not intended for use in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
The Pioneer Posterior Cervico-Thoracic System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, and connecting components used to build a cervico-thoracic spinal construct.
The Pioneer Posterior Cervico-Thoracic System components are manufactured from medical grade titanium alloy and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together.
The Pioneer Posterior Cervico-Thoracic System can be attached to FDA approved pedicle screw systems (e.g. Quantum® Spinal Fixation System or Streamline TL Spinal System) using parallel connectors.
The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes a 510(k) submission for a medical device called the Pioneer Posterior Cervico-Thoracic System. This type of submission is for establishing substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria related to a diagnostic output or outcome.
Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device (e.g., sensitivity, specificity, AUC) does not directly apply to this 510(k) submission.
Instead, the "acceptance criteria" here revolve around demonstrating substantial equivalence to a predicate device. The "study" proving this involves mechanical testing and comparison of intended use, materials, and design.
Here's how to frame the information based on the provided document:
Acceptance Criteria and Evidence for Substantial Equivalence (for a 510(k) Submission)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Pioneer Posterior Cervico-Thoracic System Performance |
|---|---|---|
| Intended Use | Must be similar to the predicate device. | "Equivalency of this device is based on similarities in intended use... to other currently marketed posterior cervico-thoracic systems." |
| Materials | Must be similar to or equivalent to the predicate device. | Manufactured from medical grade titanium alloy and medical grade cobalt chromium, which "may be used together." Implied to be similar/equivalent to predicate. |
| Design | Must be similar to the predicate device. | "Equivalency of this device is based on similarities in... design to other currently marketed posterior cervico-thoracic systems." Consists of rods, hooks, polyaxial screws, high-angle screws, locking caps, and connecting components. |
| Mechanical Properties | Must demonstrate comparable mechanical properties to the predicate device. | "Mechanical testing demonstrated comparable mechanical properties to the predicate device." |
| Safety and Effectiveness | Implied to be similar to legally marketed predicate device, relying on the established safety and effectiveness of the predicate. | Not explicitly stated as "performance results," but the conclusion of substantial equivalence implies acceptable safety and effectiveness based on predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: This refers to the mechanical test samples.
- Sample Size: Not explicitly stated in the document. The document mentions "Testing per recognized ASTM standards was presented (ASTM F 1717 Static and Fatigue, Compression and Torsional testing, ASTM F543 Screw Insertion and Screw Pullout testing)." ASTM standards usually specify sample sizes for such tests, but the specific number of units tested is not provided in this summary.
- Data Provenance: The provenance is from internal testing conducted by the manufacturer, Pioneer Surgical Technology. The document does not specify country of origin for the data beyond that. This is a pre-clinical (bench-top) study, not a clinical study involving patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. For a mechanical performance test establishing substantial equivalence for an orthopedic implant, "experts" in the sense of clinicians establishing ground truth (e.g., radiologist for imaging) are not used. The "ground truth" is typically defined by the test standard (e.g., ASTM F1717 specifies how fatigue testing should be conducted and what constitutes failure).
4. Adjudication Method for the Test Set
- Not Applicable. As this is mechanical testing to established standards, there is no adjudication process involving human interpretation of results in the way there would be for a clinical diagnostic study. The tests are designed to produce quantifiable, objective results against specified criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists interpreting images, assisted by AI). This 510(k) submission is for an orthopedic implant, where the primary evidence presented for substantial equivalence is mechanical testing and design/material comparison.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a surgical implant, not an algorithm or diagnostic tool. The performance evaluated is the physical mechanical integrity of the implant components.
7. The Type of Ground Truth Used
- For mechanical properties, the "ground truth" is defined by the recognized ASTM standards (ASTM F 1717 and ASTM F543) which dictate the testing methodology and acceptance criteria for mechanical performance (e.g., static and fatigue strength, screw insertion and pullout forces). The objective measurements obtained during these tests are compared against the expected performance based on the predicate device.
- For intended use, materials, and design, the "ground truth" is the characteristics of the predicate device.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of an orthopedic implant's 510(k) submission. This refers to data used to train AI models, which is irrelevant here.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.