(205 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 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 (T1-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, favored 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 Pioneer Quantum® Spinal Rod System using parallel connectors.
The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
This 510(k) summary for the "Pioneer Posterior Cervico-Thoracic System" is a medical device submission seeking clearance for market, not a study report demonstrating acceptance criteria with performance data. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.
The document primarily focuses on establishing substantial equivalence to previously approved predicate devices, a common pathway for 510(k) clearance, rather than presenting a detailed performance study against specific acceptance criteria.
Here's an analysis based on the provided text, highlighting what can and cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics for a performance study. The "acceptance criteria" for a 510(k) in this context is typically demonstrating substantial equivalence to predicate devices in terms of intended use, design, materials, and technological characteristics.
- Reported Device Performance: The document states "Testing per recognized ASTM standards was presented." However, it does not provide the specific results or performance values from these tests, nor does it define what values would constitute "acceptance." The performance is implicitly considered acceptable if it allows for a determination of substantial equivalence.
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance (Summary Only) | Details from Document |
|---|---|---|
| Similar Intended Use | Similar to predicate devices | Yes, detailed in "Intended Use" section. |
| Similar Design | Similar to predicate devices | Yes, implied by discussion of components (rods, hooks, screws, etc.). |
| Similar Materials | Medical grade titanium alloy and cobalt chromium, following ASTM standards | Yes, specified in "Description" and "Material" sections. |
| Similar Technological Characteristics | Similar to predicate devices | Yes, implied by the substantial equivalence argument. |
| Meets recognized ASTM standards for performance | Testing per recognized ASTM standards was presented | Yes, stated under "Performance Data," but no specific results are provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "Testing per recognized ASTM standards was presented," which implies mechanical or material testing, not human subject testing. The sample sizes for such engineering tests (e.g., fatigue, static strength) would be dictated by the specific ASTM standards followed, but these details are not provided.
- Data Provenance: Not applicable in the context of human data. For materials and mechanical testing, the data would originate from laboratory tests conducted by the manufacturer or a third-party lab. No information on country of origin is provided. The tests are prospective in nature (conducted for the submission), not retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This information pertains to studies involving clinical data, image interpretation, or diagnostic device performance where expert consensus is used to establish ground truth. This 510(k) summary is for a spinal implant system and does not contain such a study.
4. Adjudication Method for the Test Set
- Not applicable. See explanation for #3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No. This type of study (MRMC) is relevant for diagnostic devices where human readers interpret outputs (e.g., images) and AI assists in that interpretation. The Pioneer Posterior Cervico-Thoracic System is a surgical implant; therefore, an MRMC study is not relevant to its clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. Not applicable, as this is a physical medical device (spinal implant), not a software algorithm.
7. The Type of Ground Truth Used
- For the mechanical and material performance mentioned, the "ground truth" would be the engineering specifications and performance characteristics defined by the relevant ASTM standards. The device is tested against these standards to demonstrate compliance. There is no biological or diagnostic "ground truth" in this submission.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI algorithms requiring data for training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See explanation for #8.
In summary, the provided document is a 510(k) summary for a spinal implant, which establishes substantial equivalence based on physical and mechanical characteristics and intended use compared to legally marketed predicate devices. It references performance testing to recognized ASTM standards but does not provide specific performance data or detailed study designs that would align with the questions about acceptance criteria, clinical studies, or AI/ML evaluation.
§ 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.